(59 days)
The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies.
The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-to-noise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.
HearID Transient-Evoked Otoacoustic Emission Analyzer (HearID+TE, T2001, and T2K)
This document is a 510(k) premarket notification for the "HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer." It is a regulatory clearance letter and "Indications for Use" statement, not a study report detailing acceptance criteria and performance. Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided from the given text. This document does not contain acceptance criteria for device performance nor reported performance metrics. It primarily addresses the regulatory clearance of the device based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided from the given text. The document does not describe any specific test set, sample sizes, or data provenance from a study.
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)
- Cannot be provided from the given text. The document does not describe any test set or ground truth establishment process involving experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided from the given text. The document does not describe any test set or adjudication method.
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
- Cannot be provided from the given text. The device described (an otoacoustic emission analyzer) is a diagnostic tool, not an AI-assisted reading system for humans. The document does not describe any MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device itself is a standalone diagnostic tool. The "Indications for Use" states it "measures various acoustic properties of the inner ear" and is "to be used by trained personnel only." This implies it provides measurements and results directly, rather than assisting a human in interpreting other data. However, the document does not detail a specific "standalone performance study" in terms of methodology or results.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided from the given text. The document does not describe how ground truth was established for any performance evaluation. The device is intended to "characterize inner-ear status and to assist in diagnosing inner-ear pathologies" based on its measurements, implying its output is directly related to the condition being assessed, rather than being compared to an external ground truth in this document.
8. The sample size for the training set
- Cannot be provided from the given text. The document does not describe a training set or a machine learning/AI model.
9. How the ground truth for the training set was established
- Cannot be provided from the given text. As above, no training set or ground truth establishment is described.
Summary: The provided text is a regulatory clearance letter, specifically a 510(k) premarket notification decision. It affirms that the device is "substantially equivalent" to legally marketed predicate devices. It discusses the device's intended use and regulatory classifications but does not contain the detailed technical study data, acceptance criteria, or performance results typically found in a clinical study report or a more comprehensive technical submission.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, represented by three curved lines that suggest wings and a head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 4 2007
Mimosa Acoustics, Inc. c/o Patricia S. Jeng, Ph.D. 60 Hazelwood Drive, Suite #209 Champaign, IL 61820
K063338 Re:
Trade/Device Name: HearID Transient-Evoked Otoacoustic Emission Analyzer (HearID+TE, T2001, and T2K) Regulation Number: CFR 874.1050
Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: October 31, 2006 Received: November 8, 2006
Dear Dr. Jeng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Patricia S. Jeng. Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of vour 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M.B. Eichelman, M.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 1
Indications for Use
510(k) Number (if known):
Device Name: HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer
Indications for Use:
The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies.
The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-tonoise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.
The HearID system comes in two versions for use with different hardware platforms.
Prescription Use X_ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONPANUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ea. An, mo
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K063338 |
|---|---|
| --------------- | --------- |
(Per 21 CFR 801.109)
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§ 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.