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810 nm and 980 nm wavelength:
MateLaser Medical Laser Therapy Systems (Model: ML HIL 30/60) emit energy in the invisible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.

980 nm wavelength:
MateLaser Medical Laser Therapy Systems (Model: ML-HIL-60) are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.

980 nm wavelength:
MateLaser Medical Laser Therapy Systems (Model: ML-HIL-60) are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)

Not Found

I'm sorry, but based on the provided FDA 510(k) clearance letter for the MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60), there is no information provided regarding acceptance criteria or the study that proves the device meets those criteria.

The 510(k) clearance letter itself is a formal notification from the FDA stating that the device is substantially equivalent to a legally marketed predicate device. It confirms the product's classification, regulation numbers, and permissible indications for use.

Crucially, a 510(k) letter does not typically contain the detailed information about the performance studies, acceptance criteria, ground truth establishment, or expert reviews that would be submitted to the FDA as part of the 510(k) premarket notification. This detailed information is part of the manufacturer's submission package, which is reviewed by the FDA, but the clearance letter is merely the outcome of that review.

Therefore, I cannot populate the table or answer the specific questions you've posed using only the provided text. To answer your questions, one would need access to the actual 510(k) submission documentation, which is not publicly available in this format.

Here's what I can tell you based on the provided text, and why I cannot answer your specific questions:

• Device: MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
• Regulation Number/Name: 21 CFR 878.4810, Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
• Regulatory Class: Class II
• Product Codes: GEX, ILY, PDZ
• Indications for Use (810 nm and 980 nm wavelength):
  • Topical heating for temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm.
  • Temporary increase in local blood circulation.
  • Temporary relaxation of muscle.
• Indications for Use (980 nm wavelength only for ML-HIL-60):
  • Surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in various medical specialties.
  • Temporary increase of clear nail in patients with onychomycosis.
• Type of Use: Prescription Use

Without the actual study data and methodology from the 510(k) submission, I cannot provide any information regarding:

1. Acceptance criteria and reported performance: Not in the letter.
2. Sample size and data provenance: No study details are provided.
3. Number of experts and qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC study details or effect size: Not mentioned, and generally not applicable for a laser therapy system unless there's a strong AI component for diagnosis/treatment planning, which isn't evident here.
6. Standalone (algorithm only) performance: Not applicable for a physical laser device in this context.
7. Type of ground truth used: Not mentioned.
8. Training set sample size: Not mentioned (as it's a physical device, "training set" in the context of an AI/ML model is not directly relevant here unless there's an embedded AI component for specific functions, which isn't described).
9. Ground truth establishment for training set: Not applicable for this type of device based solely on the provided letter.

The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, which can involve performance testing, but the details of those tests are not part of the clearance letter itself.

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