(218 days)
The BIOFLEX LD-R100 Treatment head device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
The BIOFLEX LD-R100 Treatment head device is to be used with the Low Intensity Laser Therapy System, BioFlex Professional System & the Prescription Unit and Related Treatment Heads. These systems were cleared under 510(k) submission K023621 & K051875 respectively. The treatment head device is a Class II Low Level Laser treatment head that apply energy, which penetrates the surface to the underlying tissues, and triggers normal cellular functions.
This document describes a 510(k) premarket notification for the BIOFLEX LD-R100 Treatment Head. The submission demonstrates substantial equivalence to predicate devices rather than providing a study specifically proving the device meets individual acceptance criteria through performance metrics.
Therefore, many of the requested categories (acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth types related to a study proving specific performance) are not applicable or cannot be extracted from this type of regulatory document.
However, based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria with reported device performance in the way a clinical study would for efficacy targets. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are the regulatory requirements for substantial equivalence, which include similar indications for use, technological characteristics (power density, wavelength, optical power, power source), and similar size and weight.
The reported "performance" is that the device meets these general equivalence criteria and is considered "safe and effective" based on its similarity to the predicate devices.
Table of Equivalence Claims (extracted from the document):
| Criterion | BIOFLEX LD-R100 Treatment Head Claim |
|---|---|
| Indications for Use | Intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue. (Claimed "Same Indications for use" as predicates) |
| Key Design Technical Characteristics | Contains LED lasers applied on the surface of the human skin. (Claimed "Similar key design technical characteristics" as predicates) |
| Power Density, Wavelength, Optical Power | "Same/similar power density, wavelength, and optical power" as predicates. |
| Size, Weight, Power Source, and Performance | "Similar size (hand held), weight, power source, and performance" as predicates. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission based on substantial equivalence to existing devices, not a clinical study with a test set of patient data. There is no information regarding sample sizes or data provenance in the context of a performance study.
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. No ground truth establishment for a patient test set is described or required for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication 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
Not applicable. This is not an AI/software device and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (treatment head for laser therapy), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this submission is the regulatory precedent set by the legally marketed predicate devices. The device is deemed safe and effective because its characteristics and intended use are substantially equivalent to devices that have already been cleared by the FDA.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 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.