Search Results

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.

Ask a specific question about this device