(28 days)
The Interacoustics Model AD226 Diagnostic Audiometer is indicated for use in The Interacoustics Model AB220 Diagnostic and assisting in the diagnosis of possible otologic disorders.
The interacoustics Model AD226 Diagnostic Audiometer is an electroacoustics instrument that produces and as a diagnectic hostring electroacousiic test instrument until processible stallegic disording tones and signals intended for acc in conductions of possible otologic disorders.
This 510(k) summary describes a traditional medical device (an audiometer) and not an AI/ML powered device. As such, many of the requested fields are not applicable or cannot be extracted from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through comparison of physical and functional characteristics, and compliance with established performance standards.
Here's the information that can be extracted, with explanations for the missing fields:
Acceptance Criteria and Device Performance
The acceptance criteria for the Interacoustics Model AD226 Diagnostic Audiometer are primarily based on its compliance with established performance and safety standards, and its similarity in function and intended use to a legally marketed predicate device.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance / Compliance |
|---|---|---|
| Performance Standards | Audiometers IEC 645-1 Type 3 | In compliance |
| ANSI 3.6-1989 (Audiometer performance) | In compliance | |
| Safety Standards | EN 60601-1:1990 (Medical electrical equipment safety) | In compliance |
| EMC Standards | EN 60601-1-2:1993 (Electromagnetic compatibility) | In compliance |
| Indication for Use | Identical to predicate device (Beltone Model 110 Audiometer) | Identical |
| Functional Equivalence | Comparison of features (frequencies, masking, transducers, etc.) | Demonstrates substantial equivalence |
1. A table of acceptance criteria and the reported device performance:
(See table above)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for this type of device submission. This 510(k) is for a hardware medical device (an audiometer), not an AI/ML algorithm. The "test set" in this context refers to the device itself being tested for compliance with standards, not a dataset of patient information. The submission does not describe clinical trials or data analysis that would require a patient-based test set.
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. Ground truth generation by experts is relevant for AI/ML models that interpret medical images or signals. For a diagnostic audiometer, performance is established through calibration and adherence to established physical and electrical standards, not through expert-labeled patient data as described in the prompt.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in studies involving human interpretation of data, often in the context of clinical trials for AI/ML devices. This submission focuses on the device's technical specifications and compliance with engineering standards.
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 study is relevant for evaluating the impact of AI on human reader performance. This submission is for a standalone diagnostic audiometer and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of AI/ML. The "standalone" performance here refers to the device operating independently, measuring auditory responses. However, this is not an AI/ML algorithm being evaluated in isolation. The document describes the device's inherent capability to produce and analyze electroacoustic signals for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. The "ground truth" for an audiometer's performance is its accurate production of calibrated sounds and its ability to consistently measure auditory thresholds as per established audiology principles and standards (e.g., ANSI 3.6-1989). This is verified through physical calibration and testing against reference equipment, not against clinical outcomes or expert consensus on patient data.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML system, so there is no "training set" of data.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth establishment process 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.