(63 days)
The IPL HAIR REMOVAL Device (Model: TFDA06S-A ) is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
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The provided FDA 510(k) clearance letter and associated Indications for Use document for the "IPL Hair Removal" device (K220927) do not contain detailed information regarding acceptance criteria, specific study designs, or performance metrics from clinical trials.
FDA 510(k) clearances typically establish substantial equivalence to a predicate device, which means the new device is as safe and effective as a legally marketed device. While a 510(k) submission includes documentation of performance testing, the public clearance letter usually summarizes the outcome rather than providing the granular data often found in premarket approval (PMA) applications or detailed clinical study reports.
Therefore, I cannot extract the specific information requested in your prompt (Table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types for test/training sets, and training set size).
The document states:
- Device Name: IPL HAIR REMOVAL (Model: TFDA06S-A)
- Indications for Use: Over-the-counter device for the removal of unwanted hair and permanent reduction in hair regrowth (defined as long-term, stable reduction measured at 6, 9, and 12 months after treatment regime completion) for adults.
- Regulatory Class: Class II
To obtain the detailed information you are requesting about specific acceptance criteria and study data, one would typically need to:
- Access the full 510(k) Summary: While not included in this document, a 510(k) Summary often contains more details about the performance data presented to the FDA. These are publicly available through the FDA's 510(k) database.
- Review the actual 510(k) submission: This document (which is usually proprietary and not publicly available in its entirety) would contain the complete study protocols, raw data, statistical analyses, and reports.
- Consult relevant publications or manufacturer's technical documentation: If the device manufacturer has published clinical data or provided more detailed technical specifications, that information would be found outside of the FDA clearance letter.
In summary, based only on the provided text, none of the specific study details you've asked for (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone, ground truth info) are present. The document confirms the device's clearance based on substantial equivalence for the stated indications.
§ 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.