(252 days)
Temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for the Lumanosity, Inc. Celebrity 500 and Celebrity 7000 devices, which are infrared lamps for therapeutic heating.
Based on the provided document, the following information regarding acceptance criteria and a study to prove the device meets them cannot be fully extracted or is not present:
- No specific acceptance criteria table is provided. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than performance-based acceptance criteria for a new clinical study.
- No specific study is described that "proves the device meets the acceptance criteria." The approval is based on equivalence to a predicate device.
- No detailed information on sample sizes, data provenance, expert qualifications, or adjudication methods for a clinical study is present. This type of detail is typically found in a clinical study report, which is not provided here.
- No information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance is present. This document discusses a physical medical device, not an AI or imaging algorithm.
- No details on training set size or how ground truth for a training set was established. This refers to machine learning which is not addressed in this document.
However, based on the document's content, here's what can be inferred or directly stated:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied by Substantial Equivalence): The device (Lumanosity Celebrity 500, Celebrity 7000) must have the "same intended use and technological characteristics" as the predicate device (TERRAQUANT SOLO PRO) to be considered substantially equivalent.
- Reported Device Performance: The document states that the Lumanosity Celebrity is intended to deliver photomodulation therapy for the purpose of temporarily improving pain in muscles and joints, and that it uses Infrared and Red photonic energy for this purpose. This implicitly means it performs similarly to the predicate for its intended use. No quantitative performance metrics are provided.
Here's a conceptual table based on the document's equivalence argument:
| Acceptance Criteria Category | Specific Criteria (Based on Substantial Equivalence) | Reported Device Performance/Characteristics |
|---|---|---|
| Intended Use | Same as predicate device: Temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated. | Lumanosity Celebrity is intended to deliver photomodulation therapy for the purpose of temporarily improving pain in muscles and joints. This aligns with the predicate's use for temporary relief of various muscle/joint discomforts. |
| Technological Characteristics | Utilizes Infrared and Red photonic energy as the primary mechanism for its intended therapeutic effects. | Lumanosity Celebrity uses Infrared and Red photonic energy. |
| Safety | Complies with IEC 62471 Photobiological Safety of Lamps and Lamp Systems Part II Guidance on Mfg Requirements relating to non-laser optical radiation safety. | The submission references compliance with IEC 62471. |
| Minor Differences | Any differences from the predicate device should not raise new questions of safety or effectiveness. | The primary difference is the Lumanosity does not contain a magnet, whereas the TQ Pro does. The FDA's approval indicates this difference did not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document is a regulatory approval based on substantial equivalence, not a description of a specific clinical performance study for the Lumanosity devices themselves. Therefore, there is no "test set" in the context of a clinical trial described.
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 / Not provided. This information pertains to a clinical study with ground truth establishment, which is not detailed in this regulatory approval letter. The "ground truth" for this approval is essentially the FDA's determination of substantial equivalence based on the submitted technical characteristics and intended use compared to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set or adjudication method is described.
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:
- No. This document pertains to a physical medical device (infrared lamp), not an AI or imaging diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This document pertains to a physical medical device (infrared lamp), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Regulatory "Ground Truth" for Equivalence: The "ground truth" in this context is the existing regulatory status and established safety and effectiveness profile of the predicate device (TERRAQUANT SOLO PRO). The Lumanosity device is deemed equivalent based on its comparison to the predicate's known characteristics and intended use. No new clinical ground truth was established for the Lumanosity device in this submission.
8. The sample size for the training set:
- Not applicable / Not provided. This refers to machine learning algorithms, which are not described in this document.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This refers to machine learning algorithms, which are not described in this document.
§ 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.