(181 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 system also has a USB port.
The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
This FDA 510(k) summary does not contain the detailed information necessary to answer all aspects of your question regarding acceptance criteria, study details, and specific performance metrics. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical trial report.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions "performance testing results" and that "the data show that the MIRIA Skin Treatment System performs in accordance with its specifications and requirements for both safety and effectiveness in similarity to the predicate device." However, specific numerical acceptance criteria or performance metrics are not provided.
The performance testing listed is:
- Software verification and validation
- Electrical Safety testing (per ANSI AAMI ES 60601-1:2005(R)2012 and A1:2012)
- EMC Testing (per IEC 60601-1-2: 2014-02)
- Histology study and computational simulations to evaluate lesion geometry
- Sample clinical data to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety.
Without the specific criteria for "lesion geometry" or "safety" from these studies, a table cannot be fully constructed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Sample clinical data were provided to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety."
- Sample size: Not specified. It only says "Sample clinical data."
- Data provenance: Not specified (e.g., country of origin, 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)
This information is not provided. The document mentions a "Histology study" and "computational simulations" to evaluate lesion geometry, and "sample clinical data" for safety and CTZ shape. It does not elaborate on how ground truth was established for these or who was involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not 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
This is not applicable as the device is a laser skin treatment system, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of typical AI algorithm evaluation. The device is a physical laser system. While it is "software-controlled," the performance testing described relates to the physical and electrical safety and the biological effect of the laser, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Based on the performance testing mentioned:
- Histology study and computational simulations: This suggests histology (pathology) would be a key ground truth for "lesion geometry." Computational simulations provide a model, not empirical ground truth.
- Sample clinical data: This would typically rely on clinical observations/assessments for safety and the confirmation of CTZ shape.
8. The sample size for the training set
This is not provided. If there was any machine learning involved in the device's control software to optimize treatment parameters, the document does not elaborate on it or any specifics about training data. Given the device type, "training set" in the context of typical AI/ML is likely not directly applicable here.
9. How the ground truth for the training set was established
This is not provided, and again, may not be applicable in the traditional AI/ML sense for this type of device.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through technical specifications, safety standards compliance, and general performance statements rather than detailed clinical study data with specific acceptance criteria, sample sizes, and ground truth methodologies, especially those relevant to AI device evaluations.
§ 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.