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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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Pajunk's MultiStim ECO is intended for nerve stimulation during anaesthesia delivery; first for identification of peripheral nerves and second for localizations. This device is indicated for adults only.

PAJUNK® GmbH Medizintechnologie is submitting this 510(k) for the MultiStim ECO handheld, battery powered peripheral nerve stimulator.
The MultiStim ECO is a nerve stimulator that is suitable for stimulation technique. It is characterized in particular by the following properties:

• small, compact device complies with the requirements of combined procedures -
• -Simple operation - manual settings are limited to the parameters proven in practice
• -No additional patient cable - cannula is directly connected to the device
  The MultiStim ECO settings are adapted to standard applications as well as the intuitively operated keyboard enable one-hand operation. A keystroke is all that is necessary for activation after switching on - an additional function selection is not required.

Basic functions/ features:
Fixed defined settings:
The frequency is predefined at 1 Hz and the stimulation pulse width at 0.1 ms.
Due to safety reasons, stimulation is first activated by a touch of the stimulation button.
Variation of the current strength
Depending on the special requirements of an application, the current strength can be gradually set on a six-level amplitude scale from 0.2 to 2.0 mA. Arrow buttons are used for the plus/minus key.
Fixation by an adhesive electrode
The MultiStim ECO has a pushbutton connection on the lower side of the device and is clicked directly on the adhesive electrode. The stimulateable cannula is connected directly to the MultiStim ECO.

The provided text is a 510(k) summary for the MultiStim ECO, a peripheral nerve stimulator, seeking substantial equivalence to the MultiStim SENSOR. The document focuses on demonstrating that the new device performs as effectively as the predicate device.

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

Acceptance Criteria and Reported Device Performance

The core of the performance acceptance criteria appears to be the congruence of output graphs between the MultiStim ECO (subject device) and the MultiStim SENSOR (predicate device) across various current (mA) settings. The device's performance is tested against specific current outputs and the corresponding voltage (mV).

Table of Acceptance Criteria and Reported Device Performance:

Additional Implicit Acceptance Criteria:

• Identical Intended Use: The MultiStim ECO must have the same intended use as the MultiStim SENSOR. This is explicitly stated and claimed to be identical, with a minor change in wording ("percutaneous" removed as obsolete).
• Identical Basic Technical Description Relevant to Clinical Use: The fundamental method of impulse generation (quartz crystal) and the non-software hardware solution are presented as core to this.
• Compliance with Recognized Standards: The device must meet a comprehensive list of IEC/EN standards for medical electrical equipment, including safety, electromagnetic compatibility, usability, and specific requirements for nerve and muscle stimulators. (See the list of standards provided on pages 10-11).
• Physical and Functional Equivalence (where applicable): Various characteristics like dimensions, FDA classification, product code, biocompatibility, power supply, pulse form, and protection type are compared, and deviations are rationalized as either equivalent or improvements/simplifications that do not negatively impact safety or effectiveness.

Study Details Proving Acceptance Criteria

1. Sample Size and Data Provenance:

   • Test Set Sample Size: The document does not specify a "sample size" in terms of number of devices tested. It describes a bench test where "the output signals of values which are adjustable at the MultiStim ECO have been compared to those with the same settings at the MultiStim SENSOR." This implies testing of at least one MultiStim ECO device against a MultiStim SENSOR for the specified current settings. There is no indication of a large-scale clinical trial or patient data.
   • Data Provenance: The data is generated from bench testing ("the desired signal combination was adjusted and visualized with an oscilloscope"). The location of the test is not specified, but the manufacturer is based in Germany. The data is prospective in the sense that it was generated for this submission to verify performance.

2. Number of Experts and Qualifications for Ground Truth:

   • This submission does not involve experts establishing ground truth in the typical sense of clinical image review or diagnostic performance. Instead, the "ground truth" is established by the engineering specifications and the measured output of the predicate device (MultiStim SENSOR), which is itself a legally marketed device. The comparison is objective, based on instrument readings (oscilloscope).

3. Adjudication Method for the Test Set:

   • Not applicable. This was a bench test with objective measurements and comparison to a known standard (predicate device output).

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No MRMC study was done. This device is a nerve stimulator, not an imaging AI or diagnostic aid that would typically involve human readers interpreting results. The comparison is at the engineering/performance level, not human-in-the-loop effectiveness.

5. Standalone Performance:

   • Yes, a standalone (algorithm only without human-in-the-loop performance) was done. The core performance testing involved measuring the output signals of the MultiStim ECO device in isolation and comparing them to those of the predicate device, using an oscilloscope. This is purely a device performance assessment independent of human interpretation or use in a clinical setting.

6. Type of Ground Truth Used:

   • The "ground truth" is the measured output characteristics (voltage at specific current settings and pulse shape) of the predicate device (MultiStim SENSOR), along with compliance to relevant medical device standards (e.g., consistency of square pulse form, 1Hz frequency, 0.1ms pulse width). It's an engineering/device specification ground truth, not a clinical outcome or pathology report.

7. Training Set Sample Size:

   • Not applicable. This is a hardware device without a "training set" in the context of machine learning or AI algorithms. The device's design is based on established electrical engineering principles and the performance of its predicate.

8. How Ground Truth for Training Set was Established:

   • Not applicable, as there is no "training set." The design and "training" (if one could use the term loosely) of the device come from established medical device engineering practices and the existing predicate device.

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SunStim Peripheral Nerve Stimulator and SunStim Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.

SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load).

The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Double Burst (DBS), Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator models have the same functions with the following exceptions: the SunStim™ Peripheral Nerve Stimulator functions do not include Double Burst and the 50 Hz Tetanus option.

The document provided is a 510(k) summary for the SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator. It describes the device, its intended use, and its substantial equivalence to a predicate device (EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator, K121743).

However, the document does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets such criteria in the way that would typically apply to AI/ML or diagnostic devices.

The "Performance Data" section lists recognized consensus standards that the device underwent tests against, which are primarily related to electrical safety, electromagnetic compatibility, risk management, and software lifecycle processes. These are general standards for medical electrical equipment and software, not performance metrics like accuracy, sensitivity, or specificity that would be expected for an AI system or device requiring clinical performance validation.

Therefore, many of the requested details about acceptance criteria and a study proving performance cannot be extracted from this document because they are not present. This document is focused on demonstrating substantial equivalence based on technological characteristics and adherence to general safety and quality standards, not a specific clinical performance study with defined criteria and results.

Here's an attempt to answer based on the available information, with many points marked as "Not provided in the document."

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The provided document describes the SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator, highlighting its substantial equivalence to a predicate device (K121743) based on its intended use, operating principle, basic design principle, operating modes, and stimulation parameters. The "performance data" section focuses on adherence to general safety, electromagnetic compatibility, risk management, and software lifecycle process standards, rather than specific clinical performance metrics.

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

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

Not provided in the document. The testing mentioned refers to conformance with general safety and engineering standards, not 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 (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical ground truth or expert review process for a test-set of patient data is described. The "testing" refers to engineering and quality assurance against recognized standards.

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

Not applicable, as no clinical data test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a peripheral nerve stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

Not applicable, as the document describes a hardware medical device (peripheral nerve stimulator), not an algorithm or AI system.

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

Not applicable, as the "testing" described is against engineering and safety standards, not based on clinical ground truth.

8. The sample size for the training set

Not applicable, as the document describes a hardware medical device, not a machine learning model requiring a training set.

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

Not applicable.

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The MiniStim* MS-IVB is a battery powered Peripheral Nerve Stimulator for monitoring the effects of skeletal muscle relaxants.

The MS-IVB is a nerve stimulator with selectable stimulus output waveforms and adjustable output amplitude. The stimulus output is intended for monitoring the depth of patient muscle and nerve relaxation while

This document is a 510(k) summary for the MiniStim* Peripheral Nerve Stimulator – Model MS-IVB, indicating it is a premarket notification for a medical device. This type of document is not designed to contain acceptance criteria and detailed study results in the typical sense of a clinical trial or algorithm performance study.

Instead, the "acceptance criteria" here refer to the device meeting various standards and demonstrating substantial equivalence to a predicate device through non-clinical testing. The "study" that proves the device meets these criteria is a series of non-clinical tests.

Here's a breakdown of the requested information based on the provided text:

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

2. Sample size used for the test set and the data provenance
The document discusses non-clinical testing of the device itself, not a test set of data from patients. Therefore, sample size and data provenance in the context of patient data are not applicable. The "sample" would refer to the physical device(s) tested. The provenance of the testing is internal to the manufacturer (Halyard Health, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes non-clinical engineering and software verification tests for the device, not a study evaluating human interpretation or a machine learning algorithm's performance against expert-established ground truth.

4. Adjudication method for the test set
This is not applicable for the same reasons as points 2 and 3. The testing involves verifying device specifications and adherence to standards, not human expert adjudication of diagnostic outcomes.

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, an MRMC comparative effectiveness study was not done. This document describes a traditional medical device (peripheral nerve stimulator), not an AI/ML-driven diagnostic or assistive technology that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" would be established engineering specifications and international standards (e.g., IEC 60601 for safety, predefined waveforms for output verification, expected software behavior).

8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.

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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 EasyMed InstrumentsCo., LTD. Peripheral Nerve Stimulator is a battery -powered device intended for monitoring the magnitude of neuromuscular blocks in general anesthesia; by delivering an electrical stimulus near a peripheral motor nerve.

The EasyMed Peripheral Nerve Stimulator devices are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load).

The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA.

All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination.

This document describes the validation of the EasyMed Instruments Co., LTD. Peripheral Nerve Stimulator.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EasyMed Peripheral Nerve Stimulator are based on compliance with specific electromagnetic compatibility (EMC) standards. The reported device performance indicates that the device passed all these tests.

Beyond these EMC specific tests, the document also mentions that "All finished products are tested and must meet all required release specifications before distribution. Testing includes physical testing (e.g. Pulse Amplitude, Pulse Width, Pulse Frequency and Low Battery Voltage Indicator) and visual examination." However, the specific acceptance criteria for these physical tests are not detailed in the provided text.

2. Sample Size and Data Provenance

The provided document does not specify the sample size used for the tests mentioned in the "Performance Data" section.
The provenance of the data is not explicitly stated as "country of origin of the data" or "retrospective or prospective." However, given EasyMed Instruments Co., LTD. is located in China, it's reasonable to infer that the testing likely occurred in China. The testing described appears to be prospective testing of the device itself, rather than retrospective analysis of clinical data.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This document describes performance testing for an electrical medical device (peripheral nerve stimulator) against engineering standards (e.g., electromagnetic compatibility). The nature of this testing does not involve establishing ground truth based on expert review of medical images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As the testing described is for engineering performance rather than clinical data interpretation, there is no adjudication method involved. The results are binary (Pass/Fail) based on predefined technical standards.

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

No MRMC comparative effectiveness study was mentioned or performed. This validation is for a medical device (a peripheral nerve stimulator), not an AI algorithm.

6. Standalone (Algorithm Only) Performance

Not applicable. This document describes the validation of a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests described is the established technical requirements and limits defined by the international standards (e.g., EN 60601-1-2, EN 55011, EN 61000-4-2, EN 61000-4-3, EN 61000-4-8). The device's performance is measured against these objective, verifiable criteria.

8. Sample Size for the Training Set

Not applicable. This device is hardware, not a machine learning model, so there is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

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The Intronix Model 8008 Myoguide System (Myoguide) is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

Myoguide is a battery powered, handheld, EMG amplifier with audio feedback, LCD EMG signal and device status display, and current stimulation ranging from 0 mA - 20 mA. This device is internally powered and rated for continuous use. The patient input connection is a type BF applied part. Myoguide will automatically power off after 30 minutes of inactivity to conserve battery life.

Myoguide is designed to amplify electrophysiological signals from muscle and provide audio feedback to assist clinicians in locating areas of muscle activity. The Stimulator can be used as an adjunct. Myoguide provides muscle and nerve localization information, to accurately guide and monitor needle electrode insertion, and/or injection of neuromodulator drugs, into a muscle in the human body. Any drug used will be that of the physician.

The large LCD display provides the complete system status at a glance. EMG audio, EMG signal display, EMG RMS Value, Integrated EMG signal strength and stimulation capability, increases efficacy for injection point localization. The simple control panel is intuitive and easy to operate.

Myoguide operates in two modes: "[EMG]" and "[Stimulation]". The default mode, "[EMG]", records electromyographic (EMG) signals from electrodes placed on the subject. The second mode, "[Stimulation]", enables Myoguide's onboard stimulator to stimulate through the needle electrode that was used to record the EMG. This enables the clinician to record and stimulate through the same needle electrode. The switch is used to change the state of operation.

The provided text is a 510(k) Summary for the Myoguide System, seeking substantial equivalence to predicate devices. It does not contain a study demonstrating the device meets specific acceptance criteria in terms of performance metrics. Instead, it relies on demonstrating equivalence in intended use and technological characteristics to previously cleared devices through non-clinical testing.

Here's an analysis based on the information provided and typical FDA 510(k) submission practices:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific quantitative acceptance criteria or report device performance in the manner of a typical performance study with metrics like sensitivity, specificity, accuracy, etc. Instead, it focuses on demonstrating compliance with safety and electrical standards and equivalence in technological characteristics to predicate devices.

The "Comparison Table" provided in the document acts as a de-facto performance comparison, showing that the Myoguide System has similar specifications and features to its predicate devices. The implicit acceptance criteria here are that the Myoguide System's characteristics are within a range comparable to the predicate devices and comply with relevant international standards.

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

• Test Set: Not applicable for this type of submission. There was no "test set" of patient data in the context of a clinical performance study. The testing was non-clinical (hardware, software, electrical safety, EMC).
• Data Provenance: Not applicable. The testing was laboratory-based, focusing on the device itself rather than clinical data.

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

• Not applicable. As no clinical data was used or generated, there was no need for experts to establish ground truth from patient cases. The "ground truth" for non-clinical testing is typically defined by engineering specifications and international standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no test set requiring expert adjudication.

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

• No, an MRMC comparative effectiveness study was not performed.
• The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."
• Therefore, there's no data on the effect size of AI assistance on human readers. The Myoguide System is a standalone medical device, not an AI-assisted diagnostic tool.

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

• Yes, in a sense, the entire submission functions as a "standalone" assessment of the device's characteristics and safety. The performance is assessed based on its inherent design, and its compliance with electrical and safety standards.
• However, it's not an "algorithm-only" performance study in the context of diagnostic AI, as the device is hardware-based with embedded software, intended for direct use by a clinician.

7. Type of Ground Truth Used

• For the non-clinical testing (hardware, software, electrical safety, EMC), the "ground truth" was established based on:
  • Software Design Specifications: The device's software was tested against its established specifications.
  • Device Hazard Analysis: Identifying and mitigating risks.
  • International Standards: Compliance with IEC 60601-1 (Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-40 (specific to electrical nerve stimulators).
  • Predicate Device Characteristics: The functional and technological characteristics of the predicate devices (STIMPOD NMS450 and Clavis EMG Device) served as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML model that requires a "training set" of data for learning. Its functionality is based on fixed algorithms and hardware design.

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

• Not applicable, as there was no training set.

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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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