(86 days)
The Amplaid Models A315 and A319 are two channel clinical diagnostic audiometers which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
The Amplaid A315 and A319 are two channel clinical diagnostic audiometers which can perform all audiometric tests normally performed in a clinical situation. They provide testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, Speech, High Frequency, Multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., Tone Decay, and M.L.D.(Masking Level Difference).
This document describes the Amplaid A315 and A319 Series clinical diagnostic audiometers and their substantial equivalence to a predicate device, the Amplaid 460 (K971747). The submission focuses on direct comparison to the predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the new device as a standalone entity.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and reported device performance:
The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the new device. Instead, the acceptance criterion is implied to be "substantial equivalence" to the predicate device in terms of safety and effectiveness.
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Amplaid A315 and A319TM) |
|---|---|---|
| Intended Use | Must be the same as the predicate device (Clinical audiometric applications) | Same as the predicate device. Intended for use by qualified/trained audiologist on adult and pediatric subjects for measurement and diagnosis of various types of hearing losses. |
| Safety | Must be as safe as the predicate device. Compliance with relevant electrical safety standards (UL, IEC) is expected. | "As safe and effective as the predicate device." Complies with UL-2601, IEC 60601 (updated standards from predicate). |
| Effectiveness | Must be as effective as the predicate device in performing all audiometric tests normally performed in a clinical situation. Compliance with audiometric standards (ISO, ANSI, IEC) is expected. | "As safe and effective as the predicate device." Performs all audiometric tests (pure tone, Speech, High Frequency, Multifrequency, Bekesy, SISI, ABLB, DLI, MLB, Tone Decay, MLD). Complies with ISO 389-1989, ANSI S3.6-1989, IEC 645-1,-2,-4. |
| Technological Differences | Minor technological differences are acceptable as long as they do not raise new questions of safety or effectiveness. | Differences in size/weight, hardcopy output (external printer option, PC integration via ASA software), and updated electrical safety standards. Minor technological differences. |
2. Sample size used for the test set and the data provenance:
The document mentions "bench and user testing data" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for a test set. The evaluation was a comparison to a predicate device.
4. Adjudication method for the test set:
The document does not describe an adjudication method for a test set.
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:
No, an MRMC comparative effectiveness study was not done. This device is an audiometer, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone (algorithm only) performance study was not done. This describes a medical device, an audiometer, which is operated by a human audiologist. The device itself is not an algorithm that performs diagnosis independently.
7. The type of ground truth used:
The "ground truth" in this context is the performance and safety established by the predicate device, Amplaid 460 (K971747). The new devices are compared against this established benchmark. There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for a novel diagnostic scenario.
8. The sample size for the training set:
Not applicable. This submission describes a hardware medical device (audiometer) and its substantial equivalence to a predicate, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for this type of device submission.
§ 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.