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The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES):

• Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury
• NeuroMuscular Electrical Stimulation (NMES):
• -Maintenance and/or increase of range of motion
• -Prevention and/or retardation of disuse atrophy
• Increase of local blood circulation -
• Reduction of muscle spasm -
• -Muscle re-education

The NESS H200® Wireless Hand Rehabilitation System is an electrical stimulation device.

The provided text is an FDA 510(k) clearance letter for the NESS H200 Wireless Hand Rehabilitation System. This document grants market clearance based on substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.

The document discusses the regulatory classification, indications for use, and general controls for the device. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about test and training sets.
• Information about expert involvement for ground truth establishment or adjudication methods.
• Details on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used for any performance evaluation.
• Sample sizes or ground truth establishment for a training set.

Therefore, I cannot extract the requested information from the provided text.

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The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.

This neuroprosthesis device consists of a RF foot sensor (Intelli-sense gait sensor), RF control unit (waist mounted / neck strap / in pocket), and a below the knee orthosis containing electrodes and a RF controlled stimulation unit (RF stim unit).

The Intelli-gait sensor detects "heel off" and "heel contact" events during gait and transmits signals to the RF stim unit. Accordingly, the RF stim unit initiates and pauses the stimulation, activating the foot dorsiflexors to ensure proper foot clearance during the swing phase and proper foot placement during the stance phase.

The NESS L300 comprises of 4 main parts:

1. A lower leg orthosis with integrated RF stim unit and electrodes, RF communication, and rechargeable battery,
2. A waist mounted (or in-pocket) Control Unit (CU), including a PDA (clinician programmer) interface, RF communication, and AAA rechargeable battery.
3. Intelli-sense gait sensor with RF communication and non-rechargeable coin battery.
4. Clinician Programmer Handheld computer (PDA)

The provided text describes a Special 510(k) submission for a modification to the NESS L300 device, not a study setting acceptance criteria based on performance data. Therefore, many of the requested details about a study and its methodology are not present in this document.

The document states: "Performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device." However, it does not provide specific details about this performance data or the study design. A Special 510(k) relies heavily on demonstrating that modifications do not raise new questions of safety or effectiveness compared to a previously cleared device.

Here's a breakdown of what can be extracted from the provided text, and what information is missing:

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 specified in the provided text.
• Data Provenance: Not specified in the provided text.
• Retrospective or Prospective: Not specified in the provided text.

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)

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set. This is a regulatory submission for a device modification, relying on equivalence to a predicate, not a de novo study with subjective ground truth.

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

Not applicable. No study with a test set requiring adjudication is 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 an electrical stimulator, not an AI or imaging device requiring human reader interpretation, so an MRMC study is not relevant here.

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

Not applicable. This device is a therapeutic neuromuscular stimulator, not an algorithm, so the concept of "standalone performance" in this context is not relevant as it would be for a diagnostic AI. Its performance is always "human-in-the-loop" in the sense that it's applied to a patient.

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

Not explicitly defined or discussed. The "ground truth" for this type of device (functional electrical stimulation) would typically be clinical outcomes data related to gait improvement, muscle re-education, range of motion, and blood flow, as described in its indications for use. However, the document does not detail how "performance data" was collected or what specific metrics were measured for the modified device versus the predicate, or what the "ground truth" reference for these outcomes would be.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. This is not an AI/machine learning device that uses a "training set."

In summary:

This document is a 510(k) summary for a device modification, emphasizing its substantial equivalence to a previously cleared predicate device. It states that "performance data demonstrates that the modified NESS L300 is as safe and effective as the predicate device," which is the core acceptance criterion for this type of submission. However, it does not provide any specific details about the nature, methodology, sample size, or results of that performance data. The document essentially asserts that such data exists and supported the claim of equivalence, rather than presenting the study itself.

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The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle reeducation, prevent/retard disuse atrophy, maintain or increase joint range of motion and increase local blood flow.

The NESS L300 neuroprosthesis device consisting of a heel sensor, control unit (waist mounted or neck strap or in pocket) and below the knee orthosis containing electrodes and a controlled stimulation unit. The heel sensor detects "heel off" and "heel contact" events during gait. It transmits signals to the stimulator, which initiates/ pauses the stimulation accordingly, thus activating the foot Dorsiflexors to ensure proper foot clearance during the swing phase, and proper foot placement during the stance phase. The NESS L300 comprises of 4 main parts: 1. A lower leg orthosis with integrated stimulation unit (stimulator) and electrodes, RF communication and rechargeable battery. 2. A waist mounted (or in-pocket) control unit (CU), including a PDA interface, RF communication and AAA rechargeable battery. 3. Foot sensor, with RF communication and non-rechargeable coin battery. 4. PDA HP iPAQ hx4700 Pocket PC. The PDA is intended to be used by the clinician for configuring the control unit with the functional parameters as appropriate for every patient.

The provided text is a 510(k) summary for the NESS L300 device, which is an external functional neuromuscular stimulator. The document declares substantial equivalence to predicate devices and outlines the device's technical specifications and indications for use.

However, the provided text does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for either training or test sets.

The document states: "The evaluation of the NESS L300 does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device." This implies that the device was deemed equivalent based on its design and intended use being similar to already cleared devices, rather than through a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested table and detailed information based on the given input because the necessary data is not present in the provided 510(k) summary. The summary is focused on establishing substantial equivalence, not on detailing a performance study with specific quantitative results against acceptance criteria.

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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.

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The NESS Children System is intended for pediatric use 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 NESS Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled switching of the stimulation between these 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 NESS Children System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.

The provided document is a 510(k) summary for the NESS Children System, which is a powered muscle stimulator. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical trial or algorithm evaluation.

Instead, the document focuses on regulatory aspects for device clearance, specifically demonstrating substantial equivalence to a predicate device (NESS System, K022776). The core of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove it meets specific performance metrics against a defined set of acceptance criteria through a dedicated study with the elements you requested.

Therefore, I cannot populate the table or answer most of your questions based on the provided text. The document refers to "Performance Standards" but states "No performance standards have been established for powered muscle stimulators under section 514 of the FDC Act. No special controls apply." This further indicates that the 510(k) process for this device did not involve predefined performance acceptance criteria and a study to meet them in the way you've described for, for example, an AI/ML device.

Here's how I would respond to your request based only on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study for NESS Children System

The provided 510(k) summary for the NESS Children System does not include specific acceptance criteria or an efficacy study demonstrating quantitative performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device (NESS System, K022776) for regulatory clearance. This regulatory pathway typically relies on comparison to a legally marketed device rather than on meeting pre-defined quantitative performance metrics through a dedicated clinical study with the elements you've outlined.

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 mentioned.
• Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned.

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

• MRMC Study Done?: No, an MRMC comparative effectiveness study is not mentioned or described. This type of study is more common for diagnostic imaging AI systems where human reader performance is a key metric.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done?: Not applicable, as this is a physical medical device (electrical stimulator), not an algorithm-only software device.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for this type of device and regulatory submission. The submission focuses on safety and effectiveness comparable to a predicate device through device description and indications for use.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable, as this is a physical medical device. There is no mention of a "training set" in the context of an algorithm.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable.

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The NESS System 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 NESS System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the thigh, or the leg is provided.
A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessorcontrolled switching of the stimulation between these 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 NESS System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.

The provided text is a 510(k) summary for the NESS System, a powered muscle stimulator. It details the device's intended use, description, and its substantial equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement, as this information is not present in the provided 510(k) submission.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Handmaster NMS1) by stating that the only difference is the provision of additional plastic splints for treating other limb sites. This type of submission generally relies on the predicate device's established safety and effectiveness rather than new performance studies for the minor modification.

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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.

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