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The me is an over-the-counter device intended for the removal of unwanted hair.

The me device is a small over-the-counter, compact system comprised of a base unit assembly with power supply, and connected, via cable, to a handheld applicator with an air-cooling system. The device incorporates Intense Pulse Light (IPL) technology (output 2-4 J/cm'), like other OTC devices for hair removal. It also uses low RF energy (output 0.4-0.8 J/cm²) delivered through the RF electrodes. The RF signal serves primarily as a safety means to ensure skin contact before the IPL pulse is emitted. The only changes made in the current version compared to the previously cleared device relate to a minor electronics and software update, and ergonomic enhancements to the applicator and base unit control panel. All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Syneron Beauty Ltd.'s mê device:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Substantial equivalence is established by showing that the new device has the same intended use, similar technological characteristics, and does not raise new safety or effectiveness questions compared to a legally marketed predicate device.

Therefore, the document does not contain the level of detail typically found in a clinical study report that establishes performance metrics against predefined acceptance criteria for a de novo device.

Despite this, I will extract the information that is present and highlight what is missing based on your request.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document strongly emphasizes that "All key characteristics, including energy source (IPL and radiofrequency), the output of energy, the settings and pulse duration remain unchanged" compared to the predicate. The "performance data" section refers to non-clinical testing to re-validate the updated version. This means the acceptance criteria were that the updated device would perform identically to the predicate device in these non-clinical aspects.

Detailed Breakdown of Study Information (Based on the Provided Text):

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

• Sample Size for Test Set: Not applicable. The "performance data" discussed refers to non-clinical engineering and software testing of the device itself (e.g., electrical safety, EMC, software V&V, system V&V), not a clinical test set of patients.
• Data Provenance: Not applicable, as this was non-clinical engineering testing.

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. Ground truth for clinical efficacy or safety was not established for this submission as it relies on the predicate device's prior establishment. The testing mentioned (electrical, EMC, software, system) would involve engineers and testers confirming adherence to technical specifications and standards.

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

• Not applicable. No clinical test set or adjudication process 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

• No. This is not an AI/software as a medical device (SaMD) submission involving human readers or comparative effectiveness for image interpretation. It's a re-submission for a physical device with minor updates based on substantial equivalence.

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

• Not applicable. This is not a software-only device. The "software verification and validation testing" refers to the embedded software within the physical device, not a standalone algorithm for diagnostic or prognostic purposes.

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

• For the non-clinical tests: The "ground truth" was adherence to established engineering standards (e.g., for electrical safety, EMC) and the functional specifications of the device's software and system.
• For the overall device's indication of hair removal effectiveness: The ground truth would refer to the data previously submitted and accepted for the predicate device (K121598), which established the efficacy of the underlying technology for hair removal. This current submission relies on the predicate's established effectiveness and safety.

8. The sample size for the training set

• Not applicable. This device does not use machine learning that requires a "training set" in the conventional sense. The "software verification and validation testing" refers to standard software development lifecycle testing, not AI model training.

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

• Not applicable, as there is no training set for a machine learning model.

Summary of what the document does provide:

The 510(k) submission for the Syneron Beauty Ltd.'s mê device (K123845) is focused on demonstrating substantial equivalence to its predicate device (K121598). The changes in the current version are described as "minor electronics and software update, and ergonomic enhancements."

To support substantial equivalence, the submission references the following non-clinical performance testing:

• Electrical safety
• Electromagnetic compatibility testing
• Software verification and validation testing
• System verification and validation testing

These tests were conducted to re-validate the updated device against the same test methods and criteria used on the predicate device. The reported outcome is that "In all instances, the modified me device functioned as intended," meaning it met the technical and safety standards required for such a device and performed comparably to the predicate for these non-clinical aspects.

The document explicitly states that "The modified me device has the same intended uses and same indications as the predicate. The technological characteristics and principles of operation are also very similar to its predicate device. The minor differences in aesthetics, software and electronics between the modified device and its predicate device do not raise any new types of safety or effectiveness questions..." This is the core argument for its acceptance under the 510(k) pathway.

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