(203 days)
The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA.
The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.
The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
The provided text describes the MIRIA Skin Treatment System and its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The document outlines performance testing conducted to verify certain aspects of the device, particularly regarding its expanded pulse energy range compared to the predicate.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions several verification methods and implies that the device performs in accordance with its specifications and requirements. However, it does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each performance metric, nor does it present the reported device performance in a comparative table against those criteria.
Information from the document (Implied Performance):
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Performance Testing) |
|---|---|
| Ability to focus energy to a depth of 0 to 1500 micrometers. | Verified: The ability of the system to focus the energy to a depth of 0 to 1500 micrometers into the skin was verified. |
| Energy delivery from 3 to 150 mJ. | Verified: Energy delivery from 3 to 150 mJ was verified. |
| Creation of conical microscopic treatment zones (CTZs) and healing post-treatment using worst-case parameter combinations. | Demonstrated: A healing study demonstrated device performance for the creation of CTZs and healing post-treatment using worst-case parameter combinations. |
| Software functions impacted by pulse energy changes. | Verified and Validated: Software verification and validation were performed for elements impacted by the change in pulse energy values, in accordance with FDA guidance and IEC 62304. The software permits only certain combinations of microbeam energy and focus depth to be selected by the user. |
| Safety and effectiveness with expanded pulse energy range. | No different issues: The expanded pulse energy range raised no different issues of safety or efficacy as demonstrated by the performance data. The data show that the MIRIA Skin Treatment System performs in accordance with its specifications and requirements for both safety and effectiveness and does not raise concerns about the safety and efficacy of the device in comparison to the predicate. |
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: The document does not specify the sample size for any of the performance tests (e.g., healing study, energy delivery verification).
- Data Provenance: The document does not provide information on the country of origin of the data, nor does it state whether the studies were retrospective or prospective.
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)
The document does not mention the use of experts to establish ground truth for any of the tests, nor does it specify their number or qualifications. The healing study implies some form of assessment, but details are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information regarding adjudication methods for the test set is 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
The MIRIA Skin Treatment System is a laser device for dermatologic procedures; it is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving "human readers" or "AI assistance" would not be applicable to this type of medical device as described in this document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The MIRIA Skin Treatment System is a physical device with software control, not an algorithm being tested for standalone performance in a diagnostic context. The document confirms it is a "software-controlled device" and that "software verification and validation" were performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implicitly refers to "healing post-treatment" as an outcome, and the "creation of conical microscopic treatment zones (CTZs)" as verifiable physical effects. However, it does not explicitly state the method used to establish the ground truth for these observations (e.g., whether CTZs were confirmed by histology/pathology or expert visual assessment).
8. The sample size for the training set
The document describes performance testing and verification, not a machine learning model that would require a separate "training set." Therefore, this information is not applicable in the context of this submission. Software verification and validation refer to testing the software's functionality and adherence to specifications, not training a predictive model.
9. How the ground truth for the training set was established
As there is no mention of a machine learning training set, this question is not applicable.
§ 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.