(59 days)
The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.
The Intense pulsed light device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G twelve models. All have adopted the same structure design, consisting of Intense pulsed light device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly product size, appearance, sapphire, skin color recognition function and enclosure color, DE01A series means without sapphire and skin color recognition function. DE01B series means with sapphire, but without skin color recognition function. DE01C series means with sapphire and skin color recognition function. DE02A series means without sapphire and skin color recognition function. DE02B series means with sapphire, but without skin color recognition function. DE02C series means with sapphire and skin color recognition function. Letter -B the enclosure color is blue, letter -G is green, which do not affect the intended use.
The provided text is a 510(k) summary for an Intense Pulsed Light (IPL) device intended for over-the-counter hair removal. It details the device's characteristics, comparison with predicate devices, and performance data submitted to support substantial equivalence.
However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of advanced AI/ML performance metrics (e.g., accuracy, sensitivity, specificity). The performance data shared are related to:
- Biocompatibility Testing: Ensuring the device materials are safe for human contact.
- Electrical Safety and EMC: Verifying the device meets electrical safety and electromagnetic compatibility standards.
- Eye Safety: Confirming the device is safe for eye exposure.
- Software Verification and Validation: Demonstrating that software meets requirements and mitigates hazards.
- Usability: Evaluating and verifying the product's usability.
These are standard regulatory requirements for medical devices, particularly for consumer-grade devices like the IPL hair removal system. They are not AI/ML performance metrics.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about a study proving this in the context of an AI-driven device, because the provided text is for a physical IPL device and does not mention any AI/ML components or associated performance studies. The request's questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are specific to the evaluation of AI/ML algorithms in medical imaging or diagnostics, which is not the subject of this 510(k) submission.
§ 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.