Search Results

The Neurovision Medical Motion Sensor is intended to detect, monitor and/or record limb movements on a physiological recorder, in adult patient sleep disorder studies, in a clinical setting.

The Neurovision Medical Motion Sensor is a disposable, multipurpose piezo accelerometer sensor configured to be self-powered (by "watch" type battery), disposable, and capable of being read by a small signal electrophysiologic monitor.

Here's a summary of the acceptance criteria and study information for the Neurovision Medical Motion Sensor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is "Bench testing," implying laboratory-based testing rather than patient-based clinical studies with human participants.

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

Information regarding the number and qualifications of experts used to establish ground truth for the test set is not provided in the document. The testing described focuses on technical performance and comparison to a predicate device, not on expert-adjudicated clinical outcomes.

4. Adjudication Method for the Test Set

An adjudication method is not applicable/not specified as the testing described is bench testing focusing on technical performance. It doesn't involve subjective interpretation that would require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. The submission focuses on substantial equivalence through bench testing.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical sensor, not an algorithm, so a "standalone algorithm only" study is not applicable. The performance testing described is inherent to the device's function.

7. The Type of Ground Truth Used

The ground truth for the performance testing appears to be based on physical movement and established electrical signal detection. For the sensitivity comparison, it relied on the "testing submitted by the predicate for 510k review," suggesting the predicate's established performance as a benchmark.

8. The Sample Size for the Training Set

This device is a hardware sensor, not an AI/ML algorithm that requires a training set. Therefore, information regarding a "training set sample size" is not applicable/not provided.

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

As the device is a hardware sensor and not an AI/ML algorithm, a "training set" and its associated ground truth establishment are not applicable.

Ask a specific question about this device

The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

The Neurovision Ink Printed Endotracheal Tube Electrode is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent Laryngel Nerve (RLN).

The provided 510(k) summary for K130806, the Neurovision Ink Printed Endotracheal Tube Electrode, does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner typically expected for AI/ML devices. This submission for the Neurovision Ink Printed Endotracheal Tube Electrode is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology. In such cases, the primary focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modifications do not introduce new questions of safety or effectiveness.

The document states that nonclinical testing was performed to demonstrate substantial equivalence. These tests focused on the functional and material characteristics of the modified device in comparison to the predicate device.

Here's an analysis of the provided information, focusing on aspects that might loosely correspond to "acceptance criteria" and "study results" in the context of this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document does not explicitly list "acceptance criteria" with quantitative targets as one might find for a new AI/ML device. Instead, it focuses on demonstrating equivalence to the predicate device through various non-clinical tests.)

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

• Test Set Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical cases. The tests described (valve functionality, electrode impedance, bend tests, biocompatibility) are non-clinical, bench-top tests performed on device samples. The specific number of device units tested for each non-clinical test is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for this submission. The tests are non-clinical (bench testing and biocompatibility).

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

• Not applicable. The ground truth for the non-clinical tests (e.g., whether a valve functions, impedance values, bend resistance, biocompatibility) is established through standardized testing protocols and measurements, not expert human interpretation of clinical data or images.

4. Adjudication Method for the Test Set

• Not applicable. There is no human adjudication for non-clinical, objective measurements like impedance or bend tests.

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 not an AI/ML diagnostic or assistive technology for human readers. It is a medical device for EMG monitoring.

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

• Not applicable. This device is not an algorithm or AI system.

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

• The "ground truth" for the non-clinical tests is based on objective, quantifiable measurements against established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and functional equivalence to the legally marketed predicate device.

8. The Sample Size for the Training Set

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

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

• Not applicable. This device is not an AI/ML algorithm.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" described in the 510(k) summary is a collection of nonclinical tests designed to demonstrate that the modified Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to its predicate device (K110989 Neurovision Ink Printed Endotracheal Tube Electrode) and that the modification (change in reinforcing material's attachment adhesive) does not alter the fundamental safety or effectiveness.

The document states:
"Nonclinical testing, including valve functionality, electrode impedance and bend tests demonstrated that the subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicate."

Additionally, biocompatibility testing was performed following ISO standards:
"Biocompatibility testing included ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity and ISO 10993-10 Irritation and Skin Sensitization."

These tests, by demonstrating equivalence in critical functional aspects and meeting safety standards for biological interaction, serve as the evidence that the modified device "meets acceptance criteria" in the context of a Special 510(k) submission. The inherent acceptance criteria for such a submission are successful completion of these tests, confirming that the device performs functionally the same as the predicate and is safe for its intended use, despite the minor material modification.

Ask a specific question about this device

The Signal Gear Urethral Catheter Electrode is intended for mucosal surface stimulation/recording from the external urinary sphincter for use in conjunction with urodynamic evaluation of the patient.

The Signal Gear Urethral Catheter Electrode is a single patient use, disposable sterile device. It consists of an adhesive, highly flexible, polyurethane film substrate that wraps around the urethral (Foley) catheter. The conductive portion of the electrode is printed onto the polyurethane film substrate in a pattern that, when the electrode is wrapped around the catheter, leaves two conductive contact surfaces forming the two electrical contacts of the electrode. The remainder of the conductive pattern is overwrapped by an additional layer of polyurethane film during manufacture in order to insulate the traces. The conductive ink used is silver, with the exception of the two electrical contacts of the electrode, which have an additional printed layer of gold ink.

Lead wires are attached that terminate in a safety connector that cannot be connected to an AC power outlet. The Electrode connects to the user's electrodiagnostic equipment. The electrode is to be used under the supervision of a physician. When the urethral catheter with the applied electrode is inserted in the human urethra, the exposed two electrical contacts of the electrode contact the mucosal lining of the urethra in the location of the external urinary sphincter muscle, and the end of the electrode with leadwire attachments are outside of the urethral meatus.

The provided 510(k) summary for the Neurovision Medical Products Inc. Signal Gear Urethral Catheter Electrode (K113771) describes a non-clinical study to support substantial equivalence. It does not present acceptance criteria or detailed performance data for clinical use, nor does it describe a study involving human subjects or AI.

Here's an analysis based on your request, highlighting what information is not present in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than defining specific performance metrics or acceptance criteria related to its intended physiological function (mucosal surface stimulation/recording) in a clinical setting.

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

• Sample Size for Test Set: Not applicable, as this was a non-clinical study.
• Data Provenance: Not applicable, as this was a non-clinical study.

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

Not applicable, as this was a non-clinical study. The "ground truth" in this context would be engineering specifications and standards for electrical, biocompatibility, and sterilization testing.

4. Adjudication Method for the Test Set

Not applicable, as this was a non-clinical study.

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

No, an MRMC comparative effectiveness study was not done and is not mentioned. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with AI assistance. The Signal Gear Urethral Catheter Electrode is a medical instrument for stimulation/recording, not a diagnostic imaging device.

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

No, a standalone (algorithm only) study was not done and is not mentioned. The device is an electrode for use in conjunction with urodynamic evaluation, implying human operation and interpretation of data. There is no mention of an "algorithm" as a component of this device's performance.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was based on:

• Engineering specifications and quality standards for manufacturing.
• Established international and industry standards for biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010).
• Standards for accelerated aging (ASTM F1980-07).
• Standards for packaging validation (UNI EN ISO 868-5, 11607-1, DIN 58953-6).
• Standards for bioburden and sterility (UNI EN ISO 11737-1, 11737-2).

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned, the ground truth for it was not established.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Non-Clinical):

The Neurovision Medical Products Inc. Signal Gear Urethral Catheter Electrode underwent several non-clinical tests to demonstrate its safety and performance, and thus its substantial equivalence to the predicate device (Dantec 13L40 St Mark's Pudendal Electrode).

The study involved:

• Inspection for defects: Manufacturing, workmanship, and packaging.
• Electrical continuity testing: To ensure proper electrical function.
• Lead wire pull testing: To assess the mechanical strength of the lead wire attachment.
• Biocompatibility testing:
  • In vitro cytotoxicity: According to ISO 10993-5:2009.
  • Irritation and delayed-type hypersensitivity: According to ISO 10993-10:2010.
• Accelerated aging: Conducted according to ASTM F1980-07 to predict shelf life.
• Packaging validation tests: Conducted according to UNI EN ISO 868-5, 11607-1, and DIN 58953-6 to ensure package integrity and maintain sterility.
• Bioburden and sterility tests: Conducted according to UNI EN ISO 11737-1 and 11737-2 to confirm the device is sterile when packaged.

The document indicates that these non-clinical tests were sufficient to demonstrate that "No new questions of safety or effectiveness are raised," supporting its substantial equivalence to the predicate device. However, specific acceptance criteria for each test (e.g., minimum pull strength, maximum cytotoxicity score) and the quantitative results are not provided in this summary. The FDA's 510(k) clearance implies that the agency found these non-clinical tests adequate for demonstrating substantial equivalence based on the provided data.

Ask a specific question about this device

This device is a manual surgical instrument for performance of dissection and nerve stimulation input to living tissue concurrently.

The Stimulating Hemostat and other manual instruments are dissectors modified by insulation and application of a connecting pin for connection to nerve stimulation. The specific instruments cleared for this modification in this 510(k) are the following:

• Scissors Hinge Hemostat, curved, fine
• Box Hinge Hemostat, curved, fine
• Scissors Hinge Hemostat, right angle
• Mosquito Hemostat, curved, fine
• Halsted Hemostat, curved
• Crile Hemostat, curved
• Kelly Hemostat, curved
• Schnidt Hemostat, curved, fine
• Gemini Hemostat, curved, fine
• Petit Point Mixter, right angle
• McCabe Dissector, curved, fine
• Jacobson Mosquito, curved, fine
• House Rosen Elevator, coarse
• Sheehy "Weapon", Large (2.4 mm)
• Probe, Ball tip
• Suction Stimulator (Neurovision model)

Here's an analysis of the provided text regarding the acceptance criteria and study for the Neurovision Dissection/Stimulating Accessory:

It's important to note that the provided documents (a 510(k) summary and the FDA clearance letter) describe a medical device that is a manual surgical instrument, not an AI/ML-based diagnostic or imaging device. Therefore, many of the typical acceptance criteria and study details relevant to AI devices, such as sensitivity, specificity, AUC, sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, are not applicable to this type of submission.

The "performance testing" described for this device focuses on reprocessing validation. The FDA clearance is based on the device being "substantially equivalent" to predicate devices, meaning it has similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness.

Here's a breakdown based on your requested information, highlighting what is present and what is not applicable:

Neurovision Dissection/Stimulating Accessory Acceptance Criteria and Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

• Same intended use.
• Similar technological characteristics.
• No new questions of safety or effectiveness raised. | The device is "substantially equivalent" to the predicate devices (Stimulating Hemostat K895676; Nerve Locator Monitor K110140).

Key Technological Similarities/Improvements:

• Modified existing instruments with insulation and connection pin for nerve stimulation.
• Uses same materials and method for insulating as predicate.
• Insulation covers hinging and tips for more precise nerve localization and reduced shorting. |
  | Reprocessing Validation:
• Cleaning instructions validated.
• Sterilization instructions validated. | Reprocessing validation testing for cleaning and sterilization instructions was conducted according to:
• ANSI/AAMI ST 79:2006
• AAMI TIR 12:2004
• AAMI TIR 30:2011

Conclusion: "These modified instruments present no additional issues with sterilization, safety or effectiveness." |

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

• Not Applicable. This is not an AI/ML or diagnostic device that uses a "test set" of data in the common sense. The "testing" referred to is engineering and reprocessing validation, not performance on a clinical dataset.

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

• Not Applicable. See point 2. Ground truth in the context of expert review of images or diagnostic data is not relevant for this device.

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

• Not Applicable. See point 2.

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 a manual surgical instrument, not an AI-assisted diagnostic or interpretative system. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant.

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

• Not Applicable. This device is a manual surgical instrument that is always "human-in-the-loop," as its function is to be manually operated by a surgeon. It does not operate as an algorithm or standalone system.

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

• For the reprocessing validation, the "ground truth" would be regulatory standards and successful adherence to those standards, demonstrating the device can be safely cleaned and sterilized.
• For the substantial equivalence claim, the "ground truth" is the established safety and effectiveness of the predicate devices and the demonstration that the new device does not alter these or introduce new risks, based on engineering analysis and comparison of materials/design.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that uses a "training set."

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

• Not Applicable. See point 8.

Ask a specific question about this device

The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation.

The Neurovision Ink Printed Endotracheal Tube Electrode is a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation and continuous EMG monitoring of the laryngeal musculature during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use with any compatible EMG monitoring system, for continuous EMG monitoring of the laryngeal musculature as well as providing an open airway for patient ventilation.

The provided 510(k) summary for the Neurovision Ink Printed Endotracheal Tube Electrode primarily focuses on establishing substantial equivalence to a predicate device through technological characteristics and non-clinical testing. It does not describe a study involving acceptance criteria for device performance in a clinical setting, nor does it involve AI, human readers, or ground truth as typically understood in the context of diagnostic or interpretive devices.

Therefore, many of the requested sections regarding acceptance criteria, study details, and expert involvement cannot be extracted from this document, as they are not applicable to the type of submission made.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) does not present a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance. Instead, it demonstrates substantial equivalence through "technological characteristics" and "nonclinical testing."

The document states that the subject device "is substantially equivalent" to the predicate device (NuVasive EMG Endotracheal Tube - K094054). The underlying acceptance criterion for this type of submission is that the new device is as safe and effective as the predicate, based on its similar design, intended use, materials, function, packaging, and sterilization.

The non-clinical tests performed, and their implied "acceptance criteria" through demonstrating substantial equivalence, are:

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

Not applicable. This submission relies on non-clinical testing and comparison to a predicate device, not a test set derived from patient data.

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

Not applicable. Since there's no clinical performance study involving diagnostic interpretation or AI, there was no need for experts to establish ground truth in that context. The "experts" involved would have been the engineers and scientists conducting the non-clinical tests and the regulatory professionals assembling the 510(k).

4. Adjudication Method for the Test Set

Not applicable. No test set involving human judgment or interpretation was used.

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

No, an MRMC comparative effectiveness study was not done. This device is an Endotracheal Tube with EMG monitoring electrodes, not an AI or imaging interpretation device.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study (algorithm only) was not explicitly performed or reported. The device itself is hardware. Its functionality (EMG monitoring) is contingent on a compatible monitoring system (which is not part of this 510(k)). This 510(k) focuses on the safety and technological equivalence of the tube and its electrodes.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established safety and performance parameters for each test (e.g., a minimum force for wire pull, acceptable limits for impedance, passing criteria for biocompatibility assays). For the overall submission, the "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a training set in that context.

9. How Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Ask a specific question about this device

The Neurovision Nerve Locator Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG Monitor with integrated detecting or warning capability. The device is intended to assist the surgeon in locating motor nerves that are at risk in surgical procedures.

The Neurovision Nerve Locator Monitor Model NV006 is a single channel evoked EMG device for surgical nerve location and monitoring. The device operates exactly as the predicate model NV004. The stimulation range for the predicate device (Model NV004) as a proactive nerve locator is up to 5.0 mA of pulsed nerve stimulation. An accessory cable adds optional "high level" stimulation (Model NV006) ranging from 3.0 to 12 mA.

Here's a summary of the acceptance criteria and the study information for the Neurovision Nerve Locator/Monitor Model NV006, based on the provided text:

Acceptance Criteria and Device Performance

Study Information:

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

   • The document states "Preclinical testing verified the design of this device and that all specified requirements were fulfilled." No specific details about the sample size of a test set (e.g., number of patients, cases, or data points) are provided.
   • The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned. Given the nature of a 510(k) for a device like a nerve monitor, most "preclinical testing" would likely involve bench testing, animal models, or potentially limited human use studies that are not described in detail here.

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

   • This information is not provided in the document.

3. Adjudication method for the test set:

   • This information is not provided in the document.

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

   • No MRMC comparative effectiveness study is mentioned. The device is a nerve locator/monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of typical MRMC studies.

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

   • The "Preclinical testing" mentioned implies standalone testing of the device's functionality. The document highlights various technical specifications and changes from the predicate device that would be subject to such testing (e.g., accuracy of delivered current, impedance measurement, alarm functions, stimulation output). However, no specific details of a formal "standalone" study are provided beyond the general statement.

6. The type of ground truth used:

   • Given that the preclinical testing verified the design and requirements, the ground truth would likely be based on:
     • Engineering specifications and standards: Conformance to ISO 60601-2-40 for stimulation output, accuracy within 5% of delivered current, and other technical requirements.
     • Functional verification: The device's ability to accurately provide impedance readings, generate anticipated audio alerts, and stimulate within specified ranges.
     • Comparison to predicate device performance: Showing that the NV006 performs at least as well as the NV004 for existing functions and that new functions (like high-stim) meet their design intent.

7. The sample size for the training set:

   • The device described is a medical instrument (hardware and embedded software) for nerve location and monitoring, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. The "logical algorithm" is described as the "Neurovision proactive nerve location algorithm," which is "Same" as the predicate device, implying it is a deterministic, rule-based algorithm rather than a learned model. Therefore, the concept of a "training set" as used for machine learning models does not apply here.

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

   • As explained above, the concept of a "training set" for a machine learning model does not apply to this device based on the provided information.

Ask a specific question about this device

The Suction Stimulator Probe is a dedicated manual surgical instrument that allows the surgeon to clear secretions and test surgical tissue with nerve stimulation at the same time and with the same instrument. It is intended for use only by a licensed physician and in conjunction with the Neurovision SE (Nerveana) Nerve locator Monitor System.

The Suction Stimulator Probe is a disposable, single use, sterile instrument that combines concurrent suction and stimulation into one device for use during tissue dissection and nerve stimulation during surgery.

The instrument consists of a stainless steel shaft, partially insulated with biocompatible PTFE and ending with a ball-tip suction. Proximal connectors attach the instrument to a nerve stimulator. A tapered type adapter attaches the device to a standard suction catheter and a finger-hole allows for adjusting the suction strength manually by the surgeon. The insulated shaft has a 2mm diameter and 2 length options of 13 or 26 cm. The ball tip feature reduces the current density of stimulation, allows stimulation along right angles, such as drill holes, and prevents bone chip clogging of the instrument.

The Neurovision Medical Products Inc. Suction Stimulator Probe (DryTouch Suction Stimulator Probe) is a Class II medical device (Product Code ETN) that combines concurrent suction and nerve stimulation in a single, disposable, sterile instrument for use during tissue dissection and nerve stimulation in surgery. It is
intended for use by a licensed physician in conjunction with the Neurovision SE (Nerveäna) Nerve locator Monitor System.

The provided document describes both the acceptance criteria and the study conducted to demonstrate substantial equivalence for the device. However, it is important to note that this is a Traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than a standalone clinical study with extensive acceptance criteria explicitly defined in terms of clinical outcomes or diagnostic performance metrics often seen with AI/ML devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission for a surgical instrument, the "acceptance criteria" are related to mechanical, electrical, and sterility performance, as well as substantial equivalence to predicate devices, rather than AI/ML diagnostic or prognostic metrics.

Note: The document does not provide specific numerical targets or thresholds for "acceptance criteria" for the bench tests (e.g., a specific range for ball tip diameter or a minimum suction flow rate). Instead, it states that these tests were conducted to "assess performance and safety" and to "test the quality of the manufacturing, the reliability of the surface area of the ball as indicating the current density of delivered stimulation, the continuity of the device as reflecting the reliability of current delivered to the tip, and finally, the gross delivery of air/suction as reflecting the suction power of the device." The FDA's substantial equivalence determination implies that these criteria were met adequately.

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

The study described is bench testing, not a clinical study involving a "test set" in the context of AI/ML or clinical efficacy.

• Sample Size for Test Set: Not applicable in the context of clinical data or AI/ML evaluations. The bench tests would have used an unspecified number of physical devices.
• Data Provenance: Not applicable in the context of country of origin of clinical data. The testing was likely conducted in a lab setting by the manufacturer (Neurovision Medical Products, Inc., in Ventura, CA, USA).
• Retrospective or Prospective: Not applicable as it refers to bench testing on physical devices, not data collection from subjects.

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

• Number of Experts: Not applicable. Ground truth for bench testing involves engineering measurements and adherence to standards, not human expert consensus for clinical image interpretation or diagnosis.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept primarily applies to clinical studies where multiple human readers or ground truth establishers might disagree, requiring a method to reach a definitive truth.

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

• MRMC Study Done: No. This is not mentioned. The device is a surgical instrument, and the submission focuses on its physical and functional equivalence to existing predicate devices through bench testing. It does not involve human readers evaluating cases with or without AI assistance.
• Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.

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

• Standalone Study Done: No. The device is a physical surgical instrument. The concept of an "algorithm only" performance study is not relevant here.

7. Type of Ground Truth Used

• Type of Ground Truth: For the bench testing, the ground truth was based on engineering measurements, established industry standards (e.g., ISO 11135-1:2007, ISO 10993-7:2008, ISO 11607), and the functional specifications of the device. This is analogous to "physical specifications" or "performance metrics" derived from controlled experimental setups.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no AI/ML component described that would require a "training set."

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

• How Ground Truth for Training Set Was Established: Not applicable.

In summary: The provided document is a 510(k) summary for a physical surgical instrument. The "study" proving acceptance criteria involves bench testing to confirm physical characteristics, electrical continuity, suction capability, and adherence to sterilization and shelf-life standards. The concept of AI/ML-specific criteria, such as test sets, training sets, expert ground truth, or MRMC studies, is not applicable to this type of device submission. Substantial equivalence was primarily demonstrated by comparing its technological characteristics and performance to legally marketed predicate devices through engineering and laboratory evaluations.

Ask a specific question about this device

The Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.

The Paired Hydrogel Electrodes are a modification of the M203KEN electrode currently distributed as the Singlet and Triplet Hydrogel Electrodes by Neurovision Medical Products. The Paired Hydrogel Electrode is created by attaching two Singlet M203KEN electrodes by their lead wires to the same DIN plug (shorting the electrodes). The Paired version is designed to provide a single pole of electrophysiological monitoring across a surface too wide to be covered by a single electrode.

Here's an analysis of the provided text regarding the Neurovision Medical Paired Hydrogel Electrode, focusing on acceptance criteria and supporting studies:

This submission is a Special 510(k), indicating a modification to an already cleared device. The focus of the performance testing is typically to demonstrate that the modified device (Paired Hydrogel Electrode) is substantially equivalent to the predicate devices and that the modification does not introduce new questions of safety oreffectiveness, or alter the fundamental scientific technology.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for performance tests (adhesion, impedance, electrophysiological properties).
  • For biocompatibility, it states "Animal testing demonstrated the Biocompatibility," implying animal subjects, but the number is not specified.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal or contracted by the manufacturer. The studies are prospective as they were conducted to support the 510(k) submission for the modified device.

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

Not applicable. This type of device (hydrogel electrode) does not typically involve human-read interpretations or ground truth established by experts in the context of clinical imagery. The performance criteria are technical and measurable (e.g., adhesion strength, electrical impedance, biological reactions).

4. Adjudication Method for the Test Set

Not applicable, as the performance testing involves measurable technical parameters, not subjective assessments requiring adjudication.

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

No. This is not the type of device or study for which an MRMC comparative effectiveness study would be performed. The device is a surface electrode for physiological monitoring, not an imaging or diagnostic AI tool.

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

Not applicable. The device itself is hardware (an electrode) that facilitates electrophysiological monitoring, which then requires an EMG unit (compatible device) and human interpretation of the signals. There is no "algorithm only" performance for an electrode.

7. Type of Ground Truth Used

• Biocompatibility: In-vitro (cytotoxicity via Agarose Overlay) and in-vivo (irritation and sensitization via animal testing according to ISO 10993).
• Physical and Electrophysiological Properties: Measured technical specifications of the device compared against the known performance of the predicate device (Singlet Hydrogel Electrode). The "ground truth" here is the established performance characteristics of the predicate device.
• Shelf-Life: Time-dependent measurements demonstrating stability over the claimed 3-year period, adhering to ANSI/AAMI EC12:2000 standards.

8. Sample Size for the Training Set

Not applicable. This is a hardware device (electrode), not a software/AI algorithm that requires a training set.

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

Not applicable, as there is no training set for this hardware device.

Ask a specific question about this device

The Neurovision Nerve Locator/Monitor is an electronic device consisting of a surgical nerve stimulator and an evoked EMG monitor with integrated detecting and warning capability. This device is intended for use in surqical procedures where motor nerves are at risk to assist the surgeon in locating these nerves. This device is intended for use only by qualified, trained medical practitioners who perform operative surgery and who fully understand that this device is only an adjuvant to proper surgical technique and good surgical judgment.

The EMGView software is an accessory to the Neurovision Nerve Locator/Monitor. When the dedicated USB output of the EMG unit is connected to a personal computer, the PC installed software provides status monitoring data, troubleshooting data, real-time EMG waveforms, and digital backup of all data obtained during clinical use of the device. The real-time display of EMG waveforms is intended to assist the surgeon with nerve integrity monitoring.

The EMGView Software is a Windows PC operating system software dedicated to viewing and documentation of the output of the Neurovision (Nerveäna) Nerve Locator/Monitor. The software is dedicated to the EMG device by a serial USB connection. The EMGView software is a read-only device and is thus incapable of modifying or controlling the Nerveäna Device.

The provided text describes the EMGView Software, an accessory to the Neurovision Nerve Locator/Monitor. It focuses on the software's safety and efficacy as part of a 510(k) submission.

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 EMGView software, being a read-only device accessory, does not affect the performance of the Nerveäna device."
• "No surgeon input is required for operation of the Nerveäna accessory."
• "The EMGView software provides additional troubleshooting tools for the surgeon to verify proper Nerveäna operation and electrode position."
• "The Database Feature of the Nerveäna provides focus by the surgeon on the issue of proper nerve location and preservation as well as providing postoperative review data that would otherwise be unobtainable in answering any questions about the relationship of nerve monitoring to the surgical outcome." |
  | Clinical Use Conformance: The software's clinical use conforms to user needs. | "The software was validated by confirming that its clinical use conforms to user needs." |
  | Requirements Verification: EMGView Software requirements were verified. | "The EMGView Software (v4.31, current version) requirements were verified using the Nerveana bench testing performance as a baseline." |

Study Information:

The provided document describes a validation process rather than a detailed clinical study with specific statistical endpoints. The primary argument for safety and efficacy relies on the software being a "read-only device accessory" that does not interfere with the core function of the predicate device (Nerveäna Nerve Locator/Monitor).

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

• Sample Size: The document does not specify a sample size for a test set. The validation appears to be based on "bench testing performance" and "clinical use conformance" rather than a formal test set of patient data.
• Data Provenance: Not applicable, as human patient data for a test set is not mentioned. The validation involves "bench testing performance" of the Nerveäna device as a baseline.

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

• Number of Experts: Not applicable. The "ground truth" for the software's performance is tied to the baseline performance of the predicate device (Nerveäna) through bench testing.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no mention of a formal test set with expert ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done or at least not described in this document. The focus is on the software being an accessory that doesn't alter the core device's performance, not on improving human reader performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: The EMGView software itself is a standalone software component in terms of its digital functions (displaying data, troubleshooting, digital backup, database). However, its "performance" is evaluated as an accessory to the Nerveäna device, which is a surgical device requiring human-in-the-loop operation. The document emphasizes that "No surgeon input is required for operation of the Nerveäna accessory," indicating the software's functions are automated, but it's not a standalone diagnostic AI.

7. The Type of Ground Truth Used

• Ground Truth Type: The ground truth appears to be the established performance of the predicate device (Nerveäna) as determined by its existing "bench testing performance." The software's requirements were "verified" against this baseline. Its clinical use was "validated by confirming that its clinical use conforms to user needs," but the specific methodology for this conformance check is not detailed.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not mention a training set. This is not an AI/machine learning device in the modern sense that would typically involve a training set. It is an accessory software displaying data and providing additional features for an existing medical device.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set.

Ask a specific question about this device