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1. To determine the activation timing of muscles.
   a) retraining of muscle activation
   b) coordination of muscle activation
2. An indication of the force produced by muscle
   a) control and maintenance of muscle contractions
3. For use in relaxation training and muscle re-education.

The EMG Retrainer is a device used to measure the bioelectrical signals produced by muscle activity. The main display will register activity and display the quantitative measurement with an analog bar display. Targets of muscle activity may be stored (utilizing audible signals on demand) configurable for activity that is within established limits or exceeding those limits depending on user preference. The EMG Retrainer also contains an auto-ranging function which eliminates manual scale adjustments unless that is the preference. The auto-ranging feature as well as the targeting function are not available on the other models and will be quite useful to the healthcare professional.

The provided text is a 510(k) summary for the Chattanooga Group, Inc. EMG Retrainer, dated September 26, 1997. It describes the device, its intended use, and comparative specifications against predicate devices to establish substantial equivalence.

Based on the information provided in the document:

1. Table of acceptance criteria and the reported device performance:

   The document does not explicitly state "acceptance criteria" as a set of quantified performance targets that the EMG Retrainer needed to meet for a specific study. Instead, it presents comparative specifications to demonstrate substantial equivalence to previously cleared predicate devices. The device performance is implicitly considered acceptable if it meets or exceeds the specifications of the predicate devices for key technical features, or if differences do not raise new questions of safety or effectiveness.

   Feature	Predicate Devices (VERIMED Myoexerciser II, Myotrac 4001, Prometheus Pathway MR20)	Chattanooga Single & Dual EMG Retrainer Performance
   Product Name	Myoexerciser II, 4001, MR20	EMG
   Pickup Config	Individual electrodes, Triangular Pattern, DeLuca in-line or Proprietary	Triangular or individual electrodes
   Active Head	No, Yes, Yes (for Proprietary)	No
   Input Impedance	>10M ohm, 1,000,000 M ohm, unknown	1,000,000 M Ohm with 4pF
   Input Noise	(Not specified for predicates)	180 dB, unknown
   CMRR (over frequency)	120dB, >130 dB, >110 dB	>120dB
   Input Ranges (rms)	8 ranges, 0.8 to 20/200/2000 uV, 1 to 800 uV true RMS	1uV to 2000uV Internal auto gain selection 8 Ranges
   Electrode Wire	2 core + Screen, 2 core + Screen, 4 conductors	2 core + Screen
   Earpiece	Yes, Yes 2.5mm Phono, Yes	Yes 2.5mm Phono
   Threshold	Above & Below, Above & Below & Difference	Above, Below & At Target per channel
   Threshold Features	N/A, Separate Hi/Lo indicating Leds	Bar Chart Dynamic Indication, set by manual, direct activity or % of activity
   Threshold Lock	4 seconds then switch to deactivate, unknown	Yes, Dynamic Threshold Setting
   Continuous Alarm	Yes, Varying pulse rates, Yes	Yes, Varying pulse rates
   Stimulator	Yes, No, Isolated Relay	No
   Historical Record	Yes, N/A, 32 Training Sessions	9 training sessions
   Battery Type	9V	3V Using AA cells
   Battery Compartment	Slide open	Slide open
   Power Consumption	6 to 11 mA, unknown	10 mA w/ Management power (Carbon, Alkaline or Ni Cad)
   Dimensions	85W140L30H, 61W112L28H, 1176938mm	81W84L40D
   Weight	180g, 70 g+bat., 280g	150g
   Pocket Clip	Yes	Yes

   The document highlights that unique features of the EMG Retrainer not available on other models, such as auto-ranging and targeting function, "will be quite useful to the healthcare professional," implying an improvement over predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   The document does not describe a clinical "test set" or a clinical study with patients. The substantial equivalence determination is based on a comparison of device specifications and intended use against legally marketed predicate devices, not on a clinical performance study. Therefore, information on sample size, data provenance (country of origin, retrospective/prospective) for a test set is not applicable or provided.

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

   Not applicable. The document establishes substantial equivalence through engineering and functional specifications comparison, not through a clinical study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   Not applicable, as no clinical test set requiring adjudication is described.

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:

   No MRMC study was done, as this submission predates widespread AI in medical devices and focuses on foundational EMG device functionality and substantial equivalence to existing devices. This device is not an AI-powered system, so the concept of improving human readers with AI assistance is not relevant here.

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

   Not applicable, as this is a physical medical device (EMG Retrainer) and not an algorithm for standalone performance evaluation in the context of AI. The performance outlined is that of the hardware device itself.

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

   Not applicable. The ground truth for establishing substantial equivalence in this context is the FDA-cleared predicate devices and their established safety and effectiveness based on their specifications and intended uses.

8. The sample size for the training set:

   Not applicable. There is no mention of machine learning or an algorithm requiring a training set in this 510(k) submission.

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

   Not applicable. No training set is mentioned or implied.

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