Search Results

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):

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.

Ask a specific question about this device

The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The SR-1 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 SR-1 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 SR-1 Skin Treatment System is a 1550nm-based laser system intended to generate thermal zones of damage in skin. The system 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 optics, scanner, laser aperture, and contact cooling interface.

The SR-1 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 a suitably trained professional in a clinical setting. There are no sterile components.

The provided text describes the 510(k) summary for the SR-1 Skin Treatment System, comparing it to predicate devices. However, it does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics in a table, sample size for test set with data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance).

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and safety and efficacy studies rather than outlining specific performance metrics for acceptance.

Here's an attempt to structure the information based on the request, extracting what is available and noting what is missing:

Acceptance Criteria and Study for SR-1 Skin Treatment System

The provided 510(k) summary does not detail specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria in the format requested. Instead, the submission relies on demonstrating substantial equivalence to predicate devices, which involves:

1. Technological Characteristics Comparison: Showing the SR-1 has similar operating principles, laser source, output power, etc., to predicate devices.
2. Safety and Performance Testing: Compliance with international standards for electrical safety, EMC, usability, biocompatibility, and laser safety.
3. In-vivo Human Study: A histological assessment comparing the thermal damage zones and healing rates to a predicate.

Therefore, a table of "acceptance criteria" as performance metrics isn't explicitly provided, as the criteria for clearance are primarily based on substantial equivalence and safety/functionality compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for clinical performance (e.g., a specific percentage of improvement in skin resurfacing) are not detailed in this document, such a table cannot be constructed from the provided text. The document states that the histological data "show that the SR-1 Skin Treatment System performs in accordance with its specifications and requirements," implying that its performance (specifically in terms of thermal damage zones and healing rate) was found comparable to the predicate.

2. Sample Size for Test Set and Data Provenance

• Sample Size for In Vivo Study: 14 healthy subjects.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be a prospective in vivo human study based on the description "A 14 day in vivo human study assessing safety, healing and MTZ morphology was performed..."

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified, other than "histological analysis" was performed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done?: No. The device is a laser treatment system, not an imaging interpretation device where human reader performance would be compared with and without AI assistance. The study described is an in vivo histological assessment.
• Effect size of human readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done?: Not directly applicable in the terms of an "algorithm only" performance for diagnosis. The device is a physical laser treatment system with software control. Software verification and validation were performed according to IEC 62304 and FDA guidance, indicating that the software's functionality was tested.

7. Type of Ground Truth Used

• Ground Truth Type: "Histological analysis" was used to determine the zones of thermal damage and healing rate in the in vivo human study.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a laser treatment system, not an AI model that requires a training set in the conventional sense (e.g., for image classification or diagnosis). Its software underwent "verification and validation testing."

9. How the Ground Truth for the Training Set was Established

• Ground Truth Establishment: Not applicable, as there is no "training set" in the context of an AI model being trained for diagnostic or predictive tasks. The software "ground truth" (i.e., its correct functionality) would be established through software requirements, design specifications, and subsequent verification and validation testing.

Ask a specific question about this device