Search Results

Date Cleared

2018-10-24

(55 days)

Product Code

GEI

Regulation Number

878.4400

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.

The 25mm, and 30mm handpieces provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The massage device is intended to provide a temporary reduction in the appearance of cellulite

The following surgical modes are applicable to the generator:

Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed

Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage. skin incisions, biopsy, cysts, abscesses. tumors. cosmetic repairs, development of skin flaps. skin tags and blepharoplasty.

Fulguration: basal cell carcinoma. papilloma. cyst destruction, tumors. verrucae, hemostasis.

Device Description

The TempSure generator has been upgraded to include additional surgical modes – Cut, Bipolar, Fulgurate, and Blend, along with the existing Coag. The power of the device for Surgical applications is a maximum of 300W. There have been no changes to the Smart Handpiece treatment with temperature sensitive handpieces.

TempSure system is used with the same existing Ellman electrosurgical accessories.

The TempSure™ System includes:
• TempSure™ Generator
• Temperature Sensing Handpieces
• IEC Power Cord
• Footswitch
• Disposable/Reusable Neutral Pad
• Surgical Fingerswitch/Foot Controlled Handpieces
• Monopolar Cables
• Disposable/Reusable Electrodes, Forceps

AI/ML Overview

The provided document is a 510(k) summary for the Cynosure TempSure System, an electrosurgical device. It primarily details the device's substantial equivalence to predicate devices based on non-clinical testing. It does not describe an AI/ML-driven medical device, nor does it involve the use of AI assistance for human readers, ground truth establishment by experts, or MRMC studies.

Therefore, many of the requested details, such as acceptance criteria for AI performance metrics (e.g., sensitivity, specificity), sample sizes for AI test sets, expert consensus for ground truth, adjudication methods, MRMC studies, or standalone AI performance, are not applicable to this submission.

The document focuses on demonstrating substantial equivalence through:

Indications for Use (IFU) Comparison: Showing the TempSure System has similar IFUs to legally marketed predicate devices.
Technological Characteristics Comparison: Highlighting similarities in energy type, modality, power output, etc.
Performance Testing (Non-Clinical): Primarily focusing on thermal effects on tissue and electrical safety/EMC.

Below is an attempt to address the relevant points based only on the provided text, while explicitly stating when information is N/A or not present.

Acceptance Criteria and Study for Cynosure TempSure System (K182365)

This submission is for an electrosurgical device and relies on showing substantial equivalence to predicate devices through non-clinical performance data and comparison of technological characteristics. It does not involve AI/ML.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" for performance metrics in the way one might for an AI/ML device (e.g., minimum sensitivity). Instead, the acceptance is based on demonstrating the similarity of the device's performance (specifically the thermally affected zone) and safety characteristics to the predicate devices.

Acceptance Criteria (Implied / Demonstrated through comparison):

Thermal Effects on Tissue: The Thermally Affected Zone (TAZ) created by the TempSure system should be similar to that created by the predicate devices (Surgitron and ForceTriad).
Electrical Safety & Electromagnetic Compatibility (EMC): The device must satisfy the requirements of relevant international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).

Reported Device Performance (as summarized in the document):

Criterion / Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Thermal Effects on Tissue	TAZ of TempSure should be similar to predicate devices.	Testing was performed on ex-vivo tissue samples (liver, kidney, and muscle) in triplicate at three power settings. The TempSure device's TAZ was compared to the ForceTriad and Surgitron devices. Conclusion: "The Thermal Effects on Tissue test showed that the thermally affected zone created by the TempSure™ device was similar to that created by the predicate devices, Surgitron and ForceTriad, in ex-vivo tissue testing. Despite their difference in maximum output power, the devices created a similar TAZ and therefore the devices can be considered substantially equivalent."
Electrical Safety and EMC	Device must comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 standards.	Conclusion: "In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe to use and meets required standards." (Specific test results or pass/fail rates are not provided in this summary, but the general compliance is stated).
General Safety and Effectiveness	Device should be safe and effective and perform as well as legally marketed predicate devices.	Overall Conclusion: "The nonclinical tests demonstrate that the TempSure™ system is safe and effective and performs as well as the legally marketed predicate devices."

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

Test Set (for Thermal Effects on Tissue): Measurements were taken "in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings." This implies a total of 27 measurements for the TempSure device and 27 for each predicate device (3 tissues * 3 power settings * 3 replicates).
Data Provenance: The document does not specify the country of origin for the ex-vivo tissue samples or if the testing was prospective or retrospective. Given it's ex-vivo tissue, the notion of retrospective/prospective typically applies to patient data, which is not what was used here.

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

N/A. This applies to AI/ML systems where human experts establish ground truth. For this electrosurgical device, "ground truth" for performance was based on physical measurements (Thermally Affected Zone, electrical parameters) rather than expert interpretation of medical images or patient outcomes data.

4. Adjudication method for the test set

N/A. Adjudication methods (e.g., 2+1, 3+1) are relevant for establishing ground truth from multiple human readers/experts, which is not applicable to the performance testing described for this electrosurgical device.

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

N/A. No clinical tests were submitted; therefore, no MRMC study, human reader improvement analysis, or AI assistance was performed or assessed.

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

N/A. No AI algorithm is involved with this device. The device itself (radiofrequency generator) is the "standalone" entity tested for its physical performance.

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

Physical Measurements / Bench Testing Standards. The "ground truth" for evaluating the device's performance was based on:
- Direct measurement of the Thermally Affected Zone (TAZ) in ex-vivo tissue.
- Compliance with established electrical safety and electromagnetic compatibility standards (IEC 60601 series). This is akin to meeting engineering specifications rather than clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set

N/A. This device does not use machine learning, so there is no "training set."

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

N/A. Not applicable, as there is no training set for an AI/ML model.

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K Number

K173199

Device Name

PicoSure Workstation

Manufacturer

Date Cleared

2018-02-07

(128 days)

Product Code

GEX

Regulation Number

878.4810

Type

Panel

Reference & Predicate Devices

K160480,K133254

Intended Use

755mm:

The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV.

532mm:

The PicoSure 532mm Laser Delivery System is indicated for tattoo removal and benign pigmented lesion removal in Skin Types I - III.

1064nm:

The PicoSure 1064nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.

Device Description

The PicoSureTM 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 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength, and are available in multiple spot sizes.

AI/ML Overview

Based on the provided text, the device in question is the PicoSure Workstation, a laser system used for tattoo removal, benign pigmented lesion removal, and treatment of acne scars and wrinkles. The information related to acceptance criteria and the study that proves the device meets them primarily pertains to the 532nm Delivery System for benign pigmented lesion removal in Skin Types I-III.

Here's an analysis of the provided information to address your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets for device performance. Instead, it describes a clinical study designed to demonstrate the safety and effectiveness of the 532nm Delivery System for benign pigmented lesions. The "acceptance criteria" here appear to be qualitative, focused on demonstrating a high level of improvement and acceptable safety profile.

Table of Performance (Inferred from Clinical Study Results):

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (532nm Delivery System for Benign Pigmented Lesions)
Clinical Efficacy	Significant improvement in benign pigmented lesions	`91.1%` of subjects at 1-month follow-up had a score of "1 – Very Much Improved" on the Global Aesthetic Improvement Scale (GAIS).
Safety	Minimal, transient, and expected adverse effects	All adverse effects were transient (resolving in 2-11 days) and in the form of reddening and blistering (expected side effects from laser treatments). No serious or unexpected adverse events reported.

Study Information:

2. Sample Size and Data Provenance

Test Set Sample Size: 30 treatment areas (from 15 subjects).
Data Provenance: The document does not specify the country of origin. The study was prospective as it involved treating subjects and following them up.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Three.
Qualifications of Experts: Blinded, board-certified Dermatologists. No explicit mention of years of experience.

4. Adjudication Method for the Test Set

The clinical efficacy endpoint was evaluated "through comparison of the pre-treatment images by three blinded, board certified Dermatologists as independent reviewers." This implies a consensus-based or independent review approach, but the specific adjudication rule (e.g., majority vote, specific tie-breaking rule if opinions differed) is not detailed beyond "independent reviewers." It wasn't 2+1 or 3+1 as stated; they were independent reviewers of the images.

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

No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not done. This study is a clinical trial assessing the laser device's direct performance on patients, not an AI-assisted diagnostic or assistive tool.

6. Standalone Performance (Algorithm Only)

This is not applicable as the device is a physical laser workstation, not an AI algorithm. The reported performance is of the physical device as operated by a clinician.

7. Type of Ground Truth Used

The ground truth for efficacy was established through expert consensus/independent review of pre-treatment and post-treatment images by board-certified Dermatologists, coupled with the clinical investigator's evaluation using the GAIS. For safety, it was the observation and reporting of adverse events during the follow-up period.

8. Sample Size for the Training Set

This is not applicable as the PicoSure Workstation is a physical medical device (laser) and not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such a device would be its engineering, calibration, and manufacturing processes.

9. How Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8. The "ground truth" for the device's design and function would be based on established medical physics principles, engineering standards, and pre-clinical testing, rather than a data-driven "ground truth" for model training.

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K Number

K171992

Device Name

SculpSure

Manufacturer

Date Cleared

2017-09-26

(85 days)

Product Code

PKT

Regulation Number

Type

Panel

Reference & Predicate Devices

K171111,K162050

Intended Use

The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Cynosure SculpSure device, specifically seeking clearance for the treatment of the submental area. It contains information about the device's
description, indications for use, and a summary of clinical and non-clinical tests conducted to demonstrate safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of pre-defined acceptance criteria with corresponding performance metrics. Instead, it describes performance outcomes that were achieved. However, based on the narrative, we can infer the implied acceptance criteria from the reported results.

Metric/Criteria (Inferred)	Acceptance Criteria (Implied)	Reported Device Performance
Efficacy: Blind Evaluation of Photos	High percentage of post-treatment photos identifiable by blind evaluators (indicating visible change).	93% (51/55) of post-treatment photographs were identifiable by blind evaluators.
Efficacy: Fat Reduction (Ultrasound)	Demonstrable and statistically significant reduction in adipose tissue thickness via ultrasound.	15.2% (1.785mm) normalized fat reduction at 12 weeks post-final treatment was shown by ultrasound imaging.
Efficacy: Patient Satisfaction	High patient satisfaction rate with the treatment.	100% (55/55 subjects) satisfaction rate reported at 12 weeks post-final treatment follow-up visit using a 6-point Likert scale.
Safety: Adverse Events	Side effects should be transient, and the majority should be mild or moderate in nature, with no significant difference across BMI groups.	All reported adverse events (swelling, pain, nodules, redness, hardness, numbness, hair loss, itching, bruising, and blisters), except for one, were transient, and the majority were mild or moderate in nature. No significant difference in safety (or efficacy) between BMI = 30 groups.
Software Verification & Validation	Software performs as intended.	Software verification and validation was performed, and it was demonstrated that the software performs as intended.
Power Output Consistency	Power output meets specification.	Testing confirmed that the power output meets specification.
Electromagnetic Compatibility (EMC) & Electrical Safety	Device meets relevant standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).	Results confirmed the device meets the standards.
Biocompatibility	Patient-contacting materials are biocompatible per ISO 10993-1.	All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible.
Submental Mask Beam Uniformity	Submental mask provides beam uniformity within +/- 15% specification.	Additional bench testing was performed to demonstrate that the submental mask provides beam uniformity to the treatment area within +/- 15% specification.

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

Sample Size for Clinical Test Set: 57 subjects were enrolled in the study for the submental area.
- 23 subjects had a BMI = 30.
- 5 patients received 1 treatment, the rest received 2 treatments.
- Efficacy analysis performed on 55 subjects (implied that 2 subjects were lost to follow-up or excluded from efficacy analysis, as 51/55 and 55/55 are reported).
- Safety analysis performed on all 57 subjects.
Data Provenance: The study was a "prospective, controlled study" conducted at "3 study centers." The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it is highly likely the study was conducted in the United States, but this is not explicitly stated.

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

Number of Experts: The document states "On an average, blind evaluators were able to identify 93% (51/55) of the post treatment photographs." The exact number of individual blind evaluators is not specified.
Qualifications of Experts: The qualifications of these "blind evaluators" are not provided in the document.

4. Adjudication Method for the Test Set

For the blind evaluation of photographs, the document only states "blind evaluation of pre- and post- final treatment (12 week) photographs." No specific adjudication method (e.g., 2+1, 3+1) is mentioned. It's unclear if multiple evaluators independently rated and then their results were averaged or if consensus was reached, or if there was a primary and secondary read.

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 document describes a clinical study for a medical device (laser system) for fat reduction, not a diagnostic AI system that assists human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable and was not conducted for this device. The efficacy endpoints were direct measurements (fat reduction, patient satisfaction) and blind photo evaluation, not diagnostic accuracy requiring human reader interaction with AI.

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

This question is not applicable to the SculpSure device as it is a physical medical device (a laser system), not an algorithm or AI software for diagnostic purposes. Its performance is measured directly by its physical effect on the body, not as a standalone software output.

7. The Type of Ground Truth Used

The ground truth for the efficacy endpoints in this study was established using a combination of:

Expert Consensus/Blind Evaluation: Implicitly, the ability of "blind evaluators" (human experts) to correctly identify post-treatment photographs served as a form of ground truth for visible changes.
Objective Measurement: Percentage change in adipose tissue thickness from baseline, measured through ultrasound imaging, provided an objective, quantifiable ground truth for fat reduction.
Patient-Reported Outcomes: Patient satisfaction measured via a 6-point Likert scale represents a subjective but crucial ground truth from the patient's perspective.
Observed Clinical Outcomes: For safety, the reporting and assessment of adverse events observed during visits forms the ground truth for safety.

8. The Sample Size for the Training Set

The document describes a clinical study to evaluate the device's performance, not to train an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The 57 subjects were part of the clinical test set (or study cohort) to assess the device's efficacy and safety.

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

This question is not applicable as there was no AI training set involved in this device submission.

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K Number

K171262

Device Name

TempSure

Manufacturer

Date Cleared

2017-09-22

(144 days)

Product Code

GEI,PBX

Regulation Number

878.4400

Type

Panel

Reference & Predicate Devices

K132665,K051644,K132949

Intended Use

The 10mm, 15mm, and 20mm Portrait handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids.
The 18mm, 25mm, and 30mm Portrait handpieces provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite
Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed

Device Description

The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and electrosurgical procedures. The intended action is achieved through application of radiofrequency energy to the patient which results in minimization of heat dissipation and cellular alteration. Output of energy is controlled via the guided user interface (GUI) and the foot and/or hand-switch. The TempSure™ system is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids, heating for the purpose of elevating tissue temperature for selected medical conditions, and hemostasis/coagulation for general surgery applications. The generator is used with a temperature sensitive handpiece for aesthetic procedures that provides real-time temperature feedback. This temperature information is displayed on the user interface that shows the temperature set point and actual tissue temperature along with procedure time, system error, and warning codes. A thermistor protrudes at the end of the temperature-sensitive handpiece at the point of patient contact, which provides a constant information feedback loop as to the tissue temperature throughout a procedure.
The TempSure™ System includes:
TempSure™ Surgical RF Generator Portrait™ Temperature Sensing Handpieces IEC Power Cord Footswitch Disposable/Reusable Neutral Pad Surgical Fingerswitch/Foot Controlled Handpieces Monopolar Cables Disposable/Reusable Electrodes

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the TempSure device:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Temperature Monitoring Accuracy	Equivalent to Fluke Infrared Thermometer (+/- 1.5°C margin for external temperature measurement tools). Ability to maintain desired temperature throughout treatment.	Average difference in temperature between the FLIR camera and the Portrait handpiece was +/- 1.5°C, demonstrating equivalence to the Fluke Infrared Thermometer. The device maintained the desired temperature throughout the treatment with no adverse events.
Thermal Effects on Tissue (TAZ)	Thermally Affected Zone (TAZ) should be similar to the predicate device (ForceTriad).	When comparing the TAZ of the TempSure to the ForceTriad on ex-vivo tissue, two of the three power bars showed overlapping results for each point, indicating similar TAZs. This was deemed substantially equivalent despite differences in maximum output power.
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2.	The device demonstrated compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	The device demonstrated compliance with IEC 60601-1-2.
Safety and Effectiveness	General safety and effectiveness equivalent to legally marketed predicate devices.	Nonclinical tests demonstrated the TempSure electrosurgical generator is safe and effective and performs as well as or better than the legally marketed predicate devices. The device meets design specifications and performance requirements.

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

Temperature Monitoring Test: "three different power settings in various treatment areas on two subjects." The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective).
Thermal Effects on Tissue Test: "performed using both devices in triplicate on three tissue samples (liver, kidney, and muscle), and three power settings." These were ex-vivo tissue samples.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation relies on objective measurements against a reference device (FLIR Thermal Camera) or comparative measurements between devices on physical tissue samples.

4. Adjudication Method for the Test Set

No adjudication method is described, as the evaluation methods relied on direct measurements or comparisons rather than expert interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The studies described are technical performance tests and ex-vivo tissue comparisons, not studies involving human readers.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This device, "TempSure," is an electrosurgical generator and not an AI or algorithm-driven diagnostic device. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply. The device's performance is tested directly.

7. The Type of Ground Truth Used

Temperature Monitoring Test: The ground truth was established by direct physical measurement using a FLIR Thermal Camera, which served as the reference standard for temperature.
Thermal Effects on Tissue Test: The ground truth for the thermally affected zone (TAZ) was established by measurements using Image-J on ex-vivo tissue samples, comparing the output of the TempSure to the predicate device (ForceTriad).

8. The Sample Size for the Training Set

The document does not describe any machine learning or AI components for which a "training set" would be applicable. The TempSure is a radiofrequency generator, and its validation relies on traditional engineering and medical device performance testing, not AI model training.

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

As no training set is described or implied, this point is not applicable.

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K Number

K171111

Device Name

Sculpsure

Manufacturer

Date Cleared

2017-06-13

(60 days)

Product Code

PKT

Regulation Number

Type

Panel

Reference & Predicate Devices

K160470,K162050

Intended Use

The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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, flanks, back, and thighs.

Device Description

AI/ML Overview

Acceptance Criteria and Study Details for SculpSure Device

The SculpSure device is intended for non-invasive lipolysis to reduce fat in specific body areas. The following information details the acceptance criteria and the study that demonstrated the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Effectiveness - Photographic Assessment	Blind evaluators able to identify 86% of post-treatment photographs (Back: 91%, Outer Thigh: 87%, Inner Thigh: 83%).
Effectiveness - Fat Reduction (Ultrasound)	At 12-week post-follow-up, average 8.6% normalized fat reduction (Back: 10.6%, Outer Thigh: 7.2%, Inner Thigh: 8.0%). All treatments had a *p-value of X% fat reduction"). Instead, it reports the observed performance and concludes that the results demonstrate safety and effectiveness for substantial equivalence. The reported performance values in the table are the actual results from the study.)

Acceptance Criteria

Reported Device Performance

Effectiveness - Photographic Assessment

Blind evaluators able to identify 86% of post-treatment photographs (Back: 91%, Outer Thigh: 87%, Inner Thigh: 83%).

Effectiveness - Fat Reduction (Ultrasound)

At 12-week post-follow-up, average 8.6% normalized fat reduction (Back: 10.6%, Outer Thigh: 7.2%, Inner Thigh: 8.0%). All treatments had a *p-value of X% fat reduction"). Instead, it reports the observed performance and concludes that the results demonstrate safety and effectiveness for substantial equivalence. The reported performance values in the table are the actual results from the study.)

2. Sample Size and Data Provenance for Test Set

Sample Size: A total of 168 subjects, making up 214 treatment areas, were enrolled in the study.
- Back: 55 subjects / 55 treatment areas
- Outer Thigh: 52 subjects / 52 treatment areas
- Inner Thigh: 61 subjects / 107 treatment areas
Data Provenance: The study was a prospective, controlled study conducted at 3 study centers. The specific country of origin is not explicitly stated, but it can be inferred to be within the US given the submission to the FDA.

3. Number of Experts and Qualifications for Ground Truth

The document mentions "blind evaluation of pre and post treatment (12-week) photographs," and "blind evaluators were able to identify 86% of the post treatment photographs." However, the number of experts used to establish the ground truth for the test set and their specific qualifications are not provided in the provided text.

4. Adjudication Method

The document states "blind evaluation of pre and post treatment (12-week) photographs." This indicates a degree of blinding. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly stated for establishing ground truth or for resolving discrepancies in photographic evaluation.

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

No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The study evaluated the device's efficacy in non-invasive fat reduction.

6. Standalone (Algorithm Only) Performance

This device is a laser system (SculpSure), not an AI algorithm. Therefore, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" does not apply to this medical device. The study evaluates the performance of the physical device as used by a human operator.

7. Type of Ground Truth Used

The efficacy of the treatment was assessed using a combination of:

Photographic assessment: Blind evaluation of pre and post-treatment photographs.
Ultrasound imaging: Measurement of percentage change in adipose tissue thickness from baseline to 12-week follow-up.

8. Sample Size for the Training Set

The document describes a clinical study to evaluate the device's safety and efficacy for specific body areas. This study serves as the primary evidence for the device's performance. The concept of a "training set" typically applies to machine learning models. For a physical device like SculpSure, the provided documentation does not refer to a separate "training set" in the context of clinical studies.

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

As mentioned above, the concept of a "training set" as it applies to software or AI algorithms is not directly relevant here. The "ground truth" for the clinical study's effectiveness was established through the objective measurements of ultrasound imaging for fat reduction and the subjective yet blinded assessment of photographic changes.

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K Number

K160470

Device Name

SculpSure

Manufacturer

CYNOSURE, INC.

Date Cleared

2016-07-21

(153 days)

Product Code

PKT,OOK

Regulation Number

Type

Panel

Reference & Predicate Devices

K150724,K150230

Intended Use

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.

Device Description

AI/ML Overview

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."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Non-invasive lipolysis of abdomen and flanks	Intended to affect the appearance of visible fat bulges in the abdomen and flanks.
Safety within specified operating parameters	Non-clinical tests (electrical safety, EMC, biocompatibility) confirm safety standards are met.
Functionality as intended	Software verification and validation confirm software performs as intended. Power output meets specification.

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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K Number

K160480

Device Name

PicoSure Workstation

Manufacturer

Date Cleared

2016-05-17

(85 days)

Product Code

GEX

Regulation Number

878.4810

Type

Panel

Cynosure, Inc. dba Ellman

Reference & Predicate Devices

K143105,K133254

Intended Use

755 nm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm 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.

1064 nm:
The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.

Device Description

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, optional 532 nm Laser Delivery System and/or 1064 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755 nm laser energy into a 532 nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PicoSure Workstation, specifically focusing on the addition of a 1064 nm Laser Delivery System. The information necessary to fully answer all aspects of your request is not entirely present in the provided document, but I will extract what is available.

Here's a breakdown of the acceptance criteria and study information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific numerical thresholds for efficacy or safety. Instead, it concludes that the device is "as effective as the predicate device" and "safe and effective."

Acceptance Criteria Category	Specific Criteria (Implicit from study goal)	Reported Device Performance (PicoSure)	Reported Performance (Predicate RevLite)
Efficacy	Overall treatment efficacy, assessed by blinded photographic evaluation using a 6-point categorical efficacy scoring scale.	4.1 / 6 overall mean score	3.7 / 6 overall mean score
Safety	Absence of deaths, serious adverse events (SAE), or unanticipated adverse device effects (UADEs).	No deaths, SAEs, or UADEs reported	(Not specified for predicate)
Comparison to Predicate	Effectiveness comparable to the predicate device.	Rated 4.1/6, showing it to be as effective as the predicate which had 3.7/6.	3.7 / 6 overall mean score

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

Sample Size: 66 subjects with a total of 79 tattoos.
Data Provenance: Not explicitly stated (e.g., country of origin). The study design indicates it was a clinical study, suggesting it was prospective.

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 reviewers.
Qualifications of Experts: Not specified beyond being "blinded reviewers." It does not state if they were dermatologists, radiologists, or had any specific years of experience.

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

Adjudication Method: "Mean scores for all three evaluators were calculated per subject to determine overall mean scores." This implies an averaging or consensus approach, rather than a specific 2+1 or 3+1 adjudication where dissenters might be reviewed by a tie-breaker.

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

MRMC Study: This was a clinical study comparing a new device (PicoSure) to a predicate device (RevLite) for tattoo removal, not an MRMC study assessing human reader performance with or without AI assistance. Therefore, this question is not applicable to the provided information.

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

This device is a laser system, not an AI algorithm. Therefore, this question about "algorithm only" performance is not applicable. The study assessed the device's clinical performance in patients.

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

The ground truth for efficacy was established by expert consensus (mean scores from three blinded reviewers) using a 6-point categorical efficacy scoring scale based on photographic evaluation.
Safety ground truth was based on the reporting of adverse events (deaths, SAEs, UADEs).

8. The sample size for the training set

This was a clinical study evaluating a medical device, not an AI algorithm that requires a training set. Therefore, this question is not applicable. The only "training" mentioned for the device itself would be internal engineering and development, not a data training set as understood in AI/ML contexts.

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

As explained above, this was not an AI algorithm study requiring a training set. Therefore, this question is not applicable.

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K Number

K150587

Device Name

Cortex Laser System

Manufacturer

Date Cleared

2015-07-21

(134 days)

Product Code

GEX

Regulation Number

878.4810

Type

Panel

Reference & Predicate Devices

K110897,K133895,K133915

Intended Use

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).

Device Description

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.

AI/ML Overview

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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K Number

K150724

Device Name

SculpSure

Manufacturer

CYNOSURE, INC.

Date Cleared

2015-07-01

(103 days)

Product Code

PKT

Regulation Number

Type

Panel