(69 days)
UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis, and leukoderma.
The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) system that emits targeted (ultra-narrow) ultraviolet wavelength that is included in the UV-B region of the electromagnetic spectrum centered at 308 mm, which is effective for the treatment of skin conditions that respond favorably to and available UV-B phototherapy. UV-B is emitted from a XeCl excimer lamp inside a handpiece used to apply targeted UVB energy to only areas that require treatment, thus allowing non-involved areas (healthy) of the skin to be spared from exposure.
The provided text describes a 510(k) summary for the VTRAC Excimer Lamp System. Unfortunately, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.
The document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting a novel study with specific performance metrics against acceptance criteria. It mentions that the device is "designed, tested and are to be manufactured in accordance with both mandatory and voluntary standards" (e.g., 21 CFR PART 820, EN60601-1, etc.) to ensure safety and effectiveness. However, it does not provide the results of such testing or a direct comparison to acceptance criteria.
Therefore, I cannot provide the detailed table and information as requested because the source document does not contain this specific type of clinical or performance study data.
Here's what I can extract based on the provided text, acknowledging the limitations:
Acceptance Criteria and Device Performance (Based on "Substantial Equivalence" Argument):
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Assumed via Equivalence) |
|---|---|
| Safe for UVB phototherapy | "poses no new issues of safety" |
| Effective for skin conditions treatable by UVB phototherapy (psoriasis, vitiligo, atopic dermatitis, leukoderma) | "is safe and effective as the legally marketed predicate devices" |
| Similar wavelength, energy, and indicated uses as predicate devices | "wavelength, energy, indicated used and safety considerations are within the current applications of UV-B phototherapy, or supported by published clinical data included in this application." |
| Complies with relevant mandatory and voluntary standards (e.g., 21 CFR PART 820, EN60601-1) | "The VTRAC Excimer Lamp System is designed, tested and are to be manufactured in accordance with both mandatory and voluntary standards..." |
Missing Information (Not available in the provided text):
- Sample size used for the test set and the data provenance: Not applicable as a specific test set for performance against acceptance criteria in a study is not described. The "published clinical data" mentioned is not detailed or provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- 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 an excimer lamp system for phototherapy, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used: Not applicable for a performance study. Clinical outcomes and expert assessment would typically be the ground truth for treatment efficacy had a study been detailed.
- The sample size for the training set: Not applicable as this is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) premarket notification for a medical device (an excimer lamp system). It focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a detailed clinical study with specific performance acceptance criteria and results from a test set. The "acceptance criteria" are implied by the safety and effectiveness of the predicate devices and compliance with general standards.
§ 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.