(27 days)
The intended use of The CUB®DIS II™ DPOAE Measurement System is to determine the presence of cochlear function.
The CUBEDIS II TM DPOAE Measurement system is designed to provide acoustic stimuli for, and rapid clinical measurement and evaluation of, odd order distortion product tones generated by the cochlea and measured in the ear canal, at the audiometric frequencies (or other frequencies, as desired), between 500 through 8,000 Hz with no known artifacts, a low noise floor system, and a high signal-to-noise ratio.
Here's a summary of the provided text regarding the CUBEDIS II™ DPOAE Measurement System, structured according to your requested categories.
Based on the provided K981460 510(k) Summary, the regulatory submission focuses on demonstrating substantial equivalence to a predicate device (Etymotic Research CUBEDIS™ Otoacoustic Emission). The information provided does not include a formal acceptance criteria table, nor a detailed study that proves the device meets specific performance criteria in a clinical sense. Instead, the document highlights technical comparisons and regulatory compliance.
Here's an attempt to interpret and present the available information in the requested format, with significant limitations due to the nature of the provided document:
Acceptance Criteria and Device Performance (Interpreted from Technical Comparison)
The document doesn't explicitly state "acceptance criteria" but rather provides a technical comparison between the CUBEDIS II™ and its predicate device, the Ariel_DSP16+. The implicit acceptance criterion is that the performance of the CUBEDIS II™ should be comparable or better than the predicate device across critical technical specifications.
| Parameter | Implicit Acceptance Criteria (Comparable/Better than Predicate) | Reported Device Performance (Mimosa DSP) |
|---|---|---|
| Input | ||
| Measurement Bandwidth | 20 kHz | Same (20 kHz) |
| ADC Resolution | 16 bit | Same (16 bit) |
| ADC Differential Nonlinearity | N/A (Predicate not specified) | $\pm0.5$ LSB |
| Instantaneous Dynamic Range - Line Inputs | 88 dB | 85 dB (Slightly lower) |
| Total Harmonic Distortion - Line Inputs | 0.025 | 0.006 (Significantly better) |
| Signal-to-Intermodulation Distortion | N/A (Predicate not specified) | 90 dB (Typ) |
| Full Scale Input Voltage | 20 Vpp | 2.9 Vpp (Significantly lower) |
| Output | ||
| Measurement Bandwidth | 20 kHz | Same (20 kHz) |
| DAC Resolution | 16 bits | Same (16 bits) |
| DAC Differential Nonlinearity | N/A (Predicate not specified) | $\pm0.5$ LSB |
| Total Dynamic Range | 88 dB | 95 dB (Better) |
| Total Harmonic Distortion | 0.025 | 0.01% (Better) |
| Signal-to-Intermodulation Distortion | N/A (Predicate not specified) | 85 dB |
| Full Scale Output Voltage | 20 Vpp | 2.8 Vpp (Significantly lower) |
Note on Interpretation: The discrepancies in "Instantaneous Dynamic Range - Line Inputs" and "Full Scale Input/Output Voltage" between the devices would typically warrant further explanation in a comprehensive submission. However, in the context of a 510(k) for substantial equivalence, the overall functionality and safety are key. The improved "Total Harmonic Distortion" and "Total Dynamic Range" in other areas might offset these differences for the intended use.
Study Details:
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Sample size used for the test set and the data provenance:
- The provided document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The comparison appears to be purely based on technical specifications and characteristics of the hardware. This is typical for a 510(k) for a device like this, where the focus is on a technical comparison to a predicate, rather than new clinical effectiveness studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention any experts or a ground truth establishment process related to a clinical test set. The ground truth for the device's technical specifications would be engineering measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned as there's no clinical test set described.
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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 or comparative effectiveness study involving human readers/AI assistance is mentioned. This device is an Otoacoustic Emissions Test Instrument, which directly measures physiological responses, not an AI-assisted diagnostic tool requiring human interpretation improvement studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is an instrument to measure physical phenomena, not an "algorithm" in the AI sense. Its primary function is to provide acoustic stimuli and measure responses.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical comparison, the "ground truth" implicitly refers to the established technical specifications and performance characteristics of both the predicate device and the new device, measured through standard engineering tests. There's no clinical ground truth (like pathology or outcomes data) mentioned in this submission summary. The intended use "to determine the presence of cochlear function" implies that the device's output is the diagnostic information, which then a clinician interprets.
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The sample size for the training set:
- N/A. This document describes a medical device for physiological measurement, not a machine learning model. Therefore, there is no "training set."
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How the ground truth for the training set was established:
- N/A, as there is no 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.