(88 days)
The Amplaid 171S is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audio!ogist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
The Amplaid 171S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, and speech.
Here's a breakdown of the acceptance criteria and study information for the Amplaid 171S Clinical Audiometer, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Amplaid 171S are primarily based on its equivalence to a predicate device, the Amplaid 308 Clinical Audiometer. The study demonstrated that the new device is "as safe and effective as the predicate device," and the acceptance criteria are met by showing comparable performance, function, and adherence to relevant standards.
Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate Device: Amplaid 308) | Reported Device Performance (New Device: Amplaid 171S) | Meets Criteria? |
|---|---|---|---|
| Indications for Use | Clinical diagnostic audiometric applications for measurement and diagnosis of various types of hearing losses by a qualified/trained audiologist on both adult and pediatric subjects. | Clinical diagnostic audiometric applications for measurement and diagnosis of various types of hearing losses by a qualified/trained audiologist on both adult and pediatric subjects (stated as "Same" and "no new indications for use"). | Yes |
| Audiometric Standards | ISO 389-1975, ANSI S3.6-1969, ANSI S3.13-1972, IEC 645 | ISO 389-1989, ANSI S3.6-1989, IEC 645-1,-2, -4 (Stated as "Same, standards have been updated.") | Yes (meets updated standards) |
| Electrical Safety Standards | UL-544, IEC 601 | UL-544, IEC 601 (Stated as "Same") | Yes |
| Energy Source | 115/230 Vac, ± 10%, 50-60 Hz | 115/230 Vac, ± 10%, 50-60 Hz (Stated as "Same") | Yes |
| Hardcopy Output | Possible via computer interface | Possible via computer interface (Stated as "Same") | Yes |
| Safety and Effectiveness | As safe and effective as the Amplaid 308. | Stated as "as safe and effective as the predicate device." | Yes |
| Technological Differences | No significant technological differences that would impact safety or effectiveness. | Stated as having "few technological differences" and "no new indications for use," implying differences are minor and do not affect equivalence for safety and effectiveness. | Yes |
Study Information
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Sample size used for the test set and the data provenance:
- The document states that "bench and user testing" were performed. However, it does not provide a specific sample size for the test set (number of subjects or assessments).
- The data provenance (country of origin, retrospective/prospective) is not specified.
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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 mentions "user testing," which implies involvement of qualified users (audiologists, as per indications for use).
- However, it does not specify the number of experts or their qualifications regarding ground truth establishment for the test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the test set results.
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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, an MRMC comparative effectiveness study was not done. This report is for a medical device (audiometer), not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a clinical diagnostic audiometer, a human-operated instrument, not an algorithm. Performance is inherently "with human-in-the-loop" (the audiologist).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Based on "bench and user testing," the ground truth for performance comparison likely involved measurements against established audiometric standards and potentially clinical assessments by audiologists comparing the output/functionality to expected clinical results for diagnosing hearing loss. The document does not explicitly state "expert consensus," but "user testing" implies clinical validation.
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The sample size for the training set:
- Not applicable. This device is a hardware instrument, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set for an 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.