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• 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

Spinal Pad

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a device called "Spinal Pad" and outlines the indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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• 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.

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• Use wherever hot applications are desirable for personal comfort and whenever A 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

Not Found

This document is a 510(k) clearance letter from the FDA for the BioScan, Inc. Light Patch, indicating that the device has been found substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical trial report or a summary of safety and effectiveness data (SSE).

Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and the study proving the device meets them. The document states "we have reviewed your 510(k) notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that BioScan, Inc. submitted data to the FDA in their 510(k) notification, but the specifics of that data are not included in this clearance letter.

To fully answer your request, external documents (such as the actual 510(k) submission, including the summary of safety and effectiveness, or clinical study reports if applicable for this type of device) would be needed.

However, I can extract the "Indications for Use" which the FDA has cleared, and this effectively defines the performance expected of the device in a broad sense, though not as specific quantitative acceptance criteria.

Summary of what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (Derived from Indications for Use - qualitative):

  • Suitable for hot applications for personal comfort.
  • 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.

• Reported Device Performance: The document states the device is "substantially equivalent" to legally marketed predicate devices for the given indications for use. This means the FDA has accepted that its performance is comparable to existing, legally marketed products performing the same functions. No specific quantitative performance metrics are provided in this letter.

2. Sample size used for the test set and the data provenance:

• Not specified in the provided text. The 510(k) letter does not include details on sample size or data provenance (e.g., country of origin, retrospective/prospective nature) of any studies conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified in the provided text. This information would typically be found in the manufacturer's 510(k) submission or a related study report, not in the FDA clearance letter itself.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not specified 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 based on the device type. The "Light Patch" appears to be a therapeutic device providing heat and pain relief, not an AI-assisted diagnostic imaging device requiring human readers. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not specified and likely not applicable. This device is a physical therapeutic product, not an algorithm, so "standalone algorithm performance" is not a relevant concept for this specific product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not specified in the provided text. Given the indications for use (pain relief, muscle relaxation, blood circulation), the ground truth for any underlying studies would likely involve participant-reported outcomes (e.g., pain scales, comfort levels), physiological measurements (e.g., temperature, blood flow), or possibly clinical assessments by healthcare professionals.

8. The sample size for the training set:

• Not specified in the provided text. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable. As the device is not an AI/ML algorithm, it does not have a "training set" in this context.

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