(83 days)
The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.
The BEAMAX applies thermal energy to human skin tissue. The energy is transmitted from a flash light source. It is transmitted to the target tissue by a hand piece that is in contact with the skin (contact mode). The device is constructed from a Man Machine Interface panel, an operating console, and a treatment hand piece.
This 510(k) submission for the BEAMAX device does not contain the detailed study information required to fully answer all aspects of your request. It's a summary document focusing on substantial equivalence, not a comprehensive clinical trial report. However, I can extract the available information and highlight the missing parts.
Here’s a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary is very high-level and does not specify quantitative acceptance criteria or detailed device performance metrics for effectiveness. It generally states: "Bench and clinical data demonstrate that the BEMAX meets the required specifications. No adverse affects have been detected."
| Acceptance Criteria (Not Specified in Document) | Reported Device Performance (General) |
|---|---|
| Specific quantitative thresholds for hair reduction, safety endpoints, etc., are not provided. | Meets required specifications (unspecified). |
| Specific quantifiable safety metrics (e.g., incidence of adverse events, severity, etc.) are not provided. | No adverse effects detected. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in the document.
- Data Provenance: "Bench and clinical data." The document does not specify the country of origin of the data, nor whether it was retrospective or prospective. It implies prospective data collection for safety and effectiveness, but details are absent.
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 specified in the document. The type of device (pulsed light hair removal) suggests that "ground truth" for effectiveness would likely be based on objective measures of hair reduction, potentially evaluated by trained technicians or practitioners, but no details are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified in the document.
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. The BEAMAX is a pulsed light hair removal system, not an AI-assisted diagnostic device that would involve human "readers" interpreting output. Therefore, an MRMC study or AI assistance effect size is not relevant to this device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. The BEAMAX is a physical device operated by a human, not an algorithm, so "standalone (algorithm only)" performance is not a relevant concept for this product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "type of ground truth." For a hair removal device, effectiveness is typically measured by outcomes data such as hair count reduction, hair growth delay, or patient satisfaction, often assessed by trained personnel or through photographic comparison. Safety would be assessed via adverse event reporting.
8. The sample size for the training set
Not applicable. The BEAMAX is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The term "training set" would apply to machine learning devices.
9. How the ground truth for the training set was established
Not applicable. As above, the device does not use a "training set" in the context of machine learning.
Summary of what's provided for K063249:
This 510(k) summary is a regulatory filing for marketing clearance based on substantial equivalence. It provides general information about the device, its intended use, and a declaration that it meets specifications and has no adverse effects. It explicitly references "Bench and clinical data" for safety and effectiveness but does not present the detailed methodology, sample sizes, specific criteria, or results of those studies. This level of detail is typically found in the full submission, not in the publicly available summary.
§ 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.