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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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