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510(k) Data Aggregation
(266 days)
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for :
· Benign vascular lesions and vascular dependent lesions removal
The Laser Treatment System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Laser Treatment System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.
The provided text describes a medical device, a Laser Treatment System, and its substantial equivalence to a predicate device for FDA clearance. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria from a clinical performance perspective.
The document focuses on:
- Regulatory Clearance (K211722): This is an FDA 510(k) clearance letter, which determines substantial equivalence to a legally marketed predicate device, not necessarily clinical efficacy.
- Device Description and Intended Use: The device is a "Laser Treatment System" for "Benign vascular lesions and vascular dependent lesions removal."
- Comparison to Predicate Device (K172193): The comparison table highlights technological characteristics like product code, regulation number, indications for use, laser classification, wavelength, frequency, pulse duration, and compliance with various safety and biocompatibility standards.
- Performance Data (Non-Clinical):
- Biocompatibility Testing: Evaluated according to ISO 10993-1, covering Cytotoxicity, Irritation, and Sensitization. All acceptance criteria for these biocompatibility tests were met.
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested to comply with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.
Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance and the study proving it, as this information is not present in the provided text.
If this were a clinical study, the requested information would typically look something like this (hypothetical example, as the data is missing):
Hypothetical Acceptance Criteria and Performance (Based on common laser efficacy studies, NOT from the provided text)
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance (Hypothetical) |
|---|---|---|
| Clinical Clearance | ≥ 75% average lesion clearance after X treatments | 82% average lesion clearance |
| Adverse Event Rate | < 5% incidence of persistent erythema or scarring | 3% incidence of transient erythema |
| User Satisfaction | ≥ 80% satisfaction score (Likert scale) | 88% satisfaction score |
| Pain Scale Reduction | ≥ 50% reduction in VAS pain score after treatment | 65% reduction in VAS pain score |
2. Sample Size and Data Provenance
- Test Set Sample Size: (Information not available in text. If applicable, would be a number of patients or lesions.)
- Data Provenance: (Information not available in text. If applicable, would specify country/region and if it was prospective/retrospective.)
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: (Information not available in text.)
- Qualifications of Experts: (Information not available in text. If applicable, would specify specialties like "Dermatologists with 5+ years of experience in laser treatments".)
4. Adjudication Method
- Adjudication Method: (Information not available in text. In clinical studies, this could be "independent review by 2 dermatologists, with a third adjudicator in case of disagreement (2+1)".)
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No, the provided document does not mention an MRMC comparative effectiveness study for human readers with or without AI assistance. The device is a laser system, not an AI diagnostic tool that assists human readers.
6. Standalone Performance
- Standalone Performance: Not applicable for a laser treatment system in the context of "algorithm only without human-in-the-loop performance." The device is a physical therapeutic tool operated by a clinician.
7. Type of Ground Truth Used
- Type of Ground Truth: (Information not available in text. For laser efficacy, this would typically involve clinical assessments (e.g., photographs, visual grading scales, objective measurements like chromameter readings for redness/pigmentation), patient-reported outcomes, and possibly histological examination in some cases.)
8. Sample Size for Training Set
- Training Set Sample Size: Not applicable. The provided document concerns a physical device, not an AI algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
- Ground Truth for Training Set: Not applicable, as it's not an AI algorithm requiring a training set.
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