(201 days)
The AuDX Otoacoustic Emissions Measurement System produces controlled acoustic signals in the ear canal and measures the resulting evoked emissions (OAEs) that are generated by the outer hair cells of the inner ear as a result of normal peripheral hearing processes. The AuDX device performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening and diagnostic test environments. The AuDX I/O is a software option intended to provide an online DPOAE Input / Output function and to be used in conjunction with the AuDX system. The AuDX I/O software enables the AuDX device user to perform DPOAE testing at different stimulus intensities in order to obtain the 'DPOAE Input / Output (I/O) function' at user defined test frequencies, frequency ratios and intensity levels, rather than keeping the stimulus tones at the same intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level at each tested frequency provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses.
As an OAE based screening tool, AuDX is indicated for use by any personnel (nurses, technicians, volunteers) who are trained to operate the device for the purpose of performing an objective, automated physiologic screening test that provides a simple pass/refer result requiring no further clinical interpretation. Additionally, as a tool that can provide diagnostic information, the device is indicated for use by trained health care professionals (audiologists, physicians) to further assess cochlear function for the purpose of diagnosis and treatment of hearing disorders. Additional information may be obtained by viewing the graphical representation of the test results and by obtaining the DPOAE I/O functions.
The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
The AuDX I/O Function is a Windows® based software application for use with the AuDX Otoacoustic Emissions Measurement System. The AuDX I/O software enables the AuDX device user to perform DPOAE testing at different test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses.
The AuDX Otoacoustic Emissions Measurement System performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. Using a combination of hardware and software, the AuDX system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the inner ear as a result of normal hearing process. The stimuli are presented via miniature receivers and the sounds in the external ear canal are recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. For transient evoked otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes are calculated and presented to the user. For distortion product otoacoustic emissions (DPOAEs), the DP and noise floor amplitudes are calculated and presented to the user. A pass or refer recommendation is assigned at the end of the test automatically based on user defined custom protocols or default test protocols and measured OAE test parameters.
The AuDX I/O is a software option to be used in conjunction with the AuDX system. The standard DPOAE test measures otoacoustic response to a series of frequency-pairs of tones, varying the frequency while keeping the level or intensity of the stimulus tones at a constant level. The AuDX I/O software option enables the AuDX device user to perform DPOAE testing at different stimulus intensities in order to obtain the 'DPOAE Input / Output (I/O) function' for user defined test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level vs. DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE response.
The provided 510(k) summary for the Natus Medical Incorporated AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function outlines its equivalence to predicate devices rather than providing a standalone study with detailed acceptance criteria and performance metrics for the new device.
Therefore, the information requested about acceptance criteria, detailed study results, sample sizes, expert qualifications, and adjudication methods for a standalone performance study is not explicitly available in the provided document. The document primarily focuses on demonstrating substantial equivalence to previously cleared devices.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document states that "Design verification and validation were performed to assure that the AuDX I/O Function meets its performance specifications and demonstrates equivalence to the Automated I/O function present in the Scout and Scout Sport OAE Test Instruments."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to Predicate Devices: |
- TEOAE and DPOAE testing
(K021801, K964132, K974076, K072033) - DPOAE I/O function
(Scout and Scout Sport Otoacoustic Emissions (OAE) Test Instruments with Automated Input / Output Software Functions) | Device is equivalent.
The AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function is stated to be equivalent to the listed predicate devices for TEOAE and DPOAE testing, and for DPOAE I/O function. |
| Performance Specifications: - Stimulus level-sensitive information about DPOAE responses.
- Calculation and presentation of:
- For TEOAEs: reproducibility and difference value between TEOAE and noise floor amplitudes.
- For DPOAEs: DP and noise floor amplitudes.
- Pass or refer recommendation based on user-defined/default protocols. | Device meets performance specifications.
The device is designed to display graphical representation of test results (stimulus level vs. DPOAE level) to evaluate stimulus level-sensitive DPOAE response information.
The system performs the specified calculations and provides pass/refer recommendations.
(Specific quantitative performance metrics are not provided in this summary.) |
| Safety and Effectiveness: | Safe and effective.
The verification and validation summary report and risk analysis documentation provided in this 510(k) supports this conclusion. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document refers to "Design verification and validation" but does not provide details on the sample size of a test set, nor the provenance of any data used in these tests.
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 explicitly stated. The device provides an automated pass/refer recommendation. While medical professionals are indicated as users, there is no mention of experts establishing a ground truth for a test set in the context of a performance study for the 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / None explicitly stated. Since a specific performance study with a test set and ground truth adjudication is not detailed, this information is not present. The device assigns pass/refer recommendations automatically.
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 / Not stated. This device is an audiometer for DPOAE and TEOAE measurements, not typically an AI-assisted diagnostic imaging device requiring MRMC studies as described. It provides objective measurements and automates pass/refer recommendations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied, but not explicitly detailed as a separate study. The device itself performs the measurements and automatically assigns a pass or refer recommendation "based on user defined custom protocols or default test protocols and measured OAE test parameters." This suggests that the algorithm's performance in generating these recommendations operates in a standalone manner once the parameters are set. However, the 510(k) submission focuses on demonstrating equivalence to predicate devices, not on a new, detailed standalone performance study for the algorithm's accuracy beyond what's inherent in the predicate's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated for a performance study. The device measures physiological responses (otoacoustic emissions). The "truth" for such a device is typically the accurate measurement of these emissions and their comparison to established physiological norms or clinical thresholds within the device's protocols. The equivalence claim infers that the measurements align with those of the predicate devices.
8. The sample size for the training set:
- Not applicable / Not stated. The document describes a medical device for measuring otoacoustic emissions, not typically a machine learning or AI algorithm that requires a "training set" in the conventional sense of pattern recognition or image analysis. Its operation is based on established audiological principles and signal processing, not a trained dataset.
9. How the ground truth for the training set was established:
- Not applicable / Not stated. As above, the concept of a training set and its ground truth is not relevant to this type of device and its 510(k) submission as described.
In summary, the 510(k) for the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. It states that design verification and validation were performed to confirm performance specifications and equivalence, but it does not provide detailed results of a standalone clinical performance study with specific acceptance criteria, sample sizes, or ground truth methodologies that would be typical for a novel diagnostic AI algorithm.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.