(85 days)
The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, telangiestasia, port wine stains, leg veins and other benign vascular lesions.
The InMode VLaze device is designed to deliver diode laser 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 VLaze device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. 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 VLaze device laser with linear scanning system, cooled sapphire output window (3 x 4mm2), 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 7°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence is delivered within the limits of 40 to 300J/cm². The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector.
The provided text describes the InMode VLaze laser surgical instrument and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance.
Instead, the document focuses on:
- Regulatory Compliance: Demonstrating that the device adheres to recognized voluntary performance standards for medical electrical equipment and laser product safety (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
- Substantial Equivalence: Arguing that the InMode VLaze device is substantially equivalent to previously cleared predicate devices (Lumenis Ltd. ET Lightsheer 1060, Quanta System SPA EVO Platform, and InMode MD Ltd. InMode Diolaze XL) based on its intended use, design, components, performance specifications (wavelength, fluence, pulse width, cooling), and safety features.
The document explicitly states under "Clinical Performance Data": "Not Applicable". This means no clinical study with human subjects was conducted to evaluate the device's efficacy or performance in terms of treatment outcomes for vascular lesions for this 510(k) submission. Therefore, it's not possible to extract the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these pertain to clinical or AI/algorithm performance evaluation, which was not part of this specific submission.
Summary of what can be extracted from the provided text:
- Device Performance (as per non-clinical testing): The device was tested for compliance with electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22). The "Non-Clinical Performance Data" section states, "The test results show that the device performance specifications meet the system requirements."
- No Clinical Study Details: The document explicitly states "Clinical Performance Data: Not Applicable." This means no clinical study measuring treatment effectiveness or outcomes was submitted or is detailed.
Therefore, based on the provided text, the following information cannot be provided:
- A table of acceptance criteria and reported device performance related to clinical efficacy or diagnostic accuracy.
- Sample sizes used for a test set for clinical performance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or effect size of human readers with/without AI assistance.
- If a standalone algorithm performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
- Sample size for a training set (as no AI/algorithm is detailed).
- How ground truth for a training set was established.
§ 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.