(136 days)
Narrow Band, Near-IR Energy, Pain Therapy Devices emit energy in the Near-IR spectrum for the 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.
The Narrow Band, Near-IR Energy, Pain Therapy Devices use LEDs to generate heat that alleviates pain. Two ranges are employed: 630 nm and 940 nm, depending on the product model, as well as a choice of continuous wave and pulse wave (BioBeam™ models only) modes. The units are available in handheld or mounted configurations.
I am sorry, but the provided text does not contain the detailed information required to fill out all the fields in your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a pain therapy device, focusing on its substantial equivalence to predicate devices rather than reporting on a specific clinical study with acceptance criteria.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics. The document implies acceptance based on substantial equivalence to predicate devices and meeting electrical safety, electromagnetic compatibility, and biocompatibility tests.
- Reported Device Performance: Not reported in quantitative terms in this summary. The device's intended use is for "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."
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not mentioned.
- Data provenance: Not mentioned, as no specific clinical study data is reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical study with a ground truth assessment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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 applicable. The device is a pain therapy device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable.
8. The sample size for the training set:
- Not applicable, as this is not an AI-based device and no training set is mentioned.
9. How the ground truth for the training set was established:
- Not applicable.
The document primarily focuses on:
- Device Name: Narrow Band, Near-IR Energy, Pain Therapy Devices (Models: BioBeam™ 660, BioBeam™ 940, MedLight™ 1630, and MedLight™ 2630)
- Sponsor: Life Without Pain, LLC
- Product Code: ILY
- Regulation Number: 21 CFR 890.5500
- Regulation Name: Infrared lamp
- Predicate Devices: Quantum WARP 10 Light Delivery System (K032229), Light Force Therapy's SuperNova (K022888), and Diomedics' Pain-X-2000 (K982546).
- Technological Characteristics: Uses LEDs to generate heat in two ranges (630 nm and 940 nm), with continuous wave and pulse wave modes. Available in handheld or mounted configurations.
- Intended Use: 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.
- Testing: Electrical safety, electromagnetic compatibility, and biocompatibility of materials in contact with the treatment site. These are general safety and performance tests, not clinical efficacy trials with specific acceptance criteria as you've outlined.
§ 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.