Search Results

The Handmaster is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegic patients due to stroke, it is also intended to provide hand active range of motion and hand function.

The Handmaster is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable.

A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.

The electrode locations allow the Handmaster to give finger and thumb extension and flexion. By pressing the Mode button on the Control Unit, the user can select from seven stimulation programs that comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. In addition to the former light glowing presentation of the active mode, the new LCD screen enables also the presentation of the name of active mode and sub-mode. A continuously changing three and two-bar combination indicates that the stimulation phase is active. A "seventh like" object indicates the stimulation intensity or the battery condition.

The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment like display.

During the initial system set-up, the clinician opens a screw secured clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the stimulation cycles, effectively speeding or slowing the cyclic hand motion.

The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device.

The Handmaster splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the forearm and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony regions. The electrodes are made from metal mesh. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A sponge is provided to facilitate wetting of the electrode pads.

Rechargeable nickel-metal-hydride (NiMH) batteries power the device. Battery status can be displayed both during device operation and while recharging the batteries. Both visual and audio battery-low warnings are provided.

The provided text is a 510(k) summary for the N.E.S.S. HANDMASTER neuromuscular electrical stimulation system. It details device descriptions, predicate devices, intended uses, and a statement of substantial equivalence. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria, as typically found for AI/algorithm-based diagnostic devices.

The document discusses "Performance Data & Substantial Equivalence" and states that "In vitro, biocompatibility, electrical and electromagnetic testing and verification and validation testing of the software were performed to ensure that the modified HANDMASTER does not raise any new questions of safety and efficacy." These are general types of testing for medical devices, but they do not provide specific metrics, acceptance criteria, or study details comparable to what would be expected for an AI system's performance evaluation against a gold standard.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device approval process than what would involve the detailed performance metrics and studies characteristic of AI-based medical devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not mentioned, as the device is a physical stimulator and not an AI diagnostic tool requiring expert-established ground truth on a test set in the conventional sense.

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

• Not mentioned.

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

• No MRMC study is mentioned. This device is a physical neuromuscular electrical stimulator, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable as this is a physical device, not a standalone AI algorithm. Its "performance" refers to its electrical stimulation and physical operation, not an analytical output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not mentioned, as the concept of "ground truth" for an AI diagnostic algorithm does not directly apply to the performance testing described for this device. The testing focused on general safety, biocompatibility, electrical, electromagnetic, and software validation.

8. The sample size for the training set

• Not mentioned, as this device does not utilize a "training set" in the context of machine learning or AI.

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

• Not applicable, as there is no mention of a training set or AI model development in the provided text.

Summary regarding the "Study that proves the device meets the acceptance criteria":

The document describes that "In vitro, biocompatibility, electrical and electromagnetic testing and verification and validation testing of the software were performed to ensure that the modified HANDMASTER does not raise any new questions of safety and efficacy." This statement indicates that tests were conducted, but it does not provide details about specific acceptance criteria or the results of these tests in a way that allows for a quantitative performance assessment as would be expected for an AI/algorithm-based device.

The basis for approval is "substantial equivalence" to previously cleared predicate devices (K952273, K982482, and K010837), rather than demonstrating performance against specific, novel acceptance criteria through a detailed clinical or diagnostic accuracy study. The changes made to the device (e.g., display, power supply, battery, materials) required verification of continued safety and efficacy through the mentioned general testing.

Ask a specific question about this device

The Handmaster is intended to be used for the following indications: Maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.

The Handmaster is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the Handmaster to give finger and thumb extension and flexion. The user can select from five stimulation programs by pressing the mode button on the control unit. The active mode is displayed by a light glowing next to the labeled mode. When the device is stimulating, the light flashes. The stimulation programs are supplied as microprocessor firmware. They comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment display. During the initial system set-up, the clinician opens a clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the with a giobal villing offectively speeding or slowing the cyclic hand motion. The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device. The Handmaster splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the comfortable oncerce and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony with bols poly arounded are made from metal foil coated with carbon-impregnated polymer. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A over and crood bottle is provided to facilitate wetting of the electrode pads. Rechargeable nickel-cadmium batteries power the device. Battery status can be displayed both during device operation and while recharging butteries. Both visual and audio battery-low warnings are provided. It is necessary to disconnect splint/electrodes in order to recharge the batteries, as the same socket is used for both.

This 510(k) summary does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Instead, the document focuses on:

• Device identification: Trade name, common/usual name, classification name, predicate devices.
• Intended use: Specific medical conditions and therapeutic goals.
• Device description: Physical characteristics, functionality, user interface, power source.
• Performance data & substantial equivalence: A statement that the device is identical to a previously cleared version and that clinical data supports the expanded indication for hemiplegic patients, but no details of that clinical data or any specific study results are provided.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The document explicitly states that the device is "exactly the same device in all aspects to the market-cleared Handmaster" with the only difference being an "expansion of the indication." This expansion is "supported by clinical data that demonstrates that the Handmaster can be safely and effectively used for this indication," but the details of this supporting clinical data are not included in this summary.

Summary of missing information based on your request:

1. Table of acceptance criteria and reported device performance: Not provided.
2. Sample size used for the test set and data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable, no AI/algorithm training set mentioned.
9. How the ground truth for the training set was established: Not applicable, no AI/algorithm training set mentioned.

Ask a specific question about this device

Ask a specific question about this device

The HANDMASTER NMS1 is intended to be used to exercise the lower arm and hand by activating the muscles thereof with electrical stimulation. As a powered muscle stimulator, the HANDMASTER NMS1 is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.

The HANDMASTER NMS1 is a portable, one-channel electrical neuromuscular stimulator for personal use in exercising the upper extremity. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the HANDMASTER NMS1 to give finger and thumb extension and flexion. The user can select from five stimulation programs by pressing the mode button on the control unit. The stimulation programs are supplied as microprocessor firmware. They comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. During the initial system set-up, the clinician opens a clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the stimulation cycles, effectively speeding or slowing the cyclic hand motion. The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately.by switching OFF the device. The HANDMASTER NMS1 splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the forearm and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony regions. The electrodes are made from metal foil coated with carbon-impregnated polymer. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A sponge-capped bottle is provided to facilitate wetting of the electrode pads. Rechargeable nickel-cadmium batteries power the device.

The provided document, K982482 for the HANDMASTER NMS1, describes a 510(k) premarket notification for a modified powered muscle stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to establish new safety and effectiveness criteria through a comprehensive clinical study with acceptance criteria in the typical sense.

Here's an analysis of the provided information relative to your requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: This document does not describe a clinical test set with human subjects or a defined "sample size" in the conventional sense for performance evaluation in a clinical study. The performance data mentioned (Oscilloscope Tracing Specification tests) are technical tests performed on the device itself, likely on a limited number of units for engineering verification.
• Data Provenance: Not applicable in the context of a clinical test set. The technical testing was performed on the modified HANDMASTER NMS1 device. The document does not specify the country of origin of the device's manufacture for these specific tests, but the submitter is based in Israel. The data would be considered prospective in relation to the submission, as it was generated to support the 510(k).

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

• This information is not applicable. The device performance was assessed via technical tests (Oscilloscope Tracing Specification tests), not against a "ground truth" derived from expert clinical assessment. The "ground truth" here is the expected electrical output characteristics described in the FDA guidance and device specifications.

4. Adjudication Method for the Test Set

• This is not applicable as there was no expert-adjudicated clinical test set.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a powered muscle stimulator, and clinical trials of this nature are generally not required for 510(k) submissions unless substantial equivalence cannot be demonstrated through other means (e.g., technical performance, material safety, and reference to existing literature).

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

• This concept is not directly applicable. The HANDMASTER NMS1 is a physical device that delivers electrical stimulation. Its "performance" refers to its electrical output characteristics. There isn't an "algorithm only" component that would be evaluated in a standalone manner distinct from the physical device's operation. The microprocessor firmware controls the stimulation programs, but its performance is inherently tied to the device's physical output.

7. The Type of Ground Truth Used

• For the technical "Performance Data" mentioned, the "ground truth" or reference standard would be the specifications outlined in Section 1 of the Draft FDA Guidance entitled "Technological Reporting for Powered Muscle Stimulators" and the internal design specifications of the device. This is a technical (engineering) ground truth, not a clinical one (like pathology or expert consensus).

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI/ML algorithm that is "trained" on a dataset in the typical sense. The microprocessor firmware contains pre-programmed stimulation programs, but these are designed based on established physiological principles and prior device iterations, not a "training set."

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

• Not applicable, as there is no "training set" for this type of device in the context of the provided documentation. The "ground truth" for the device's operational characteristics (e.g., waveform shape, frequency, intensity levels) is based on engineering design, medical literature regarding neuromuscular electrical stimulation, and regulatory guidance for powered muscle stimulators.

Ask a specific question about this device

The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

The MyCycle Handmaster Victory wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Quickie 2hp Titanium Wheelchair. The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical. based on the documentation available to applicant regarding this wheelchair. The only difference is that the MyCvcle device is not of Titanium but of conventional metal materials. However, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.

The provided text describes a 510(k) submission for the MyCycle Handmaster Victory Wheelchair. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing. Instead, the submission relies on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of why the requested information cannot be fully provided:

• Reliance on Predicate Device: The core of this 510(k) is that "Inasmuch as the device is substantially identical in every dimension to the Quickie 2hp Titanium Wheelchair, the same test results that are exhibited by the Quickie 2hp Titanium Wheelchair are applicable to the MyCycle Handmaster Light Wheelchair." This means MyCycle did not conduct independent performance studies to establish acceptance criteria for their device. They are asserting that the predicate device's existing performance data applies.

The following information summarizes what is available in the provided text, addressing the points where possible, and explicitly stating when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The MyCycle device itself was not independently tested to establish these criteria. The submission relies on the existing performance data of the predicate device (Quickie 2hp Titanium Wheelchair). The sample size for the predicate device's original testing is not provided in this document.
• Data Provenance: Not applicable for MyCycle's device directly. The "documentation available to applicant regarding this wheelchair" for the predicate device is mentioned, but its specific provenance (country, retrospective/prospective) is not detailed.

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

• Not applicable. No independent "ground truth" establishment or expert review for the MyCycle device's performance data is described, as it relies on the predicate device's existing data.

4. Adjudication Method for the Test Set

• Not applicable. No independent testing or adjudication for the MyCycle device's performance is described.

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

• No. This is not applicable to a wheelchair device's performance assessment. MRMC studies are typically for medical imaging diagnostics involving human readers and AI systems.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No. This is not applicable. The device is a physical wheelchair, not an algorithm or AI system.

7. Type of Ground Truth Used

• Not applicable for the MyCycle device directly. The "ground truth" for the performance claims is implicitly the established and accepted performance of the predicate device (Quickie 2hp Titanium Wheelchair) through its own testing and regulatory clearance.

8. Sample Size for the Training Set

• Not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

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

• Not applicable. See point 8.

Ask a specific question about this device

The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.

The MyCycle Handmaster Light wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Breezy Wheelchair (K880280). The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical, based on the documentation available to applicant regarding this wheelchair. The only difference is that in place of a single wheel carrier, the MyCycle Handmaster Light wheelchair instead utilizes two vertical carriers in parallel to better distribute the load. Accordingly, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.

The provided text doesn't contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial or performance study with quantified metrics.

Instead, the submission for the MyCycle Handmaster Light Wheelchair relies on demonstrating substantial equivalence to a predicate device, the Breezy Wheelchair. This means the acceptance criteria are implicitly met by showing the new device is functionally and structurally the same as an already approved device.

Here's how the information aligns with your request:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of a dedicated performance study for the MyCycle Handmaster Light Wheelchair itself. The "testing" referred to is a reliance on the existing test results and approvals for the Breezy Wheelchair (K880280).
• Data Provenance: The provenance of the Breezy Wheelchair's data is not provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. Ground truth, in this context, refers to the established safety and effectiveness of the existing predicate device, the Breezy Wheelchair, as determined by previous regulatory processes. No new expert panel was convened for the MyCycle Handmaster Light Wheelchair's equivalence determination.

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

• Not applicable. No new test set for the MyCycle Handmaster Light Wheelchair required adjudication. The "adjudication" was the FDA's regulatory review of the substantial equivalence claim.

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 physical wheelchair, not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance.

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

• Not applicable. This device is a physical wheelchair, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" is the previously established safety and effectiveness of the Breezy Wheelchair (K880280) and the Wijit manual power attachment through their respective regulatory approvals and subsequent market performance. This implicitly includes any testing and expert evaluations undertaken for those predicate devices.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. This is not a machine learning or AI device.

Ask a specific question about this device

The N.E.S.S. HANDMASTER NMS1 is intended to be used to exercise the lower arm and hand by activating the muscles thereof with electrical stimulation. As a powered muscle stimulator, the HANDMASTER NMS1 is intended to be used for the following indications: Maintenance or increase of range of motion, reduction of spasticity, prevention or retardation of disuse atrophy, facilitation and re-education of voluntary motor function, and influencing local blood circulation.

The HANDMASTER NMS1 is a portable, one-channel electrical neuromuscular stimulator for personal use in exercising the upper extremity. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable.

The HANDMASTER NMS1 is used for exercising the hand, conditioning selected muscles of the forearm and hand. It is intended for use by patients suffering from upper limb paralysis due to injury or disease of the central nervous system such as cervical spinal cord injuries or stroke.

A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.

The electrode locations allow the HANDMASTER NMS1 to give finger and thumb extension and flexion. The user can select from five stimulation programs by pressing the mode button on the control unit. The active mode is displayed by a light glowing next to the labeled mode. When the device is stimulating, the light flashes. The stimulation programs are supplied as microprocessor firmware. They comprise either cyclic or continuous activation of the finger and thumb extensors and flexors.

The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment display.

During the initial system set-up, the clinician opens a clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the stimulation cycles, effectively speeding or slowing the cyclic hand motion.

The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device.

The HANDMASTER NMS1 splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the forearm and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony regions. The electrodes are made from metal foil coated with carbon-impregnated polymer. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A sponge-capped bottle is provided to facilitate wetting of the electrode pads.

Rechargeable nickel-cadmium batteries power the device. Battery status can be displayed both during device operation and while recharging the Sources. Both visual and audio battery-low warnings are provided. It is necessary to disconnect splintelectrodes in order to recharge the batteries, as the same socket is used for both.

I am sorry, but the provided text does not contain enough information to complete all sections of your request about acceptance criteria and study details. The text focuses on describing the device's technical characteristics and demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical performance study with acceptance criteria.

Here's what I can extract and what is missing:

Acceptance Criteria and Device Performance Study Details for N.E.S.S. HANDMASTER NMS1

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the "Performance Data" section describes specification tests rather than clinical performance with defined acceptance criteria related to therapeutic outcomes. The acceptance criteria implied here are that the device's electrical output characteristics meet its design specifications and function as intended.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The text describes oscilloscope tracing specification tests conducted on a single device (the "NESS HANDMASTER NMS1 device"). This is a technical verification, not a clinical study involving a test set of patient data. Therefore, this information is not applicable in the typical sense of a clinical trial.

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

Not applicable. The performance data describes technical measurements of the device's electrical output, not a clinical assessment requiring expert-established ground truth.

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

Not applicable, as this was a technical specification test, not a clinical study requiring adjudication of findings.

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. The device is a neuromuscular electrical stimulator, not an AI-powered diagnostic tool, and the provided text does not describe an MRMC study.

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

Not applicable. The "Performance Data" section describes functional testing of the device's electrical outputs, not the performance of an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the reported performance data consisted of the expected electrical output characteristics of the device as per its design specifications. This is a technical manufacturing/design specification, not a clinical ground truth.

8. The sample size for the training set

Not applicable. The described tests are technical verification of a physical device, not related to an AI model or a training set.

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

Not applicable. There is no mention of a training set for an AI model.

Ask a specific question about this device