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The microFET2™ System is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury or for sports medicine applications, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle group being tested.

The microFET2™ is an ergonomically designed hand-held, battery operated, digital muscle tester. Which is an accurate, portable Force Evaluation Testing (FET) dynamometer, designed specifically for taking objective, reliable, and quantifiable muscle testing measurements, and is used to record a person's ability to resist force for a specific muscle or muscle group being tested.

The device's ergonomic design allows for its use ambidextrously, depending on stabilization requirements, by being held in either hand using an elastic strap for convenience and comfort. The size and weight of the device allows the examiner/tester to use the same procedures and methods of muscle testing techniques without causing injury to the clinician or patient.

This document is a 510(k) premarket notification decision letter from the FDA for the Hoggan Scientific MicroFET2™ System. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific clinical acceptance criteria in the way an AI/ML medical device submission would.

Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details, are not applicable to this type of submission for a physical medical device like a dynamometer.

The document discusses functional testing of the device (such as electrical safety and software functionality, and biocompatibility), but this is different from the clinical performance evaluation of an AI algorithm.

Here's a breakdown of what can be extracted and what cannot:

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

The document broadly states that "All necessary verification steps met pre-determined acceptance criteria to confirm safety and effectiveness" and "All data met pre-determined acceptance criteria." It also lists functional tests performed. However, it does not provide a quantitative table of acceptance criteria vs. specific measured performance for the device's primary function (muscle strength measurement). It focuses on comparative equivalence to a predicate device and safety/EMC standards.

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

• Not applicable / Not provided. This device is a physical dynamometer, not an AI/ML algorithm that processes a "test set" of data in the sense of patient images or readings. The "testing" refers to hardware and firmware verification. No clinical trial data of specific patient cohorts for performance metrics is discussed.

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

• Not applicable. Ground truth in the context of an AI/ML device would refer to disease labels or measurements on patient data. This document describes a physical measurement device where the "ground truth" would be the actual force applied, which is measured by a calibrated load cell. Expert labeling is not relevant here.

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

• Not applicable. No expert adjudication process is described as it's not a performance evaluation involving subjective human interpretation of outputs.

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 is not an AI-assisted device. It's a direct measurement tool.

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

• Not applicable. This device is a physical tool for direct measurement of force; there is no "algorithm only" performance separate from the device's operation.

7. The type of ground truth used:

• The "ground truth" for a dynamometer's accuracy would typically be established by using calibrated weights or force meters to verify the load cell's readings against known forces within its measurement range. The document states "Resistance based strain gauge (Load Cell) with microprocessor to convert analog signal to digital, calibrated data," implying that calibration is an inherent part of its operation. It does not elaborate on the specific calibration process or "ground truth" for accuracy testing.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of an AI/ML algorithm.

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

• Not applicable. There is no "training set" for this device.

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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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Any situation where the hand grip or pinch strength would be a valuable piece of data in the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s).
To measure grip or pinch strength in an injured and uninjured hand.
To conduct pre-employment screening for physically demanding job activities.
To establish an industrial strength testing program in general, and to match the strength of workers to the strength demands of specific job duties in the workplace.

The KaDance 2000 system is designed to aid in the identification of fine motor performance issues, (median nerve entrapment), which may be present in either or both hands of a human. The system is non-invasive. This is accomplished by measuring how the thumb (digit 1), index finger (digit 2) and little finger (digit 5) maintain a grip throughout several repetitive exercisers. The applied forces exerted by the digits measured as a function of time. Measurements may be made as rapidly as once every 2 ms for all three digits simultaneously. The system consists of 1) hand sensor, 2) a data control module and laptop computer, 3) KaDaLink™ computer with KaDance 2000 software running. Data is displayed as force over time.

Here's an analysis of the provided 510(k) submission for the KaDance 2000 Hand Sensor System, focusing on acceptance criteria and study details:

The provided document (K012492 for the KaDance 2000 Hand Sensor System) is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study acceptance criteria and results in the same way a PMA or a more extensive clinical study report would.

Key takeaway: This 510(k) submission does not contain specific acceptance criteria, detailed study designs, or performance metrics for a clinical study proving the device meets those criteria. It relies heavily on a claim of "extensive safety, performance, and validations" and "equivalence in safety and efficacy to its predicated devices."

Therefore, many of the requested elements cannot be extracted directly from this document. I will provide what is available and note when information is missing.

Acceptance Criteria and Device Performance Study Analysis

Based on the provided K012492 510(k) submission for the KaDance 2000 Hand Sensor System:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not specify quantitative acceptance criteria or detailed, quantifiable performance metrics for the KaDance 2000 system. The "performance specifications" are mentioned but not detailed.

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

• Test set sample size: Not specified.
• Data provenance: Not specified. The submission mentions "extensive safety, performance, and validations" and "final testing for the systems," implying internal testing rather than a large-scale clinical study with external data. There is no mention of country of origin or whether data was retrospective or prospective.

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

• Number of experts: Not applicable/not specified.
• Qualifications of experts: Not applicable/not specified.

Missing Information: The nature of the testing described (functional and performance tests) does not involve expert ground truth establishment in the traditional sense of diagnostic accuracy studies.

4. Adjudication method for the test set

• Adjudication method: Not applicable/not specified.

Missing Information: Adjudication is typically relevant for studies involving subjective interpretation (e.g., medical image reading), which is not the primary focus of the described "performance tests" for a force measurement device.

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

• MRMC study: No, an MRMC study was not done, nor would it be relevant for this type of device.
• Effect size: Not applicable.

Missing Information: The KaDance 2000 Hand Sensor System is a force measurement device, not an AI-assisted diagnostic tool involving "human readers" or "AI assistance" in the way MRMC studies typically assess.

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

• This question is less relevant for a dynamometer device. The device itself is the "algorithm" or measurement tool. Its "standalone performance" is implicitly what the "functional requirements and performance specifications" tests were designed to ensure. However, the document does not detail how this standalone performance was assessed or quantified.

Missing Information: Specific details on the methodology and results of any standalone performance assessment are not provided beyond a general statement of "testing."

7. The type of ground truth used

• Ground truth: For a force measurement device, the "ground truth" would typically involve calibrated force standards or reference measurements. The submission mentions "performance tests" but does not specify the ground truth methodology or reference standards used.

8. The sample size for the training set

• Training set sample size: Not applicable/not specified.

Missing Information: This device is a measurement tool, not an AI/ML model that would require a "training set" in the conventional sense. The "training set" concept is not relevant to the described device development and testing.

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

• Ground truth for training set: Not applicable/not specified.

Missing Information: As the concept of a "training set" does not apply to this device, neither does the establishment of its ground truth.

In summary, the K012492 510(k) submission for the KaDance 2000 Hand Sensor System focuses on demonstrating substantial equivalence to a predicate device (Digit-grip with LCD K981730) and claims general "extensive safety, performance, and validations." It explicitly states that "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." However, it does not provide the specific acceptance criteria, detailed study designs, or quantified results of these tests in this public summary. Many of the questions above are designed for AI/ML-driven diagnostic devices, which this dynamometer is not.

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