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The ARP POV Sport is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

The ARP POV Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The ARP POV Sport is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated.

The POV Sport's electrical impulses allow triggering action potential on motoneurones of motornerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the POV Sport can impose on the stimulated muscles are able to improve or facilitate muscle performance.

The ARP POV Sport is considered a technique of muscle training.

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) summary for the ARP POV Sport, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices for safety and effectiveness rather than presenting a study with specific acceptance criteria for performance.

Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not available in the provided document.

The document primarily states that the device's safety has been demonstrated through compliance with electrical safety standards and that its modes, frequency, output, and indications for use are substantially equivalent to predicate devices.

Here's an attempt to answer the questions based only on the provided text, acknowledging the limitations:

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

This information is not provided in the document. The document primarily focuses on regulatory compliance and substantial equivalence to predicate devices rather than specific performance metrics against pre-defined acceptance criteria.

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 in the document. The "Test Data" section only states that "The ARP POV Sport has been demonstrated safe by testing to IEC 60601-2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-4:2000." These are electrical safety standards, not a clinical performance study involving a patient test set.

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 as there is no described clinical performance study with a test set.

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

This information is not provided as there is no described clinical performance study with a 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

An MRMC study is not mentioned in the document. This device is a powered muscle stimulator, not an AI-assisted diagnostic tool that would typically involve human readers.

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

This information is not applicable as the device is a physical powered muscle stimulator, not an algorithm.

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

This information is not provided as there is no described clinical performance study with a ground truth. The "ground truth" for this type of device's safety and effectiveness determination is typically established by compliance with recognized standards and demonstration of similar operational parameters to legally marketed predicate devices.

8. The sample size for the training set

This information is not provided as there is no mention of an algorithm or a training set.

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

This information is not provided as there is no mention of an algorithm or a training set.

Summary of the Study and Acceptance Criteria from the Text:

The document describes the ARP POV Sport as a powered muscle stimulator. The "study" mentioned for demonstrating its safety and effectiveness is primarily regulatory.

• Acceptance Criteria (Implied):

  • Compliance with electrical safety standards: IEC 60601-2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-4:2000.
  • Substantial equivalence to predicate devices (Compex Sport K011880, TheraStim Muscle Stimulator K893851, and Endurance Therapeutics Model T1040 K060846) in terms of modes, frequency, output, and indications for use.

• Reported Device Performance (from the text):

  • "The ARP POV Sport has been demonstrated safe by testing to IEC 60601-2-10, IEC 60601-1-1:2000, IEC 60601-1-2:2008, and IEC 60601-1-4:2000."
  • "The device compared to the predicate is substantially equivalent, safe and as effective."

It's important to understand that this 510(k) summary is for a traditional medical device (a muscle stimulator), not an AI/ML-driven diagnostic or treatment device, which is why much of the requested information (related to AI performance studies) is not present.

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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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