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DermRays Revive is intended for hair reduction. Permanent hair reduction is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

DermRays Revive is also intended for treatment of wrinkles.

DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

DermRays Revive uses a diode laser with an output wavelength of 1064nm, to act on the dermis through the epidermis, and the laser energy is absorbed by the target tissues (melanin, hemoglobin, and water).

Due to the selective photothermal effect of the laser, it can treat wrinkles, without damaging the skin. Simutaneously, the laser can act on the melanin in the hair follicles, destroy hair follicles in the growth around the hair follicles, so as to remove hairs.

The device consists of a power adapter, a power cord and a main unit.

The provided text is a 510(k) summary for the DermRays Revive device, which is a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical trial or extensive performance testing with clearly defined metrics.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert ground truth establishment, and MRMC studies are not present in this document because they are generally not required for a 510(k) submission that relies on demonstrating substantial equivalence to existing predicate devices, especially when no clinical testing was performed.

However, based on the information provided, here's what can be extracted and what is explicitly stated as not performed:

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

The document does not provide a specific table of quantitative "acceptance criteria" for the device's clinical performance (e.g., a specific percentage of hair reduction or wrinkle improvement expected). Instead, it demonstrates substantial equivalence to predicate devices based on shared technical characteristics and intended use. The "performance" assessment is primarily through non-clinical testing to ensure safety and functionality.

The table presented (Table 1) is a comparison of the proposed device's technical specifications and intended uses against its predicate devices, not acceptance criteria for clinical efficacy.

Table 1: Comparison of Proposed Device (DermRays Revive) with Predicate Devices (Summary)

Study Proving Device Meets Acceptance Criteria:

The study proving the device's substantial equivalence and suitability for market is detailed through non-clinical testing as follows:

• Biocompatibility Testing: Performed on parts contacting skin (ISO 10993-1, -5, -10, -23)
• Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22 and IEC 60825-1.
• Software Verification and Validation: Performed according to FDA guidance.
• Performance Testing - Bench: Appearance, Function, Safety, Label.
• Shelf Life Test: Accelerated aging test and subsequent performance test.
• Cleaning and Disinfection Verification: Simulated cleaning and disinfection test and subsequent performance test.

The document explicitly states: "No clinical testing has been performed." This is a critical point for the remaining questions.

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

• Test Set Sample Size: Not applicable in the context of a clinical test set, as no clinical testing was performed. The non-clinical tests involved samples of the device and its components.
• Data Provenance: The general context of the submission implies that all testing (biocompatibility, electrical safety, software, bench performance) was conducted by or for Wuhan Lotuxs Technology Co., Ltd. (China). The document does not specify whether these tests were done retrospectively or prospectively, but typically, pre-market non-clinical testing for a 510(k) is performed prospectively.

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

• Not Applicable: Since no clinical studies were performed, there was no "ground truth" to establish for a test set by human experts (like radiologists for imaging devices). The ground truth for the non-clinical tests is based on adherence to established engineering, safety, and performance standards.

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

• Not Applicable: No clinical test set requiring expert adjudication was utilized.

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: The document explicitly states "No clinical testing has been performed." Therefore, no MRMC study was conducted, and no human-AI interaction or improvement was assessed. The device described is a laser instrument, not an AI diagnostic or assistance tool.

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

• Not Applicable: This device is a physical laser instrument. While it has software, its "performance" is primarily mechanical and energy delivery, not an algorithm providing a diagnostic or analytical output that would have a standalone performance metric in the way AI algorithms do. The software verification and validation ensured the software performs as intended for device operation, not as a standalone analytical tool.

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

• Not Applicable for Clinical Performance: As no clinical studies were performed, there was no clinical "ground truth" established from expert consensus, pathology, or outcomes data for efficacy.
• For Non-Clinical Tests: The "ground truth" for the non-clinical tests is defined by the requirements of the standards themselves (e.g., maximum allowable cytotoxicity, specific electrical safety thresholds, software functionality specifications).

8. The sample size for the training set

• Not Applicable: There is no mention of a "training set" for an algorithm in the context of this laser device submission.

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

• Not Applicable: As no training set was mentioned.

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Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction.

Permanent hair reduction is defined as the 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. Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The Diode Laser Hair Removal device models LHR-V6S-1064 and LHR-V6S/B-1064 emit pulses of invisible infrared laser light of 1064nm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.

Here's an analysis of the provided text regarding acceptance criteria and studies demonstrating device performance:

Unfortunately, the provided document does not contain information about acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity) of a diagnostic or AI-driven device, nor does it describe a study proving the device meets such criteria.

The document details a 510(k) premarket notification for a Diode Laser Hair Removal device (LHR-V6S-1064, LHR-V6S/B-1064). The focus of this submission is on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, indications for use, and non-clinical safety testing.

Here's a breakdown of why the requested information isn't present and what information is provided:

Key Takeaways from the Document:

• Device Type: It's a physical medical device (laser for hair removal), not a diagnostic or AI-powered software device.
• Regulatory Pathway: 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive performance studies against specific acceptance criteria.
• No Clinical Study: The document explicitly states: "No clinical testing has been performed." This directly indicates that there aren't clinical performance metrics or studies to assess against acceptance criteria.
• Focus on Substantial Equivalence: The primary goal of the submission is to show that the proposed device is "as safe, as effective, and performs as well as or better than the predicate device" based on design, specifications, and non-clinical tests.

Response to your specific questions based on the provided document:

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

   • N/A. The document does not define specific performance acceptance criteria for a diagnostic or AI algorithm, nor does it report performance metrics against such criteria. The "performance testing" mentioned (Appearance, Function, Safety, Label, Shelf Life, Cleaning and Disinfection) are general bench tests for a physical device, not performance metrics like sensitivity or accuracy for a diagnostic.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. No clinical test set or data for performance evaluation (e.g., diagnostic accuracy) is mentioned because "No clinical testing has been performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. No clinical test set requiring ground truth established by experts is mentioned.

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

   • N/A. No clinical test set requiring adjudication is mentioned.

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. This device is for hair removal, not a diagnostic tool with AI assistance for human readers. No MRMC study was conducted.

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

   • N/A. This is a physical laser device, not an algorithm.

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

   • N/A. No clinical ground truth is established as no clinical studies were performed.

8. The sample size for the training set:

   • N/A. This refers to a dataset for training an algorithm. This device is not an AI algorithm.

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

   • N/A. As above, this is not an AI algorithm.

Information that is available about device equivalence and non-clinical testing:

• Non-Clinical Tests Submitted:
  • Biocompatibility Testing: According to ISO 10993-1:2018, including in vitro cytotoxicity (ISO 10993-5:2009), skin sensitization (ISO 10993-10:2021), and irritation (ISO 10993-23:2021). These tests were performed for parts contacting intact skin.
  • Electrical Safety and Electromagnetic Compatibility Testing: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22, and IEC 60825-1.
  • Software Verification and Validation: Performed according to FDA guidance for software in medical devices.
• Concise summary for performance testing (Bench Tests):
  • Appearance, Function, Safety, Label.
  • Shelf Life Test (accelerated aging).
  • Cleaning and Disinfection Verification.

In summary, the provided document is a 510(k) clearance for a laser hair removal device, focusing on demonstrating substantial equivalence through technical specifications and non-clinical safety tests, not clinical performance against specific acceptance criteria for a diagnostic or AI device.

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Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Har Removal is also intended for permanent reduction in hair regrowth defined as a 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.

The Diode Laser Hair Removal device models LHR-V8S-810, LHR-V8-810, LHR-V4S-810, and LHR-V4-810 emit pulses of invisible infrared laser light of 810mm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.

The provided document describes a 510(k) premarket notification for a Diode Laser Hair Removal device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and safety/performance testing of physical aspects of the device, not its AI/ML performance.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
• Standalone performance (AI/ML without human-in-the-loop).
• Type of ground truth used (for AI/ML).
• Sample size for the training set.
• How ground truth for the training set was established.

The document lists "Performance Data" which includes Biocompatibility Testing and Electrical, EMC, and laser output, Safety and Performance Testing. These are standard safety and engineering tests for a physical medical device, not performance studies for an AI/ML algorithm.

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The Powersculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

The Powersculp laser lipolysis system is a diode laser system. Electrically efficient semiconductors generate optical radiation (1060 mm) which is used to deliver laser energy to subcutaneous tissue layers. The Powersculp laser lipolysis system is capable of peak powers of 50W. The main components of Powersculp laser lipolysis system are a console and four applicators.

The provided text describes a 510(k) premarket notification for the "Powersculp laser lipolysis system" and primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for de novo performance validation as one might see for an AI/ML device.

Therefore, the document does not contain the specific information required to answer questions 1-9 comprehensively for a device proving it meets acceptance criteria through clinical studies. The submission explicitly states that clinical tests were not performed for the Powersculp given its substantial equivalence to already marketed devices.

However, I can extract information related to the device's technical specifications and how the manufacturer states the device meets safety and effectiveness requirements by relying on existing predicate devices and non-clinical testing.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is explicitly lacking for the prompt's requirements:

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence" to Predicates)

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence (SE) to legally marketed predicate devices. The performance is not measured against explicit clinical thresholds in this document, but rather by showing comparable technology and safety.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) based on substantial equivalence, there are no specific performance acceptance criteria like sensitivity, specificity, or accuracy for a diagnostic AI. Instead, the acceptance is based on demonstrating the proposed device is as safe and effective as the predicates. The "performance" is implicitly tied to the general performance of the predicate devices.

The table below summarizes the comparative attributes that, when deemed "similar" or "same" to the predicate, imply acceptance for a 510(k) submission.

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

• Sample Size: N/A for clinical testing. The submission states: "Lotuxs belives that the proposed device Powersculp laser lipolysis system PSP050 does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference."
• Data Provenance: N/A for clinical testing of the proposed device itself. Any referenced clinical data would be from the predicate devices (likely retrospective studies conducted by their manufacturers).

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

• N/A. No de novo clinical test set was used for the proposed device, as no clinical studies were performed.

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

• N/A. No de novo clinical test set was used.

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. This device is a laser system for lipolysis, not an AI-assisted diagnostic or imaging device for human readers. No MRMC study was mentioned or required.

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

• N/A. This applies to an algorithm/AI, not a physical laser system. The "performance" of the device is its ability to perform lipolysis, not to interpret data.

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

• N/A. For this 510(k), the "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness of the predicate devices and robust non-clinical (bench) testing of the proposed device itself. The non-clinical tests included:
  • Software verification and validation (demonstrated performance as intended per FDA guidance).
  • Power output testing (confirmed specification).
  • Electromagnetic compatibility (EMC) and electrical safety testing (confirmed compliance with standards ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
  • Biocompatibility assessment of patient-contacting materials (per ISO 10993-1).

8. The sample size for the training set

• N/A. This device has no "training set" in the context of an AI/ML model.

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

• N/A. Does not apply to this type of device.

Summary of how the device meets acceptance criteria (implicit in a 510(k)):

The Powersculp laser lipolysis system meets the implicit acceptance criteria for a 510(k) clearance by demonstrating substantial equivalence (SE) to legally marketed predicate devices (K160470 and K150230 Sculpsure). The manufacturer asserted that the proposed device has the same indications for use, fundamental operating theory, structure, components, laser type, lipolysis method, wavelength, pulse width, cooling method, and patient attachment method as the predicate devices.

Minor differences in spot size, power density, peak power, and power supply were argued not to affect safety and effectiveness. Non-clinical tests, including software verification and validation, power output testing, electromagnetic compatibility, electrical safety testing, and biocompatibility assessment, were performed to demonstrate that the device itself is safe and performs as intended, in line with recognized standards. This approach, outlined in Section 9 and 10 of the K191068 submission, negates the need for new clinical trials for this specific device.

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