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The Poly Clear combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

The Poly Clear is a portable device that has three separate detachable treatment heads, each containing a total of 1,820 LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment heads) for the device. 6 pairs of protective eyewear are included with the device.

The provided text is a 510(k) summary for the Poly Clear device, which is a light therapy device for treating mild to moderate acne vulgaris. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data.

Crucially, the document explicitly states that "no clinical studies required" (page 6). This means there are no acceptance criteria related to a clinical study demonstrating the device's efficacy in treating acne vulgaris, nor is there a study detailing device performance against such criteria.

The acceptance criteria provided in the document and the associated "study" (non-clinical testing) are focused on safety and technological equivalence.

Here's an analysis based on the information provided, highlighting the absence of clinical performance data:

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

The document does not present acceptance criteria for clinical performance (e.g., reduction in acne lesions) because it states no clinical studies were required. The "performance" discussed is primarily non-clinical.

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

• For safety and bench testing: The document does not specify sample sizes (e.g., number of devices tested). These are typically laboratory tests on a representative number of units. The provenance is internal testing performed by the sponsor or contracted labs.
• For usability testing: The document mentions "intended users" were involved in the Usability/Label Comprehension study, but does not state the sample size, country of origin, or whether it was prospective or retrospective. It's almost certainly prospective as it's a study conducted for this submission.

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)

Not applicable. For non-clinical (engineering/safety) testing, "ground truth" is established by adherence to recognized international standards and specifications, rather than expert human assessment of medical images or conditions. For usability, the "ground truth" is the ability of intended users to successfully operate the device and understand instructions, as observed during the usability study, not by experts establishing clinical truth.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpreting diagnostic results or assessing patient outcomes, particularly when there is subjectivity. The provided non-clinical testing does not involve such methodologies.

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 Poly Clear device is a light therapy device, not an AI-powered diagnostic or assistive tool. No MRMC studies were conducted, as the device does not involve "human readers" or AI assistance in this context.

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

Not applicable. The Poly Clear is a hardware device, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by:

• International Consensus Standards: For electrical, EMC, and lamp safety, the ground truth is compliance with the specified IEC standards.
• Device Specifications: For performance bench tests (e.g., power density, timer), the ground truth is meeting the manufacturer's defined specifications.
• Observational Data/User Feedback: For usability testing, the ground truth is the successful demonstration of understanding and operation by the intended users during the study.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

In summary: The 510(k) submission for the Poly Clear device relies on demonstrating substantial equivalence through non-clinical testing (safety and performance bench tests) and comparative analysis of technological characteristics with predicate devices. No clinical studies were required, and therefore, no clinical performance acceptance criteria or corresponding clinical efficacy data are present in this document.

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The Poly Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Poly Rejuv is a portable device that has a detachable treatment head, containing a total of 1,820 red LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment head) for the device. 12 pairs of protective eyewear are included with the device. The device is sold as Over the Counter (OTC) to commercial establishments only and not for home use. The Poly Rejuv is not intended to be used by laypersons. Poly Rejuv is intended to only be operated by a person who has been trained by the Sponsor according to their Customer Training Plan.

The Poly Rejuv device (Model 633) is intended for dermatological use to treat periorbital wrinkles by emitting red region energy. The clearance is based on substantial equivalence to predicate devices, supported by non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the Poly Rejuv Model 633 does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., specific percentage reduction in wrinkles, or a statistical significance level for improvement). Instead, substantial equivalence is established through comparison of technological characteristics with a predicate device and extensive non-clinical (bench) testing. The "acceptance criteria" can be inferred as demonstrating that the device is as safe and effective as legally marketed predicate devices, with no new issues regarding safety and effectiveness.

The table below summarizes the key comparative characteristics presented in the 510(k) summary that serve as the basis for demonstrating this "acceptance."

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

The submission does not describe a clinical study or a test set of data (e.g., patient data). The clearance is based on non-clinical (bench) testing and comparison of technical specifications to predicate devices. Therefore, there is no mention of sample size for a test set or data provenance from a human study.

The testing conducted was primarily hardware-related (electrical safety, EMC, lamp safety, device-specific safety, usability, and bench testing for power density, timer, functions, use life, and storage conditions) and software validation. These tests are conducted on the device itself, not on human subjects.

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)

Not applicable, as no clinical test set or ground truth by medical experts was described for this 510(k) submission. The evaluation was based on engineering and performance standards conformance.

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

Not applicable, as no clinical test set requiring adjudication was described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an LED therapy system for wrinkle reduction, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

Not applicable. This is a physical medical device (LED therapy system), not an algorithm.

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

Not applicable, as no clinical ground truth from human studies was used for this 510(k) submission. The "ground truth" for the non-clinical testing was based on established engineering and safety standards (e.g., IEC standards) and the specified performance characteristics of the device and its predicates.

8. The sample size for the training set

Not applicable. As no artificial intelligence (AI) or machine learning (ML) algorithm is mentioned in the submission, there is no "training set" in that context. The device's software was subjected to validation testing, but this is distinct from training an AI model.

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

Not applicable, as no training set for an AI/ML algorithm was described.

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