(54 days)
Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Hand-held IPL device (JOVS 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. Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.
The provided text is a 510(k) Summary for a medical device (Hand-held IPL device), which is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel device performance claims.
Therefore, the document does not contain the information requested regarding specific acceptance criteria, a study proving the device meets those criteria, or details about test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details typical for an AI/ML device submission for which these questions would be highly relevant.
The performance data section (Section 7) briefly mentions:
- Electrical Safety and Eye Safety: Stating that testing was performed to and passed various IEC standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83). This implies that meeting these standards' requirements for safety would be the acceptance criteria for these aspects. No specific numerical performance figures are given beyond "passed."
- Software Verification and Validation: Mentions that software documentation consistent with a moderate level of concern was submitted, and "System validation testing... demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels." This is a high-level statement and does not provide specific performance metrics or studies.
- Usability: States that usability testing was performed to and passed IEC 60601-1-6.
In summary, the document addresses safety and basic performance by stating compliance with recognized electrical safety, eye safety, and usability standards, and that software requirements were met and hazards mitigated. However, it does not provide the specific type of detailed performance study data (e.g., sensitivity, specificity, accuracy, or comparative clinical effectiveness metrics) that would typically be described with the types of questions posed in your prompt, particularly related to AI/ML device performance.
This 510(k) submission primarily relies on demonstrating substantial equivalence through comparison of technological characteristics and confirmation of compliance with established safety standards for similar devices, rather than a novel clinical validation study with the metrics you've requested.
§ 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.