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This device is a nerve stimulation device designed to be used by an anesthetist during:

1. General anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes.

2. Regional anesthesia, for the purpose of:

i. nerve mapping using the non-invasive Nerve Mapping Probe (supplied)

ii. nerve locating using invasive needles (not supplied)

The STIMPOD NMS450 is a quantitative Neuromuscular Transmission (NMT) Monitor which provides real-time quantitative feedback utilizing tri-axial accelerometery.

The STIMPOD NMS450 is also a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.

The STIMPOD NMS450 currently makes use of 3 dimensional acceleromyography (AMG) as the measurement technology of choice for objective Neuromuscular Transmission (NMT) monitoring in surgery. Although AMG is still the de-facto standard in industry, the use of electromyography (EMG) has gained renewed interest in NMT monitoring applications where the introduction of robotic surgeries, new surgical techniques, and changes in workflow, for instance, made the use of AMG impracticable.

In order to address this steadily increasing market demand for EMG sensor technology in NMT monitoring applications, Xavant identified the need to design and develop a dedicated NMT Monitoring Cable (EMG) that could be used interchangeably with the existing NMT Monitoring Cable (AMG) already in use with the STIMPOD NMS450.

The NMT Monitoring Cable (EMG) was specifically designed for use with the STIMPOD NMS450 to assist anaesthesiologists in theatre with monitoring the efficacy of Neuromuscular Blocking Agents (NMBAs).

The NMT Monitoring Cable (EMG) was designed with an intelligent EMG signal processing module (henceforth referred to as the µEMG) on one end of the cable for connection to an EMG electrode, and with a standard FireWire connector on the other end for connection to the STIMPOD NMS450.

The provided text describes the 510(k) premarket notification for the STIMPOD NMS450 Nerve Stimulator, focusing on its substantial equivalence to a predicate device (STIMPOD NMS450, K102084) and a reference device (Senzime, Tetragraph, K190795) with the addition of a new NMT Monitoring Cable (EMG) accessory.

However, the document does not provide specific acceptance criteria or an explicit study proving the device meets those criteria with detailed performance metrics. Instead, it states that "The subject device met or exceeded the stated acceptance criteria for each performance test." It then lists the types of performance tests conducted.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I detail specific sample sizes, ground truth establishment, or multi-reader multi-case study results, as this information is not present in the provided text.

Based on the available information, here's what can be extracted:

Acceptance Criteria and Reported Device Performance:

The document broadly states that the device met or exceeded acceptance criteria, but it does not provide the specific criteria or quantitative performance results.

Study Information (Based on available text):

2. Sample size used for the test set and the data provenance:
   This information is not provided in the document. The text only lists the types of performance tests conducted, but not the specific methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. The performance tests mentioned are primarily technical and engineering-focused (e.g., electrical safety, biocompatibility), which typically rely on standardized measurements rather than expert-established ground truth in the context of clinical interpretation.

4. Adjudication method for the test set:
   This information is not provided in the document.

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 applicable/provided. The device is an electrical peripheral nerve stimulator for monitoring neuromuscular blockade, not an AI-assisted diagnostic imaging tool with human readers. No MRMC study or AI-assistance evaluation is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable/provided in the context of an algorithm's performance. The device itself (STIMPOD NMS450 with the new EMG cable) performs measurements and stimulation; its "performance" is evaluated through the technical tests listed.

7. The type of ground truth used:
   For the technical performance tests mentioned (functional, electrical safety, EMC, biocompatibility, battery life, tensile strength, stimulation parameters), the ground truth would be established by engineering standards, specifications, and physical measurements rather than clinical ground truth like pathology or outcomes data. The document states that the device "met or exceeded the stated acceptance criteria," implying these criteria are based on defined technical standards and specifications.

8. The sample size for the training set:
   This information is not applicable/provided. The STIMPOD NMS450 is a hardware device with an accessory. There is no mention of a "training set" in the context of machine learning or AI models, as this is not an AI/ML powered device.

9. How the ground truth for the training set was established:
   This information is not applicable/provided as there is no mention of a training set or AI/ML components.

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The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment of post-surgical pain, post traumatic acute pain problems, as well as an adjunct for pain control due to rehabilitation.

The STIMPOD NMS460 Nerve Stimulator is a hand held low frequency neuromodulation Transcutaneous Electrical Nerve Stimulation (TENS) device, used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain, as well as an adjunct for pain control due to rehabilitation exercises. The STIMPOD NMS460 Nerve Stimulator offers two types of waveforms for the management of pain. The first is a Monophasic Square Wave, which is typical of normal TENS machines. The second waveform is a Hybrid RF waveform which consists of a Monophasic Square Wave with a superimposed Radio Frequency waveform. This waveform is proprietary and is unique to STIMPOD NMS460 Nerve Stimulator.

The provided document is a 510(k) summary for the STIMPOD NMS460 Nerve Stimulator. It focuses on demonstrating substantial equivalence to a predicate device (Acticare, K081835) rather than presenting a study to prove acceptance criteria in the traditional sense of clinical performance measures.

Here's an analysis of the requested information based on the document provided:

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics that the device had to achieve (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it demonstrates an equivalence to a predicate device through technical characteristics and adherence to recognized electrical safety and EMC standards.

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

The document describes non-clinical testing for electrical safety, EMC, and safety of nerve/muscle stimulators. It does not mention a "test set" in the context of patient data or clinical performance evaluation. The data provenance would be laboratory testing results against specified standards. Countries of origin for the device submission are South Africa and the USA (FDA).

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 submission relies on non-clinical engineering and safety standards testing, not on clinical performance evaluated against expert-established ground truth.

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

This information is not applicable as the submission relies on non-clinical engineering and safety standards testing, not on clinical performance evaluation requiring adjudication.

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 applicable. The device is a nerve stimulator for pain relief, not an AI-assisted diagnostic or interpretation device that would involve human "readers" or benefit from an MRMC study in this context.

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

This information is not applicable. The device is hardware-based for electrical nerve stimulation, not an algorithm, and its use inherently involves human interaction for application and control.

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

For the non-clinical tests, the "ground truth" implicitly refers to the requirements and specifications within the cited international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) regarding electrical safety, EMC, and specific nerve/muscle stimulator safety. There is no clinical "ground truth" such as pathology or outcomes data presented in this 510(k) summary.

8. The sample size for the training set

This information is not applicable. The device is not an AI/Machine Learning model that requires a training set. The submission focuses on device characteristics and compliance with standards.

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

This information is not applicable. As stated above, there is no training set for an AI/Machine Learning model.

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The STIMPOD ST2-3010 is a nerve stimulation device designed to be used for the purpose of nerve locating using invasive electrodes or needles (not supplied)

The STIMPOD ST2-3010 device is a battery powered peripheral nerve stimulator that can be used for the purpose of nerve locating using invasive electrodes or needles (not supplied). The STIMPOD ST2-3010 is a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle. The stimulus is generated by a constant current source. The waveform is a monophasic square wave with 3 options for pulse width. These are: 0.1, 0.2 and 0.3 milliseconds. The unit dimensions are 145mm x 90mm x 30mm with a weight of 130 g

I'm sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and study details for a medical device. The document is a 510(k) premarket notification for a nerve stimulator, focusing on demonstrating substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and comparison to a predicate, but it does not describe specific acceptance criteria and the results of a study (like a clinical trial or performance study) to prove the device meets those criteria.

In particular, the document lacks information on:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses "safety testing" and references IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10), indicating that the device passed these electrical and electromagnetic compatibility tests. However, these are general device safety standards, not specific performance criteria for a diagnostic or AI-based device's clinical accuracy that would require the kind of study details you've requested.

Therefore, I cannot fill in the table or provide the requested study details based on the provided text.

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The Stimtrode™ is intended to be used by an anesthetist during a peripheral nerve block procedure for nerve localization using invasive electrodes/needles (supplied separately).

The Stimtrode device is a battery powered peripheral nerve stimulators that can be used for

• · nerve locating using invasive electrodes/needs (not supplied)
  The stimulus is generated by a constant current source. The waveform is a square wave with 3 options for pulse width. These are: 0.1, 0.3 and 0.5 milliseconds.
  The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected.
  The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises of a nerve locating needle that is attached at time of use.

The provided text is a 510(k) summary for the Stimtrode Nerve Stimulator. It describes the device, its intended use, and its technological characteristics. However, it does not contain any information about acceptance criteria, a study proving device performance, sample sizes used, data provenance, ground truth establishment, or any comparative effectiveness studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Xavant Technology, XPOD/XMAP Nerve Stimulator K072092) and confirming its regulatory classification and intended use.

Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, study information, sample sizes, experts, adjudication, MRMC, standalone, ground truth type, training set size, training ground truth) as this information is not present in the provided text.

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This product is a nerve stimulation device designed to be used by an anesthetist during

1. General Anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied).
2. Regional Anaesthesia for the purpose of
   a. Nerve mapping using the non-invasive Nerve Mapping Probe (supplied).
   b. Nerve locating using invasive electrodes/needles (not supplied).

The STIMPOD NMS450 is a battery powered peripheral nerve stimulators that can be used for

• nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
• nerve locating using invasive electrodes/needles (not supplied)
• general anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes (not supplied)
  The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.
  The anode comprises of an ECG electrode (not supplied). The cathode comprises of
• a permanently attached nerve mapping probe (supplied) for nerve mapping,
• and/or a separate nerve locating needle (not supplied) for nerve locating,
• and/or another ECG electrode (not supplied) for NMBA monitoring, depending on the mode of the unit.

The provided text is a 510(k) summary for the STIMPOD NMS450 Nerve Stimulator. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving independent device performance against those criteria through a new study.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies, is not present in this 510(k) summary.

The document states:

• "There are no significant differences between the STIMPOD NMS450 Nerve Stimulator and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use."
• "The STIMPOD NMS450 has been subjected to extensive safety, performance and product validations prior to release." (However, no details of these validations or their acceptance criteria are provided in the public summary).
• The conclusion emphasizes substantial equivalence based on "clinical use, technical and biological considerations" to predicate devices, and that it "does not raise any new questions of safety and effectiveness."

In the context of a 510(k) submission for substantial equivalence, a manufacturer generally demonstrates that their new device is as safe and effective as a legally marketed predicate device. This often involves showing that the technical characteristics, intended use, and performance are similar or identical, rather than conducting a new clinical study to establish and meet novel acceptance criteria for a new device type.

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This product is a nerve stimulation device designed to be used by an anesthetist during regional anesthesia for the purpose of

1. nerve mapping using the non-invasive Nerve Mapping Probe (supplied) and
2. nerve locating using invasive electrodes/neeldes (not supplied)

The STIMPOD NMS400 is a battery powered peripheral nerve stimulators that can be used for

• nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
• nerve locating using invasive electrodes/needles (not supplied)
  The stimulus is generated by a constant current source. The waveform is a square wave with various pulse width options.
  The anode comprises of an ECG electrode (not supplied). The cathode comprises a permanently attached nerve mapping probe (supplied), and/or a separate nerve locating needle (not supplied), depending on the mode of the unit.

The provided text (K093591) is a 510(k) summary for a medical device (STIMPOD NMS400 Nerve Stimulator). It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for clearance in the US. This process typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information. The sections you asked for, such as sample size for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are typically part of a comprehensive clinical study report, which is not included in this 510(k) summary.

In summary, based on the provided text, the device's acceptance criteria and any study demonstrating their fulfillment are not described.

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The XPOD/XMAP is a nerve stimulation device intended to be used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied. The XMAP is intended for percutaneous nerve mapping using the non-invasive Nerve Mapping Probe (supplied). The XPOD is intended for nerve localization using invasive electrodes/neEdles (not supplied).

The XPod/XMap devices are battery powered peripheral nerve stimulators that can be used for

• nerve mapping using the non-invasive Nerve Mapping Probe (supplied)
• nerve locating using invasive electrodes/needles (not supplied)
  The stimulus is generated by a constant current source. The waveform is a square wave with 2 options for pulse width. These are: 0.1 and 0.3 milliseconds.
  The units will continuously check for a closed circuit at 2Hz. Once a closed circuit is detected, the twitches will repeat at 2Hz, until an open circuit is detected.
  Visual feedback of the current amplitude as well as pulse-width is given by means of an LCD screen.
  The unit is permanently attached to the anode. The anode comprises a modified ECG type pad. The cathode comprises a permanently attached nerve mapping probe, in the XMap model, and a separate nerve locating needle in the XPod model.

The provided document is a 510(k) summary for the XAVANT Technology XPOD/XMAP Nerve Stimulator. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide the requested table and information based on the input text. The document focuses on regulatory submission and affirmation of substantial equivalence rather than performance study results.

Here's what I can extract from the provided text for relevant sections, noting the absence of the requested performance study details:

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

• Cannot be provided. The document does not describe acceptance criteria or report performance data from a study. It outlines technological characteristics (e.g., current ranges, pulse width, voltage) but does not present these as performance metrics against acceptance criteria.

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

• Cannot be provided. The document does not mention any clinical or performance studies, and therefore, no sample size for a test set or data provenance is detailed.

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)

• Cannot be provided. No test set or ground truth establishment process is described.

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

• Cannot be provided. No test set or adjudication method 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

• Cannot be provided. This device is a nerve stimulator, not an AI-assisted diagnostic tool. An MRMC study is not relevant here, and no such study is mentioned.

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

• Cannot be provided. This device is a hardware nerve stimulator, not an algorithm. Standalone performance as typically understood for AI or software is not applicable or detailed.

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

• Cannot be provided. No ground truth establishment is described.

8. The sample size for the training set

• Cannot be provided. No training set is mentioned as this is a hardware device, not a machine learning model.

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

• Cannot be provided. No training set or ground truth establishment is described.

Summary of what the document does provide:

• Device Description: The XPOD/XMAP devices are battery-powered peripheral nerve stimulators used for nerve mapping (XMAP) and nerve localization (XPOD).
• Technological Characteristics:
  • Stimulus Modes: Square wave, repeating at 2Hz.
  • Current Ranges:
    • XMAP: 0 - 20mA (adjustable in 1mA increments)
    • XPOD: 0.0 - 1.6mA (adjustable in 0.1mA increments); 1.6 - 5.0mA (adjustable in 0.2mA increments)
  • Pulse Width: 0.1ms, 0.3ms
  • Stimulation Voltages: Max 100V p-p for both XMAP and XPOD.
  • Waveform: Constant Current Monophasic Squarewave.
• Intended Use: Used by an anesthetist during regional anesthesia procedures wherever peripheral anesthesia is normally applied.
• Predicate Devices: HDC CORP, Neuro-Trace III (K023342) and Stockert GmbH, Stimuplex HNS12 (K052313).
• Conclusion: The device is found substantially equivalent to predicate devices based on design, function, materials, operational principles, and intended use. This implies that the device is expected to perform adequately for its intended purpose, similar to existing devices on the market, but does not include explicit performance study data or acceptance criteria against which it was tested.

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