(84 days)
PEACH 2, PEACH 2 Duo and PEACH 2 Go are over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
Not Found
Based on the provided text, the document is an FDA 510(k) clearance letter for a medical device called PEACH 2, PEACH 2 Duo, and PEACH 2 Go. This letter does not contain information about acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the clearance is based on a determination of substantial equivalence to existing devices, not necessarily on a new clinical study demonstrating specific performance metrics against acceptance criteria. For 510(k) submissions, manufacturers often rely on non-clinical performance data (e.g., electrical safety, electromagnetic compatibility, biocompatibility, mechanical testing) and comparison to a predicate device's performance to establish substantial equivalence. Clinical studies are often not required for 510(k) clearances unless the device raises new questions of safety or effectiveness.
Therefore, I cannot provide the requested information for the following reasons:
- Acceptance Criteria Table: The document does not specify any performance-based acceptance criteria for the device, nor does it report any device performance metrics from a study.
- Study Details: There is no mention of a study (clinical or otherwise rigorous performance study) described in the provided text that would provide information on:
- Sample size for a test set or training set.
- Data provenance.
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
The document is a regulatory approval letter, not a study report. To get the information you asked for, you would need to refer to the actual 510(k) submission (if it were publicly available and contained such a study) or the manufacturer's own internal documentation or publications.
§ 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.