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The PowerPlay model PPRT-01 is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure wraps. This device can be used to:

• . Temporarily increase blood circulation in the treated areas;
• . Temporary relief of minor muscle aches and pains.

The PowerPlay Muscle Massager is a lightweight, portable, rechargeable battery powered OTC device that is intended to be used by individuals to relieve minor muscular aches and pains and to temporarily increase blood circulation in the treated arcas.
The system utilizes pneumatically controlled, single bladder compression wraps actuated by an electronically controlled air pump unit and solenoid valves. The intermittent compression provided by the system simulates stroking and kneading of the hands. All pump, battery and control components are protectively housed in a plastic case. A mylar control panel overlays 4 tactile touch control switches, an LED display for monitoring pressure, LED "selected channel", "low battery" and "charging" indicators. There is also a port for connecting the battery charger/AC adapter plug.
The compression wraps consist of a Polyvinyl Chloride (PVC) air bladder encased inside soft, non-woven medical fabric (made from Polyester or Softesse - a fabric composed of common kitchen sponge material), which is adhered to the PVC air bladder. The wraps are supplied clean, non-sterile, packaged individually. A calf, ankle, knee, hip or shoulder massage wrap may be supplied with the PPRT -01 system or available as accessory items.
In operation, the user selects any number of 3 different outputs (Port 1, Port 2 and/or Port 3) and sets the pressure desired for each port (30, 50 or 70 mmHg). An LED corresponding to each output indicates the selected ports, with the digital display indicating the pressure setting for each (see instructions for use). User determined compression wraps containing air bladders are connected to the unit via externally accessible plastic quick-disconnect air ports. The control unit then inflates the wraps to the preset pressure. The LED that corresponds to the activated output channel flashes slowly while that wrap is being filled with air. Wrap pressure is monitored by an integrated pressure transducer and system software. Once the pressure reaches the proper level, the pump is turned OFF for a predetermined "rest" period, and the wrap deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the next wrap is sequenced, and so on. This cycle repeats for 20 minutes on each output (preset treatment period) and then that output turns off. When all selected outputs have completed their 20 minute treatment period the unit powers off. The unit power can be turned off at any time by pressing and holding the I/O button for approximately 2 seconds.
The "rest" period is internally preset to allow each wrap approximately 30 seconds between inflations in order to ensure adequate deflation time between compressions. When multiple outputs are selected, only one wrap is inflated at a time.

The provided document is a 510(k) submission for the PowerPlay Muscle Massager (Model PPRT-01). It describes the device, its intended use, and comparative information with predicate devices to establish substantial equivalence. However, it explicitly states that no formal clinical testing was performed and that non-clinical testing (electrical safety, EMC, mechanical integrity, environmental, and life cycle testing, and in-house bench testing) was used to establish performance characteristics.

Therefore, many of the requested items regarding acceptance criteria from a clinical study, sample sizes, expert ground truth, adjudication methods, and MRMC studies, cannot be answered from this document because such studies were not conducted or reported.

Here's an attempt to answer the questions based on the information available:

PowerPlay Muscle Massager (Model PPRT-01) - Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Since no formal clinical testing was performed, there are no specific performance metrics like sensitivity, specificity, or accuracy derived from a clinical study for clinical acceptance criteria. The acceptance criteria focused on establishing substantial equivalence to predicate devices through non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable: No formal clinical test set or data provenance (country of origin, retrospective/prospective) is described as no clinical testing was performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable: No clinical test set or expert ground truth was established as no formal clinical testing was performed.

4. Adjudication Method for the Test Set

Not Applicable: No clinical test set or adjudication method was used as no formal clinical testing was performed.

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 device is a physical, inflatable leg massager and does not involve AI or human "readers" in the context of an AI-assisted diagnostic or interpretive system. No MRMC study was conducted.

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

Not Applicable: This device is a physical massager and does not have an "algorithm" in the sense of a standalone AI diagnostic tool. Its performance is related to its mechanical and electrical function.

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

For the non-clinical testing, the "ground truth" was based on engineering specifications, regulatory standards, and performance characteristics of legally marketed predicate devices. For example, pressure delivery was validated against the performance of predicate devices.

8. The sample size for the training set

Not Applicable: As no AI or machine learning algorithm is involved, there is no "training set" in the conventional sense. The development of the device would involve engineering design and testing, not algorithmic training data.

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

Not Applicable: See response to item 8.

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