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510(k) Data Aggregation
(98 days)
The UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.
The UltraShape Power System is comprised of multiple components, including the control unit and an ultrasonic transducer. The UltraShape Power System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
Here's a breakdown of the acceptance criteria and study information for the UltraShape Power System, based on the provided document:
Acceptance Criteria and Device Performance
| Criteria | Reported Device Performance |
|---|---|
| Primary Endpoint for Flanks Study: At least 80% of treated versus control flanks and pre-versus post-treatment photographs were correctly identified by 2 blinded reviewers. | Met Endpoint: Blinded reviewers (by agreement between the blinded reviewers) correctly identified both the pre-/post-treatment photographs as well as the treated/un-treated flanks in 80% (36 of 45) subjects. |
| Secondary Endpoints for Flanks Study: | |
| - Fat thickness reduction on the treated flank compared to the control flank, measured by ultrasound.** | Statistically Significant: Fat thickness reduction results following UltraShape treatment were statistically significantly greater compared to controls as measured by ultrasound. |
| - Fat thickness reduction on the treated flank compared to the control flank, measured by caliper. | Greater Reduction: Fat thickness reduction results following UltraShape treatment were greater compared to controls as measured by caliper (reaching statistical significance in absolute fat thickness reduction at 16 week follow up). |
| - Investigator satisfaction assessment. | Satisfied: Investigators were satisfied with results following UltraShape treatment for 70% of the subjects at 4 week follow up, 53% of the subjects at 8 week follow up, and 43% of the subjects at 16 week follow up. |
| - Subject satisfaction self-assessment. | Satisfied: At 4, 8, and 16 weeks following end of treatments, 43%, 47%, and 41% of the subjects were satisfied or very satisfied. |
| - Subjects' comfort level assessed immediately after each treatment. | No to Minimal Pain: Subjects reported no to minimal pain for each of the three treatments. |
| Safety Results for Flanks Study: No adverse events reported. | Met: No adverse events were reported after 141 treatment sessions were conducted. The only immediate responses recorded were mild and resolved completely within days without any intervention. |
| Primary Endpoint for Thighs Study: At least 80% of treated versus untreated thighs and pre-versus post-treatment photographs were correctly identified by 2 blinded reviewers. | Met Endpoint: Blinded reviewers (by agreement between the blinded reviewers) correctly identified both the pre-/post-treatment photographs as well as the treated/un-treated thighs in 81% (30 of 37) subjects. (Even with worst case imputation for missing data, 64% were successes). |
| Secondary Endpoints for Thighs Study: | |
| - Circumference reduction on treated thigh compared to control thigh. | Statistically Significant: UltraShape treated thighs showed statistically significantly greater circumference reduction compared to the control thighs at each follow up visit. |
| - Fat thickness reduction on the treated thigh compared to the control thigh, measured by ultrasound. | Statistically Significant: Fat thickness reduction results following UltraShape treatment were statistically significantly greater compared to controls as measured by ultrasound. |
| - Fat thickness reduction on the treated thigh compared to the control thigh, measured by caliper. | Greater Reduction: Fat thickness reduction results following UltraShape treatment were greater compared to controls as measured by caliper, although the difference was not statistically significant at all visits. |
| - Investigator satisfaction assessment. | Satisfied: Investigators were satisfied with results following UltraShape treatment for 77% of the subjects at 4 week follow up, 81% of the subjects at 8 week follow up, and 68% of the subjects at 16 week follow up. |
| - Subject satisfaction self-assessment. | Satisfied: At 4, 8 and 16 weeks following end of treatments, 62%, 61% and 68% of the subjects were satisfied or very satisfied. |
| - Subjects' comfort level assessed immediately after each treatment. | No to Minimal Pain: Subjects reported no to minimal pain on average for each of the three treatments. |
| Safety Results for Thighs Study: No adverse events reported. | Met: No adverse events were reported after 128 treatment sessions were conducted. The only immediate responses recorded were mild and resolved completely within days without any intervention. |
Study Information
The document describes two separate clinical studies, one for the flanks and one for the thighs.
1. Sample size used for the test set and the data provenance
- Flanks Study:
- Sample Size: 48 subjects enrolled and treated (46 completed the study).
- Data Provenance: Prospective, multi-center clinical study conducted at 3 U.S. sites.
- Test Set Description: Each subject received 3 biweekly treatments on one randomized flank, while the other flank remained un-treated throughout the study (serving as an internal control). Follow-up was at 4, 8, and 16 weeks after the last treatment. Comparisons were made between treated vs. control flanks and pre- vs. post-treatment.
- Thighs Study:
- Sample Size: 47 subjects enrolled.
- Data Provenance: Prospective, multi-center clinical study conducted at 3 U.S. sites.
- Test Set Description: Each subject received 3 biweekly treatments on one randomized thigh, while the other thigh remained un-treated (serving as an internal control). Follow-up was at 4, 8, and 16 weeks after the last treatment. Comparisons were made between treated vs. control thighs and pre- vs. post-treatment.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 2 blinded reviewers were used for both the flanks and thighs studies.
- Qualifications: The specific qualifications of the reviewers (e.g., dermatologists, plastic surgeons, years of experience) are not explicitly stated in the provided text. They are simply referred to as "blinded reviewers."
3. Adjudication method for the test set
- Adjudication Method: For both flanks and thighs studies, the primary endpoint was considered met if the reviewers "identified correctly (by agreement between the blinded reviewers)" the pre-/post-treatment and treated/un-treated images. This indicates that agreement between the two reviewers was required for a successful identification. This can be considered a form of "consensus" adjudication.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study involving AI assistance was NOT done. The studies described evaluate the device's efficacy in achieving fat reduction, with visual assessment by human reviewers as one endpoint. The device itself is for fat reduction, not for diagnostic assistance that would typically involve AI.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The UltraShape Power System is a medical device that delivers focused ultrasound energy for lipolysis. It is not an AI algorithm for diagnostic purposes. The evaluation is of the direct physical effect of the device on the body.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
-
For Efficacy (Fat Reduction):
- Visual Assessment: Expert consensus (agreement between 2 blinded reviewers) on identifying treated vs. control and pre- vs. post-treatment photographs.
- Objective Measurements: Pathology (not directly, but indirectly by measuring fat thickness reduction via ultrasound and caliper, which are objective clinical measurements representing the outcome of lipolysis).
- Outcomes Data: Investigator satisfaction, subject satisfaction, and comfort level self-assessments were also gathered as secondary outcomes.
-
For Safety: Clinical observation of adverse events and immediate responses.
7. The sample size for the training set
- Not applicable. The provided text describes clinical studies evaluating a physical medical device. It does not mention a "training set" in the context of an AI algorithm. The device's technological characteristics and settings (frequency, burst duration, node duration, user interface, power intensity levels, focal distribution) were "previously cleared" or "previously conducted" in relation to predicate devices, implying prior developmental testing and optimization, but not necessarily a "training set" in the machine learning sense.
8. How the ground truth for the training set was established
- Not applicable. As the concept of a "training set" for an AI algorithm is not relevant here, the establishment of ground truth for such a set is also not discussed. The clinical studies aim to demonstrate the device's effectiveness and safety, not to train an algorithm.
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(136 days)
The SlimShape System is indicated for non-invasive lipolysis (breakdown of fat) of the abdomen. The device is indicated for reduction in circumference of the abdomen.
The SlimShape System is comprised of a console and an applicator that delivers radiofrequency energy to the fat tissue and also applies mechanical vacuum to the treatment area. The SlimShape System is designed to enable hands-free abdominal treatment that is based on a predefined user protocol. The system also incorporates a skin temperature control mechanism as a safety feature during treatment. Users interface with and control the SlimShape System via the touch-screen panel.
Here's a breakdown of the acceptance criteria and study details for the SlimShape System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance |
|---|---|
| Primary: Statistically significant abdominal circumference and fat reduction post SlimShape treatment at the final follow-up compared to baseline, based on tape measurements and ultrasound imaging. | Primary: Met endpoint; Both the midline reduction in abdominal circumference and the reduction in abdominal fat layer were statistically significant at the final follow-up compared to baseline. Specifically: - Average of 1.98 ± 2.53 cm reduction in abdominal circumference - Average of 6.03 ± 3.09 mm reduction (-24.5% ± 11.3%) in fat thickness measured by ultrasound at 12 weeks follow-up compared to baseline. |
| Secondary: - Correct identification of the pre- and post-treatment photos as demonstrated in at least 70% or greater of treated subjects. - Abdominal circumference reduction at each visit, based on tape measurements. - Abdominal fat reduction at each visit, measured by Ultrasound. - Subject's self-assessment for satisfaction and recommendation. - Subject satisfaction self-assessment. - Subject's discomfort (pain) level after each treatment. | Secondary: - The blinded reviewers assessed correctly 86% of the photographs. - The amount of circumference reduction was statistically significant compared to baseline at each visit, as well as at the upper and lower abdomen. - The majority of the subjects were satisfied (53% at treatment 3, 62% at 4 week follow up, 59% at 8 week follow up and 59% at 12 week follow up). - Most of the subjects reported they will recommend this procedure (75%, 76%, 76% and 77% reported they recommended at treatment 3, 4, 8 and 12 weeks follow up, respectively). - Most subjects (91%) reported none to moderate pain for each treatment. |
| Safety: No serious or unanticipated adverse events. | Safety: There were no reports of serious or unanticipated adverse events, with 8 mild adverse events after 144 treatments. No subjects discontinued from the study due to adverse events. The immediate responses included erythema and edema, which resolved completely within several hours without any intervention. Histology data from a separate study of 11 healthy subjects also confirmed safety, showing discrete areas of fat necrosis solely within subcutaneous tissue, with intact dermal and epidermal layers and no adverse skin events. |
2. Sample size used for the test set and the data provenance
- Sample Size: 52 subjects were enrolled and treated in the primary clinical study.
- Data Provenance: The study was a prospective, single-arm, self-controlled, single-site clinical study. The country of origin for the data is not explicitly stated, but the submission is from Syneron Medical Ltd. in Israel, suggesting the study might have been conducted there or internationally under their purview.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 2 blinded reviewers.
- Qualifications of Experts: Not specified in the provided text. They are only described as "blinded reviewers" for visual assessment of photographs.
4. Adjudication method for the test set
- Adjudication Method: Not explicitly stated as a formal adjudication method like "2+1" or "3+1." For the visual assessment of pre- and post-treatment photographs, it mentions "visual assessment of the before and after photographs by 2 blinded reviewers." It doesn't detail how discrepancies between the two reviewers were handled, if any.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not explicitly done. The study's focus was on the performance of the SlimShape device itself, not comparing human reader performance with and without AI assistance. The "blinded reviewers" assessed photographs, but it was to validate the device's effect, not to evaluate human reader improvement with an AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this device is not an AI/algorithm-only device. The SlimShape System is a physical device that delivers radiofrequency energy and vacuum. Its performance is measured directly by its effects on subjects, not as a standalone algorithm. The "software verification and validation" mentioned is for the device's control software, not a diagnostic algorithm.
7. The type of ground truth used
- Ground Truth: A combination of objective measurements and expert assessment:
- Objective Measurements: Tape measurements for abdominal circumference and ultrasound imaging for fat thickness reduction are primary objective ground truths.
- Expert Assessment: Blinded reviewers' assessment of pre- and post-treatment photographs contributed to a secondary effectiveness endpoint.
- Patient Reported Outcomes: Subject satisfaction, recommendation, and pain levels served as additional self-reported ground truth.
- Histology data: From a separate study, histology confirmed the safety profile by demonstrating fat necrosis without epidermal/dermal damage.
8. The sample size for the training set
- The document describes a single clinical study involving 52 subjects, which appears to be the primary study for performance evaluation. It does not explicitly mention a separate "training set" for an AI algorithm. If this refers to the data used to develop the device's operational parameters (e.g., specific RF settings, vacuum levels), that information is not detailed here. The focus is on the clinical validation of the final device.
9. How the ground truth for the training set was established
- Given that this document describes the validation of a physical medical device (SlimShape System) rather than an AI/ML algorithm, the concept of a "training set" for ground truth as typically understood in AI is not directly applicable. The device's operating parameters would have been developed through engineering, bench testing, and potentially earlier pilot studies or design validation, rather than explicitly "training" an algorithm against a ground truth dataset in the same way an AI model is trained. The document focuses on the validation of the device against clinical outcomes.
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(115 days)
The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and for use on the flanks.
The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducers are electro-mechanical devices that convert an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle. The UltraShape System has two treatment modes available, the Single Focus Deep Mode and the Super Mode.
The Synergy UltraShape System, a focused ultrasound stimulator for aesthetic use, was evaluated for safety and effectiveness in non-invasive lipolysis of the flanks. The device delivers focused ultrasound energy to disrupt subcutaneous adipose tissue (SAT) for fat breakdown.
Here's a breakdown of the acceptance criteria and the study proving it meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Primary Endpoint) | Reported Device Performance | Met? |
|---|---|---|
| Fat reduction in flanks evaluated by visual assessment of randomized photographs of before (baseline) versus after (16 weeks following last treatment), as well as treated versus control flanks, by 2 blinded reviewers. | Primary: Met endpoint; blinded reviewers identified correctly (by agreement between the blinded reviewers) both the pre-/post-treatment photographs as well as the treated/un-treated flanks in 80% (36 of 45) subjects. (Sensitivity analysis: If one subject with poor photo quality, for whom fat reduction was observed, was imputed as a failure, the success rate would be 78%, which would not meet the 80% threshold. However, this subject was excluded from the primary endpoint assessment due to photograph quality, and the presented result is based on 45 subjects.) | Yes |
| Secondary Effectiveness Endpoints: | Secondary: | |
| * Fat thickness reduction on the treated flank compared to the control flank, measured by ultrasound. | * Fat thickness reduction results following UltraShape treatment were statistically significantly greater compared to controls as measured by ultrasound. | Yes |
| * Fat thickness reduction on the treated flank compared to the control flank, measured by caliper. | * Fat thickness reduction results following UltraShape treatment were greater compared to controls as measured by caliper (reaching statistical significance in absolute fat thickness reduction at 16 week follow up). | Yes |
| * Investigator satisfaction assessment. | * Investigators were satisfied with results following UltraShape treatment for 70% of the subjects at 4 week follow up, 53% of the subjects at 8 week follow up, and 43% of the subjects at 16 week follow up. | N/A |
| * Subject satisfaction self-assessment. | * At 4, 8 and 16 weeks following end of treatments, 43%, 47%, and 41% of the subjects were satisfied or very satisfied. | N/A |
| * Subjects' comfort level assessed immediately after each treatment. | * Subjects reported no to minimal pain for each of the three treatments. | N/A |
| Safety Results: No reported adverse events and anticipated immediate responses (mild erythema, edema) resolved completely within days without intervention. | No adverse events were reported after 141 treatment sessions. The only immediate responses recorded were mild and resolved completely within days without any intervention. | Yes |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 48 subjects were enrolled and treated in the study, with 46 subjects completing the study. The primary endpoint assessment was based on 45 subjects due to the poor quality of one post-treatment photograph.
- Data Provenance: The study was a prospective, single-arm, self-controlled, multicenter clinical study conducted at 3 U.S. sites. The data is thus prospective and from the U.S.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 2 blinded reviewers.
- Qualifications: The document does not explicitly state the specific qualifications (e.g., radiologist, years of experience) of the blinded reviewers. It only specifies that they were "blinded reviewers."
4. Adjudication Method for the Test Set
- The primary endpoint was met "by agreement between the blinded reviewers." This implies a consensus-based adjudication, specifically that both reviewers had to agree on the correct identification of pre/post-treatment and treated/untreated flanks.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated as being performed to evaluate human reader improvement with or without AI assistance. This study focused on the device's efficacy in achieving fat reduction through visual assessment and physical measurements, not the performance of human readers assisted by AI.
6. Standalone (Algorithm Only) Performance
- This study did not focus on standalone algorithm performance. The UltraShape System is a device for physical treatment and relies on visual and measurement assessments by human observers (investigators, subjects, blinded reviewers) and physical measurement tools (ultrasound, caliper) to determine its effectiveness. While the device has software components for control and guidance, the performance evaluation is for the device's physical effect on the body, not a diagnostic algorithm.
7. Type of Ground Truth Used
- The ground truth for the primary endpoint was established by expert consensus (agreement between 2 blinded reviewers) on photographic assessments.
- For secondary endpoints, objective measurements (ultrasound, caliper) were used to quantify fat thickness reduction, and subjective assessments (investigator and subject satisfaction, comfort level) were collected.
8. Sample Size for the Training Set
- The document refers to "several separate prospective studies" for clinical evaluation and states that nonclinical performance testing was "previously conducted" and "In vivo testing in an animal model was performed." However, it does not explicitly state a separate "training set" for the UltraShape System's clinical evaluation in the context of this 510(k) submission. The clinical data presented here is the definitive study for the device's substantial equivalence to the predicate. The UltraShape System itself is a physical device, and its "training" might refer to development phases or prior versions, but not a dataset for an AI algorithm in the way it's typically understood. The presented clinical study is the test set for this specific submission's claims.
9. How the Ground Truth for the Training Set Was Established
- As noted above, a distinct "training set" for the clinical effectiveness of this specific device version isn't detailed in the same manner as an AI algorithm's training data. The device's development and prior clearances (K141708, K133238, K160896) would have involved extensive R&D and testing, where engineers and clinicians established desired performance characteristics. The nonclinical testing (biocompatibility, beam profile, acoustic power, thermal measurements, software verification, electrical safety, in vivo animal testing) described in the document served to validate the device's core functionality and safety prior to humanitarian clinical trials. The "ground truth" for these aspects would be derived from laboratory measurements, adherence to standards, and observation of physical effects.
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(89 days)
The CO2RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including; aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee),
The CO-RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Standard Handpiece of the COJRE System is indicated for the following:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- laser skin resurfacing .
- laser dermabrasion
- . laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
wrinkles, rhytids, and furrows (including fines and texture irregularities) . Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, . seborrheic wart, and verruca seborrheica;
- . vermillionectomy of the lip;
- cutaneous horns;
- solar/actinic elastosis; ●
- chelitis, including actinic chelitis; ●
- lentigines, including lentigo maligna or Hutchinson's malignant freckle
- uneven pigmentation/ dyschromia;
- acne scars;
- surgical scars: ●
- keloids including acne keloidalis nuchae;
- . hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum);
- . tattoos;
- telangiectasia;
- removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
- superficial pigmented lesions: .
- adenosebaceous hypertrophy or sebaceous hyperplasia; .
- . rhinophyma reduction;
- cutaneous papilloma (skin tags):
- milia:
- . debridement of eczematous or infected skin;
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
- nevi, including spider, epidermal and protruding;
- neurofibromas:
- laser de-epithelialization: .
- tricoepitheliomas;
- xanthelasma palpebrarum; ●
- . svringoma
Laser ablation, vaporization and for excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions; .
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.
Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
. verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
- . fungal nail treatment;
- porokeratoma ablation:
- ● ingrown nail treatment;
- neuromas/fibromas, including Morton's neuroma: ●
- debridement of ulcers;
- other soft tissue lesions. .
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
● leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue;
- nasal obstruction: ●
- adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages; ●
- lymphangioma removal; ●
. removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tonque and vocal cords;
● superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease; - rhinophvma:
- verrucae vulgares (warts);
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
. conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- . leukoplakia (vulvar dystrophies);
- herpes vaporization; ●
- urethral caruncle vaporization; ●
- . cervical dysplasia:
- benign and malignant tumors; ●
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- treatment of ulcerous lesions, including aphthous ulcers; ●
- excision and ablation of benign and malignant lesions; ●
- leukoplakia;
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia; ●
- condyloma:
- erythroplasia ●
The Fractional Handpiece of the CO2RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Surgical Handpiece of the CO2RE System is indicated for the following:
Dermatology & Plastic Surgery
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- . vermillionectomy of the lip;
- cutaneous horns:
- removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
- . rhinophyma reduction;
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease . (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions:
- . neurofibromas:
Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions; .
- . Moh's Surgery;
- Lipectomy; .
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and ● subunqual warts.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.
Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
- . verrucae vulgares/plantar (warts), including paronychial, periungal, and subunqual warts:
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- choanal atresia,
- nasal obstruction:
- adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages;
- lymphangioma removal; ●
- removal of vocal cord/fold nodules, polyps and cysts;
- . removal of recurrent papillomas in the oral cavity, nasal cavity, larynx,
pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
. laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-● assisted esophaqodivertuculostomy (ELAED)]; - stenosis, including subglottic stenosis;
● tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; - pulmonary bronchial and tracheal lesion removal;
benign and malignant nodules, tumors and fibromas (larynx, pharynx, ● trachea, tracheobronchial/endobronchial); - benign and malignant lesions and fibromas (nose and nasal passages);
- benign and malignant tumors and fibromas (oral);
- stapedotomy/stapedectomy:
- acoustic neuroma in the ear;
. superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
telangiectasia/hemangioma of larynx, pharynx and trachea (includes ● uvula, palatal or upper lateral pharyngeal tissue);
cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal ● fold motion impairment), and cordal lesions of larynx, pharynx and trachea; - myringotomy/tympanostomy (tympanic membrane fenestration);
- uvulopalatoplasty (LAUP, laser UPPP);
- turbinectomy and turbinate reduction/ablation;
- septal spur ablation/reduction and septoplasty; ●
- partial glossectomy;
- tumor resection on oral, subfacial and neck tissues;
- rhinophyma:
- verrucae vulgares (warts); ●
- gingivoplasty/gingivoctomy.
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
conization of the cervix, including cervical intraepithelial neoplasia (CIN), ● vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- . incision and drainage (I&D) of Bartholin's and nubuthian cysts;
- benign and malignant tumors;
- hemangiomas.
GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
- endometrial lesions, including ablation of endometriosis; ●
- excision/lysis of adhesions; ●
- salpingostomy
- oophorectomy/ovariectomy: ●
- fimbrioplasty;
- metroplasty;
- microsurgery (tubal);
- uterine myomas and fibroids;
- ovarian fibromas and follicle cysts: ●
- uterosacral ligament ablation;
- hysterectomy.
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
- posterior fossa tumors;
- peripheral neurectomy; ●
- benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including ● basal tumors), acoustic neuromas, lipomas and large tumors);
- arteriovenous malformation;
- pituitary gland tumors (transphenoidal approach). .
Spinal Cord
incision/excision and vaporization of benign and malignant tumors and ● cysts:
- intra- and extradural lesions;
- laminectomy/ laminotomy/ microdiscectomy. ●
Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy .
- menisectomy;
- chondromalacia;
- . chondroplasty:
- ligament release (lateral and other);
- excision of plica; ●
- partial synovectomy.
General
- debridement of traumatic wounds; ●
- debridement of decubitus and diabetic ulcers; ●
- microsurgery;
- artificial joint revision; ●
- PMMA removal.
General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- debridement of decubitus ulcers, stasis, diabetic and other ulcers; ●
- mastectomy;
- debridement of bums;
- rectal and anal hemorrhoidectomy;
- breast biopsy;
- reduction mammoplasty;
- cytoreduction for metastatic disease;
- . laparotomy and laparoscopic applications;
- mediastinal and thoracic lesions and abnormalities: ●
- skin tag vaporization;
- atheroma:
- cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
- pilonidal cyst removal and repair;
- abscesses;
- other soft tissue applications.
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- gingivectomy- removal of hyperplasias;
- . qinqivoplasty:
- incisional and excisional biopsy;
- incision of infection when used with antibiotic therapy; ●
- frenectomy (frenum release);
- excision and ablation of benign and malignant lesions: ●
- homeostasis;
- operculectomy;
- crown lengthening:
- removal of soft tissue, cysts and tumors;
- . oral cavity tumors and hemangiomas:
- abscesses:
- extraction site hemostasis;
- salivary gland pathologies;
- preprosthetic gum preparation; ●
- . partial glossectomy;
- periodontal gum resection.
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia; ●
- condyloma; ●
- Phimosis:
- Erythroplasia.
The Syneron CO2RE is a computer controlled radio-frequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The Syneron CO>RE is comprised of multiple components, including the control unit and three handpieces (standard, fractional and surgical). Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.
The provided document is a 510(k) Premarket Notification from the FDA for the Syneron CO2RE Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics in the typical sense of a diagnostic or AI-driven device.
Therefore, many of the requested elements (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory submission. This document describes the device's intended uses, technological characteristics, and results of various safety and performance tests, but not a study of its clinical diagnostic performance against specific acceptance criteria with quantifiable metrics.
Here's an attempt to answer the questions based only on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria with corresponding performance metrics in a quantifiable sense (e.g., sensitivity, specificity, accuracy) as would be expected for a diagnostic or AI device. Instead, it states that the device "performs as intended" based on various tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification & Validation | Software version is appropriate for release. |
| Electrical Safety & Electromagnetic Compatibility | Passed applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22). |
| Biocompatibility | Biocompatibility of patient-contacting components established per FDA guidelines. |
| Sterilization | Sterilization parameters validated. |
| Performance Data | Histological analysis performed to evaluate device effects across a range of treatment parameters. Device performs as intended. |
| Substantial Equivalence | Has the same intended use and similar indications, technological characteristics, and principles of operation as predicate devices. Technological differences do not raise new safety/effectiveness questions, and performance testing showed the device performs as intended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "histological analysis" but does not specify the sample size, data provenance, or whether it was a test set in the context of a statistical study to meet performance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes a laser system intended for surgical and dermatological applications, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document and is not applicable to the type of device and testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document and is not applicable. The device is a surgical laser system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document and is not applicable. The device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance data, the document mentions "Histological analysis has been performed to evaluate the device effects across a range of treatment parameters." Histological analysis generally refers to the examination of tissue samples under a microscope, which would serve as a form of pathological ground truth for evaluating the effects of the laser on tissue. No other type of ground truth is explicitly mentioned for clinical effectiveness.
8. The sample size for the training set
This information is not provided in the document. The device is a physical laser system, not an AI algorithm that typically requires a training set.
9. How the ground truth for the training set was established
This information is not provided in the document, as it's not relevant for this type of device.
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(185 days)
The eTwo Skin Treatment System is intended for dermatological procedures.
The Sublative RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62 mJ/pin, the Sublative RF applicator is limited to skin types I-IV.
The Sublime applicator is indicated for non-invasive wrinkles treatment. At higher energy levels greater than 100 J/cm², the Sublime applicator is limited to skin types I-IV.
The eTwo Skin Treatment System is a mobile system combining two existing technologies and applications for dermatological procedures.
The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface via an array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots of skin to temperatures that result in ablation and resurfacing of the skin that comes in contact with the multi-electrode pins.
The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.
The document provided is a 510(k) summary for the Syneron Medical Ltd.'s eTwo Skin Treatment System. It describes the device, its intended use, and provides evidence to support its substantial equivalence to predicate devices. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|---|
| Effectiveness (Wrinkle Reduction) | Reduction in wrinkles in treated areas at 12 weeks following last treatment session compared to baseline, based on photographic assessments by three independent blinded evaluators using the Fitzpatrick Wrinkle and Elastosis Scale. Goal: 50% of subjects to show improvement. | 71% of study subjects achieved wrinkle reduction under the proposed parameters. |
| Safety | Favorable safety profile (occurrence of device-related adverse events). Low incidence of severe adverse events and no subjects discontinuing due to adverse events. | 6.9% (5/72 subjects) experienced device-related adverse events, all mild to moderate and resolved. No serious adverse events or discontinuations due to adverse events. |
| Investigator Assessment | (Implicit: Improvement in facial appearance) | 77% of subjects rated as improved from baseline (at least 1 unit improvement in Fitzpatrick Scale). 91% showed overall improvement in facial appearance. |
| Patient Satisfaction | (Implicit: High level of satisfaction) | ≥63% of subjects reported being satisfied or very satisfied with treatment throughout follow-up. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study): 72 subjects
- Data Provenance: Prospective multi-center clinical study. The document does not specify the country of origin, but Syneron Medical Ltd. is based in Israel and the FDA review is for the US market, suggesting a multinational or US-focused study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Three independent blinded evaluators.
- Qualifications: The document does not explicitly state the qualifications of these evaluators (e.g., "radiologist with 10 years of experience"). It only identifies them as "independent blinded evaluators."
4. Adjudication Method for the Test Set
- The document states that the primary endpoint was based on "photographic assessments by three independent blinded evaluators." It implies a consensus or majority read, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done. This study evaluated the performance of the device itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This is not an AI/algorithm-only device. The eTwo Skin Treatment System is a medical device (electrosurgical device) operated by a human, so a "standalone" algorithm-only performance study is not applicable in this context. The clinical study assessed the device's performance when used by clinicians.
7. Type of Ground Truth Used
- The ground truth for the primary effectiveness endpoint was established through expert consensus/assessment (three independent blinded evaluators using the Fitzpatrick Wrinkle and Elastosis Scale based on photographic assessments).
- Additional assessments included investigator observations and subject self-reported satisfaction.
- Safety data was based on observed adverse events.
8. Sample Size for the Training Set
- This document describes a clinical study for the eTwo Skin Treatment System, which is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the typical sense for model development. The 72 subjects were for the clinical evaluation of the device's performance, not for training a software model.
- Software verification and validation were performed for minor software changes, but no training set for an AI algorithm is mentioned or relevant here.
9. How the Ground Truth for the Training Set Was Established
- As stated above, there is no mention of an AI algorithm or a training set in the context of this device's evaluation. Therefore, this question is not applicable based on the provided text.
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(104 days)
The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
The purpose of this submission is to increase acoustic intensity and to add an additional smaller ultrasound transducer.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Syneron UltraShape System
Intended Use: The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" with numerical thresholds in a table format. However, it describes the effectiveness (circumference reduction) and safety outcomes that demonstrate the device's performance met the requirements for substantial equivalence.
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance (Effectiveness) | Reported Device Performance (Safety) |
|---|---|---|
| Effectiveness: | ||
| Non-invasive reduction in abdominal circumference | Average -2.37 cm circumference reduction at the midline (at final follow-up, 12 weeks after last treatment). | Not applicable for effectiveness. |
| Maintain effectiveness in weight-stable subjects | Midline circumference reduction results in weight-stable subjects (-2.18 cm) were very similar to the overall population. | Not applicable for effectiveness. |
| Patient satisfaction | The majority of subjects in the UltraShape studies reported overall satisfaction with treatment. | Not applicable for effectiveness. |
| Safety: | Not applicable for safety. | Maintained safety profile through long-term follow-up. Only events were mild to moderate in severity and resolved within a few hours or days. No device-related serious adverse events. In a separate safety study, only one minor event occurred, from which the patient completely recovered without intervention. Subjects reported minimal discomfort. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Effectiveness & Safety Studies): 102 enrolled subjects (across "two, separate, prospective, single arm studies").
- Sample Size (Additional Safety Study): 21 patients.
- Data Provenance: The document does not explicitly state the country of origin of the data. The submitter, Syneron Medical Ltd., is located in Yokneam Illit, Israel. The studies were prospective clinical evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not specify the number of experts used to establish a "ground truth" for the test set or their qualifications. The study primarily evaluated objective measurements (circumference reduction, weight) and patient-reported outcomes (satisfaction, adverse events) rather than expert interpretation of images or other data requiring "ground truth" consensus in the typical sense.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given the primary endpoints were objective measurements (circumference reduction) and patient-reported outcomes (satisfaction, adverse events), an adjudication process like "2+1" or "3+1" (common for expert interpretation of medical images) would not be directly applicable. Adverse events were likely reported and categorized by the clinical investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The studies were "single arm studies" and focused on the performance of the UltraShape device itself, not on comparing it to human reader performance or assessing human reader improvement with AI assistance. The device is a direct treatment modality, not an AI diagnostic aid for human interpretation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the clinical studies described evaluate the standalone performance of the UltraShape System as a treatment device. This device is not an algorithm for diagnosis or interpretation that would typically involve a "human-in-the-loop" for performance evaluation. Its efficacy is measured directly by its effect on abdominal circumference and its safety profile.
7. The Type of Ground Truth Used
The "ground truth" for effectiveness was based on objective anatomical measurements (abdominal circumference reduction) and patient-reported outcomes data (satisfaction, discomfort). For safety, it was based on adverse event reporting and assessment.
It was not based on expert consensus, pathology, or direct "ground truth" in the diagnostic sense.
8. The Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This is because the UltraShape System is a physical medical device that delivers focused ultrasound energy, not an AI/ML algorithm that requires a training dataset in the conventional sense. The "training" for such devices involves rigorous engineering, design, and internal testing before clinical studies.
9. How the Ground Truth for the Training Set Was Established
As stated above, this device is not an AI/ML algorithm that relies on a "training set" with ground truth in the typical fashion of machine learning. Therefore, the concept of establishing ground truth for a training set is not applicable to this device. Any "ground truth" for its development would be engineering specifications, physical principles, and non-clinical testing results (e.g., beam profile, acoustic power, in vitro and in vivo animal studies).
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(514 days)
The Transcend is indicated for temporary reduction in circumference of the abdomen.
The Syneron Transcend is an optical energy in the Infra Red range and a radio frequency of 1 MHz powered system. The device consists of a console and two applicators that deliver electromagnetic energy (IR light and Radio Frequency) and vacuum to treated tissue for the temporary reduction in circumference of the abdomen. The Transcend console includes a control panel, power supply modules, vacuum pump, main Digital Signal Processor, umbilical cable and an adaptor- for connecting the two available applicators, two applicators and two LCD touch-screens.
The Syneron Transcend System is indicated for the temporary reduction in circumference of the abdomen.
Here's an analysis of the provided information regarding its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Temporary reduction in circumference of the abdomen | Satisfied: Clinical study data "demonstrated significant reduction in waist circumference." |
| Safety Profile | Satisfied: "No serious adverse events related to the treatment were reported." Also, lab tests for electromagnetic compatibility, electrical safety, and biocompatibility indicated performance "according to specifications and functions as intended." |
| Efficacy | Satisfied: The clinical study "demonstrated significant reduction in waist circumference." This efficacy was evaluated at 1 week, 1 month, and 3 months post-treatment. |
| Compliance with specifications | Satisfied: Lab tests indicated the device "performs according to specifications and functions as intended." The device also "fulfills the requirements for safety and efficacy." |
| Substantial Equivalence | Satisfied: The device was deemed substantially equivalent to predicate devices (Syneron VelaShape system (K071872) and Alma Lasers Accent UniForm Massager Handpiece (K082622)) based on similar indications, technological characteristics, and principles of operation. Performance data showed differences did not adversely impact performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "over 100 subjects"
- Data Provenance: The study was a "prospective, multicenter" study. While the specific countries are not mentioned for the primary study described, it's clear it was a clinical study. The document also states "Additional data from clinical experience outside the United States further supports the performance of the Transcend for the intended use," suggesting international data might have been considered supplementary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. The efficacy was evaluated based on "change in abdomen circumference from baseline to post treatment," which is an objective measurement rather than a subjective assessment requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an aesthetic/medical treatment device (laser/RF system for circumference reduction), not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The "device" in this context is a physical medical system (hardware and associated technology) that requires human operation for treatment. The performance evaluated was of the device's effect on human subjects, not an algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used
The ground truth used was objective physical measurement: "change in abdomen circumference from baseline to post treatment." This is a quantifiable outcome measure.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of clinical studies for efficacy. The terminology "training set" typically applies to machine learning algorithms. The clinical studies described are for evaluating the performance of the medical device itself.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of clinical efficacy evaluation, the method for establishing its ground truth is not applicable.
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(134 days)
The me is an over-the counter device intended for the removal of unwanted hair.
The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm2), like other OTC devices for hair removal. It also uses low RF energy (output 0.4-0.8 J/cm2) delivered through the RF electrodes. The RF signal serves primarily as a safety means to ensure skin contact before the IPL pulse is emitted.
The provided text describes the "me" device, an over-the-counter light-based hair removal system. However, it does not provide specific, quantifiable acceptance criteria or a detailed study meeting those criteria in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study against predefined numerical targets.
Based on the provided information, here's what can be extracted and what is missing:
Description of Acceptance Criteria and Performance Study for the "me" Device
The provided 510(k) summary for Syneron Medical Ltd.'s "me" device details various tests conducted to support its substantial equivalence, including clinical studies for safety and efficacy. However, it does not explicitly define quantifiable acceptance criteria (e.g., "device must achieve X% hair reduction") or present a study that directly proves the device meets such criteria as a standalone performance benchmark. Instead, the clinical studies aim to demonstrate effective use, safety, and label comprehension, which are then used to support substantial equivalence.
Therefore, the table below reflects what was reported from the clinical studies rather than a direct comparison against pre-defined numerical acceptance criteria.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (from Clinical Studies) |
|---|---|
| Efficacy: Not explicitly quantified with a numerical target. Implied: "effective use of the device" for hair removal. | "Significant hair clearance was achieved for all skin types groups (skin type I-VI), even without the monthly maintenance treatments." |
| Safety: Not explicitly quantified with a numerical target. Implied: Device must be safe under intended and overuse conditions. | No adverse events observed even under overuse conditions (simulated frequent use). |
| Label Comprehension & Usability: Not explicitly quantified with a numerical target. Implied: Consumers must be able to understand instructions and use the device safely. | "Confirmed adequate label comprehension and correct device use in an OTC environment." |
-
Sample Size Used for the Test Set and Data Provenance:
- Efficacy and Safety Study (Intended Use):
- Sample Size: 87 patients
- Provenance: "multi-center (4 sites)" - specific country of origin not stated, but implied to be within settings relevant to an OTC device. This was a prospective clinical study.
- Dedicated Study (Overuse Safety):
- Sample Size: 37 patients
- Provenance: Not explicitly stated, but also a clinical study. Implied to be prospective.
- Label Comprehension Study:
- Sample Size: 63 participants
- Provenance: Not explicitly stated. Implied to be prospective.
- Usability Testing:
- Sample Size: 46 subjects
- Provenance: Not explicitly stated. Implied to be prospective.
- Efficacy and Safety Study (Intended Use):
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number or qualifications of experts used to establish "ground truth" for the hair removal efficacy assessment. It only states that the study "evaluated the efficacy...". It is implied that clinicians or researchers involved in the multi-center study would have performed these assessments, but their specific roles or qualifications are not detailed.
-
Adjudication Method for the Test Set:
- The document does not provide any information regarding an adjudication method (e.g., 2+1, 3+1, none) used for assessing the clinical outcomes.
-
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This question is not applicable to the "me" device. The "me" is a physical hair removal device, not an AI-assisted diagnostic or imaging tool involving human readers. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation as described.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The "me" device is a user-operated physical device, not an algorithm. Its "standalone performance" would be its direct effect on hair reduction when used by a human, as evaluated in the clinical efficacy study.
-
The Type of Ground Truth Used:
- For the efficacy study, the ground truth for hair reduction would have been based on clinical assessment/measurement of hair clearance. The specific method of measurement (e.g., hair counts, photographic assessment by experts, patient self-assessment) is not detailed in the summary.
- For safety, the ground truth was based on the absence of adverse events as observed by clinicians/researchers during the studies.
- For label comprehension and usability, the ground truth was based on participant responses to questions and observations of their device usage.
-
The Sample Size for the Training Set:
- The document does not mention a "training set" in the context of device development or clinical evaluation. This concept is typically relevant for machine learning algorithms, which are not described as part of the "me" device.
-
How the Ground Truth for the Training Set Was Established:
- As there is no mention of a "training set" in the provided document, this question is not applicable.
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(21 days)
The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
The VelaShape treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.
The provided document describes a 510(k) summary for the Syneron Medical Ltd's VelaShape System, specifically concerning a modification to its infrared (IR) light source. This is a special 510(k) submission, meaning it's for a modification to a previously cleared device (VelaShape K071872).
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., specific reductions in cellulite or circumference, pain relief scores, etc.). This submission is for a hardware modification, not a new device or a new clinical claim.
The performance data provided focuses on the technical aspects of the modification.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance of new light source compatible with previously cleared specifications (Technical) | "Verification testing was performed to evaluate this modification to ensure the performance of the new light source is compatible with the previously cleared specifications." "Performance testing demonstrates that the VelaShape system performs according to specifications and functions as intended." |
| No new issues of safety or effectiveness (Clinical/Safety) | "The modification of the IR light source to LED raises no new issues of safety or effectiveness." |
| Does not affect indications for use | "The change of the IR light source... does not affect the indications for use..." |
| Does not alter fundamental scientific technology background | "...nor does it alter the fundamental scientific technology background of the device..." |
| Does not affect mode of use | "...nor does it affect the mode of use." |
| No labeling changes affecting indications for use | "There are no labeling changes that affect the indications for use of the device." |
| Electromagnetic compatibility or electrical safety not required (Technical) | "Electromagnetic compatibility or electrical safety testing was not required to support this modification." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable or not specified. This submission focuses on engineering verification of a hardware change rather than a clinical trial for a new claim. The "performance data" refers to technical testing, not human subject data.
- Data Provenance: Not applicable for patient data. The modification involves a change in a component for an existing device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of clinical studies, typically refers to expert diagnoses or pathology results. This submission describes engineering verification, not a clinical study requiring ground truth establishment by medical experts.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set subject to expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is not an AI-powered diagnostic or assistive tool. It is a physical medical device for cosmetic and pain relief treatments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm with "standalone performance" in the way an AI diagnostic tool would.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this modification is based on the previously cleared specifications and performance of the device before the change. The "performance testing" was to ensure the new component meets those existing specifications and that the overall system still "functions as intended" based on its original design and claims.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device and submission.
Summary of the Study and Device Proof of Acceptance:
The "study" described is a verification testing process to confirm that a minor hardware modification (changing the infrared light source from a tungsten halogen lamp to an LED) in the VelaShape system does not negatively impact its performance, safety, or effectiveness, and that it remains substantially equivalent to the original cleared device.
The proof the device meets "acceptance criteria" (which are implicit and relate to maintaining the original device's cleared performance and safety profile) is through engineering and performance testing. The document states that "Verification testing was performed to evaluate this modification to ensure the performance of the new light source is compatible with the previously cleared specifications" and that "Performance testing demonstrates that the VelaShape system performs according to specifications and functions as intended."
The core assertion is that "The modification of the IR light source to LED raises no new issues of safety or effectiveness," thereby allowing it to continue to meet its established indications for use related to minor muscle aches and pain, muscle spasm, local blood circulation, temporary reduction in cellulite appearance, and temporary reduction of thigh circumferences. No new clinical trials or human subject data were presented because the modification was deemed to not affect the foundational scientific technology or clinical performance.
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(182 days)
Dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The eMatrix CO2 is a Fractional CO2 laser device intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue including skin. The device console houses the major units of the system that include the laser module, the power supply, the scanner and all other electrical components. Laser is transmitted to the tissue via a series of lens integrated into the articulated arm. The system parameters are controlled via a LCD touchscreen and proprietary SW.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the performance evaluation of the eMatrix CO2 device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in a numerical format often seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the performance evaluation focuses on the device's ability to achieve its intended physical effects on tissue.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device produces morphological changes consistent with ablation, coagulation, and resurfacing of soft tissue, including skin. | Performance Evaluation of skin biopsies revealed morphological changes, which were created under the impact of the eMatrix CO2 of skin resurfacing, as expressed via demarcated zones of ablation and coagulation. |
| Device demonstrates different impacts in depth and width based on treatment modes. | The different treatment modes led to a different impact in depth and width of the tissue. |
| Affected zones become deeper with increased energy levels. | The affected zones tended to become deeper as the level of energy employed was increased. |
| Device maintains a uniform fractional phenotype, leaving intact, non-affected tissue between treated spots. | The affected zone were of uniform fractional phenotype, leaving intact, non-affected tissue between treated spots. |
| Device meets labeled performance claims and is substantially equivalent to predicate devices. | Conclusion: We have demonstrated that the eMatrix CO2 meets its labeled performance claims, and that it is substantially equivalent to the predicate devices. (This is a summary statement based on the qualitative findings described above and comparison to predicates.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only mentions "skin biopsies" being evaluated. It does not provide an explicit numerical sample size for the test set (e.g., number of biopsies, number of subjects).
- Data Provenance: Not specified in the provided text. It does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number of experts used or their qualifications for establishing ground truth. The evaluation mentions "morphological changes, which were created under the impact of the eMatrix CO2," implying a direct observation of the physical effects on tissue, likely by pathologists or histologists.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method (e.g., 2+1, 3+1). The evaluation appears to be a direct physical assessment of biopsy results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for diagnostic imaging devices where human readers interpret results. The eMatrix CO2 is a therapeutic laser device, and its performance evaluation focused on its direct physical effects on tissue.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm-only performance study was not conducted. The eMatrix CO2 is a physical medical device, not a software algorithm, so this type of study isn't applicable.
7. The Type of Ground Truth Used
- The ground truth used was based on histopathological examination of skin biopsies. The "morphological changes" and "demarcated zones of ablation and coagulation" observed in the biopsies served as the direct evidence (ground truth) of the device's effect.
8. The Sample Size for the Training Set
- The document describes a "Performance Evaluation of skin biopsies" which appears to be the primary study for demonstrating performance. There is no mention of a separate training set or any machine learning/AI component that would require one. The validation is based on the direct physical outcomes on the test biopsies.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a training set for a machine learning model, this question is not applicable. The "ground truth" (histopathological observations) was established for the performance evaluation biopsies directly.
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