(90 days)
The Echo Wadu-OAE is a device used by otolaryngologists, audiologists, and nurses for screening hearing in infants and adults to record otoacoustic emissions elicited from either transient or distortion product stimuli.
Echo Master- OAE
Here's an analysis of the provided text regarding the Hortmann EchoMaster-OAE device, focusing on the requested acceptance criteria and study information:
Based on the provided text, it's not possible to extract the detailed information requested regarding acceptance criteria, device performance, and study specifics. The document is an FDA 510(k) clearance letter for the Hortmann EchoMaster-OAE, indicating that the device has been found substantially equivalent to a predicate device.
This type of document typically does not contain the detailed technical specifications, acceptance criteria, or performance study results that would be submitted to the FDA as part of the 510(k) application. The 510(k) letter itself is an administrative response from the FDA to the manufacturer, granting market clearance.
Therefore, I cannot populate most of the requested fields accurately from this document. I can, however, extract the following:
1. A table of acceptance criteria and the reported device performance
This information is not present in the FDA 510(k) clearance letter. The letter confirms substantial equivalence, which implies that the device met certain performance criteria comparable to a predicate device, but it does not detail those specific criteria or the
reported performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the FDA 510(k) clearance letter.
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)
This information is not present in the FDA 510(k) clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the FDA 510(k) clearance letter.
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
This information is not present in the FDA 510(k) clearance letter. The device, an "Echo Master-OAE," is an otoacoustic emission device, which is typically a diagnostic tool rather than an AI-assisted diagnostic aid that would involve human readers interpreting results in the same way a radiologist interprets images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the FDA 510(k) clearance letter.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not present in the FDA 510(k) clearance letter.
8. The sample size for the training set
This information is not present in the FDA 510(k) clearance letter.
9. How the ground truth for the training set was established
This information is not present in the FDA 510(k) clearance letter.
Additional Information from the Document:
- Device Name: Hortmann EchoMaster-OAE
- Regulatory Class: II
- CFR: 874.1050
- Product Code: 77EWO
- Indications For Use: The EchoMaster-OAE is a device used by otolaryngologists, audiologists, and nurses for screening hearing in infants and adults to record otoacoustic emissions elicited from either transient or distortion product stimuli.
To obtain the requested detailed study information, one would need to access the full 510(k) submission (if publicly available or by contacting the manufacturer) or any published studies related to the device's performance. The FDA clearance letter primarily serves as confirmation of market authorization based on substantial equivalence.
§ 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.