(89 days)
The InMode Hair Removal (HR) device is indicated for use for hair removal.
The InMode Hair Removal (HR) device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between 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 InMode HR 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 Hair Removal 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 HR 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 to the hand piece to the console via a connector.
The manufacturer, InMode MD Ltd., states that the InMode Hair Removal (HR) device is substantially equivalent to two predicate devices: Lumenis Ltd.'s LightSheer (K001746) and Quantel Derma GmbH's Leda EPI 808 (K090762). Therefore, the acceptance criteria for the InMode Hair Removal (HR) device are based on demonstrating its equivalence to these predicate devices in terms of design, performance, and safety.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Demonstrates equivalence to predicate devices) | Reported Device Performance (InMode Hair Removal (HR) device) |
|---|---|---|
| Intended Use/Indications for Use | Same as predicate devices for hair removal. | Indicated for use for hair removal, same as predicate devices. |
| Design and Components | Similar to predicate devices (console with power supply, software, cooling system, touch screen UI; water-cooled hand piece with cable/connector; foot switch). | Similar design and components to predicate devices. |
| Performance Specifications | Similar wavelength, fluence, pulse width, pulse repetition rate, spot size, and cooling as predicate devices (LightSheer and Leda EPI 808). | Similar performance specifications (wavelength, fluence, pulse width, pulse repetition rate, spot size, cooling) to predicate devices. Bench tests showed same laser output specifications as Leda EPI 808. |
| Safety Features | Substantially equivalent to safety features in predicate devices. | Safety features substantially equivalent to predicate devices. Device complies with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, and IEC 60601-1-4. |
| Software and Specifications | Any minor differences meet system requirements and do not raise new safety or effectiveness concerns. | Performance tests demonstrated that minor differences meet system requirements and do not raise new safety or effectiveness concerns. |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable for a human subject test set. The document describes non-clinical bench testing.
- Data provenance: Not explicitly stated for specific data points, but the testing was conducted by InMode MD Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a non-clinical bench test comparing output parameters, not a clinical study requiring expert ground truth for efficacy.
4. Adjudication method for the test set:
- Not applicable. The "test set" refers to bench testing to compare device parameters, not a clinical trial requiring adjudication of outcomes.
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 device is a hair removal laser, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance assessment focused on the device's technical specifications and safety compliance. "Clinical Performance Data: Not Applicable" is explicitly stated. Therefore, a standalone algorithm performance study (as would be relevant for software/AI) was not performed. The performance evaluation was based on bench testing of the physical device's output parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance data, the "ground truth" was established by the specified laser output parameters of the predicate devices (Leda EPI 808) and compliance with various international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22, IEC 60601-1-4).
8. The sample size for the training set:
- Not applicable. This device is a laser system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there was no training set for a machine learning algorithm.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.