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Thermal Massage Bed (2D-LX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;

• temporary relief of minor muscle and joint pain, and stiffness
• temporary relief of minor joint pain associated with arthritis
• temporary increase in local circulation where applied
• Relaxation of muscles

Thermal Massage Bed (2D-LX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;

• temporary relief of minor muscle and joint pain, and stiffness
• temporary relief of minor joint pain associated with arthritis
• temporary increase in local circulation where applied
• Relaxation of muscles

The given document is a 510(k) summary for the INAREX Thermal Massage Bed (2D-LX). It mainly focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and specific study performance data for the device itself against those criteria.

Therefore, many of the requested details cannot be extracted from this document, as it describes a clearance based on substantial equivalence, not a direct clinical validation study with specific performance metrics.

Here's a breakdown of what can and cannot be provided based on the input:

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

This information is not provided in the document. The document focuses on demonstrating equivalence to predicate devices (Ceragem-C and Ceragem-RH1) regarding intended use, design, and function, rather than setting specific acceptance criteria for performance metrics (e.g., specific temperatures, massage force, or clinical outcomes) and then reporting the INAREX device's performance against those. The comparison table provided lists technical specifications (Voltage, Power, Frequency, Ambient temperature, Classification) and shows them to be comparable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document states "Testing was performed according to 'Harmonized Standard'. Software testing and validation were done according to EN 60601-1-4. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent." This is a general statement about engineering and software validation, not a clinical test set with human subjects.

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)

This information is not provided. No clinical ground truth establishment is described for a test set.

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

This information is not provided. No clinical test set or adjudication method 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

This information is not applicable/not provided. The device is a "Thermal Massage Bed," not an AI-powered diagnostic or interpretive system that would involve human "readers" or AI assistance in that context.

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

This information is not applicable/not provided. The device is a physical therapy bed; it does not involve algorithms in a standalone diagnostic or interpretive capacity.

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

This information is not provided. No clinical ground truth is mentioned. The testing described pertains to safety and performance according to harmonized standards (e.g., electrical safety, software validation), not clinical outcomes.

8. The sample size for the training set

This information is not applicable/not provided. This device does not appear to involve machine learning or a "training set" in the context of AI development.

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

This information is not applicable/not provided. As above, no training set or ground truth for it is mentioned.

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