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1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increase of blood flow in the treatment area.
5. Prevention or retardation of disuse atrophy in post-injury type conditions.
6. Muscle re-education.
7. Maintaining or increasing range of motion.

SysStim 208, Model ME 208: The microprocessor controlled SysStim 208 produces low volt current through one channel. The unit produces an asymmetrical electrically balanced waveform. There are three modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz and Surge-80 Hz, On/Off times variable. The SysStim 208 is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the SysStim 208 is the Patient Termination Switch, which is connected to the jack located on back of the unit.

SysStim 208A, Model ME 208A: The microprocessor controlled SysStim 208A produces low volt current through two channels. The unit produces an asymmetrical electrically balanced waveform. There are four modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz, Surge-80 Hz, On/Off times variable and Recip-80 Hz, output alternates between the two channels. The Sys*Stim 208A is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the Sys+Stim 208A is the Patient Termination Switch, which is connected to the jack located on back of the unit.

The provided 510(k) summary for the Sys*Stim® 208/208A, Model ME 208/208A does not describe acceptance criteria or a study to prove the device meets acceptance criteria.

The document is a "510(k) Summary" which serves to demonstrate substantial equivalence to previously cleared predicate devices. It provides a detailed comparison of the technological characteristics of the Sys*Stim® 208/208A with its predicate devices (Chattanooga's Intelect LV110/LV120 and AMREX' MS322/MS324). This comparison serves as the basis for the FDA's determination of substantial equivalence, meaning that the new device is as safe and effective as the predicate device(s) and does not raise new questions of safety or effectiveness.

Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. Instead, the document presents the specifications of the new device and compares them to predicate devices, implying that matching or being within acceptable ranges of the predicate device specifications is the "acceptance" for substantial equivalence.
• Reported Device Performance: The document lists the technical specifications and operational parameters of the Sys*Stim® 208/208A. These are not "reported performance" from a study but rather the design specifications of the device.

Missing Information (Not described in the provided document):

2. Sample size used for the test set and the data provenance: Not applicable. This document is a technical comparison for substantial equivalence, not a clinical or performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrical muscle stimulator, not an AI-assisted diagnostic tool or imaging device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices.

8. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is a medical device clearance, not an AI/machine learning model submission.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the document):

The document does not describe a "study" in the traditional sense of a clinical trial or performance evaluation with specific acceptance criteria. Instead, it presents a technical comparison and declaration of substantial equivalence. The "study" is the comparison made between the Sys*Stim® 208/208A and its legally marketed predicate devices (Chattanooga's Intelect LV110/LV120 and AMREX' MS322/MS324). Mettler Electronics Corp. asserts that their devices are substantially equivalent to these predicates based on similar intended use, technological characteristics (waveform, output modes, power, timer settings, safety features like automatic shut-off and patient override), and compliance with relevant regulations (21 CFR 898).

The detailed tables comparing the specifications of the new device to the predicates serve as the evidence to "prove the device meets acceptance criteria" for regulatory clearance based on substantial equivalence. The acceptance criteria are implicitly that the new device's specifications and performance must be sufficiently similar to the predicate devices and not raise new questions of safety or effectiveness.

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