(88 days)
The Hand-held IPL device (JOVS Graphene Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.
The Hand-held IPL device (JOVS Graphene Hair Removal Device) is a personal, light-based, hair reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only. The Hand-held IPL device (JOVS Graphene Hair Removal Device) includes JOC-910-Yellow and JOC-910-Emerald. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.
The provided text describes the regulatory clearance of a Hand-held IPL device (JOVS Graphene Hair Removal Device) by the FDA, based on its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it detail a comparative effectiveness study involving human readers or standalone AI performance.
The "Performance Data" section (Page 7 & 8) refers to various standard tests conducted for medical devices, such as:
- Biocompatibility Testing: ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and skin sensitization).
- Electrical Safety and Eye Safety: IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83.
- Software Verification and Validation: Stated as consistent with a moderate level of concern, with system validation testing demonstrating met requirements and mitigated hazards.
- Usability: IEC 60601-1-6.
These are standard engineering and safety tests for the device itself, not performance metrics for an AI algorithm's diagnostic capabilities or improvement of human reader performance. The document explicitly states: "Performance data supports that the device is safe and as effective as the predicate device for its intended use." This "performance data" refers to the types of tests listed above, which demonstrate the device's adherence to safety standards and its functional characteristics (e.g., energy density, wavelength) being comparable to legally marketed predicates.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device's performance or its impact on human readers, as the provided document is for a physical IPL device and describes a substantial equivalence determination based on standard device safety and performance characteristics, not an AI algorithm.
The document does not contain the following information, which would be relevant for an AI/ML study focused on diagnostic performance:
- A table of acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
- Reported device performance against those criteria.
- Sample sizes for test sets used for AI model evaluation.
- Data provenance for AI evaluation (e.g., retrospective/prospective, country of origin).
- Number/qualifications of experts for AI ground truth.
- Adjudication methods for AI ground truth.
- MRMC comparative effectiveness study details (effect size of AI assistance).
- Standalone AI performance metrics.
- Type of ground truth used for AI (e.g., pathology, outcomes data).
- Sample size and ground truth establishment for AI training sets.
§ 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.