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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

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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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

• 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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The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.

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.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 47 subjects (all female).
   • Data Provenance: Prospective, single-arm, self-controlled, multicenter clinical study conducted at 3 U.S. sites.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Number of Experts: 2 blinded reviewers.
   • Qualifications: The document does not specify the qualifications of the blinded reviewers (e.g., radiologist with X years of experience). It only states they were "blinded reviewers."

4. Adjudication Method for the Test Set:

   • The device performance indicates that the primary endpoint was met by "agreement between the blinded reviewers." This implies a consensus-based adjudication method, likely 2 out of 2 agreement, for the visual assessment of photographs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study design was a prospective, single-arm, self-controlled study rather than a comparative effectiveness study comparing AI with and without human assistance. The primary endpoint involved human reviewers assessing photographs, but it was for standalone device effectiveness, not to measure human improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No, this study was not a standalone (algorithm only) performance study. The primary effectiveness endpoint relied on assessment by "blinded reviewers" of photographs, which inherently involves human-in-the-loop performance for evaluation.

7. Type of Ground Truth Used:

   • The primary ground truth for the effectiveness endpoint was expert consensus (agreement between the two blinded reviewers) based on visual assessment of photographs of pre- and post-treatment thighs, as well as treated vs. untreated thighs.
   • Secondary endpoints used objective measurements like ultrasound and caliper measurements for fat thickness reduction, and investigator and subject satisfaction assessments.

8. Sample Size for the Training Set:

   • The document describes a clinical study to evaluate the device, not an AI or algorithm, so there is no mention of a "training set" in the context of machine learning. The clinical study itself served to demonstrate the device's performance in humans.

9. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as this is not an AI/machine learning device that would require a separate training set with established ground truth. The study evaluated the direct effects of the UltraShape System on human subjects.

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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

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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The UltraShape Power 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 Power System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape Power 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 Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.

The primary purpose of this submission is to add an increased acoustic intensity level to the device. Additional minor changes since the prior clearances were also included as part of this submission.

The UltraShape Power System is a medical device designed for non-invasive reduction of abdominal circumference by disrupting subcutaneous adipose tissue (SAT) using focused ultrasound energy.

1. Acceptance Criteria and Reported Device Performance:

The primary efficacy endpoint for the UltraShape Power System was the reduction in abdominal circumference and fat thickness. While specific acceptance criteria for "statistically significant" were not explicitly detailed in terms of a numerical threshold, the study's results demonstrated strong positive outcomes.

2. Sample Sizes and Data Provenance:

• Test Set (Clinical Evaluation):

  • Main Study: 43 enrolled subjects.
  • Additional Safety Study: 21 patients.
  • Data Provenance: Not explicitly stated, but the submission is from Syneron Medical Ltd. (Israel), and the study likely took place in a clinical setting related to their operations. It can be inferred to be prospective as it describes recruitment, treatment, and follow-up over specified time periods.
  • Demographics (Main Study): Mean age 48 years, 95% female, all Caucasian.

• Training Set: Not applicable for this type of device and study. The studies described are clinical trials for safety and effectiveness, not for training a machine learning algorithm.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable in the context of this device. The "ground truth" for efficacy was objective measurements (abdominal circumference, fat thickness) and patient-reported outcomes (satisfaction, comfort). These do not require expert consensus in the same way an imaging diagnostic device might.

4. Adjudication Method:

Not applicable. The study utilized objective physical measurements and patient self-assessment questionnaires, not the adjudication of expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This was a standalone clinical evaluation of a physical device for aesthetic purposes, not a diagnostic imaging device requiring expert interpretation.

6. Standalone Performance (Algorithm Only):

Yes, in a sense. The described clinical studies (43 subjects, 21 patients) evaluate the device only without human-in-the-loop performance influencing the primary efficacy outcomes. The device is operated by a healthcare professional, but the effectiveness measurements (circumference, fat thickness reduction) are direct outcomes of the device's action on the body, not a human interpretation of an algorithm's output.

7. Type of Ground Truth Used:

• Efficacy:
  • Objective Measurements: Abdominal circumference reduction (measured physically).
  • Objective Measurements: Fat thickness reduction (presumably measured by imaging, though the method isn't specified, it's an objective physical change).
• Safety: Observational data for adverse events and patient-reported comfort/discomfort.
• Patient Satisfaction: Self-reported patient satisfaction and willingness to recommend.

8. Sample Size for the Training Set:

Not applicable. This is not a device driven by a machine learning algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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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.

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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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

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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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.

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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The Contour I V3.1 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 Contour I is comprised of multiple components, including the control unit and ultrasonic transducer. The Contour I V3.1 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 Contour I 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 details for the Syneron Contour I V3.1 System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria is inferred from the statement: "The primary effectiveness endpoint measured the difference between the change in circumference for device and control phases...relative to the protocol-specified clinically meaningful threshold of -1.5 cm." The reported device performance ("average circumference reduction of -2.0 cm") significantly exceeded this threshold, indicating a positive outcome.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Primary Endpoint (ITT population): n=109 (subjects in Group 1 who completed both control and device phases)
• Safety Population: 150 subjects (118 in Group 1, 32 in Group 2)
• Data Provenance: The study was a "multicenter, randomized, controlled study." The origin country is not specified, but the device submitter is from Israel. The study was prospective in nature, involving active treatment and follow-up.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth in this study was objective quantitative measurement (abdominal circumference reduction) rather than expert interpretation of images or clinical findings.

• Number of Experts: Not applicable in the traditional sense of image interpretation.
• Qualifications of Experts: It is stated that the "individual measuring the subject's abdominal circumference was not the same person who treated the subject, and was blinded to the subject's treatment group." This implies trained personnel, but specific qualifications (e.g., years of experience in performing circumference measurements) are not provided.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 typically apply to the resolution of conflicting expert opinions for ground truth establishment. Since the primary endpoint was an objective measurement, an adjudication method in this sense is not applicable. The blinding of the assessor to the treatment group served to minimize bias in the measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study typically evaluates the performance of human readers (e.g., radiologists) with and without AI assistance on diagnostic tasks. The Contour I System is a therapeutic device for aesthetic body contouring; its effectiveness is measured by direct physical changes (circumference reduction), not by a diagnostic reading task.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The study describes the performance of the device (Contour I V3.1 System) in performing subcutaneous adipose tissue disruption. This can be considered a "standalone" evaluation of the device's therapeutic effect, as it directly acts on the tissue. There isn't an "algorithm" in the sense of a diagnostic AI, but the device's mechanical and acoustic properties are what achieve the therapeutic effect. The clinical trial directly assesses this effect.

7. The Type of Ground Truth Used

The ground truth used was objective quantitative measurement of change in abdominal circumference. This is an outcomes-based measurement directly reflecting the device's intended therapeutic effect.

8. The Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning. The clinical study described is an evaluation study of the device's safety and effectiveness in humans.

• However, the document mentions "In vivo and ex vivo testing in the animal model was performed. In addition, ex vivo testing on the Contour I family of devices demonstrated the treatment effects of the Contour I, and supported its safety and efficacy profile for the intended use." These non-clinical studies could be considered forms of "training" or development data used to optimize the device's parameters before human trials, but a specific sample size for such a "training set" for an algorithm is not provided as the device is not an AI diagnostic tool.

9. How the Ground Truth for the Training Set Was Established

As there is no explicitly defined "training set" for an AI algorithm in the document, the establishment of ground truth for a training set (in the machine learning sense) is not applicable.

However, for the non-clinical studies (animal and ex vivo) mentioned, the "ground truth" would have been established through direct observation of treatment effects on tissue, histological analysis, and physical/acoustic measurements.

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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

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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