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The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.

5.1 Digital Hand Dynamometer(SH5003)
In health care environment, accurate and objective data is required for reimbursable rehabilitation services, making the SAEHAN Digital Hand Dynamometer an indispensable tool.
Ideal for routine screening of grip strength and initial and ongoing evaluation of clients with hand trauma and dysfunction.
Virtually leak-proof hydraulics and isometric design ensure accurate, reproducible results and years of reliable service.
A shock-resistant rubber cap protects the stainless steel gauge and a wrist strap prevents accidental damage if dropped.
The SAEHAN Digital Hand Dynamometer combines Precision with convenient features:
-Dual-scale readout displays isometric grip force from 0-300 lbs.(0-136 Kg)
-Peak-hold needle automatically retains the highest reading until reset.
-Handle easily adjusts to five grip position, from 1 3/8" -3 3/8", in half-inch increments.
5.2 Digital Pinch Gauge(SH5006)
Unlike conventional pinch gauges, The SAEHAN Digital Pinch Gauge's unique design frees the client to perform a true pinch pattern because the therapist, not the client, supports the weight of the gauge.
A highly accurate pinch-force measurement, devoid of artifact, is the result. Red indicator needle remains at maximum reading until reset.
Measures pinch force to 601bs. includes instructions, handy carrying case.

The provided 510(k) summary for the SH5003 Digital Hand Dynamometer & SH5006 Digital Pinch Gauge focuses on demonstrating substantial equivalence to a predicate device and safety/performance based on compliance with electrical and EMC standards. It does not contain information about formal acceptance criteria for a study proving device performance in terms of clinical accuracy, sensitivity, specificity, etc., nor does it describe a study involving human subjects or AI.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown based on the available information:

1. Table of acceptance criteria and reported device performance:

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

Not applicable. The document describes compliance with electrical and EMC standards, not a clinical study with a test set of human subjects or data.

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

Not applicable. No clinical ground truth was established in a study described here.

4. Adjudication method for the test set:

Not applicable. No clinical study with adjudication was 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:

Not applicable. This device is a digital hand dynamometer and pinch gauge, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a measurement tool; it does not involve an algorithm generating independent diagnoses.

7. The type of ground truth used:

For the "study" (i.e., testing for safety and performance standards), the "ground truth" would be the specifications and requirements of the EN/IEC 60601-1 and EN/IEC 60601-1-2 standards.

8. The sample size for the training set:

Not applicable. No algorithm training was performed or described.

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

Not applicable. No algorithm training was performed or described.

Summary of the Study Mentioned:

The "study" referenced in the 510(k) summary is not a clinical performance or comparative effectiveness study as might be expected for an AI device. Instead, it refers to regulatory compliance testing:

• Study Purpose: To demonstrate the electrical, mechanical, environmental safety, and overall performance of the SH5003 Digital Hand Dynamometer and SH5006 Digital Pinch Gauge, and electromagnetic compatibility (EMC).
• Methodology: Testing was conducted according to international standards:
  • EN/IEC 60601-1 (1990) for electrical, mechanical, environmental safety, and general performance.
  • EN/IEC 60601-1-2 (2001) for electromagnetic compatibility (EMC).
• Results: "All test results were satisfactory." This indicates that the device met the requirements specified in these standards.
• Conclusion: Based on these tests and a comparison to a predicate device (Dynamometer (FCE Series) of Ametek, Inc. K042889), Saehan Corp. concluded that the SH5003 & SH5006 devices are safe, effective, and substantially equivalent to the predicate device.

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The intended use of the Chatillon FCE and MSC series dynamometers is for performing manual muscle testing to measure muscle strength. The target population for this product is individuals recovering from physical injury or for sports medicine applications.

The Chatillon FCE and MSC series dynamometers are diagnostic devices used for evaluating muscle strength. These instruments are powered by a rechargeable battery (4.8 VDC) which supplied a regulated 2.5 VDC excitation voltage to a strain gauge load cell. The analog output from the load cell (2 mV/V) is then converted to a digital signal that is directly proportional to the applied force. This digital signal is then sent to a microprocessor, which converts the signal to a force value that is stored in memory and/or displayed on the dynamometer graphical display. This design has been used for many years in industrial force measuring instruments and has been also used for physical therapy, occupational medicine and sports medicine. These medical dynamometers are a repackaged version of the industrial force measurement instruments and are designed with special medical attachments that are appropriate for performing manual muscle testing and ergonomic analysis.

The provided text is a 510(k) summary for a medical device (dynamometer) and a letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory approval, not a scientific study report.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, and performance metrics as it is not present in the provided text.

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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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