(242 days)
The 'ABaer System with ABaer I/O Function' is indicated for use when it is necessary for a trained health care professional to measure or determine cochlear function. 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 ABaer I/O Function is a Windows® based software application for use with the ABaer Hearing Screening System. The ABaer I/O software option enables the ABaer device user to perform DPOAE Input/Output (I/O) testing at different test frequencies, frequency ratios and intensity levels in addition to the ABR and OAE based hearing screening functions. 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 ABaer Hearing Screening System (HSS) performs an automated auditory evoked response (ABaer) screening and/or an automated otoacoustic emissions (AOAE) screening. The automated auditory brainstem response test (ABaer) involves placement of three recording electrodes on an infant's head. The electrodes record electrical activity generated by the auditory nervous system that results from the presentation of a click stimulus into the patient's ear via acoustic transducers (i.e. insert earphones, headphones, OAE probe, acoustic ear couplers). The system collects and averages evoked potential data in order to perform ABR based screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the automated screening function and enhancing speed of test completion in the same manner as in the predicate device (K021801). The device presents the resulting POVR score and a Pass/Refer recommendation to the user.
The automated otoacoustic emissions (AOAE) screening functionality of the ABaer system involves producing controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions that are generated by the inner ear as a result of normal hearing processes. The ABaer device performs both distortion product otoacoustic emissions (DPOAE) tests and transient evoked otoacoustic emissions (TEOAE) tests.
The OAE stimuli are generated 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, averages and analyzes data samples until specified measurement and test 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 the test protocol parameters and measured OAE parameters.
The ABaer I/O is a software option to be used in conjunction with the ABaer system. The standard DPOAE test measures otoacoustic response to a series of frequency-pairs of tones, varving the frequency while keeping the level or intensity of the stimulus tones at a constant level. The ABaer I/O software option enables the ABaer 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 levelsensitive information about DPOAE response.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ABaer with ABaer I/O Function device:
1. Acceptance Criteria and Reported Device Performance
The submission for the ABaer with ABaer I/O Function is a 510(k) premarket notification. This type of submission primarily focuses on establishing "substantial equivalence" to legally marketed predicate devices, rather than establishing specific quantitative performance acceptance criteria in the same way a de novo or PMA submission might. The document repeatedly states equivalence to predicate devices, which implies that the device's performance is acceptable if it is comparable to the established performance of those predicates.
Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices. The "reported device performance" is the assertion of equivalence to these predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| ABR based testing performance: Equivalent to predicate device K021801 (ABaer Cub with Automated OAE and ABR) including POVR algorithm for signal quality, automated screening, and test speed. | "With respect to the ABR based testing, the ABaer with ABaer I/O Function is equivalent to the predicate device cleared under K021801." |
| TEOAE and DPOAE testing performance: Equivalent to predicate devices K021801, K964132 (Bio-logic Scout and Scout Sport OAE), and K072033 (Otodynamics Otoport) for OAE parameters (reproducibility, difference value for TEOAE & DP, noise floor amplitudes for DPOAE, pass/refer recommendations). | "With respect to TEOAE and DPOAE testing, the ABaer with ABaer I/O Function is equivalent to the devices cleared under K021801, K964132, and K072033." |
| DPOAE I/O function performance: Equivalent to automated Input / Output Software functions in predicate devices K964132 (Scout and Scout Sport OAE). This includes the ability to perform DPOAE testing at different stimulus intensities and present graphical representations of stimulus level vs. DPOAE level. | "With respect to DPOAE I/O function, the ABaer with ABaer I/O Function is equivalent to the automated Input / Output Software functions present in the Scout and Scout Sport Otoacoustic Emissions (OAE) Test Instruments." |
| Safety and Effectiveness: Meets performance specifications and demonstrates equivalence to functionalities in respective predicate devices. | "Design verification and validation were performed to assure that the ABaer with ABaer I/O Function meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices." "The verification and validation summary report and risk analysis documentation provided in this 510(k) support the conclusion that the ABaer System with ABaer I/O Function is safe and effective." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any details about:
- The sample size used for any test set (e.g., number of subjects or recordings).
- The data provenance (e.g., country of origin, retrospective or prospective nature).
The submission relies on "Design verification and validation" and "risk analysis documentation" to support its claims of equivalence, but the specifics of these tests (including sample sizes and data characteristics) are not disclosed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any details about:
- The number of experts, if any, used to establish ground truth.
- The qualifications of such experts.
The nature of the device (an audiometer and evoked response stimulator) suggests that ground truth would typically be established through established audiology protocols and objective physiological measurements, rather than subjective expert consensus on interpretations of complex images or signals requiring multiple expert reads. However, the document does not elaborate on how ground truth was established for any testing.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. Given the lack of information on expert involvement and specific test sets, an adjudication method is not mentioned.
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
A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric. This device is an automated physiological measurement tool; therefore, an MRMC study comparing human reader improvement with AI assistance is not applicable to its stated function or the information provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is described as performing "automated auditory evoked response (ABaer) screening" and "automated otoacoustic emissions (AOAE) screening," and it provides a "Pass/Refer recommendation." This inherently implies standalone algorithm performance. While a trained healthcare professional uses the device and interprets the DPOAE I/O function (which provides "stimulus level-sensitive information"), the core screening functions (ABR, TEOAE, DPOAE with Pass/Refer) are driven by the algorithm itself.
The claim of "equivalence" to predicate devices, which also perform automated screening, suggests that the standalone performance of the ABaer system's algorithms is being validated against the performance of those established, FDA-cleared devices. However, no specific standalone performance metrics or study details are provided.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any testing. For devices measuring physiological responses like ABR and OAE, ground truth is typically established through:
- Established audiological diagnostic criteria: Based on a combination of different audiological tests (e.g., behavioral audiometry, tympanometry, acoustic reflex testing) and clinical assessment, often considered the "gold standard."
- Pathology/Clinical Outcomes: In some cases, confirmed diagnoses or long-term outcomes could serve as ground truth, but this is less common for screening devices that identify risk.
Given the device's function and the focus on "equivalence," it is highly probable that the ground truth for "verification and validation" would have involved comparison against established clinical assessments or existing, validated audiometric devices.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This is common for 510(k) submissions of this type, especially for devices developed through traditional engineering and signal processing methods rather than deep learning or machine learning, where distinct training and test sets are fundamental. The "ABaer I/O Function" is described as a "software option," implying feature extension rather than a new AI model requiring extensive new training.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, this information is not provided.
§ 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.