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The InMode Diolaze device is indicated for use for hair removal and for permanent reduction in hair regrowth, 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.

The InMode Diolaze device is designed to deliver optical energy to the skin via a precooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The scanning system embedded into the laser of the InMode Diolaze device hand piece allows efficient treatment with less risk of overlap. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment.

The InMode Diolaze device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and user interface including an LCD screen and functional buttons. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode Diolaze device laser with linear scanning system, cooled sapphire output window (8 x 50mm), and electronic shutter.

The sapphire light guide is located on the front tip of the hand piece and delivers the laser beam energy to the treated tissue, while cooling the skin. The pair of thermoelectric coolers (TECs) located on both sides of the sapphire block provide cooling to a temperature of 4°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence (light energy density) is delivered within the limits of 10 to 60J/cm². The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector.

This document is a 510(k) Pre-Market Notification from the FDA regarding the InMode Diolaze Device. It addresses the device's substantial equivalence to other legally marketed devices, primarily for hair removal and permanent reduction in hair regrowth.

Based on the provided text, the InMode Diolaze Device did not undergo a clinical study to prove its performance against acceptance criteria. Instead, its acceptance was based on non-clinical performance data and substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance: No specific performance acceptance criteria related to a clinical outcome are described, nor are clinical performance results provided. The acceptance concerned the device's technical specifications and safety matching those of predicate devices.
2. Sample sizes used for the test set and the data provenance: No test set of clinical data was used; the evaluation was based on comparisons to predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth was established through expert review of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no 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: Not applicable. This device is a laser for hair removal, not an AI for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No clinical ground truth was used. The "ground truth" for substantial equivalence was the established specifications and safety profile of the predicate devices.
8. The sample size for the training set: Not applicable as no machine learning model was developed or trained for this device.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance and Study Justification (based on the provided text):

The InMode Diolaze Device's acceptance by the FDA was based on its substantial equivalence to existing, legally marketed predicate devices. This approach, common for 510(k) submissions, means the device was determined to be as safe and effective as a predicate device and did not require new clinical performance data.

The justification for this substantial equivalence included:

• Identical Design and Components: The InMode Diolaze device is described as identical to the InMode Hair Removal (HR) device (K123682) in its console, handpiece, and foot switch. It is also similar in design and components to the Leda EPI 808 (K090762) predicate device.
• Identical/Similar Performance Specifications: The device's performance specifications (wavelength, fluence, pulse width, pulse repetition rate, spot size, and cooling) are stated to be identical to the InMode HR device and similar to the Leda EPI 808.
• Identical/Equivalent Safety Features: The safety features are deemed substantially equivalent to the predicate devices.
• Non-Clinical Performance Data: Bench tests were conducted on the InMode Hair Removal (HR) device (which is stated to be the same device as the InMode Diolaze) to compare its laser output parameters to those of the Leda EPI 808 predicate device. These tests demonstrated that the InMode HR device (and thus the Diolaze) has the same laser output specifications as the predicate.
• Adherence to Standards: The device complies with relevant IEC standards for medical electrical equipment, safety of laser products, and particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment.

A dedicated clinical study (as would be typical for proving performance against specific clinical acceptance criteria for novel devices) was explicitly stated as "Not Applicable" for this 510(k) submission. The core of the acceptance was the demonstration that the InMode Diolaze product possesses the same fundamental technology, specifications, and safety profile as already cleared devices, making it "substantially equivalent."

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