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The P4-Fitness is intended for stimulation of healthy muscles in order to enhance and facilitate improved muscle performance. The P4-Fitness is therefore properly considered as a technique or method for muscle training.

The P4-Fitness is NOT intended for use in any therapy or for the treatment of any medical conditions or diseases. The P4-Fitness training programs are not designed or intended for injured or otherwise impaired muscles and use of the P4-Fitness on such muscles is contraindicated.

The P4-FITNESS is a battery-powered device for transcutaneous neuromuscular electro-stimulation. It has two channels (outputs) of stimulation, each with independent intensity control. The P4-FITNESS delivers low voltage stimulation impulses at both of its outputs synchronously. The stimulation output voltage waveforms are in form of trains of monophasic, rectangular, compensated impulses with a zero net current. Such waveform character is true, when the outputs are connected to any resistor in a range from 100 Ω to 10,000 Ω.

The P4-FiTNESS device has six (6) different stimulation timing sequences. The users can select any of these stimulation programs, as appropriate for their objectives. For each stimulation program, the stimulation ON and OFF times, the impulse frequencies and impulse durations are different; all of these parameters are preset at the factory. There are no user accessible controls that can change either the frequency or impulse duration during a treatment. The only user accessible controls are ON/OFF switches. intensity knobs (increase or decrease) and the Program Select switch. The stimulation impulses are low voltage, low frequency, rectangular in shape. The device is housed in a plastic enclosure and is powered by a 9-volt alkaline, non-rechargeable battery, Accessories include output cables, battery, electrode pads and User Manual. There is no provision for an AC adapter; the device can not be connected to any AC electrical power circuit.

The device delivers stimulation pulses of 50v (peak value) ± 10% onto 500Ω at maximum settings, which corresponds to 100 mA (peak value) current intensity. The impulse frequencies produced by the device are in a range of 1 Hz to 120 Hz, with the frequency modulation patterns and timing thereof dependant on the choice of stimulation program. The waveform is rectangular, compensated monophasic with duration time from 40 us to 340 µs. The current impulses are also rectangular, monophasic and compensated, with zero net charge (no DC current) when measured on 500 chms load. The tetanization stimulation impulses include ramp modulation, which permits for gradual increase of the contraction intensity during training.

The provided text is a 510(k) summary for the Valmed Corp. P4-FITNESS Powered Muscle Stimulator. It describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence. However, this document does not detail a study proving the device meets acceptance criteria in the format requested.

The summary focuses on demonstrating substantial equivalence to a predicate device (COMPEX® Sport, K011880) through physical laboratory bench tests and comparisons of electrical parameters and intended use. There is no mention of a clinical study with acceptance criteria for device performance as would typically be described for a new diagnostic or AI-based device.

Here's an analysis based on the information provided, highlighting why the requested table and study details cannot be fully generated:

1. Table of acceptance criteria and reported device performance:

This cannot be fully generated as the document does not define specific "acceptance criteria" for the P4-FITNESS device's performance that would typically be seen in a clinical trial. Instead, it focuses on demonstrating substantial equivalence to a predicate device (COMPEX® Sport) by comparing technical parameters.

2. Sample sized used for the test set and the data provenance:

• Test Set: The "test set" in this context refers to the physical device samples used for bench testing.
  • Sample Size: One P4-FITNESS device (serial number 04 011001) and one COMPEX® Sport device (serial number CSM 00625).
  • Data Provenance: The tests were conducted at the Valmed manufacturing site in Martigny, Switzerland. The tests were "physical laboratory bench tests." This is not a human subject study, so "country of origin of the data" and "retrospective or prospective" are not applicable in the typical clinical study sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This was a technical comparison study, not a clinical study requiring expert ground truth for patient data. The "ground truth" was established by objective measurements of electrical parameters.

4. Adjudication method for the test set:

• Not applicable. There was no adjudication of clinical outcomes or expert opinions. The comparison was based on direct physical measurements.

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 not an AI device or a diagnostic device involving human readers. There was no MRMC study.

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

• Not applicable. This is an electrical stimulation device, not an algorithm.

7. The type of ground truth used:

• Objective technical measurements. The ground truth for the comparison was the measured electrical parameters of the P4-FITNESS device, compared against the measured electrical parameters of the predicate device.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

• Not applicable. No training set was used.

Summary of the "Study" mentioned:

The primary "study" referred to in this 510(k) summary to prove substantial equivalence is a technical comparison study involving physical laboratory bench tests.

• Test: Physical laboratory bench tests conducted at the Valmed manufacturing site in Martigny, Switzerland.
• Purpose: To confirm technical substantial equivalence between the P4-FITNESS (NEW DEVICE) and the COMPEX® Sport (PREDICATE DEVICE).
• Methodology: Direct comparison of electrical output parameters (voltage, current, frequency, impulse duration, charge, waveform characteristics) between the two devices. The "detailed results and waveforms of these measurements are in Valmed file and available for inspection."
• Outcome: The tests "confirmed technical substantial equivalence between the PREDICATE and NEW DEVICES." This implies that the P4-FITNESS performs electrically in a manner comparable to the legally marketed predicate device.

The document also references older research (Cywinski, Zoll, Scott, Vrbova, Dubovitz, Kidd, Oldham, Maher) from the 1970s and 1980s that established the safety standards for transcutaneous electrical stimulators (like ANSI/AAMI NS-4-1985) and the general effectiveness of muscle stimulation. These are not studies specifically conducted on the P4-FITNESS device for 510(k) clearance, but rather foundational scientific literature. The document notes that "As indicated in the attached clinical studies (Attachment 5), these changes include increases in muscle contraction speed, muscle strength and endurance, increases in muscle mass and vascularization as well as changes in muscle cell metabolism..." However, Attachment 5 is not provided in the given text, and therefore, details of those clinical studies (if they directly relate to the P4-FITNESS performance against acceptance criteria) cannot be extracted.

Ask a specific question about this device

Electrical Muscle Stimulator (EMS) devices should only be used under advice from physician or a qualified health professional as adjunctive therapy for the treatment of medical conditions. The intended application is for stimulation of all parts of a body except head and frontal part of the neck. Specific applications include:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy;
• Increasing local blood circulation;
• Muscle re-education;
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
• Maintaining or increasing range of motion of extremities.

Powered Muscle Stimulator

This document indicates a 510(k) clearance for a P4-PHYSIO Powered Muscle Stimulator. The document does not describe acceptance criteria or a study proving that the device meets acceptance criteria. It focuses on the substantial equivalence determination for the device based on its indications for use. Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device