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The LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne.

The LED Light Therapy Device is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm) and/or in the blue light region of the spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. This device is made up of a main unit and therapy head. The light gathering cover is also referred to as the snoot. The snoot helps to establish the correct treatment distance.

The document describes a 510(k) premarket notification for a medical device called "LED Light Therapy Device" (Models KN-7000C and KN-7000C2), indicated for the treatment of mild to moderate inflammatory acne. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with quantifiable metrics like sensitivity or specificity.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or effect size for AI improvement) is not present in the provided text. The submission relies on demonstrating similarity to already cleared predicate devices.

However, the document does contain information about non-clinical tests performed to ensure safety and usability. These non-clinical tests can be considered as acceptance criteria for regulatory compliance and device safety/functionality rather than clinical efficacy.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with "acceptance criteria" in terms of clinical performance metrics, nor does it report specific clinical performance against such criteria. Instead, it demonstrates compliance with recognized safety and electrical standards, and usability.

Non-Clinical Acceptance Criteria and Reported Performance (Based on provided text):

2. Sample Size for Test Set and Data Provenance

• Non-Clinical Tests (Biocompatibility, Electrical Safety, Photobiological Safety, Software V&V): The document does not specify a "sample size" in terms of number of devices for these tests. These are typically performed on a representative sample or prototype.
• Usability Study:
  • Sample Size: "The required number of participants was obtained through networking, social media and advertising in the local newspaper." A specific number is not given, but implies a sufficient number for a usability assessment.
  • Data Provenance: Conducted in Hudson Falls, NY, USA. The study appears to be prospective for evaluating the device's usability with human participants.

3. Number of Experts for Ground Truth & Qualifications

Not applicable. This was a non-clinical evaluation for regulatory compliance and substantial equivalence, not a clinical study requiring expert-established ground truth for performance metrics.

For the usability study, the "ground truth" was essentially the participants' ability to understand and use the device. The evaluators were the participants themselves, and the study was conducted by Dave Oberhelman, Plant/Compliance Manager at UVBioTek.

4. Adjudication Method

Not applicable. No clinical ground truth requiring adjudication methods was established.

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

No. The document describes a 510(k) submission based on substantial equivalence and non-clinical testing. It does not include a comparative effectiveness study, especially one involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is an LED light therapy device, not an AI or software algorithm that would have "standalone performance" in the typical sense of diagnostic or prognostic AI. The "software verification and validation" (Section 9) refers to the embedded software in the device, ensuring its functional correctness and safety, not a standalone clinical performance evaluation.

7. Type of Ground Truth Used

• For Non-Clinical Tests: The "ground truth" was adherence to established international and national standards (ISO, IEC, AAMI/ANSI).
• For Usability Study: The "ground truth" was the participants' demonstrated ability to understand and operate the device correctly, and their feedback on the user manual.

8. Sample Size for Training Set

Not applicable. The document does not describe a machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable. No training set for an AI algorithm was used.

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

The Photodynamic Therapy Device KN-7000A is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the light spectrum (633±10mm) and/or in the blue light region of the light spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. There are three irradiators available, Blue LED, Red LED and Blue/Red LED. This device is mainly made up of the main frame, the irradiator, and the lifting stand.

I am sorry but the provided documents do not contain the details necessary to complete the request. The document is a 510(k) premarket notification for a Photodynamic Therapy Device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

Specifically, the following information is missing:

• Acceptance Criteria and Reported Device Performance Table: While the document mentions "performance effectiveness" and "performance safety," it does not list specific acceptance criteria or quantitative performance metrics.
• Sample size for the test set and data provenance: No information is provided about a specific "test set" or its size, country of origin, or whether it was retrospective or prospective.
• Number of experts used to establish ground truth and their qualifications: The document does not describe any human-established ground truth for a test set.
• Adjudication method: No adjudication method is mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of an MRMC study or any effect size for human readers with and without AI assistance.
• Standalone (algorithm-only) performance: The document describes a "Photodynamic Therapy Device," which is a light-emitting device, not an algorithm. Therefore, standalone algorithm performance is not applicable or discussed.
• Type of ground truth used: Since no test set or ground truth establishment is described, this information is not available.
• Sample size for the training set: There is no mention of a "training set" as the device is not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable, as there is no training set described.

The document primarily focuses on:

• Comparing the specifications of the proposed device (Photodynamic Therapy Device KN-7000A) to a predicate device (Aklarus Phototherapy System) to establish substantial equivalence.
• Listing compliance with general medical device standards (e.g., IEC 60601 series).
• Mentioning a thermal performance test on human volunteers to ensure skin temperature remains below 41 degrees C.
• Software verification activities.

It does not present a clinical study with detailed acceptance criteria and performance results in the context of an AI/ML device typically associated with such a request.

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