(416 days)
The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia.
Not Found
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":
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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.
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Sample size used for the test set and the data provenance: Not Available in the provided text.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Available in the provided text.
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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.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Available in the provided text.
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The sample size for the training set: Not Available in the provided text.
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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.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.