(389 days)
The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System and is intended to record evoked responses upon presentation of sensory stimuli to the facial nerve. The product is indicated for use as an assessment tool to supplement the case history information, physical examination, imaging studies, and/or other sensory evaluations conducted by or on the order of the physician.
The ENoG Protocol is a feature of the Navigator Pro with AEP Software Evoked Response System; a Windows® based software application for use with the Navigator Pro hardware platform for the recording of evoked responses (i.e., electrical potentials) upon the presentation of sensory stimuli.
The ENoG Protocol works on the basis of a repeating stimulus-response cycle. It is a convenience feature developed for the user to quickly set up testing for Electroneuronography evaluation of the facial nerves. The protocol utilizes the existing technology of the evoked response somatosensory function of the software. The evoked response from the patient is recorded through the use stimulus electrodes positioned near the mastoid, a cathode behind the earlobe, and an anode in front of the earlobe with the forehead as the ground.
The provided document describes a 510(k) summary for the Navigator Pro, AEP Software Modification - ENoG, which is an evoked response somatosensory stimulator. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of reported device performance metrics like accuracy, sensitivity, or specificity.
Instead, the submission focuses on substantial equivalence to predicate devices by comparing technological characteristics and ensuring safety and effectiveness through adherence to design control specifications and risk analysis. The "study" mentioned below refers to the safety and effectiveness summary provided in the document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific acceptance criteria (e.g., minimum sensitivity, specificity, or quantifiable performance metrics) for the ENoG Protocol, nor does it report numerical device performance against such criteria. The "acceptance" discussed is primarily in the context of substantial equivalence to predicate devices and adherence to quality systems and risk management.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a clinical performance study using a test set of patient data with a specified sample size.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. There's no mention of a test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no test set for which an adjudication method would be required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without AI assistance. The device is not presented as an AI-assisted diagnostic tool in this context, but rather as a software modification to an existing evoked response system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. The document explicitly states: "The ENoG protocol feature does not make any final decisions that result in any automatic forms of diagnosis or treatment. All program 'results' require a review by a physician or other qualified healthcare professional, and may be modified, overridden or deleted as determined by a qualified user." This indicates that the device is intended for use with a human-in-the-loop, and no standalone performance study without human intervention is mentioned.
7. Type of Ground Truth Used
Not applicable. Since no performance study comparing device output to a known truth is described, there's no mention of the type of ground truth used.
8. Sample Size for the Training Set
No. The document does not describe a machine learning algorithm that requires a training set. The ENoG Protocol is described as a "convenience feature" and a "Windows® based software application" that utilizes "existing technology of the evoked response somatosensory function of the software."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning algorithm.
Summary of the "Study" (Safety and Effectiveness Summary):
The "study" or assessment demonstrating safety and effectiveness relied on:
- Internal Product Development Procedures: The device was developed in accordance with Bio-logic's internal product development procedures, which are stated to meet ISO-9001, ISO 13485:2003, and FDA QSR Design Control specifications.
- Hazard/Risk Analysis: A detailed Fault Tree Analysis (FTA) was performed for the Evoked Potential family of products.
- Risk Assessment: A detailed Risk Assessment for the AEP Software was written in accordance with ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices.
- Human-in-the-Loop: A key aspect of safety is that "All program 'results' require a review by a physician or other qualified healthcare professional, and may be modified, overridden or deleted as determined by a qualified user." The program also allows users to review raw data and perform other analyses.
- Substantial Equivalence: The primary argument for market clearance is that the ENoG Protocol is substantially equivalent to legally marketed predicate devices, with differences in technological characteristics not raising new issues of safety or effectiveness.
In conclusion, the given document describes a regulatory submission centered on substantial equivalence and a risk management approach to safety, rather than a clinical performance study with specific quantitative acceptance criteria and reported device performance.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).