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The ARP Rx100 is intended for the following applications:

• Relaxation of muscle spasms
• Prevention or retardation of disease atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion

The system consists of a table top electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes. Control parameters are software controlled through an LCD touch screen.

The provided text is a 510(k) premarket notification for a medical device, the ARP Rx100 Powered Muscle Stimulator. It details the device's intended use and claims substantial equivalence to a predicate device, the TheraStim Muscle Stimulator (K893851).

However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond safety testing. The "Test Data" section only states: "The ARP Rx100 has been demonstrated safe by testing to IEC 60601-2-10. The Device compared to the Predicate is substantially equivalent, safe and as effective." This indicates electrical safety and a claim of equivalence based on comparison, not a direct performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and a study proving the device meets them, as this information is not present in the provided text.

Here's what I can extract and state based on the provided document:

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

• Information Not Found: The document does not specify performance-based acceptance criteria (e.g., target accuracy, sensitivity, specificity, or specific physiological outcomes) for the ARP Rx100 or its reported performance against such criteria. The only "test data" mentioned refers to safety testing and a general claim of substantial equivalence.

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

• Information Not Found: The document does not describe any specific test set for performance, nor does it mention sample size, country of origin, or whether any data was retrospective or prospective. The "Test Data" section refers to safety testing to a standard (IEC 60601-2-10), which typically involves device-level testing, not patient-level data.

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)

• Information Not Found: This information is not relevant or present as there is no described test set or ground truth establishment related to clinical performance.

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

• Information Not Found: This information is not relevant or present as there is no described test set.

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

• Information Not Found: This is a powered muscle stimulator, not an AI-assisted diagnostic device. Therefore, an MRMC study or AI-related metrics are not applicable and are not mentioned.

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

• Information Not Found: This is a powered muscle stimulator, not an algorithm-only device. Therefore, standalone algorithm performance is not applicable and is not mentioned.

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

• Information Not Found: There is no mention of a performance study requiring ground truth data.

8. The sample size for the training set

• Information Not Found: The document does not describe any training set, as it is related to a physical device rather than a machine learning model.

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

• Information Not Found: Not applicable as there is no training set described.

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