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The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively evaluating muscle strength. The person being tested (patient) is told to push or pull against the instrument using a particular muscle group. The physician/therapist performing the test (operator) resists the push or pull for a predetermined time period. The instrument measures the instantaneous push or pull force produced by the patient and stores the maximum value of the force during a single test in memory.

The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively evaluating muscle strength. These instruments are powered by a rechargeable battery (7.5 Vdc) which supplies a regulated 5 Vdc excitation voltage to a strain gage load cell. The output from the load cell passes through an A/D converter which produces a digital signal that is directly proportional to the applied force. This signal is then sent to a microprocessor which converts the signal to a force value that is stored in memory and/or displayed on an LCD. This basic design has been used for many years in industrial force measuring instruments that have found their way into hospitals, clinics and other similar facilities through industrial distributors. The instrument submitted herewith is a repackaged version of the industrial instrument with attachments that are more appropriate for performing manual muscle testing.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CSD200MT Dynamometer:

This document describes a very simple device (a dynamometer) and not an AI/ML powered device. Therefore, many of the questions regarding AI/ML specific criteria (such as multi-reader multi-case studies, training sets, and detailed ground truth establishment methods) are not applicable. I will extract the relevant information for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a separate "test set" in the context of different units being tested. Instead, it describes a process for calibrating and verifying each individual instrument.
• Data Provenance: Not applicable in the context of clinical study data. The "testing" involves internal quality control and calibration procedures performed by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. The "ground truth" for the device's accuracy is established through physical weights that are certified and traceable to N.I.S.T. (National Institute of Standards and Technology). This is a metrological standard, not expert opinion.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Accuracy is determined by comparing the device's reading to the known values of certified weights.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not done. This is a simple diagnostic device (dynamometer) that measures physical force, not an imaging or diagnostic AI/ML device that requires interpretation by readers.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

• Standalone Performance: Not applicable in the context of AI/ML. The device itself operates in a "standalone" manner in that it measures and displays force without human "interpretation" of its internal workings or output for its primary function. However, the application of the device (manual muscle testing) inherently involves a human operator (physician/therapist).

7. The Type of Ground Truth Used

• Type of Ground Truth: Physical standards (certified weights traceable to N.I.S.T.).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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