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The 300 PV is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (NMES), transcutaneous electrical nerve stimulation (TENS), interferential current stimulation (IFS) and functional electrical stimulation (FES).

As a NMES device, the 300 PV is indicated for the following conditions:

• Retarding or preventing disuse atrophy .
• . Maintaining or increasing range of motion
• Re-educating muscles .
• Relaxation of muscle spasm .
• Increasing local blood circulation .
• Prevention of venous thrombosis of the calf muscles immediately after . surgery

As a TENS device, the 300 PV is indicated for the following conditions:

• Symptomatic relief and management of chronic, intractable pain .
• Adjunctive treatment for post-surgical and post-trauma acute pain .

As an IFS device, the 300 PV is indicated for the following conditions:

• Symptomatic relief of acute pain .
• Symptomatic relief and management of chronic pain .

As a FES device, the 300 PV is indicated for the following condition:

• Stimulation of the muscles in the leg and ankle of partially paralyzed . patients to provide flexion of the foot and thus improve the patient's gait.

The Empi 300 PV Complete Electrotherapy System (300 PV) is a battery-powered, multifunction device intended to provide clinicians with the flexibility to prescribe multiple stimulation therapy regimens with the same device. The 300 PV offers the following features:

• . Two independent stimulation channels (CH1 and CH2), each of which can provide NMES, TENS, IF, or FES therapy. HV therapy can be accomplished using CH1.
• Two independent intensity controls corresponding to each of the stimulation ● channels with a maximum stimulation of 100 mA from each channel.
• Timed therapy sessions
• Continuous or cycled stimulation
• . Adjustable pulse rates
• . Adjustable ON and OFF time controls
• . Balanced asymmetrical and symmetrical biphasic waveforms
• Thirteen preprogrammed regimens: five for NMES; one for TENS; one for ● IF; two for HV and four that can be customized by the clinician (two NMES and two HV).
• Lock option for clinician to control treatment regimens and stimulus intensity .
• Pause button for patient to pause stimulation. During pause, the timer will ● not countdown if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero.
• . Optional external hand or foot switch used to control the device output during when used as an FES device for gait training

The provided text is a 510(k) summary for the "300 PV Complete Electrotherapy System." It details the device's indications for use and states its basis for substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria.

510(k) summaries primarily focus on demonstrating substantial equivalence to legally marketed predicate devices, often by comparing design, materials, indications for use, and performance characteristics. They typically do not include detailed performance studies with acceptance criteria in the way a PMA (Pre-Market Approval) or a de novo submission might.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as a specific performance study dataset is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrotherapy device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this is an electrotherapy device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document discusses the basis for substantial equivalence by comparing the 300 PV to predicate devices like the Empi Focus, JACE Tristim, and RS Medical RS-4M+. It highlights improvements over the Empi Focus (simplified user interface, addition of interferential and high voltage regimens) and notes that specific features (high voltage galvanic stimulation, interferential current stimulation) are available on other predicate devices. This comparison serves as the "proof" for substantial equivalence rather than a new performance study against defined acceptance criteria.

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