(254 days)
The ABC Hair Removal System is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments.
The ABC Hair Removal System is composed of a base unit, umbilical cord, handpiece, chiller system with chiller coolant, cleaning wipes, ABC lubricant, power supply and safety components.
The provided text does not contain detailed information about specific acceptance criteria, reported device performance metrics in a table format, sample sizes used for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance data, or training set details.
The document is a 510(k) summary and an FDA clearance letter for the ABC Hair Removal System. It primarily focuses on demonstrating substantial equivalence to predicate devices for its intended use.
Here's a breakdown of what is available and what is not:
1. A table of acceptance criteria and the reported device performance:
- Not provided. The document states: "The clinical studies demonstrated that the ABC System functions as intended with no serious adverse events." However, no specific performance metrics (e.g., % hair reduction, duration of hair reduction) or acceptance criteria (e.g., "must achieve X% hair reduction in Y% of subjects") are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified. The document only mentions "Clinical data was collected in a prospective clinical study."
- Data provenance: Prospective clinical study. Country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided. The nature of "ground truth" (e.g., hair counts, expert assessment) is not detailed, nor are any experts mentioned in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is for hair removal, not an AI-assisted diagnostic device requiring human reader interpretation. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device for hair removal, not an algorithm. Its "performance" is its ability to remove hair, which is evaluated directly on users.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implied Outcomes Data: The study evaluated "safety and effectiveness." For a hair removal device, effectiveness typically refers to the degree and duration of hair reduction, which would be measured directly (e.g., by hair counting or photographic assessment) as an outcome. However, the specific method used to establish this outcome (e.g., blinded hair counts, subjective patient assessment scale) is not detailed.
8. The sample size for the training set:
- Not applicable/Not provided. This is a hardware device, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set for an algorithm is discussed.
§ 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.