(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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2000
Mr. Bradford Melancon HORTMANN AG P.O. Box 1119 Dripping Springs, TX 78620-1119
Re: K994033 Trade Name: Hortmann EchoMaster-OAE Regulatory Class: II CFR: 874.1050 Product Code: 77EWO Dated: November 26, 1999 Received: November 26, 1999
Dear Mr. Melancon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Bradford Melancon
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number (if known): K994033
Device Name: Echo Master- OAE
Indications For Use:
The Echo Wadu-OAE is a device used by
otolaryngologists, audiologists, and nurses for
sereening hearing in infants and adults
to record otoacoustic emissions elicited
from either transient or distortion product
stimuli.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
510(k) Number
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign Off)
Division of Ophthalmic Devices
§ 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.