(66 days)
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
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Accuracy | ± 0.5% of full scale + one least significant count (translated to ± 0.6 lb) |
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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JAN 27 1997
510(k) Summary
Submitter's Information: 1. John Chatillon & Sons, Inc. 7609 Business Park Drive Greensboro, NC 27409-9301 Contact - Mr. Joe Troy 1-800-367-0244 Ext. 3120 or (910) 668-0841
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Classification Name: 2. Common/Usual Name: Proprietary Name:
Dynamometer Dynamometer Dynamometer - Model CSD200MT -
Predicate Device: 3. John Chatillon & Sons, Inc. Model CSD200 Dynamometer
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The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively 4. 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 repackages version of the industrial instrument with attachments that are more appropriate for performing manual muscle testing.
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This new Chatillon Model CSD200MT Dynamometer is one more diagnostic ર. device to be added to the existing familar devices previously approved. 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 results of each test must be manually recorded.
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The predicate device utilizes a load cell as the force measuring element, a printed ર. circuit board to process the signal produced by the load cell and a display (LCD) to indicate the results.
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510(k) Summary of Safety and Effectiveness
- This new Chatillon Model CSD200MT Dynamometer is one more diagnostic device to be 】. added to the existing familar devices previously approved. 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 operator can then recall the peak push/pull force that occurred during the test using the keypad. The results of each test must be manually recorded.
- These instruments are powered by a rechargeable battery (7.5 Vdc) which supplies a 2. 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.
- The design accuracy of this instrument is ± 0.5% of full scale, + one least significant count 3. which translates to + 0.6 lb.
- Each individual instrument is calibrated and then checked for accuracy using weights that 4. are checked annually by the State of North Carolina, certified and traceable to N.I.S.T. The instrument is mounted in a test fixture and a 20 lb. weight is applied. Additional 20 lb. weights are applied until the full capacity of the instrument, 100 lb., is reached. This five point calibration ensures the accuracy of the instrument over its full operating range. The unit is then inspected using a different set of weights to verify that the readings do not vary by more than + 0.6 lb. at the five calibration points.
Based on the above, the risk of personal injury that could be caused by the use of this instrument is considered negligible. If a patient's threshold of pain is reached, a test can immediately be terminated by the operator without relying on any action but relaxing the resistance applied.
The use of a 7.5 Vdc rechargeable battery as the power source removes any potential for shock or other electrical involvement.
Future developments anticipated for these instruments will only involve the number of test results that can be stored in memory, manipulation of the data within the microprocessor or possibly a change in the physical size and/or shape of the case that encloses the instruments. Any change in the basic technology used in the instruments will be the subject of a separate submittal.
§ 888.1240 AC-powered dynamometer.
(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.