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HealthLight™ MicroController, MiniPro, ProNeurolLght, and Pro Unit are intended for the following indications for use:

1. Provides heat therapy, i.e., temporarily relieves minor pain, stiffness and muscle spasm.

2. Temporarily increases local blood circulation.

It is an Rx Only medical device.

The BioRemedi HealthLight™ is a scalable system consisting of seven different shaped/sized pads holding LEDs that may be used with any of three controllers, the differences being a two, a three or a four port configuration. Any pad, alone, or in any combination with any other pad, may be used with any of these three controllers.

The provided text is a 510(k) summary for the BioRemedi HealthLight™ System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria. Therefore, much of the requested information is not explicitly present.

However, based on the nature of a 510(k) submission for a Class II device, we can infer some aspects of what would typically be involved, even if the detailed study isn't described. The document primarily highlights similarities and differences between the proposed device and its predicate.

Here's an analysis of the provided information in the context of your request:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it argues for "substantial equivalence" to a predicate device, the SMI™ SpectroPad (K931261). The "reported device performance" is implicitly that it operates similarly to the predicate device in terms of providing heat therapy, temporarily relieving minor pain, stiffness, and muscle spasm, and temporarily increasing local blood circulation.

Study Details

The document emphasizes "substantial equivalence" rather than a de novo clinical study with specific performance metrics against acceptance criteria. Therefore, most of the following information is not provided or not applicable in the context of this 510(k) summary.

1. Sample size used for the test set and the data provenance: Not applicable/not provided. The submission relies on demonstrating similarity to a device already on the market, not a new clinical trial generating new data. There is no "test set" in the sense of a data set used for performance evaluation of an AI algorithm.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. This type of information would be relevant for studies evaluating diagnostic accuracy, especially in AI.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
4. 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/not provided. This is relevant for AI-assisted diagnostic tools, not for a light therapy device demonstrating substantial equivalence.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This device is a physical therapy device, not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device (the SMI™ SpectroPad). The justification is that if the new device is sufficiently similar to the predicate and doesn't raise new questions of safety or effectiveness, it can be cleared. The clinical effects of the predicate device (pain relief, circulation increase) would have been established historically through clinical evidence or common medical knowledge for infrared therapy.
7. The sample size for the training set: Not applicable/not provided. This device is not an AI algorithm.
8. How the ground truth for the training set was established: Not applicable/not provided.

Key Points from the Document Related to Equivalence:

• Predicate Device: SMI™ SpectroPad (K931261)
• Similarities:
  • Pulsed infrared devices.
  • Use a separate controller to power flexible pads attached by a cable.
  • Pads contain an array of light-emitting diodes.
  • Controllers designed to power more than one pad at a time.
  • Powered by plug packs converting mains power to 12VDC.
• Differences (and justification why they don't impact safety/effectiveness):
  • HealthLight™ operates with a microprocessor (vs. solid-state for Anodyne/SMI).
  • HealthLight™ has a timer and auto shut-off after 30 minutes (Anodyne lacks this). This difference is presented as a safety improvement.
  • HealthLight™ controller is designed to fail in a "SAFE mode" (shut off), whereas Anodyne's can fail in an UNSAFE mode. This is also presented as a safety improvement.
  • HealthLight™ uses 5-pin DIN plugs for removable cables, and a removable power supply (vs. soldered RCA connectors and power supply lead for Anodyne). This is presented as common practice for electronic devices.
  • HealthLight™ is Rx Only, while the predicate was OTC. This is a difference in classification of use but doesn't inherently imply adverse impact on safety/effectiveness when prescribed by a doctor.

The conclusion states: "BioRemedi has demonstrated that its BioRemedi HealthLight™ System meets its specifications, is safe and effective for its intended use, and is substantially equivalent to the referenced predicate device." This is the core claim for a 510(k) submission.

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