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The Natus VikingQuest is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP) , Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Natus VikingQuest may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The VikingQuest is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general. Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Natus VikingQuest is intended to be used by a qualified healthcare provider.

The Natus VikingQuest is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based.

The provided text describes the 510(k) premarket notification for the Natus VikingQuest, a diagnostic electromyograph. The information focuses on its substantial equivalence to predicate devices and adherence to various medical device standards. However, it does not contain specific details about acceptance criteria, reported device performance in terms of clinical accuracy or effectiveness, sample sizes for test sets, data provenance, ground truth establishment, or clinical study designs (like MRMC or standalone performance).

The document primarily outlines the regulatory compliance, technological characteristics, and intended use of the device, rather than detailed clinical performance evaluations against specific acceptance criteria.

Therefore, for aspects related to acceptance criteria and a study proving device performance, the information is largely absent in the provided text.

Here's what can be extracted based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified. The document describes engineering and regulatory compliance testing rather than clinical study data.

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

• Not applicable as no clinical test set or ground truth establishment by experts for performance against a diagnosis is described. The "ground truth" mentioned pertains to compliance with engineering and safety standards.

4. Adjudication method for the test set:

• Not applicable as no human adjudication of clinical results 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:

• No mention of an MRMC study or AI assistance. The Natus VikingQuest is a diagnostic electromyograph for acquiring, displaying, analyzing, and reporting electrophysiological information, not an AI-driven interpretation system.

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

• The document describes a medical device (electromyograph) for use by a qualified healthcare provider. It does not describe a standalone algorithm or AI performance. The performance verified is for the entire device as a system.

7. The type of ground truth used:

• For the regulatory and engineering tests (biocompatibility, software, electrical safety, EMC, usability), the "ground truth" is compliance with established international standards (ISO, IEC, AAMI/ANSI) and FDA guidance documents. There is no mention of pathology, expert consensus on clinical findings, or outcomes data in the context of the device's diagnostic accuracy proving.

8. The sample size for the training set:

• Not applicable. The document describes a medical device, not an AI/machine learning algorithm with distinct training and test sets in the typical sense. Software development was "rigorously verified and validated consistent with FDA guidance documents and standards," implying traditional software testing, not machine learning model training.

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

• Not applicable, for the same reasons as point 8.

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ViMove2 is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device obiectively measures, records and analyzes angular movement and muscle activity.

Under the direction of the healthcare professional, the software quides the patient through a series of dynamic movements and static postures in standing and sitting positions. ViMove2 then measures the range of motion and muscle activity, streams the data live via BTLE to a host device, e.g. PC, tablet or smart phone, and generates a personalized assessment report including comparisons to normative values.

ViMove2 is comprised of the following key components:

• · 4 Wireless Sensors (2 movement and 2 muscle activity)
• · Disposable Application Pads for attaching sensors to the patient.
• · ViMove software package

The provided text describes a 510(k) submission for the ViMove2 device, which is a wireless system for measuring movements and muscle activity of the lower back/lumbar spine. The submission aims to demonstrate substantial equivalence to a predicate device (ViMove, K142494).

However, the provided text does not contain acceptance criteria or detailed results of a study proving the device meets specific performance criteria beyond general compliance with standards. It states that "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but it does not present the specific acceptance criteria for these assessments or the numerical results from such testing.

Therefore, I cannot fulfill all parts of your request with the information provided. I will fill in the available information and indicate where data is missing from the text.

Acceptance Criteria and Device Performance (Based on available information)

The document primarily focuses on establishing substantial equivalence for the ViMove2 device to its predicate ViMove, emphasizing changes in size, components, and wireless technology. It mentions that "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but does not provide specific quantitative acceptance criteria or the reported performance data against such criteria.

Study Details (Based on available information):

The document mentions "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but it doesn't provide specific details about this "validation testing" that would allow us to answer all your questions.

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

   • Not provided. The document states "testing was performed," but does not specify the number of subjects or the data collection methodology (retrospective/prospective, country of origin).

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

   • Not provided. The document does not describe how the ground truth for the "validation testing" was established, nor does it mention the involvement or qualifications of experts for this purpose.

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

   • Not provided. No details on adjudication methods for establishing ground truth are mentioned.

4. 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/Not provided. The ViMove2 device is described as a measurement and reporting tool for movement and muscle activity, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies. The document does not mention any studies evaluating human reader improvement with the device.

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

   • The document implies that the device is a standalone measurement system that provides objective data and reports. The "validation testing" would likely represent standalone performance, but the specific metrics and results are not provided. The device quantifies movement and muscle activity; it's not an "algorithm" in the sense of an AI model interpreting complex data for a diagnosis.

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

   • Not explicitly stated/Provided. For ROM measurements, ground truth is typically established using highly accurate motion capture systems or goniometers. The document only mentions that testing was done to validate ROM and posture assessment but does not specify the ground truth method.

7. The sample size for the training set:

   • Not applicable/Not provided. The ViMove2 device is a sensor-based measurement system, not a machine learning/AI device that requires a "training set" in the typical sense for algorithm development. If there was any internal calibration or model fitting, the details are not provided in this public summary.

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

   • Not applicable/Not provided. (See point 7).

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Cadwell Sierra Summit:

Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities.

Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Cadwell Sierra Ascent:

Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system.

Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems.

The Sierra Summit provides a variety of test protocols spanning the various test modalities above.

The Cadwell Sierra Summit consists of the following major components:

• Sierra Summit console base unit with integrated control panel ●
• Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
• Laptop or Desktop computer (Windows OS) with keyboard and mouse ●
• Display monitor ●
• Summit software

The Sierra Summit has the following optional accessories/components:

• Remote Head Box (for 3-12 channel amplifier) ●
• StimTroller (Hand Held Electrical Stimulator)
• Electrical Stimulator Switch Box ●
• Footswitch (single) ●
• Visual Stimulators (LED Goggles, LCD Checks)
• VEP Calibration Sensor
• Headphones or other auditory transducers
• Reflex Hammer
• Temperature Probe ●
• Cart
• Isolation Transformer or Medical Grade Power Strip
• Printer

The provided text is a 510(k) Summary for the Cadwell Sierra Summit and Cadwell Sierra Ascent devices. It details the device descriptions, indications for use, and a summary of technical characteristics compared to predicate devices, along with performance testing. However, it does not include specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) or detailed results from studies designed to prove the device meets such criteria.

The "Performance Testing - Bench" section mentions conformance to various standards and internal requirements, concluding that "Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards." This is a general statement of compliance, not a presentation of performance data against specific acceptance criteria.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

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

This information is not provided in the document. The document states compliance with "predetermined specifications and applicable standards" for various tests (biocompatibility, software, electrical safety, EMC, and bench performance), but it does not list specific numerical acceptance criteria or quantitative performance results for the device.

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

This information is not provided in the document. The document describes "Performance Testing - Bench" and "Verification and validation activities," but it does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective).

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 provided in the document. The document refers to the device being used by "qualified medical practitioners" for diagnosis but clarifies that the device "does not provide any diagnostic conclusion about the patient's condition to the user." There is no mention of experts establishing ground truth for any test sets related to diagnostic performance.

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

This information is not provided in the document. There is no mention of an adjudication method.

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:

This information is not provided in the document. The device is a diagnostic electromyograph for measuring electrophysiological data and supporting the diagnosis of neuromuscular diseases. It is not described as an AI-assisted device for interpretation or diagnosis to be used "with AI vs without AI assistance" by human readers in the context of improving effectiveness. The document states, "This device does not provide any diagnostic conclusion about the patient's condition to the user."

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

This information is not provided in the document. Given the nature of the device (electromyograph for data acquisition and analysis, not providing diagnostic conclusions), it typically functions as a tool for a human practitioner, rather than as a standalone diagnostic algorithm.

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

This information is not provided in the document. As no specific performance studies against a diagnostic "ground truth" are detailed, the type of ground truth is not mentioned.

8. The sample size for the training set:

This information is not provided in the document. No training data or training set sample size is mentioned, as the device is not an AI/machine learning model in the sense of requiring a training set for diagnostic outcome prediction.

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

This information is not provided in the document. As no training set is mentioned, the method for establishing its ground truth is also not.

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ViMove is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

ViMove is comprised of five key components:

• 4 Wireless Sensors (2 for movement and 2 for muscle activity)
• Disposable Application Pads for holding the wireless sensors. movement (DAP-M) and muscle (DAP-E) sensors
• Recording and Feedback Device (RFD) is worn in the patient's pocket or within one meter of the sensors
• Recharging Cradle
• ViMove software package

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes the ViMove device as "substantially equivalent" to predicate devices, particularly the Insight Discovery and Vicon. The performance testing focused on proving this substantial equivalence rather than fulfilling specific numeric acceptance criteria for novel claims.

• Non-invasive medical device
• Surface Electromyography (compared to Insight Discovery)
• Provides Real-time biofeedback
• Energy detected from muscle activity only (not delivered)
• Wireless Inclinometer
• Rechargeable batteries in wireless sensors (compared to Insight Discovery, Vicon N/A)
• ISM band - 2.4GHz (compared to Insight Discovery, Vicon N/A)
• Real-time objective measurement of Range of Motion
• Dedicated Software
• Report generated for health care professional
• ABS used for Case (compared to Insight Discovery, Vicon No)
• Device used on Spine
• Isolated USB/Ethernet to connect to PC |
  | Measurement Capabilities | Assessed against Insight Discovery. Specifics on range or precision are not provided, but the conclusion is "substantially equivalent." |
  | Accuracy (Range of Motion) | "The accuracy of the ViMove was tested and compared to the accuracy of the Vicon and found to be substantially equivalent for measuring range of motion in the sagittal and coronal anatomical planes." |
  | Compliance to International Standards | Complied with:
• ISO 14971 (Risk Management)
• ISO 13485 (Quality Management)
• ISO 14155 (Clinical investigation, Good clinical practice - though no clinical data was submitted)
• IEC 60601-1 (Electrical Safety)
• IEC 60601-1-2 (EMC)
• ISO 15223 (Medical device symbols)
• ISO 10993-5 (In vitro cytotoxicity)
• ISO 10993-10 (Irritation and skin sensitization)
• 16 CFR 1500 (FHSA Regulations for Cytotoxicity, Sensitization and Primary Skin Irritation tests)
• IEC 62304 (Software life cycle processes) |
  | Mechanical Durability | Bench tested to withstand:
• Crush and shock (drop) tests for components (IEC 60601-1)
• DAP-M/E assembled with MD sensors: drop test from 1.5 meters onto hardwood floor with concrete base & crush force of 25kg.
• RFD: drop from 2m onto hardwood floor with concrete base without functional damage & crush force of 25kg. |

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

The document does not specify a separate "test set" sample size for proving substantial equivalence in terms of performance metrics like accuracy. The evaluation was primarily comparision of the ViMove's features and its performance to existing predicate devices (Insight Discovery and Vicon).

• Clinical Data: "Not applicable." This indicates there was no clinical study conducted with human subjects specifically for this 510(k) submission to generate new performance data from a "test set."
• Data Provenance: The performance assessment was based on bench testing and comparison to existing predicate devices' known performance. There's no mention of country of origin for any human subject data, as none was used. The study is not prospective or retrospective in the clinical sense, as it's a device comparison and bench testing.

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

Not applicable. As no clinical data or "test set" involving human subjects was used to establish novel performance claims or ground truth in this submission, no experts were utilized for this purpose. The device's "accuracy" was compared to a predicate device (Vicon), implying the Vicon's output served as a reference or "ground truth" for that specific comparison, but the document doesn't detail how Vicon's "ground truth" itself was established in this context.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

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

Not applicable. No MRMC study was conducted or referenced. The device is a measurement tool, not an interpretive AI tool that would assist human readers in diagnosing cases.

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

The accuracy comparison described ("The accuracy of the ViMove was tested and compared to the accuracy of the Vicon...") suggests a standalone performance evaluation of the ViMove's ability to measure range of motion. It was compared directly to another device (Vicon) without human intervention in the measurement process itself, thus evaluating its "algorithm only" performance for that specific function.

7. Type of Ground Truth Used

• For the accuracy of range of motion, the ground truth was effectively the measurement provided by the Vicon device, which itself is a commercially available and presumably validated goniometer. The document states, "The accuracy of the ViMove was tested and compared to the accuracy of the Vicon..."
• For other performance characteristics, the "ground truth" was established by compliance with voluntary standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and bench testing criteria (e.g., drop test parameters, crush force).

8. Sample Size for the Training Set

Not applicable. The ViMove is a measurement device that employs sensors and software. The submission does not indicate the use of AI/machine learning requiring a "training set" in the context of its 510(k) summary. The "software life cycle processes" standard IEC 62304 is mentioned, but this refers to general software development practices, not necessarily machine learning model training.

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

Not applicable, as no training set for an AI/machine learning algorithm was referenced in this submission.

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Surface Electromyography with range of motion functional capacity assessment grip and pinch strength.

The Intended Use Section is identical to the original device PMRU (K022719) To provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns. To establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress. To pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities, and refer pain sources. To evaluate a baseline muscle activity for preemployment screening, sport medicine. To look at chronic vs. acute muscle function and range of motion to ascertain good effort with FCE, range of motion, and gripping, and pinch. To ascertain the ischemic activity of muscles. To ascertain chronic damage to muscles. To monitor the frequency range for cardiac muscle.

The Physical Monitoring Registration Unit-S, (PMRU-S) like the legally cleared PMRU combines surface EMG with functional capacity sensors range of motion, grip and pinch strength sensors. This integration allows for a reproducible, objective interpretation of muscle function and effort via the range of motion, fce, pinch and grip. All muscle groups of the body from cervical (to mid back, low back and extremities can be monitored with the device). Bilateral muscle testing is done to compare antagonist muscle groups. The devices monitors bilateral muscle activity with the force produced by the patient while he or she pulls on the strain gauge, with the range of motion. is to provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To measure surface emg along the spine, extremities or cervical region. To measure the EMG with functional tasks, to measure the EMG with range of motion, to measure the EMG with pinch and or grip. This this is identical to the already cleared PMRU.

Here's an analysis of the provided text regarding the PMRU-S device, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) Summary for substantial equivalence, not a detailed clinical study report. Therefore, some information, particularly regarding specific performance metrics and detailed study methodologies, might be summarized or omitted in comparison to a full scientific publication.

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria or a specific study designed to prove the device meets these criteria in a broad sense. Instead, it focuses on demonstrating substantial equivalence to a predicate device (PMRU K022719). The primary "acceptance criteria" presented are implied through this comparison, meaning the PMRU-S must perform at least as well as the predicate device in its fundamental functions.

The validation testing described focuses on accuracy and repeatability of individual sensor components.

Implied Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Validation Testing)

Study Details

The document describes validation tests rather than a traditional clinical study with human subjects, given that the changes are primarily related to wireless data transmission and power.

1. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for the "validation tests." It refers to "weights" for FCE, Pinch, and Grip, "inclinometer testing" for Range of Motion, and a "Signal Generator" for EMG. This suggests a laboratory-based testing environment with physical standards or simulated inputs, not a human patient test set.
   • Data Provenance: Not explicitly stated, but the nature of the tests (using signal generators, weights, inclinometers) suggests it was in-house (e.g., at the manufacturer's facility) and not from human subjects in a clinical setting. It would be considered prospective as it was conducted specifically for this submission.

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

   • Not applicable. The "ground truth" for these validation tests was established by objective physical standards (e.g., known weights, known angles from an inclinometer, specified signals from a signal generator). Human experts were not involved in establishing this type of ground truth.

3. Adjudication method for the test set:

   • Not applicable. Since the ground truth was based on objective physical standards, there was no need for human expert adjudication. The device's measurements would be compared directly to the known values of the standards.

4. 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 (PMRU-S) is a diagnostic measurement tool (EMG, ROM, strength) and not an AI-powered image analysis or diagnostic support system that would typically be evaluated with an MRMC study involving human readers.

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

   • Yes, implicitly. The validation tests described (using signal generators, weights, inclinometers) represent a form of standalone performance evaluation, as they assess the sensor's ability to accurately capture physical parameters without human interpretation of the device's output in a diagnostic context. The device itself (the sensors and data acquisition) is being tested in a "standalone" fashion against known inputs.

6. The type of ground truth used:

   • Physical Standards/Calibration References: Known weights for FCE, Pinch, and Grip; inclinometer readings for Range of Motion; and signal generator outputs for EMG.

7. The sample size for the training set:

   • Not applicable. This device is described as operating on established physical principles (EMG, strain gauges) and is demonstrating equivalence to a predicate. There is no mention of machine learning or AI algorithms that would require a "training set" in the conventional sense. The device's calibration and underlying algorithms would likely have been developed and tested on previous data, but not in the context of a "training set" for this specific 510(k) submission.

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

   • Not applicable for the reasons outlined in point 7.

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The PBI MyoVision 3G WireFree™ Systems are indicated to provide the clinician with EMG activity, skin temperature, angles of the patient's motion information during therapies that include muscle relaxation training and re-education.

The MyoVision 3G WireFree™ System consists of handheld scanner devices which receive and transmit signals to a system hub. The data from the devices is displayed on a personal computer.
The MyoVision 3G WireFree™ System is designed to measure and visually present physiological signals corresponding to muscle activity (surface EMG), range of motion, and maps of heat generated by the human body. This device is intended to provide the clinician with a patient's EMG activity, skin temperature, and range of motion during therapies that include muscle relaxation training and re-education.
The MyoVision 3G WireFree™ System consists of four (4) physiological parameter scanners, a system hub, and proprietary application software. The four scanners are the
static surface EMG scanners (ScanVision™),
dynamic surface EMG scanner (DynaVision™),
range of motion inclinometers (FlexVision™), and
thermograph (ThermoVision™).
Data collected by the scanners is wirelessly transmitted to a computer via a system hub (either SoloVision™ or PhysioMonitor™) for data processing, data storage, and visual display. The wireless feature provides for data collection efficiency and ease of use. The proprietary application software was developed and validated by Precision Biometrics, Inc. (PBI).

The provided document (K123399) by Precision Biometrics Inc. for their MyoVision 3G WireFree™ System does not include acceptance criteria or a study that directly proves device performance against specific acceptance criteria in the manner typically seen for AI/ML-enabled devices.

This submission is a 510(k) Premarket Notification for a diagnostic electromyography device, which relies on demonstrating substantial equivalence to a legally marketed predicate device (Fasstech, Insight Millennium III (K023209)). The summary focuses on technological character differences and non-clinical performance data to support this equivalence.

Here's an analysis based on the information provided, specifically addressing the questions concerning acceptance criteria and study details:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for device performance in the document. The submission focuses on compliance with established standards (like those from AAMI, IEC, ISO) and demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: Instead of specific performance metrics against acceptance criteria, the document states: "Performance testing per standardized methods and PBI test protocols for bench data was conducted and provides support that the MyoVision 3G WireFree™ System is substantially equivalent to currently marketed predicate devices." And "Non-clinical performance test protocols and results demonstrate that, in consideration of its intended use, the design, labeling, and packaging of the MyoVision 3G WireFree™ System is compliant with all applicable standards."
  • No numerical performance data (e.g., accuracy, sensitivity, specificity, or error rates) are reported for the device's functions (EMG activity, skin temperature, range of motion).

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

• Sample Size for Test Set: Not applicable or not reported. The document describes "bench data" and "non-clinical performance test protocols," implying testing was conducted on the device hardware and software against standards, not on a clinical test set of patient data.
• Data Provenance: Not applicable, as there's no mention of a clinical test set with patient data.

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

• Not applicable. There is no mention of a human-adjudicated test set or ground truth established by experts.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication is 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. This device is an electromyography, range of motion, and thermography system that measures physiological signals directly. It's not an AI/ML-enabled device designed to assist human readers in interpreting complex images or data in a comparative effectiveness study scenario.

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

• Not explicitly stated for an "algorithm only" performance because the device's function is to collect and display physiological signals. Its performance is measured by the accuracy and reliability of these measurements against established standards, not by an algorithm's classification accuracy. The "proprietary application software" was "developed and validated by Precision Biometrics, Inc.," but details of this validation are not provided in terms of standalone performance metrics.

7. The type of ground truth used

• For the non-clinical performance, the "ground truth" would be established by the specifications and measurement ranges defined by the standards (e.g., ANSI/AAMI EC12:2006 for ECG electrodes, IEC 60601-1 for safety and essential performance, IEC 60601-2-40 for electromyographs). The device's measurements would be compared against these standard requirements, rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Not applicable. This is not an AI/ML device that requires a training set of data with established ground truth.

Summary of the Study:
The study described is a set of non-clinical performance tests conducted per standardized methods and PBI test protocols for bench data. These tests aimed to demonstrate that the MyoVision 3G WireFree™ System (hardware and software combined for signal acquisition and display) is compliant with applicable standards (e.g., ANSI/AAMI, IEC, ISO) and is substantially equivalent to the predicate device (Fasstech, Insight Millennium III). The document explicitly states, "Clinical data was not necessary to support that the MyoVision 3G WireFree™ System is substantially equivalent to the currently marketed predicate device."

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Surface electromyography with video recording, range of motion tracking, isometric functional testing and pinch and grip strength measuring.

The CMAP Pro™ is a stand-alone, battery operated dynamic muscle function monitoring system, with a number of surface electromyography (sEMG) sensors connected to various parts of the subject's body for data collection. The data are then directly fed into a system for conditioning, acquiring, and transmitting sensor data. Analyzed signals include sEMG readings, motion detection, and muscle strength measurements. The system acquires continuous analog signals and then digitizes these signals by sampling at a rate of 2kHz. These data are then transferred wirelessly to an all-in-one PC for processing using software.. The system is capable of monitoring and video recording data from (SEMG) sensors connected to various muscle groups in the human body. During the acquisition of sEMG signals, the system will simultaneously acquire motion tracking of the body, isometric functional testing and pinch and grip strength measuring.

Here's a breakdown of the acceptance criteria and study information for the CMAP Pro™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "validation tests were performed."

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

The provided text does not specify the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method used for the test set.

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

The provided text does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide information on the effect size of human readers improving with AI vs. without AI assistance. The CMAP Pro™ is described as a diagnostic device, not one that directly assists human readers in interpreting images or data in an "AI-assisted" context. Its comparisons are against a previous version of the company's own device.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance evaluation was conducted for the device's components. The document states:

• "validation tests were performed to validate the accuracy and repeatability of the range of motion (ROM) sensors, the FCE sensor, and the EMG leads."
• "It was shown through the validation tests that the ROM sensors, FCE sensor, and EMG test leads captured data accurately and repeatably."

This indicates that the device's ability to accurately and repeatably acquire data was tested independently of a human operator making interpretations. The "algorithm only" aspect would refer to the device's internal processing and measurement capabilities.

7. Type of Ground Truth Used

The ground truth used for performance testing was likely:

• Reference measurements/standards for accuracy and repeatability: For the ROM, FCE, and EMG leads, the validation would have involved comparing the device's measurements against established, more precise, or gold-standard methods or known physical properties to determine accuracy and consistency (repeatability).

The text doesn't specifically use terms like "expert consensus" or "pathology," but rather implies instrumental validation against known benchmarks or highly accurate measurement techniques.

8. Sample Size for the Training Set

The provided text does not specify the sample size for any training set. Given that this is a 510(k) for a hardware-based diagnostic electromyograph, and not an AI/machine learning algorithm, the concept of a "training set" in the context of machine learning is unlikely to apply in the same way. The device's functionality is based on direct signal acquisition and processing, not learning from a dataset.

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

As noted above, the concept of a "training set" as typically understood in machine learning is not explicitly applicable or mentioned for this device. Therefore, the method for establishing ground truth for a training set is not provided. The validation focused on the intrinsic performance of the sensors and data acquisition.

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The Focus is intended for use by a healthcare provider to perform nerve conductions and EMG studies as an aid in the evaluation of patients with diseases of muscle and nerves. The machine can also use electrical stimulus or sound stimulus for evoked potentials (EP) studies.

The Focus is a 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms. The device provides functionality for the Electromyography (EMG), Nerve Conduction Studies (NCS), and Evoked Potential (EP) testing for a range of clinical applications and has a fast, intuitive and flexible graphical user interface (GUI) that conforms to a Windows philosophy. The Focus EMG Device consists of a handheld electronic unit, a stimulator unit with steel electrodes and felt pads, and a footswitch.

The TeleEMG Focus EMG Device is intended for use by healthcare providers to perform nerve conduction and EMG studies, and for evoked potentials (EP) studies using electrical or sound stimulus.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a neurodiagnostic testing system (hardware and software) and not an AI/ML device making diagnostic claims, the acceptance criteria are based on compliance with established medical device safety and performance standards rather than specific diagnostic accuracy metrics. The "reported device performance" refers to the successful completion of these compliance tests.

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

The document explicitly states: "No clinical testing was conducted to support this submission."
Therefore, there is no test set in the sense of patient data for clinical evaluation, and no data provenance in that context. The testing was non-clinical (hardware, software, and safety standard compliance).

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

Not applicable. As no clinical testing was performed, there was no "test set" requiring expert-established ground truth. The acceptance criteria were based on engineering, safety, and performance standards.

4. Adjudication method for the test set

Not applicable. No clinical test set.

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 diagnostic electromyograph machine, not an AI-assisted diagnostic tool that interprets or analyzes data to improve human reader performance. Its function is to acquire and display electrophysiological data for a healthcare provider to interpret.

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

Not applicable. The device is a hardware and software system for data acquisition and display, designed for human-in-the-loop use by a healthcare provider. It does not perform standalone diagnostic interpretation.

7. The type of ground truth used

For the non-clinical performance testing, the "ground truth" would be the specifications defined by the relevant international standards (IEC 60601 series, IEC 62471) and the functional specifications and design requirements internally established for the device itself. For example, for noise levels, the ground truth is that the device noise should be less than 0.6 µVrms, or for the LED goggles, the luminance should be below the 10,000 cd/m² admissible limit.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product that relies on a "training set" of data in the conventional sense. Its software performs signal acquisition, processing, and display based on established algorithms and embedded logic, not learned patterns from a large training dataset.

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

Not applicable, as there is no training set.

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The CERSR® Electromyography System is intended to be used by properly trained technicians and/or physicians in clinical settings. The CERSR® Electromyography System is indicated for use to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.

The CERSR® is an Electromyography System. The CERSR® Electromyography System is specifically designed for a real-time recording of muscle electrophysiology. The CERSR® Electromyography System allows for a real-time recording from multiple locations by applying an array of surface electrodes over the anatomical region of interest. Each electrode is connected to its own channel with a preamplifier, amplifier, buffers and filters. The CERSR® Electromyography System produces a user display of the myoelectric signals. These recordings may be viewed in one of three standard formats, as a typical waveform, RMS display or a frequency spectral analysis plot. The system consists of the following components: 1) a system cart comprised of a CPU: 2) a mouse and keyboard; 3) monitor; 4) printer; 5) two buffer amplifiers; 6) power distribution box. which contains a filter buffer box; 7) isolation transformer; 8) two power supplies; and 9) a static ground system. The CERSR® system contains software and includes a disposable electrode array. Additional accessories provided with the system include a goniometer, a flexible transparent ruler, and two 3-pound weights.

The provided text is a 510(k) Summary for the SpineMatrix CERSR® Electromyography System. It describes a modification to an existing device, emphasizing that the changes are primarily hardware upgrades for user convenience and system robustness, with no new features or capabilities.

This submission does not detail a study proving the device meets acceptance criteria in the context of an AI/ML medical device, as it describes an electromyography system, not an AI system. Therefore, most of the requested information regarding acceptance criteria, performance metrics, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies is not applicable to this document. The term "acceptance criteria" here refers to standard medical device safety and performance testing, not AI model performance.

Below is an attempt to address the request based on the limited, relevant information available in the provided text, and explicitly state what information is not present because it pertains to an AI/ML context not applicable here.

Acceptance Criteria and Device Performance

The "acceptance criteria" for this device, as demonstrated in the 510(k) submission, are primarily established through compliance with recognized medical device standards and non-clinical performance testing to ensure safety, electromagnetic compatibility, biocompatibility, and software functionality. The device is a direct modification of a previously cleared device, and the demonstration of "substantial equivalence" is the primary regulatory pathway.

1. Table of Acceptance Criteria and the Reported Device Performance

Summary of Device Performance: The non-clinical performance testing demonstrated that the device performs as safely and effectively as the legally marketed predicate device. The changes did not raise any new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:
Not applicable. This is not an AI/ML device that uses a "test set" in the sense of a dataset for validating model performance. The testing involved compliance with engineering standards and physical/electrical/software testing, not data-driven performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no "ground truth" established by experts in the context of an AI/ML model for this device. The ground truth for this medical device's performance is compliance with established electrical, safety, and biocompatibility standards, and functional verification of the software/hardware.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is relevant to this type of device submission.

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, and no MRMC study was conducted or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no standalone algorithm or AI model in this device. It is an electromyography system that monitors and displays bioelectric signals directly from muscles.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's validation is the adherence to and successful performance against established engineering, safety, and biocompatibility standards (e.g., IEC, ISO, ASTM). The efficacy is presumed to be equivalent to the predicate device because the fundamental technology and intended use remain unchanged.

8. The sample size for the training set:
Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the ground truth for the training set was established:
Not applicable. No training set exists for this device.

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