Search Results

• Use wherever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional
• Provides temporary relief of minor aches and pains in muscles and joints
• Aids in the relaxation of muscles
• Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
• Provides a temporary increase in local blood circulation

BioPack

This document is a 510(k) clearance letter from the FDA for a device called "BioPack" (and "Light Patch", though the section provided focuses on BioPack). It primarily addresses the regulatory approval process and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the provided text. The document is a regulatory approval notice, not a clinical study report or a technical specification document.

Here's what can be inferred or stated based on the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The FDA letter confirms substantial equivalence to a predicate device, but does not detail specific performance metrics or acceptance criteria met by the BioPack itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.

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 available in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.

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 BioPack is described as a hot application device for therapeutic use, not an AI-assisted diagnostic or interpretative device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device. The BioPack is a physical therapeutic device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in the provided text. Given the device's indications for use (minor aches and pains, muscle relaxation, local blood circulation), ground truth would likely be established through clinical outcomes, patient-reported symptoms, or physiological measurements, but the document does not specify.

8. The sample size for the training set: Not applicable and not available. This device is not an AI/ML algorithm that would have a "training set."

9. How the ground truth for the training set was established: Not applicable and not available.

Ask a specific question about this device