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1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms

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

2. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms

• Symptomatic relief and management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

3. Indications for DC (Direct Current) Mode

• Relaxation of muscle spasm

4. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:

• Temporary increase in local blood circulation
• Temporary relief of minor muscle and joint aches, pains and stiffness
• Relaxation of muscles
• Temporary relief of muscle spasms
• Temporary relief of minor pain and stiffness associated with arthritis

The new Sys*Stim® 240 neuromuscular stimulator features nine discrete waveforms designed to facilitate clinical versatility. Waveforms may be combined with on-off programs for neuromuscular education as well as frequency and amplitude modulation programs for optimal pain management.

New touch-sensitive technology has been used to make starting a treatment easy. The high-resolution color display allows clinicians to monitor all treatment parameters continuously. The patented M Wheel™ provides easy navigation through all of the menus.

Clinicians can add full-featured light therapy capabilities to the SysStim 240 by purchasing either the cluster or laser applicator package. The laser applicator has an 80 mW, 785 nm, laser diode and the cluster emits 500 mW at 600 and 950 nm. Applicator holders are provided with each applicator and can be attached to the sides of the SysStim 240.

Treatment protocols complete with electrode placement quidance allow clinicians to quickly program treatment parameters for their patients. There is even space to save special treatment protocols for each waveform and for light therapy.

The Sys*Stim 240 has an optional battery pack so that clinicians can take either electrical stimulation or light therapy to their patients. A carrying case is also available which holds the units and all the accessories necessary for therapy on the road.

The Mettler Sys*Stim 240 is a neuromuscular stimulator and low-level light therapy device. The provided text describes its features, intended uses, and lists performance testing certifications but does not contain information about a study proving specific performance acceptance criteria for diagnostic or clinical efficacy aspects that would typically require a test set, ground truth, or expert evaluation.

Instead, the acceptance criteria and supporting "study" are focused on compliance with established electrical safety, electromagnetic compatibility (EMC), and laser safety standards, as well as showing substantial equivalence to a predicate device based on technical specifications and functional capabilities.

Here's a breakdown of the information requested, based on the provided text:

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

The acceptance criteria are primarily compliance with various electrical safety and performance standards. The "reported device performance" is the certification of compliance.

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(A) Interferential current stimulation, Premodulated Bipolar Mode and Faradic Stimulation Mode is indicated for:

1. Symptomatic relief and management of chronic (long term) intractable pain.
2. Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain conditions.
   (B) Electrical Muscle Stimulation ( Russian and Galvanic-Interrupted ) is indicated for:
3. Relaxation of Muscle spasm.
4. Prevention or Retardation of disuse atrophy.
5. Increasing local blood circulation.
6. Muscle re-education.
7. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
8. Maintaining or increasing range of motion.
   ( C) Galvanic-DC Continuous mode is indicated for :-
9. Relaxation of muscle spasm.

ANALGESIC PULSER AP-439 is an electrical nerve muscle stimulator with two outputs and four channels. It offers various waveforms including Monophasic, Biphasic, Sinewave & D.C. Line. It has different modes of stimulation such as Faradic, Interferential, DC continuous, and DC Interrupted, with specified maximum output current and voltage for each. It also provides different modulation options for amplitude and frequency.

The provided text is a 510(k) summary for the "Analgesic Pulser AP-439," an Electrical Nerve Muscle Stimulator. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria in the manner one would typically expect for a modern AI/ML device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly that the device's technical specifications and intended uses are substantially equivalent to legally marketed predicate devices.

Study Description:

The document describes a submission for a 510(k) premarket notification. This process is not a clinical study in the sense of a trial designed to prove device effectiveness or safety through statistical analysis against specific acceptance thresholds. Instead, it's a demonstration that the new device is "substantially equivalent" to one or more devices already legally marketed (predicate devices) in terms of intended use, technological characteristics, and safety and effectiveness.

The "study" here is a comparison of technical specifications and intended uses between the proposed device (Analgesic Pulser AP-439) and three predicate devices: Sys stim 226, Sys stim 206 (both from Mettler Electronics Corp.), and Sportx (from Staodyn). The document argues that the AP-439 has the same intended use as the predicates and its technical specifications are comparable, thus ensuring similar safety and effectiveness.

2. Sample Size for Test Set and Data Provenance

Not applicable. This is not a study involving a test set of patient data, but rather a technical and functional comparison of a new device to existing ones.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the context of clinical expert consensus or pathology for diagnostic devices, is not a concept applied in this 510(k) submission for an electrical stimulator. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by their prior clearance.

4. Adjudication Method for the Test Set

Not applicable. There is no test set of patient data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a comparison for an electrical stimulation device, not an image-reading or diagnostic AI system that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical electro-mechanical product, not an algorithm. Its performance is demonstrated by its adherence to technical specifications that are comparable to previously cleared devices.

7. Type of Ground Truth Used

The "ground truth" implicitly used is the regulatory clearance and established safety/effectiveness of the predicate devices. The submission argues that because the AP-439 operates on similar principles, has comparable technical specifications, and shares the same intended use as these legally marketed devices, it can be considered substantially equivalent.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that learns from a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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