(84 days)
The Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with an attached probe (that is placed in the outer ear canal) which emits sound that evokes otoacoustic emissions. A microphone in the probe picks up the emissions if any are present, and the device then analyzes the emissions and mathematically separates noise from cochlear emissions. The presence of these emissions indicates cochlear function in adults, infants and children. The instrument requires no active participation from the patient.
Otoacoustic emissions (OAEs) are low-level audio-frequency sounds that are generated by the outer hair cells of the cochlea in response to sound input. The presence of OAEs is an indication of cochlear function. If the Echo-Screen signals a "pass" reading as it analyzes the presence of OAEs, the clinician can determine that the cochlea is operating normally.
The Fischer-Zoth Audiologic System model 'Echo-Screen' is based upon Otoacoustic Emissions and it is similar to the Grason Stadler Inc. GSI70 AudioPath Screener and the Otodynamics OAE Analyser, model ILO88. The 'echo-screen' is a handheld, automated OAE-based screeming-system which is easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics.
The provided K982642 510(k) summary for the "Echo-Screen" device does not contain a specific study proving the device meets particular acceptance criteria through quantifiable performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.
Here's a breakdown of the information requested, based on the provided document:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity for detecting hearing disorders). Instead, it establishes that the device's technological characteristics and intended use are similar to predicate devices and that it meets specified safety and quality standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence (to predicates) | - Powered by rechargeable battery |
| - Battery low indicator | |
| - Safety Compliance: IEC 601-1 and UL2601-1 | |
| - Audiometry: Tones (clicks) presented to a miniature speaker, OAE response received and registered, click tone quality and amplitude controlled via SW and HW, limited to max 85dB SPL. | |
| - OAE probe design: One speaker and a microphone (vs. two speakers and a microphone for GSI70) | |
| - SW: Echo-screen Automated Evaluation SW (vs. GSI 60 SW) | |
| - Supporting SW: C-based SW for evaluation results, artifact rate, stimulus stability; export of test results and patient data possible. | |
| Safety Standards Compliance | - Designed to meet IEC601-1, UL2601, and VDE750. |
| - Max. output level controlled via Software to 85dB SPL. | |
| - Electronic hardware designed to prevent excessive decibels. | |
| Quality Management System Compliance | - Will be certified according to ISO 9001 (EN29001). |
| Medical Device Classification Compliance | - Will be certified according to EN46001 Class I or Class IIa device. |
| EMC Compliance | - Group 1 (medical equipment, conducted and radiated emissions) - EN 25011 |
| - IEC801-3 Radiated Electromagnetic Field Susceptibility | |
| Regulatory Compliance (EU) | - Conforms to provisions of European Council Directive 93/42EEC - CE Mark. |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set or clinical study with a sample size for evaluating performance. The submission relies on demonstrating substantial equivalence to predicate devices and compliance with relevant standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No performance study with a test set and ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable. No performance study with a test set is described.
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. The "Echo-Screen" is an automated screening device, not an AI-assisted diagnostic tool that would involve "human readers" interpreting outputs in the way an MRMC study would typically evaluate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as an "automated OAE-based screening system" with "Automated stimulus adjustment and online control" and "Signal statistical criterion for 'PASS' condition." This implies a standalone (algorithm only) performance in generating a "pass" or "refer" result for OAEs. However, the document does not present quantitative performance metrics (e.g., sensitivity, specificity) for this standalone performance. The "effectiveness" is primarily described in terms of its ability to detect OAEs and that their presence indicates cochlear function, similar to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state a type of ground truth used for performance validation. Given the device's nature as an OAE screener, the implied 'ground truth' for "effectiveness" would be the presence or absence of true OAEs, and indirectly, the presence or absence of cochlear function. However, no study measuring this against a gold standard (e.g., comprehensive audiological assessment) is presented.
8. The sample size for the training set
Not applicable. The document describes the device's design and technological characteristics, and its equivalence to predicate devices. It does not refer to an AI model that underwent a "training set." The "evaluation SW" is based on "signal statistics" rather than machine learning from a large training dataset.
9. How the ground truth for the training set was established
Not applicable. As there is no mention of a training set for an AI model, there is no description of how ground truth would have been established for it.
§ 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.