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The LYFT device is intended to be used:

LED functional mode

To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face. To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.

Micro Vibration functional mode

As an electrically powered device intended for medical purposes to relieve minor aches and pains.

The LYFT is a hand-held, rechargeable Li-Polymer battery powered device used for the treatment of mild to moderate acne, preorbital wrinkles, and the relief of minor aches and pains. The LYFT devices combines two (2) functional modes of operation, LED and micro vibration. The LED functional mode provides narrow bandwidth spectral output in the blue (430 ± 5 nm) and red (625 ± 5 nm) ranges. The micro vibration functional mode operates at a fixed frequency of 3 MHz ± 5%. The LYFT device uses a supplied power adaptor and is rechargeable.

The provided text describes a 510(k) premarket notification for the device LYFT and assesses its substantial equivalence to a predicate device, Ultra Renew Plus (K132833). However, the document does not contain specific acceptance criteria, reported device performance data, results from a clinical study for performance, nor details about sample sizes, ground truth establishment, or expert qualifications that would be typically found in a clinical study report proving a device meets acceptance criteria.

The document primarily focuses on non-clinical testing for safety and technological equivalence.

Here's an analysis based on the absence of the requested information in the provided text:

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

No explicit acceptance criteria or reported device performance for clinical effectiveness are provided in the document. The tables present technological characteristics for comparison with the predicate device, not performance against clinical endpoints.

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

Not applicable. The document does not describe a clinical performance study with a test set. The tests mentioned are non-clinical (e.g., in vitro, electromagnetic compatibility).

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. The document does not describe a clinical performance study that would require expert-established ground truth.

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

Not applicable. No clinical performance study is 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. The LYFT device is a light therapy and micro-vibration device, not an AI or imaging diagnostic tool that would typically involve an MRMC study with human readers.

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

Not applicable. The LYFT device is a physical therapeutic device, not an algorithm.

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

Not applicable. As no clinical performance study for effectiveness is detailed, there's no mention of ground truth for such a study. The "ground truth" for the non-clinical tests would be the established ISO or IEC standards.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning algorithm or a clinical study that would have a training set.

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

Not applicable. As there's no training set mentioned, this information is not provided.

Summary of Device and Evidence Provided in the Document:

The provided document is a 510(k) summary for the LYFT device. It focuses on demonstrating substantial equivalence to a predicate device (Ultra Renew Plus K132833) rather than proving the device meets clinical performance acceptance criteria through a standalone study.

The device has two functional modes:

• LED functional mode:
  • To emit energy in the red and blue region of the spectrum to treat mild to moderate acne on the face.
  • To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.
• Micro Vibration functional mode:
  • As an electrically powered device intended for medical purposes to relieve minor aches and pains.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to establish safety and technological equivalence, as listed in the "Summary of Non-Clinical Test Reports."

Non-Clinical Tests Performed (acting as evidence for substantial equivalence rather than clinical performance):

• In Vitro Cytotoxicity: Performed according to ISO 10993-5 standards.
• Skin Sensitization Test and Skin Irritation Tests: Performed according to ISO 10993-10 standards.
• Electromagnetic Compatibility Test: Performed according to IEC 60601-1-2 standards.
• Electrical Safety and Essential Performance Test: Performed according to IEC 60601-1; IEC 60601-2-57; IEC 60601-1-11 standards.
• Usability: Performed according to IEC 62366-1.
• Software Verification and Validation Test: Performed according to FDA “Guidance for Pre Market Submissions and for Software Contained in Medical Device.”

These tests demonstrate the device's safety and adherence to recognized standards, which are part of the criteria for substantial equivalence to a legally marketed predicate device. The document explicitly states: "the test results show that the subject device is substantially equivalent to the predicate devices in the market."

The comparison table (Table 1 and the subsequent table on page 5) highlights the technological similarities between LYFT and the predicate Ultra Renew Plus to support the claim of substantial equivalence.

Technological Characteristics Comparison (instead of performance criteria):

The conclusion states that based on this analysis, the LYFT "raises no different questions of safety or effectiveness and has been found to be substantially equivalent to the predicate devices."

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