(90 days)
The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.
The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation.
This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.
The patient group includes all ages and sexes.
Not Found
This document describes a 510(k) premarket notification for the DPOAE20, Eclipse audiometer system. The information provided is very limited in terms of what is typically included in a study proving device performance against acceptance criteria. There is no specific study described in the provided text that outlines acceptance criteria and corresponding device performance metrics.
However, based on the nature of a 510(k) submission, we can infer some general aspects and note the absence of detailed information for most of your requested points.
Here's an analysis based on the provided text, highlighting what is not available and what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Not Available: The document does not provide a table of acceptance criteria or reported device performance metrics. For an audiometer, typical performance criteria might include accuracy of stimulus presentation (frequency, intensity), sensitivity, specificity, and reliability of OAE detection.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available: No information regarding the sample size used for any test set or the provenance of data (country, retrospective/prospective) is provided.
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 Available: The document does not mention any expert review process or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: No adjudication method is mentioned.
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
- Not Applicable/Not Available: This device is an audiometer for DPOAE (Distortion Product Otoacoustic Emission) measurements. It is a diagnostic tool, not an AI-assisted interpretation device that would involve "human readers" in the context of improving interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Inferred (Standalone Functionality): The DPOAE20 system is described as a device that "records and processes" the OAE response and "then displayed on the computer screen for evaluation." This implies that the device itself performs the measurement and initial processing stand-alone to generate the OAE data. While human interpretation ("evaluation") is required, the core function of generating the OAE response is standalone. No specific "standalone performance study" details are provided, but the device's function is inherently standalone in its data acquisition and processing steps.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available/Implied Clinical Standard: For an audiometer like this, the "ground truth" for its performance would typically be established by comparing its measurements to established clinical standards for DPOAE acquisition and potentially against other validated audiometric tests or objective measures of hearing function. No specific ground truth method is detailed in this document.
8. The sample size for the training set
- Not Available: No information about a training set or its sample size is provided. This type of device (an audiometer) typically relies on engineering validation and calibration against known acoustic standards rather than machine learning training sets.
9. How the ground truth for the training set was established
- Not Available/Applicable: As there's no mention of a training set, there's no information on how its ground truth would be established.
Summary:
This 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, as opposed to providing a detailed clinical study report with acceptance criteria and performance data against those criteria. The provided text primarily establishes the device's identity, its indications for use, and the regulatory decision for market clearance. It does not contain the specific study details you've requested. For such information, one would typically need to review the full 510(k) submission or associated clinical validation reports if they were part of the submission.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2006
Interacoustics A/S, Assens c/o Mr. Daniel Eggan Interacoustics USA 7625 Golden Triangle Drive Eden Prairie, MN 55344
Re: K060539
Trade/Device Name: DPOAE20, Eclipse Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: February 6, 2006 Received: March 24, 2006
Dear Mr. Eggan:
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 – Mr. Daniel Eggan
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo tetel notification. The FDA finding of substantial equivalence of your device to a legally promation houring 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 in you a stato office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notifieation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gottorers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours;
M.B. Eckhaus, 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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DPOAE20 - Eclipse System 510k Notification
Revision A
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Indications for Use
510(k) Number (if known):
Device Name: DPOAE20 Indications For Use:
The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.
The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation.
This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.
The patient group includes all ages and sexes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K660539
Page 1 of
Author Ejvind Christensen
page 8/30
§ 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.