(57 days)
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate the maximum non-blistering dose for a particular patient.
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.
The subject device is the Multi-Micro Dose ("MMD") Tip.
The Multi-Micro Dose ("MMD") tip provides another method, separate of the MED mode, for determining the Optimal Therapeutic Dose ("OTD") for each patient. The OTD is the power setting on the XTRAC Phototherapy system customized for each patient that enables the user to provide patient specific treatment doses. As an alternative to the trial and error method of the MED mode, using the MMD Tip can often determine the optimal XTRAC power setting with a single test application.
The MMD Tip filters and reduces the laser output, providing four different dose levels in a single application. The reaction of the target area to the different dose levels assists in determining the patient specific Optimal Therapeutic Dose ("OTD").
The MMD Tip design places four (5mm x 5mm) square filters in the laser aperture.
The MMD Tip design is constructed of similar materials and components as the predicate tip. It connects to the XTRAC hand-piece in the same manner as the standard Tips of the XTRAC system.
This document describes the MMD Tip, an accessory for the XTRAC laser system. The document is a 510(k) premarket notification and focuses on establishing substantial equivalence to a legally marketed predicate device (K073659 - Strata Skin Sciences - XTRAC).
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance:
The document primarily states that "The performance was within pre-defined acceptance criteria" for the bench tests. It does not provide specific numerical acceptance criteria or the exact reported performance values. It only lists the tests performed and a general statement of compliance.
| Acceptance Criteria (Not explicitly stated in numerical terms) | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Tip Dose Accuracy and Uniformity | Met performance criteria |
| Tip Transmission | Met performance criteria |
| Tip Shelf Life | Met performance criteria |
| Tip Shipping | Met performance criteria |
| Biocompatibility Testing (ISO 10993-1): | |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-irritant |
| Irritation or Intracutaneous Reactivity | Non-toxic |
| Acute Systemic Toxicity | Non-toxic |
| Material Mediated Pyrogenicity | Non-toxic |
2. Sample size used for the test set and the data provenance:
- Bench Testing: The document does not specify the sample size for any of the bench tests (Tip Dose Accuracy and Uniformity, Tip Transmission, Tip Shelf Life, Tip Shipping). It merely states that "We performed testing to support the filtration performance of the MMD Tip" and "We have performed bench tests and found that the MMD Tip... met all requirements specifications."
- Biocompatibility Testing: The document does not specify the sample size used for the biocompatibility tests.
- Data Provenance: Not specified, but given the nature of the tests (bench and biocompatibility), the data would originate from laboratory or manufacturing testing. There is no mention of human subject data for proving the device's functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this submission. The MMD Tip is an accessory to a laser system used to calculate the Optimal Therapeutic Dose (OTD) for patients. The studies described are bench and biocompatibility tests, not clinical studies involving expert interpretation of results to establish ground truth about medical conditions.
4. Adjudication method for the test set:
This information is not applicable. There is no mention of a human test set requiring adjudication in this submission.
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:
This information is not applicable. The MMD Tip is a physical accessory for a laser system. It is not an AI-powered diagnostic or assistive device, and therefore no MRMC study or AI-related effectiveness study was conducted or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The MMD Tip is a physical device, not an algorithm.
7. The type of ground truth used:
- Bench Testing: The ground truth would be established by physical measurements and engineering specifications, e.g., using calibrated measuring equipment to verify dose accuracy and transmission, or environmental chambers for shelf-life testing.
- Biocompatibility Testing: The ground truth is established by adherence to recognized international standards, specifically ISO 10993-1 tests, which have defined endpoints for toxicity, sensitization, etc.
8. The sample size for the training set:
This information is not applicable. The MMD Tip is a physical accessory and does not involve AI or machine learning that would require a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as above.
§ 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.