(57 days)
The Global Med Systems Milesman Compact Laser is intended for use in dermatological and general surgical procedures including hair removal and permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. It is intended for use on all skin types (Fitzpatrick skin types 1-VI), including tanned skin.
The Global Med Systems Milesman Compact Laser delivers pulsed laser energy at 810 nm to the surface of the skin using a handpiece which contains the laser diodes. The Milesman Compact consists of the following components:
- The main console unit
- Handpiece
- Umbilical (between main console and handpiece)
- Footswitch
The system is operated using the touch screen on top of the main console unit. Firing of the laser is controlled with either the footswitch or the trigger on the handpiece.
During hair removal, the laser emits a wavelength of light that is absorbed by the pigment (melanin) in the hair. The light energy is converted to heat, which damages the tube-shaped sacs within the skin (hair follicles) that produce the hair. This damage inhibits or delays future hair growth.
The face of the hand piece which comes into contact with skin is actively cooled with a circulating coolant fluid.
The Global Med Systems Milesman Compact Laser (K203804) did not provide acceptance criteria and device performance that would traditionally be found in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. The provided document is a 510(k) summary for a laser surgical instrument and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than clinical efficacy or AI model performance.
Therefore, many of the requested fields regarding acceptance criteria, study methodologies for AI, expert involvement, and ground truth are not applicable or cannot be extracted from this document because it describes a hardware device, not an AI/ML-powered one.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria for AI model performance and corresponding reported device performance, as it is not an AI/ML device. Instead, the device's performance is demonstrated through compliance with various safety and electrical standards, and through a comparison of technological characteristics with predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a laser surgical instrument, and no clinical test set data for an AI/ML model is involved or reported. The performance data provided is focused on engineering and safety standards compliance.
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)
Not applicable. As this is not an AI/ML device, there is no "ground truth" to establish through expert consensus for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set for an AI/ML model to require an adjudication method.
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
Not applicable. This is not an AI/ML device, so no MRMC study or AI-assisted human reader performance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device, so no standalone algorithm performance was assessed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no "ground truth" in the context of an AI/ML model for this device. The assessment of the device's capabilities is based on its functional specifications and compliance with safety standards.
8. The sample size for the training set
Not applicable. This device is a laser surgical instrument and does not involve AI model training.
9. How the ground truth for the training set was established
Not applicable. There is no training set or associated ground truth for an AI model.
Summary of Relevant Performance Data from the Document (Non-AI/ML):
The performance data provided for the Global Med Systems Milesman Compact Laser focuses on the following non-clinical assessments to support its safety and design verification:
- Standards Compliance:
- IEC 60825-1 Edition 3.0 2014-05: Safety of laser products – Part 1: Equipment classification and requirements
- IEC 60601-2-22: Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- Biocompatibility Testing:
- Compact Biocompatibility report for in vitro cytotoxicity
- Compact Biocompatibility report for Dermal Irritation
- Compact Biocompatibility report for Skin Sensitization
- Electrical Safety and Electromagnetic Compatibility (EMC):
- IEC 60601-1:2005: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Note: A gap analysis was performed to demonstrate compliance with FDA-recognized standard AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012.
- Software Verification and Validation Testing:
- Considered a "major" level of concern.
- Testing performed at unit and integrated levels using written protocols.
- Acceptance criteria defined by the Software Requirements Specification (SRS).
- Verification tested actual outputs against expected outputs for pre-established inputs.
- Validation performed at the system level using simulated use scenarios.
- Traceability matrix used for thoroughness.
- All software successfully passed verification and validation testing.
Conclusion stated in the document (Non-AI/ML):
The non-clinical data support the safety of the device and design verification and validation demonstrate that the Global Med Systems Milesman Compact device performs as intended in the specified use conditions. It performs comparably to the predicate device (and reference device) for the same intended use and shares similar indications, design features, and functional features, making it as safe, effective, and performant as the legally marketed predicate devices.
§ 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.