(150 days)
The InMode Diolaze XL System is intended for hair removal and permanent hair reduction defined as stable, long-term reduction in hair counts at 6,9 or 12 months following a treatment regime.
The InMode Diolaze XL device is designed to deliver optical energy to the skin via a pre-cooled 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 hand piece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode Diolaze XL device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The 810nm diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece comprises the InMode Diolaze XL with 20 diode laser bars stacked vertically. The diode is enclosed to the sapphire light guide. The diode laser produces up to 3000W peak optical power.
The provided FDA 510(k) summary for the InMode Diolaze XL device does not describe acceptance criteria in the context of a study definitively proving the device meets those criteria, nor does it present the results of a clinical study demonstrating performance against such criteria.
Instead, the document details the device's technical specifications and asserts its "substantial equivalence" to a predicate device (Lumenis Ltd. Lightsheer Desire (ET) K151947) based on similarities in intended use, technological characteristics, and compliance with recognized performance standards (non-clinical data).
Therefore, I cannot extract the specific information requested in your prompt as it is not present in the provided text.
Here's a breakdown of what is and is not in the document:
1. A table of acceptance criteria and the reported device performance
- Not present for clinical performance. The document provides a table comparing the InMode Diolaze XL's technical specifications (wavelength, fluence, pulse duration, cooling temperature) to the predicate device. It also states the device "operates in accordance with the device design requirements and performs within the range of laser specifications as to that of the predicate device." This is a general statement about non-clinical performance and not specific to clinical acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. No clinical test set or data provenance is mentioned.
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 present. No clinical ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. No clinical adjudication method is mentioned.
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 present. This device is a laser for hair removal, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not present. This device is a laser for hair removal, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No clinical ground truth is mentioned. The "ground truth" for showing substantial equivalence appears to be the predicate device's existing clearance.
8. The sample size for the training set
- Not present. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Not present. No training set for an algorithm is mentioned.
Summary of what the document does provide regarding "performance":
The document focuses on non-clinical performance testing and substantial equivalence.
- Non-Clinical Performance Data: The InMode Diolaze XL device's laser output parameters were evaluated for compliance with recognized consensus standards:
- AAMI ANSI: ES 60601-1:2005/(R)2012 and A1:2012. C1:2009/(R)2012 . and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2007-03(Modified), Medical Electrical Equipment Part 1-● 2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-22 Edition 3.1 2012-10, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1: Edition 2.0 2007-03, Safety of laser products - Part 1: Equipment classification and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)].
- Reported performance: "The results of these performance tests demonstrated that the InMode Diolaze XL device operates in accordance with the device design requirements and performs within the range of laser specifications as to that of the predicate device and therefore, is substantially equivalent to the predicate device."
- Clinical Performance Data: "Not Applicable" is explicitly stated.
The basis for clearance is demonstrating that the InMode Diolaze XL has similar technological characteristics and the same intended use as a legally marketed predicate device, and that these similarities do not raise different questions of safety and effectiveness. This is typical for a 510(k) submission, especially when clinical data is not deemed necessary due to substantial equivalence.
§ 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.