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The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia.

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This is a 510(k) clearance letter for a medical device called FibroLux, an infrared lamp indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia. This document does not contain the kind of detailed performance study information typically provided for AI/ML-based medical devices or diagnostic tools.

Therefore, I cannot provide answers to most of your requested points because the information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on a detailed performance study with acceptance criteria and ground truth analysis.

Here's what I can extract and state based on the provided text, and where I must indicate that the information is "Not Available in the provided text":

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not Available in the provided text.
   • Reported Device Performance: Not Available in the provided text. The device received 510(k) clearance based on substantial equivalence to a predicate device, not on specific performance metrics outlined in this document.

2. Sample size used for the test set and the data provenance: Not Available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Available in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Available in the provided text.

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 Available in the provided text. This is not an AI-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Available in the provided text. This is not an AI-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Available in the provided text.

8. The sample size for the training set: Not Available in the provided text.

9. How the ground truth for the training set was established: Not Available in the provided text.

Summary of what is available:

• Device Name: FibroLux
• Indication for Use: "The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia."
• Regulatory Clearance: 510(k) clearance (K212189) based on substantial equivalence to a predicate device.
• Device Type: Infrared Lamp (Product Code: NHN)
• Regulatory Class: Class II
• Type of Use: Prescription Use

The provided document is a regulatory communication, not a clinical study report. To get the requested information, you would need to consult detailed clinical study reports or 510(k) summary documents if they contain such information. However, for a device cleared via substantial equivalence, often detailed performance studies with explicit acceptance criteria and ground truth establishment in the manner described are not a primary component of the 510(k) submission itself, but rather rely on the safety and effectiveness of the predicate device.

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MR4 Laser is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Not Found

The provided FDA letter (K171354) is a 510(k) clearance for a medical device called the "MR4 Laser." This type of letter generally confirms substantial equivalence to a predicate device and does not describe the detailed clinical study results or acceptance criteria used to prove the performance of the device itself. Instead, it relies on the predicate device's established safety and effectiveness.

Therefore, none of the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment can be extracted from this document.

This document primarily focuses on:

• Device Name: MR4 Laser
• Regulation Number/Name: 21 CFR 890.5500, Infrared Lamp
• Regulatory Class: Class II
• Product Code: NHN
• Indications for Use: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
• Regulatory Status: Substantially Equivalent to legally marketed predicate devices.

To get the information you are requesting, one would typically need to review the full 510(k) submission itself, which contains the detailed technical and performance data that led to this clearance. The FDA letter is merely the conclusion of their review of that submission.

Ask a specific question about this device