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Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.

The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.

This document is a 510(k) summary for the Cynosure SculpSure device, which is a diode laser system intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a dedicated study with performance metrics. Therefore, many of the requested details about acceptance criteria, detailed study design, and performance metrics are not explicitly available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical performance data for specific clinical outcomes. The clinical performance is described in terms of "affecting the appearance of visible fat bulges."

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

• Test Set Sample Size: "Not applicable, no change in indication for use." This implies that the current 510(k) submission did not include a new clinical test set to prove device efficacy for the stated indications. Instead, it relies on the previous approvals of its predicate devices.
• Data Provenance: Not applicable for a new clinical test set in this submission. The original predicate devices' approvals would have contained this information. It is not mentioned whether any retrospective or prospective data was used for this specific submission beyond the predicate device references.

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

• Not applicable as no new clinical test set was submitted for this 510(k) for evaluating efficacy.

4. Adjudication Method for the Test Set:

• Not applicable as no new clinical test set was submitted for this 510(k).

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

• No MRMC comparative effectiveness study is mentioned in this 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and safety, not on comparative effectiveness with human readers.

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

• The SculpSure device is a physical laser system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The device's performance is inherently linked to its physical output and application by a user.

7. The Type of Ground Truth Used:

• For the intended use of "affecting the appearance of visible fat bulges," the ground truth in previous studies for the predicate devices (or the original SculpSure K150230) would likely have involved clinical assessment of fat reduction (e.g., circumferences, caliper measurements, imaging such as ultrasound or MRI, and potentially patient/physician satisfaction surveys). However, this specific 510(k) does not detail new efficacy studies.
• For non-clinical tests:
  • Software verification and validation: Ground truth is the predefined functional requirements and specifications of the software.
  • Power output testing: Ground truth is the specified power output range.
  • Biocompatibility: Ground truth is ISO 10993-1 standards.
  • Electrical safety and EMC: Ground truth is the specified international standards (e.g., IEC 60601-1).

8. The Sample Size for the Training Set:

• Not applicable as this 510(k) is not for an AI/algorithm-based device that requires a training set in the typical machine learning sense. The device is a physical laser system.

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

• Not applicable for the same reason as point 8.

Summary of the Study that Proves Device Meets Acceptance Criteria (based on the provided document):

The provided document (K160470) is an administrative change to a previous 510(k) and refers back to the original substantial equivalence determination for SculpSure (K150724 and K150230). This specific submission does not contain new clinical studies to prove efficacy. Instead, it relies on demonstrating substantial equivalence to its own previously cleared versions and other predicate devices, citing "no change in indication for use."

The "studies" that support the device meeting acceptance criteria (in terms of safety and performance for its intended use) are:

• Non-clinical tests:
  • Software verification and validation.
  • Power output testing.
  • Electromagnetic compatibility (EMC) and electrical safety testing (per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
  • Biocompatibility assessment (per ISO 10993-1).

These non-clinical tests aimed to ensure the device's technical specifications, safety, and compatibility were met, demonstrating that the device "should perform as intended in the specified use conditions." The efficacy for "non-invasive lipolysis of the abdomen and flanks" was established in the earlier 510(k) submissions for the predicate SculpSure devices.

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The CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, neurosurgery, orthopedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

• · Laser skin resurfacing.
• · Treatment of furrows and wrinkles.
  · Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
• · Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
• · Blepharoplasty.
• · Site preparation for hair transplants.
• · The fractional scanner is for skin resurfacing.

The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er: Y AG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.

The provided document is a 510(k) summary for the Cortex Laser System, which is a medical laser device. It outlines the device's indications for use, technological characteristics, and claims of substantial equivalence to predicate devices. However, this document does not contain information related to acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document explicitly states: "Performance Data: None submitted." This means that no clinical performance data was provided or reviewed for this 510(k) submission. Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving the device meets them based on the provided text.

Based on the document, I can only provide the following:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: "Performance Data: None submitted."

2. Sample sized used for the test set and the data provenance: Not applicable, as no performance data or test sets were submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set data requiring adjudication was submitted.

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. The device described is a surgical laser, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a surgical laser, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance data requiring ground truth was submitted or its establishment described.

8. The sample size for the training set: Not applicable, as no training set for an algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is mentioned.

In summary, the provided FDA 510(k) document for the Cortex Laser System focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting clinical performance data or studies against specific acceptance criteria.

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The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.

The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.

Here's a breakdown of the acceptance criteria and study information for the Cynosure SculpSure device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 35 subjects initially enrolled. 34 subjects returned for the 12-week post-treatment photographic evaluation.
• Data Provenance: The study was a prospective clinical study conducted at two centers. The racial demographics included Caucasian, African American, and Hispanic subjects. The country of origin for the data is not explicitly stated, but given the FDA submission, it is highly likely to be the United States.

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

• Number of Experts: Three blinded evaluators.
• Qualifications of Experts: Board-certified dermatologists.

4. Adjudication Method for the Test Set

• The photographic evaluations were performed individually by three blinded evaluators. The text states, "In 95% of the total individual evaluations the evaluators correctly identified the before and after images." This suggests that the performance was aggregated from individual assessments, but it does not specify a formal adjudication method like a 2+1 or 3+1 consensus. It seems each individual expert's correct identification contributed to the overall 95% figure.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This study focused on the effectiveness of the device itself, with experts evaluating photographic outcomes as a primary endpoint.

6. Standalone (Algorithm Only) Performance

• No, a standalone (algorithm only) performance study was not explicitly mentioned or performed as described. The primary endpoint involved human evaluators (dermatologists) assessing photographs. The device itself is a laser system, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

• Expert Consensus/Opinion: For the primary endpoint (photographic evaluation), the ground truth was established by the agreement of board-certified dermatologists on the correct identification of before and after images, implying visual assessment of aesthetic improvement.
• Quantitative Measurement: For the secondary and tertiary endpoints, objective measurements were used:
  • Ultrasound Measurements: To determine the change in adipose layer thickness.
  • Subject Satisfaction Survey: To gauge patient perception of outcome.

8. Sample Size for the Training Set

• The document does not explicitly state a sample size for a "training set." The clinical study described involved 35 subjects and appears to be the primary study for demonstrating effectiveness, not a separate training set for an AI algorithm. The device is a laser, not an AI-driven diagnostic.

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

• As there's no mention of an AI-specific "training set" in the context of this device and study, the method for establishing ground truth for such a set is not applicable based on the provided text. The clinical study's results are presented as evidence of the device's performance.

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The Cynosure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.

The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.

Here's a breakdown of the acceptance criteria and the study that proves the device (Cynosure SculpSure) meets these criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:
   • Sample Size: 49 subjects initially, with 43 subjects returning for the 12-week post-treatment photographic evaluations.
   • Data Provenance: The study was a prospective clinical study conducted at two centers. The countries of origin are not specified, but the governing body (FDA) is US-based, suggesting it was likely conducted in the US.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Number of Experts: Three blinded evaluators.
   • Qualifications: Board-certified dermatologists.
3. Adjudication method for the test set:
   • The text states that photographs "were evaluated individually by three blinded evaluators." It doesn't explicitly mention an adjudication method like 2+1 or 3+1 for discrepancies. However, the reported 88% correct identification is presented as a singular consensus or aggregate result across all individual evaluations.
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 human readers improving with AI vs. without AI assistance was not done. This study focuses on the effectiveness of the SculpSure device for lipolysis, not on software/AI interpretation.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   • No, this device is a laser system for medical treatment. The "performance" being evaluated is the physical effect of the laser on target tissue, and the subsequent aesthetic and physiological changes, not the performance of an algorithm.
6. The type of ground truth used:
   • For Primary Endpoint (Photographic Evaluation): Expert consensus (specifically, correct identification by blinded evaluators) implicitly serves as the ground truth for aesthetic improvement.
   • For Secondary Endpoint (Adipose Layer Thickness): Objective quantitative measurement via ultrasound scans serves as the ground truth for fat reduction.
   • For Tertiary Endpoint (Satisfaction): Subjective patient satisfaction surveys.
   • For Pre-Clinical (Mechanism of Action): Histologic examination and quantitative measurements comparing hyperthermic and hypothermic (predicate) treatments, suggesting a pathology-based ground truth for cellular injury and fat reduction comparability.
7. The sample size for the training set:
   • The document describes a single clinical study that serves as the basis for performance evaluation. It does not explicitly mention a separate "training set" in the context of machine learning or AI algorithm development. The study described is a clinical validation study for the device's efficacy and safety.
8. How the ground truth for the training set was established:
   • As there's no explicitly mentioned training set for an AI algorithm, this question is not directly applicable. The "ground truth" for the overall device effectiveness and safety was established through a clinical trial with the methodologies described above (photographic evaluation by experts, ultrasound measurements, patient surveys, and pre-clinical histologic analysis).

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755 nm:
The PicoSure workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I-III.

The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, an optional 532 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. This 532 nm Laser Delivery System converts the 755 nm laser energy into a 532 nm wavelength and is available in multiple spot sizes.

The provided document describes the Cynosure PicoSure™ Workstation with 532 nm Laser Delivery System (K143105) for tattoo removal. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with specific thresholds for device performance. Instead, it describes a comparative clinical study where the PicoSure device was deemed "as effective as" a predicate device (RevLite Q-Switched Nd:YAG Laser System K133254) based on a qualitative scoring scale.

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

• Sample Size: 18 subjects with a total of 23 tattoos.
• Data Provenance: Not explicitly stated, but clinical trials for FDA submissions are typically conducted in the US or in countries with comparable regulatory standards. The document doesn't specify if it was retrospective or prospective, but clinical studies for regulatory approval are generally prospective.

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

• Number of Experts: Three (3) blinded reviewers.
• Qualifications of Experts: Not specified in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: "Mean scores for all three evaluators were calculated per subject to determine overall mean scores." This indicates that the scores from the three reviewers were averaged. It's not a 2+1 or 3+1 method, but rather a direct averaging.

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 involving AI assistance was not done. This study solely compared the PicoSure device to a predicate laser device (RevLite) in the context of human-conducted laser treatments. AI assistance is not mentioned.

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

• No, a standalone algorithm performance study was not done. The device in question is a laser system, not an AI algorithm. The performance evaluation was for the laser system's ability to remove tattoos when operated by humans.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus based on a "6 point categorical efficacy scoring scale" applied to photographs. This is a form of clinical assessment/subjective evaluation.

8. The Sample Size for the Training Set

• Not applicable. The device is a physical laser system, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for this device would be its engineering design, development, and manufacturing processes, which are informed by scientific principles and prior knowledge of laser-tissue interaction, not a data training set.

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

• Not applicable. As explained above, this is a physical device, not an AI/ML algorithm that uses a training set with established ground truth.

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SideLaze800™ is an accessory to deliver optical energy for Cynosure 1440mm wavelength lasers and intended to be used with Cynosure 1440nm wavelength lasers for surgical incision, vaporization, ablation, and coagulation of soft tissue (including skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and gland) laser assisted lipolysis and the treatment of primary axillary hyperhidrosis.

The Cynosure 1440nm Wavelength laser is solid state Nd: YAG laser, having a neodymium rod as a lasing medium. Laser activation is by footswitch. Overall weight of the laser is 220lbs, and the size is 38.6"x16.5"x35.5" (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. SideLaze800™ Laser Beam Delivery Accessory is an optional side-firing fiber optic accessory used with the Cynosure Lasers with 1440nm wavelength. The SideLaze800™ option is intended to offer physicians a convenient accessory.

This document describes the SideLaze800™ Laser Beam Delivery Accessory for Cynosure 1440nm Wavelength Lasers, and its application for the treatment of primary axillary hyperhidrosis. Since this is a medical device submission, the "acceptance criteria" discussed are related to demonstrating safety and effectiveness for a new indication for use rather than statistical performance metrics typical of AI/ML devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are implied by the clinical study's objective: demonstrating the device is safe and effective for treating primary axillary hyperhidrosis. The reported device performance focuses on the clinical outcomes observed in the study.

2. Sample Size and Data Provenance

• Sample Size (Test Set): 59 subjects
• Data Provenance: The study was conducted at 4 study centers. The location of these centers (e.g., country of origin) is not specified. The study appears to be prospective as subjects underwent treatment and were followed up for 12 months.

3. Number of Experts and Qualifications

The document mentions "Physician Satisfaction Scale (PSS)" and "blinded evaluation of pre and post photographs from starch iodine test results." It does not explicitly state the number or specific qualifications of the physicians or experts involved in these evaluations. It can be inferred that these evaluations were performed by qualified medical professionals.

4. Adjudication Method

The document mentions "blinded evaluation of pre and post photographs from starch iodine test results." This implies a form of adjudication for objective assessment, but the specific method (e.g., how disagreements were resolved, 2+1, 3+1) is not detailed. It's only stated that the evaluation was "blinded."

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

No MRMC study comparing human readers with and without AI assistance was mentioned. This device is a laser-based medical device, not an AI/ML diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth for effectiveness was established through a combination of:

• Clinical outcomes:
  • Subject-rated Hyperhidrosis Disease Severity Scale (HDSS) scores.
  • Physician Satisfaction Scale (PSS).
  • Blinded evaluation of pre and post photographs from starch iodine test results (an objective measure of sweat production).
  • Direct observation of "reduction, ablation and fragmentation of the sweat glands" (likely from biopsy or other imaging, though not explicitly stated how this was observed in all subjects).
• Safety data: Adverse event reporting.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML system requiring a training set in the conventional sense. The "training" or development of the device likely involved engineering and preclinical testing before the clinical study.

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

Not applicable, as there's no "training set" for an AI/ML algorithm. The safety and effectiveness for a medical device are established through a combination of engineering design, preclinical testing, and clinical trials. The previous clearance of the SideLaze800™ for other soft tissue applications (K121127) also provided a foundation for its known performance characteristics, with this submission specifically adding the hyperhidrosis indication based on the clinical study.

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The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.

The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The 1540 Fractional Non-ablative Laser and 2940 Fractional Abaltive Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrides, furrows, fine lines, textural irregularities, dyschromia and pigmend lesions.

The 1440 Fractional Non-ablative Laser Handpiece and 2940 Fractional Ablative Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularties, dyschromia and pigmented lesions.

The MaxIR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (FFB).

The Max series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae, removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including port wine stains, hemangiomas, aniomas, telangiectasias, rosacea, facial and leg veins. The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.

The Palomar Icon® Aesthetic System including attachable treatment handpieces is designed to deliver pulses of broadband incoherent or laser light to a predetermined target site. The Palomar Icon® Aesthetic System consists of three stacking modules that contain an internal power supply, control electronics, Chiller Module, Heat Exchanger Module, Base Module, remote interlock, emergency-off button, footswitch, power control, and front panel monitor with indicators. They system includes multiple treatment hadnpieces attached to the Base Module. Each Handpiece provides laser energy at a specific wavelength or Intense Pulsed Light (IPL) at a specific range.

The provided text is a 510(k) summary for the Palomar Icon Aesthetic System, a medical device. It describes the device, its intended use, and a comparison to a legally marketed predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical outcomes or diagnostic accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Palomar Icon Aesthetic System, K110907) based on technological characteristics and non-clinical tests (sterilization validation). Clinical performance studies with defined acceptance criteria and statistical analysis are not detailed in this submission.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: The document does not specify quantitative acceptance criteria for clinical performance (e.g., specific percentages of wrinkle reduction, hair removal efficacy, or lesion clearance) or report device performance against such criteria.
• Sample size and data provenance for the test set: No clinical test set is described.
• Number and qualifications of experts for ground truth: No ground truth establishment related to clinical outcomes is mentioned.
• Adjudication method: Not applicable as no clinical test set/ground truth is described.
• MRMC comparative effectiveness study: No such study is mentioned. The device is a laser system, not an AI-assisted diagnostic tool.
• Standalone performance: The document deals with a physical medical device, not a standalone algorithm.
• Type of ground truth used: Not applicable as no clinical endpoints are being evaluated against a ground truth.
• Sample size for the training set: No training set for an algorithm is described.
• How ground truth for the training set was established: Not applicable.

The document does include the following relevant information:

• Nonclinical tests submitted: Sterilization Validation.
• Conclusions drawn from non-clinical data: An Autoclave Sterilization Validation of the 10 x 10 and 6 x 6 Focal Guide Assemblies was conducted. The test articles, negative controls, and environmental controls all exhibited no growth of G. stearothermophilus after being subjected to 3 half cycle rounds of specific gravity cycle settings, meeting an SAL of ≤10⁻⁶. Functional testing showed that the sterilization did not affect device function. This indicates the device meets sterilization efficacy standards.

In summary, this document is a regulatory submission for substantial equivalence based on technological similarity and non-clinical safety (sterilization). It does not present a clinical study with acceptance criteria for performance related to its intended aesthetic and dermatological uses.

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The PicoSure™ workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure™ workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.

The PicoSure™ workstation is a high powered Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.

The provided text describes the Cynosure Picosure™ Workstation and its indications for use. It includes a summary of clinical study findings related to the device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size for the Test Set:
  • The study included 40 subjects.
  • 38 subjects returned for the 4-month evaluation, which is the test set for the photo and FWSS evaluations.
• Data Provenance: The document does not specify the country of origin. The study was conducted as a prospective clinical trial, as evidenced by "before and after" evaluations and follow-up at 4 months post-treatment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Three blinded evaluators were used.
• Qualifications of Experts: The document does not specify the qualifications of these evaluators (e.g., dermatologists, plastic surgeons, years of experience).

4. Adjudication method for the test set

• The document implies a consensus or independent evaluation method, as it states "three blinded evaluators, who were able to identify correctly the before and after images in 91% of the 38 subjects." It doesn't explicitly state an adjudication method like 2+1 or 3+1 for discrepancies, but given the high agreement (91%), it might not have been a significant issue or simply not detailed in this summary. It appears each evaluator made an independent judgment, and the percentage reflects the overall agreement across all three for the majority of cases.

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 involving AI assistance was not done. The study evaluated the effectiveness of the laser device itself, with human evaluators assessing the outcome of the treatment without AI assistance.

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 primary focus was on the efficacy of the Picosure™ Workstation when applied to human subjects, with human evaluators determining the success of the treatment.

7. The type of ground truth used

• The ground truth for the effectiveness of the treatment was established by expert assessment of photographs (for correct identification of before/after images) and the Fitzpatrick Wrinkle Severity Scale (FWSS) scores, also assessed by experts, indicating a clinical improvement. Safety ground truth was based on reported adverse events.

8. The sample size for the training set

• This document describes a clinical study to demonstrate the effectiveness of the medical device as a treatment. It is not describing the development or validation of an AI algorithm, so there is no mention of a training set in the context of machine learning. The "training set" for the device's efficacy would be considered the prior research and development that led to the device's design, but this is not a data set in the AI sense.

9. How the ground truth for the training set was established

• As there is no AI algorithm being described, there is no training set ground truth in the context of an AI algorithm. The device's "ground truth" for its intended performance is based on the underlying scientific principles of laser-tissue interaction and prior clinical research on similar technologies, not on a labeled dataset for an algorithm.

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755 nm:
The Cynosure Elite+ Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowting when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

1064 nm:
The Cynosure Elite+ Laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Cynosure Elite+ laser has an Alexandrite crystal rod as the lasing medium, with a wavelength of 755 nm. The 1064 nm wavelength is generated from the Nd:YAG laser head.

Laser activation is by either by finger or foot switch. The overall weight of the laser is 180 lbs and the size is 41 x 15 x 25 in (HxWxD).

Electrical equipment is 208/240 VAC, single phase, 30A, 50/60 Hz.

The modifications to this device are four handpieces allowing for a larger treatment area; 18 mm, 20 mm, 22 mm and 24 mm. The 1064 Nd:YAG laser did not require any modifications to support the new handpieces. Minor modifications, including rod diameter change and lamp fill pressure change, were made to the Alexandrite laser to increase the energy to support the larger spot sizes. The software continues to control the energy based on the handpiece attached. This prevents the increase in available energy from the laser from increasing the fluence of the existing spot sizes.

This document is a 510(k) premarket notification for the Cynosure Elite+ Laser, seeking clearance for a modified device. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel clinical study data to prove the device meets specific acceptance criteria in a clinical setting.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning clinical performance metrics, cannot be fully extracted from this document in the way it would be for a direct clinical performance study.

However, based on the provided text, I can infer the acceptance criteria relate to the engineering and software performance specifications and that the study proving acceptance was non-clinical testing.

Here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Important Note: The "acceptance criteria" here are engineering and operational parameters demonstrating equivalence to the predicate device, not clinical efficacy or safety endpoints for the expanded spot sizes. The document explicitly states "None" for clinical tests submitted.

The Study that Proves the Device Meets the Acceptance Criteria:

The document describes non-clinical tests as the study proving the device meets its performance requirements.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. As this was non-clinical engineering and software testing, the "sample size" would refer to the number of devices or test cycles, which is not detailed.
• Data Provenance: Not specified, but it would be internal testing conducted by Cynosure Incorporated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this was non-clinical engineering and software testing. Ground truth was established by engineering specifications and direct measurement/validation against those specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as this was non-clinical engineering and software testing. Adjudication methods are typically for human interpretation in clinical studies.

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 done. This device is a laser system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a medical laser system, not an algorithm. The "standalone" performance here refers to the laser's physical and software operation, which was tested non-clinically.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical tests, the ground truth was based on engineering specifications, direct physical measurements, and software requirement validations.

8. The sample size for the training set:

• Not applicable. This device is a laser system, not an algorithm that requires a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• Not applicable for the reason above.

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The PicoSure™ workstation is indicated for tattoo and benign pigmented lesion removal.

The PicoSure™ workstation operating with the 3mm or 6mm handpiee and the FOCUS lens array is indicated for the treatment of acne scars in Fitzpatrick skin types I-IV.

The PicoSure™ workstation is a high-powered, Q-switched Alexandrite system that delivers laser energy in the 755-nm wavelength. The system consists of a console that houses the power supply, control electronics and the laser. Laser energy is delivered to the skin via an articulated arm. The laser is activated using a footswitch.

The provided document describes the PicoSure™ Workstation, a laser system indicated for tattoo and benign pigmented lesion removal, and for the treatment of acne scars when operating with specific handpieces and the FOCUS lens array. The document presents two clinical studies to support the safety and effectiveness of the device for acne scar treatment. Below is an analysis of the acceptance criteria and study data based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined acceptance criteria values for these metrics. The reported performance implies these results were considered sufficient to demonstrate substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

• Acne Scars Study (Clinical Study 1):

  • Sample Size (Test Set): 17 patients completed the study, with a total of 46 acne scars treated.
  • Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as it describes treatment and follow-up observations.

• Tissue Response Study (Clinical Study 2):

  • Sample Size (Test Set): 3 subjects (2 on arm, 1 on leg).
  • Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical study, as it describes treatment and subsequent biopsies.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Acne Scars Study:

  • Number of Experts: Three blinded evaluators.
  • Qualifications: The specific qualifications (e.g., radiologist, years of experience) of these evaluators are not specified in the provided text. They were described as "blinded evaluators."

• Tissue Response Study:

  • Number of Experts: Not explicitly stated for establishing ground truth from biopsies, but biopsies would typically be analyzed by pathologists.
  • Qualifications: Not specified.

4. Adjudication Method for the Test Set

• Acne Scars Study: The method for reaching consensus among the three blinded evaluators regarding the "before and after images" or for determining the "mean improvement score" is not explicitly detailed. It can be inferred that their evaluations were aggregated, but the specific adjudication (e.g., voting, expert consensus meeting) is not described.
• Tissue Response Study: For the biopsy analysis, an adjudication method is not detailed. Typically, a qualified pathologist would interpret the biopsies, and potentially a second opinion might be sought for complex cases, but this is not mentioned.

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

• A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus without AI assistance, was not performed, nor is it applicable to this device. The PicoSure Workstation is a laser device, not an AI diagnostic or assistance tool for human readers. The study involved human evaluators assessing photographic outcomes of a treatment device.

6. Standalone Performance

• A standalone (algorithm only without human-in-the-loop performance) study was not applicable and therefore not conducted. The PicoSure Workstation is a physical laser device used for treatment, not a standalone AI algorithm.

7. Type of Ground Truth Used

• Acne Scars Study: The ground truth for effectiveness was based on:
  • Expert Consensus/Opinion: Evaluations by three blinded evaluators of before/after photographs.
  • Subjective Satisfaction: Non-blinded treating physician's satisfaction scores and subjects' self-reported satisfaction.
• Tissue Response Study: The ground truth for safety (tissue response) was based on Pathology via biopsies taken at various time points after treatment.

8. Sample Size for the Training Set

• The document describes clinical studies used to assess the performance of the device, not to train an AI algorithm. Therefore, a "training set" in the context of machine learning is not applicable to this device and its studies. The clinical studies served as validation for the device's efficacy and safety.

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

• As a training set for an AI algorithm is not applicable, the method for establishing its ground truth is not relevant to the information provided. The "ground truth" discussed in the context of these studies refers to the outcomes measured in the clinical trials themselves by evaluators, physicians, and pathological examination.

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