(14 days)
The Crystal , Record & Optima are generally intended for dermatological use. The device is specifically indicated for removal of hair by using selective light energy.
The Crystal & Record are two models of the same device. The Optima is an additional commercial name of the Record. The device applies photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a light source to the target tissue by a Treatment Handpiece that is in contact with the skin.
The provided text describes a 510(k) submission for the Crystal, Record, and Optima photoepilation systems. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics to fill out the table and answer all the requested questions.
The document states: "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications." but does not elaborate on what those specifications are, how they were measured, or the results.
Therefore, many sections of your request cannot be fulfilled from the provided text. I will fill in what can be inferred or explicitly stated.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be fully provided. The document states "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications," but it does not specify what those specifications are (the acceptance criteria) nor does it report the specific performance metrics achieved by the device.
2. Sample sized used for the test set and the data provenance:
- Cannot be provided. The document mentions "clinical data" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. The document does not describe how ground truth was established, nor does it mention any experts for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. The document does not describe any adjudication method.
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:
- Cannot be provided. The device is a photoepilation system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with AI assistance for human readers is not applicable or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided directly. The device, being a photoepilation system, operates as a standalone system by design (it's applied to the skin to remove hair). However, the document does not describe a formal "standalone performance study" in the context of diagnostic AI algorithms. It merely states that the device was tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. The document does not specify how "ground truth" (e.g., successful hair removal) was established for its clinical data.
8. The sample size for the training set:
- Cannot be provided. The document does not mention any training set, as it describes a medical device, not an AI model requiring a distinct training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is mentioned for this type of device.
Here is a summary of what can be extracted, and where information is missing:
The acceptance criteria and study data are explicitly not detailed in the provided 510(k) summary. The document states that "Bench and clinical data demonstrate that the Crystal, Record & Optima meet the required specifications" and that "No adverse affects have been detected." However, it does not list these specifications (acceptance criteria) or present the actual results from the bench and clinical studies that prove they were met.
| Aspect | Description from provided text / Status |
|---|---|
| Acceptance Criteria (Specific performance metrics) | Not provided. The document states "meet the required specifications" but does not define them. |
| Reported Device Performance | Not provided. The document states "Bench and clinical data demonstrate..." but does not present the specific results. |
| Sample Size (Test Set) | Not provided. "Clinical data" is mentioned, but sample sizes are absent. |
| Data Provenance (Test Set) | Not provided. |
| Number of Experts (Ground Truth - Test Set) | Not provided. |
| Qualifications of Experts (Ground Truth - Test Set) | Not provided. |
| Adjudication Method (Test Set) | Not provided. |
| MRMC Comparative Effectiveness Study (AI vs. without AI assistance) | Not applicable. This is a photoepilation system, not an AI diagnostic tool. |
| Standalone Performance Study (Algorithm only) | Implicitly "Yes" as a medical device, but no specific study details provided. |
| Type of Ground Truth Used (e.g., pathology, outcomes data) | Not provided. |
| Sample Size (Training Set) | Not applicable/Not provided. This is a medical device, not an AI model. |
| How Ground Truth for Training Set was Established | Not applicable/Not provided. |
§ 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.