(40 days)
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held auditory test instrument designed to evoke or stimulate the generation of distortion product otoacoustic emissions (DPOAEs), utilizing pure-tone stimulus presentation, for the purpose of determining the presence of cochlear function in adults, children and infants.
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held device designed to provide an objective measure of outer hair cell function through the measurement of otoacoustic emissions (OAEs). The ERO.SCAN system has both receivers and microphone built into the screener. The DSP board is housed in a hand-held device.
The provided text describes a 510(k) premarket notification for the ERO•SCAN Otoacoustic Emissions Test Instrument, seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical trials that establish device performance against specific acceptance criteria.
Therefore, the document does not contain information about explicit acceptance criteria in the form of performance metrics (like sensitivity, specificity, accuracy) with corresponding acceptance thresholds, nor does it detail a study designed to prove the device meets such criteria through a traditional clinical validation process. Instead, it focuses on comparing the technological characteristics of the ERO•SCAN device to its predicate, the Etymotic Research Cub Dis Otoacoustic Emissions Test Instrument.
However, we can infer "accepted" performance characteristics by examining the "Performance Characteristics" listed for both the predicate and the ERO•SCAN device in the comparison table, as these are implicitly deemed acceptable for an Otoacoustic Emissions Test Instrument.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly the performance characteristics of the predicate device. The "reported device performance" is the ERO•SCAN's characteristics.
| Characteristic | Predicate Device (Cub 'Dis System) Performance (Implicit Acceptance Criteria) | ERO•SCAN Device Performance (Reported Device Performance) |
|---|---|---|
| Noise Floor | 0 dB SPL @ 1 kHz | 0 dB SPL @ 1 kHz |
| Frequency Range | 500 Hz – 8 kHz | 2 kHz – 5 kHz |
| Stimulus Intensity Range | 40 – 70 dB SPL | 45 – 65 dB SPL |
| Maximum Output | ≤ 90 dB SPL | ≤ 90 dB SPL |
Note: The differences in Frequency Range and Stimulus Intensity Range between the predicate and the ERO•SCAN describe variations in their technical specifications, which are deemed acceptable for the intended use through the substantial equivalence argument, rather than being "failures" to meet a criterion. The core functionality and safety aspects (like maximum output) are maintained or improved.
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 describe a clinical study with a test set of patient data. The substantial equivalence argument is based on a technical comparison of device specifications and principles of operation.
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 applicable. No clinical test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical 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. This device is an Otoacoustic Emissions Test Instrument, a diagnostic tool, not an AI-assisted interpretation system for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone instrument for measuring otoacoustic emissions. Its performance is inherent to its design and technical specifications, which are compared to the predicate. It's not an "algorithm only" in the sense of a software-based AI interpreting data externally. The "Software algorithms are essentially equivalent" to the predicate, implying that the underlying computational methods for processing signals are similar or the same as an already accepted device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device and submission, the "ground truth" for demonstrating safety and effectiveness implicitly relies on the established safety and effectiveness of the predicate device. The comparison focuses on technical and functional equivalence, ensuring the new device operates on the same principles and provides similar, safe, and effective measurements. There isn't a "ground truth" derived from patient outcomes or expert consensus specifically for validating the ERO•SCAN's diagnostic accuracy in the way a new imaging algorithm might be evaluated.
8. The sample size for the training set
Not applicable. This document describes a medical device seeking substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This document describes a medical device seeking substantial equivalence, not a machine learning model requiring a training set.
§ 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.