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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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