(47 days)
The iPulse i150 System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology. The iPulse i150 system emits a wavelength of 530nm to 1200nm and is specifically intended for the long term stable, or permanent, reduction in hair.
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The provided text is a 510(k) clearance letter from the FDA for the "IPL iPulse i150 System" and indicates that the device is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed information about specific acceptance criteria and the results of a study demonstrating fulfillment of those criteria as it is primarily a regulatory clearance based on substantial equivalence.
The information requested in your prompt (e.g., specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, expert qualifications, etc.) are usually found in the original 510(k) submission document itself, which is not included here. This letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.
Therefore,Based on the provided document, I cannot fulfill your request for the following reasons:
- No acceptance criteria or device performance data is stated: The document is an FDA clearance letter based on substantial equivalence, not a summary of performance study results against specific criteria.
- No study details are provided: The letter does not describe any specific study conducted to prove the device meets acceptance criteria.
- Specifics of the requested details are absent: All points listed in your request (sample sizes, data provenance, expert details, adjudication, MRMC study, standalone performance, ground truth types, training set details) are not present in this regulatory clearance letter.
To obtain the information you're looking for, you would typically need to refer to the original 510(k) submission document from the manufacturer or publicly available summaries of those submissions that may include clinical or performance data.
§ 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.