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The device is intended: To provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the radiant infrared heat provides topical heating for: the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of minor joint pain associated with arthritis; the temporary increase in local circulation where applied; muscle relaxation. The device is easy and safe to use and can therefore be used in hospitals as well as at home and in gymnasiums. The MASSAGE BED VM9100R as been produced for over-the-counter use.

The MASSAGE MATTRESS VM9100RM is an electrically powered motorized multi-functional physical therapy mattress. It is intended to provide muscle relaxation therapy by delivering heat and soothing massage. The massage function is delivered by oscillating motors that are embedded in the mattress body. The heat function is delivered by two components (1) a back pad and (2) a calf pad both containing a heating panel. In both cases, radiant infrared heat is emitted. Both, the oscillating function and the heated pressure apply light pressure as well as radiate infrared heat to the user.

The provided text is a 510(k) summary for the MASSAGE MATTRESS VM9100RM, a physical therapy device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets such criteria.

The document primarily focuses on:

• Product Description: How the device works (oscillating motors for massage, heating panels for heat).
• Technological Characteristics Comparison: Highlighting differences from the predicate device (e.g., oscillating motors vs. jade rollers, power supply type).
• Standards Tested: Listing various EN standards related to electrical safety and product testing that the device adheres to.
• Intended Use Statement: The medical claims for which the device is being cleared (muscle relaxation, minor pain relief, increased circulation).

Therefore, I cannot provide the requested information, as it is not present in the given text.

To answer your specific points:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available. No "test set" is mentioned in the context of clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No ground truth establishment is described.
4. Adjudication method: Not available.
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 a physical therapy device, not an AI diagnostic imaging tool or similar device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

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