(28 days)
The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing-related disorders. Auditory stimuli are presented to the patient's ear through an earphone or headphones, and the corresponding Auditory Brainstem Responses (ABR) from the patient are recorded using EEG electrodes placed on the scalp. Standard ABR testing is most used clinically for 2 reasons: (1) to predict behavioral audiometric thresholds, and (2) as an audiological testing tool to assist in the assessment of possible auditory nervous system abnormalities.
The Bio-logic Auditory Evoked Potential (AEP) family of products is used for the recording, display, computation, and manipulation of human physiological data, for auditory screening purposes and to provide assistance in the neurological assessment and treatment of auditory sensory disorders. The predicate device referenced above is the latest in a series of complete systems of this type marketed by Bio-logic.
The Navigator Pro Evoked Potential Predicate Device performs Auditory Brainstem Response (ABR) recording functions with two channels of simultaneous data recording. The software for the Navigator Pro implements the standard ABR functions common to most similar systems on the market for many years.
The standard ABR test works on the basis of repeating a stimulus-response cycle. An auditory stimulation (click, tone, etc.) is presented to the patient through the use of an earphone or headphones. The EEG response from the brain is read through the use of one or more scalp electrodes placed on the patient. The response time of interest is approximately from 1 - 20 milliseconds following the stimulus. The response voltage readings for this time period are amplified, digitized and stored in the AEP system computer's memory. The stimulation is then repeated, the EEG response is read again, and this cycle is repeated many times. Each time the response is read, it is averaged together with all previous responses. The final data record is the result of averaging several thousand (usually 2000-3000) responses. This averaging process is necessary because the ABR signal is very small, much lower in voltage than the surrounding EEG "noise" present in the recording. The noise is averaged out over the many readings, because the noise will have a very low average net value. The result from the averaging process will be the signal.
The reason for this 510(k) is that the software for the host computer (PC) in the Evoked Potential system has been modified. The host computer software for the Predicate Device is DOS-based, whereas the host software for this modified Bio-logic AEP program is WINDOWS-based. The WINDOWS program has the same features and functionality as that of the predicate device, but with improved user interfaces and overall ease-of-use. The functions of the hardware are the same as those of the Predicate Device (Navigator Pro) hardware. The host computer software for control of the hardware has the same functionality as that of the DOS-based Predicate Device software. Direct hardware control of all Navigator Pro functions is provided from the Digital Signal Processor (DSP) and its program code located inside the Navigator Pro module, instead of directly from the host computer program. (There are no changes to the DSP program code in the Navigator Pro module as a result of this host computer software modification.) By distributing the hardware-specific functions to the DSP, the Windows-based host computer program has fewer real-time demands, and performance and reliability are improved. Together, the hardware and software implement the same functionality and perform the same intended use as the Predicate Device, but with improved ease-of-use and flexibility for the user.
This document describes a 510(k) submission for a modification to the Bio-logic Evoked Potential (EP) System. The core of the submission is to demonstrate substantial equivalence to a predicate device, the Bio-logic Navigator Pro (K994149), due to a software update from DOS-based to WINDOWS-based.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter for comparison | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | No change from predicate device. | No differences. The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing-related disorders. Auditory stimuli are presented to the patient's ear through an earphone or headphones, and the corresponding Auditory Brainstem Responses (ABR) from the patient are recorded using EEG electrodes placed on the scalp. Standard ABR testing is most used clinically for 2 reasons: (1) to predict behavioral audiometric thresholds, and (2) as an audiological testing tool to assist in the assessment of possible auditory nervous system abnormalities. The Bio-logic Navigator Pro EP System can be used for patients of all ages, from children to adults, including infants and geriatric patients. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional. |
| Population | No change from predicate device. | No differences. Can be used for patients of all ages, from children to adults, including infants and geriatric patients. |
| Hardware Configuration | No change from predicate device. | No differences. Both devices use the Navigator Pro patient connection hardware module. The functions of the hardware are the same as those of the Predicate Device (Navigator Pro) hardware. |
| Computer Control Software | Maintain same features and functionality as predicate device; improve user interfaces and ease-of-use. | The modified Evoked Potential device has changes to the AEP software program running in the PC (host computer). These changes allow full use of the Windows operating system functions and GUI features. The Predicate Device uses the DOS operating system or runs in a "DOS Window" with very little Windows compatibility. The Windows program has the same features and functionality as that of the predicate device, but with improved user interfaces and overall ease-of-use. The host computer software for control of the hardware has the same functionality as that of the DOS-based Predicate Device software. |
| Patient information and tracking. | No change from predicate device. | No differences. |
| Patient connections (transducers and electrodes) | No change from predicate device. | No differences. |
| Host Computer to Patient Connection Module Communications | No change from predicate device. | No differences. The communication from the PC (host computer) to the Navigator Pro patient connection module is provided through a serial port cable for both devices. |
| Presentation of Data / User Interface | Improve ease-of-use, flexibility, and efficiency, without significant changes to underlying AEP features and functions. | Changes have been made in the modified device software to incorporate GUI features and functionality common to most Windows programs on the market today. Computer system users are very familiar with standard Windows features. Therefore, these changes increase ease-of-use and provide improved flexibility and efficiency for the user, with no significant changes to the underlying AEP features and functions. |
| Physical Characteristics | No change from predicate device. | No differences. |
| Safety Characteristics | No change from predicate device; ensure no adverse effects on product safety and effectiveness. | No differences. The patient connection and isolation circuits are the same for both products. A detailed Hazard/Risk analysis for the EP family of products was performed using the Fault Tree analysis (FTA) approach, and a detailed Risk Assessment for the modified Evoked Potential product was written in accordance with ISO-14971, the International Standard: Application of Risk Management to Medical Devices. |
| Product Labeling | No change from predicate device. | No differences. |
| Anatomical sites | No change from predicate device. | No differences. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state a specific sample size used for a test set or the data provenance for evaluating the modified device's performance. The submission focuses on demonstrating substantial equivalence by comparing technological characteristics and functionality to the predicate device.
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)
The document does not mention a test set with independently established ground truth or the involvement of external experts for such a purpose. The safety and effectiveness summary relies on internal product development procedures, risk analysis, and direct comparison to the predicate device's established functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no specific test set requiring ground truth establishment is detailed, there is no mention of an adjudication method.
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 MRMC comparative effectiveness study was done or mentioned. The device is an Evoked Potential System software modification, not an AI-assisted diagnostic tool for "human readers" in the traditional sense of medical imaging. The software provides data recording, display, computation, and manipulation, with program "recommendations" subject to review by a qualified healthcare professional.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This would not apply in the typical sense for this device. The existing ABR test itself is an "algorithm" of signal averaging, which is fundamental to the evoked potential technology. The changes are to the host computer software that controls the hardware and presents the data. The document explicitly states: "As with the Predicate Device, the modified software does not make any final decisions that result in any automatic forms of diagnosis or treatment. All program "recommendations" are subject to review by a qualified health care professional, and may be modified, overridden or deleted as determined by the qualified user." Therefore, the device is not intended for standalone (algorithm-only) diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that the submission is for a software modification of an existing evoked potential system, and not a new diagnostic algorithm, the concept of "ground truth" for a test set as typically used in AI/diagnostic studies is not directly applicable here. The "ground truth" for the device's functionality is implicitly derived from the long-standing clinical acceptance and performance of the predicate device and the standard physiological principles of ABR testing. The "truth" being established is that the new software performs the same core functions and produces physiologically accurate representations of ABR data as the predicate device.
8. The sample size for the training set
The document does not refer to a training set in the context of machine learning. The software modification is a re-platforming of existing functionality from DOS to Windows, not the development of a new algorithm requiring a training set.
9. How the ground truth for the training set was established
As there is no mention of a training set, the establishment of ground truth for such a set is not applicable or addressed in this submission.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).