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The TheraKnit Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS and NMES stimulating devices. The knitted garments deliver the stimulation signals generated by the stimulator to the body parts with which they are in contact. These body parts include hands, feet, arms, legs, shoulder, back (pads).

The TheraKnit Garment Electrodes are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, sleeves and flat fabric used for pads. The conductivity is derived from the silver content of the Nylon yarn. The garment electrodes are available in a variety of sizes ranging from small to extra large for gloves and small to large for socks and sleeves. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The devices can be used dry or wet when in contact with the skin. The entire surface of each garment electrode is very conductive having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.

Acceptance Criteria and Device Performance Study for TheraKnit Garment Electrodes

The provided 510(k) summary for the TheraKnit Garment Electrodes (K053214) outlines its claims of substantial equivalence to predicate devices, but it does not explicitly state quantitative acceptance criteria or detailed results of a study designed to prove the device meets specific performance thresholds.

Instead, the submission focuses on demonstrating equivalence through shared technological characteristics and general bench testing, which is common for devices seeking 510(k) clearance based on substantial equivalence.

Here's an analysis based on the provided text, addressing your specific points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study proving these (mostly implied) acceptance criteria is described as "Bench testing" and "Comparative testing":

• Bench testing: "Bench testing has been done with this device demonstrating that it meets design controls." This is a general statement indicating the device underwent internal testing to ensure it functions as designed, but specific results or quantitative criteria met are not detailed.
• Comparative testing: "Comparative testing was done between the TheraKnit garments and the predicate devices for resistance measurement and comparison." This directly addresses the electrical resistance criterion and aims to show similarity to the legally marketed predicate devices. The text states that "The resistance of the knitted garment for both TheraKnit and the predicate devices are less than 7 ohms/inch," indicating this comparative testing confirmed the TheraKnit's conductivity is within the same range as the predicates.

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

• Test Set Sample Size: Not specified. The document does not provide any numbers for the test set used during bench or comparative testing.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given it's bench and comparative testing relating to physical properties, it would most likely be prospective laboratory testing.

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

• Not Applicable. The study described focuses on technical performance characteristics (like resistance) and design controls of the device itself, rather than diagnostic accuracy or clinical outcomes that would require expert ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. As the testing was technical/bench-based, there would be no need for an adjudication method typically used for clinical or image-based studies.

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

• No. An MRMC study was not done. The device is a cutaneous electrode, not a diagnostic imaging or AI-assisted interpretation tool that would typically involve human readers. The comparative effectiveness focused on technical specifications rather than human performance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• Not Applicable (in the conventional sense). This device is not an algorithm or AI system. Its performance (e.g., conductivity) is standalone in the sense that the device itself performs this function, but the context of "standalone performance" usually refers to AI systems. Its intended use is with human-operated TENS/NMES devices.

7. The Type of Ground Truth Used

• Calibration/Measurement Standards and Predicate Device Performance. For the resistance measurements, the ground truth would be established through calibrated measuring equipment providing an objective standard for "ohms/inch." For the comparative testing, the performance of the legally marketed predicate devices served as a de facto "ground truth" or benchmark against which the TheraKnit's performance was compared to demonstrate equivalence.

8. The Sample Size for the Training Set

• Not Applicable. The device is not an AI/ML model that requires a training set.

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

• Not Applicable. The device is not an AI/ML model.

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The BREVIO is intended for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies.

The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display.

The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.

The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results.

The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change.

The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.

The BREVIO device is a hand-held nerve conduction velocity measurement device intended for use in the diagnosis and monitoring of peripheral neuropathies. The 510(k) summary provides limited details on formal acceptance criteria or detailed study results. Based on the provided text, the device's performance was evaluated through bench testing and comparative human testing against a predicate device.

Here's an attempt to organize the information based on your request, with significant limitations due to the brevity of the study description in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the "comparative human testing." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature) for this human testing. Given the context of a 510(k) submission in the US, it is implied the testing was likely conducted in the US, but this is not explicitly stated. The testing seems to be prospective in nature, given its description as "comparative human testing" conducted to demonstrate correlation.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth in the "comparative human testing." The testing was a comparison between the BREVIO device and a predicate device, implying the predicate device's readings served as a comparative reference.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted to evaluate human reader improvement with AI assistance. The "comparative human testing" described seems to be a direct comparison of device measurements, not a study of human readers using the device with and without AI assistance. Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only) Performance

The device is implicitly standalone in its measurement capability, as it "automatically picks out the latency and amplitude of waveforms." The "comparative human testing" involved comparing the BREVIO device's measurements directly against a predicate device, which inherently implies standalone performance of the BREVIO in generating those measurements. However, no specific "standalone" study, separated from human involvement in interpretation or adjudication of those measurements, is explicitly detailed. The statement that "These automatically chosen values may be manually adjusted by the user" indicates that while the algorithm provides initial values, human-in-the-loop interaction is an expected part of its use.

7. Type of Ground Truth Used

For the "comparative human testing," the "ground truth" was established by the measurements obtained from a legally marketed predicate device. The document states, "Comparative human testing was done demonstrating a high correlation between the BREVIO device and a predicate device for latency and amplitude comparison." This implies the predicate device acted as the reference standard.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This suggests that the device's automatic latency and amplitude detection capabilities might have been developed through internal engineering and testing, rather than a formal, disclosed machine learning training paradigm with a specific dataset.

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

Since no training set is mentioned, the method for establishing its ground truth is also not provided.

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The Nervepace® ViewScope 200VS is intended to be used as a waveform display nerve conduction monitor. Currently the digital electroneurometer (K843924A ) displays the latency value derived from an action potential. This is accomplished by setting a threshold value into the circuitry and when the onset of the action potential reaches the threshold value it trips the timing circuit and the display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry of the electroneurometer has the complete waveform from which the latency value was derived and this can be delivered to a digital storage oscilloscope for complete waveform display.

The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the ViewScope to examine the features of the waveform generated by the stimulus. The physician can determine the action potential latency, amplitude, configuration and duration.

Not Found

This document is an FDA 510(k) clearance letter for the NERVEPACE ViewScope Model 200VS. It confirms the device's substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information based only on the provided text. The document is strictly an approval letter, not a performance study report.

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