(95 days)
The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and the automatic recording of ABR waveforms makes it EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it EF 15/2013 a 2 channon ADA and the manual programmability options well suited for waverom baood occorning and and and and specific threshold test to operating room applications and cochlear implant tests. operating foom applications and over over of the Auditory Brainstem Response The E. 1915 a bacil unk allowing of the ABR and earlier and later potentials. The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli. Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Doll of these byotone are of paist and other health professionals concerned with measuring auditory functions.
Not Found
I'm sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for the Interacoustics Eclipse system.
The document is a 510(k) premarket notification letter from the FDA to Interacoustics AS, indicating that the device is substantially equivalent to legally marketed predicate devices. It lists the trade/device name, regulation numbers, and indications for use.
Specifically, it lacks the following information that would be needed to answer your questions:
- A table of acceptance criteria and reported device performance: The document confirms the FDA found the device "substantially equivalent" but does not detail specific performance metrics or acceptance criteria used in a study.
- Sample sizes used for the test set and data provenance: No information on test sets, sample sizes, or data origin (country, retrospective/prospective).
- Number of experts and their qualifications for ground truth: No mention of experts or their roles in establishing ground truth.
- Adjudication method for the test set: Not discussed.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No indication that such a study was performed or any effect sizes.
- Standalone algorithm performance: The document describes the system's intended use in diagnosis and evaluation, implying human interaction, but doesn't detail standalone algorithm performance.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
The document primarily addresses the regulatory approval process (510(k) clearance) based on substantial equivalence to predicate devices, rather than a detailed clinical study report with specific performance metrics and study methodologies.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2005
Interacoustics AS c/o Daniel Eggan Interacoustics USA 7625 Golden Triangle Drive Eden Prairie, MN 55344
Re: K052562
Trade/Device Name: Eclipse (Cabinet name), TEOAE25, EP15, EP25 or the combination of Systems Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, GWJ Dated: November 29, 2005 Received: November 30, 2005
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 for association 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 r your device 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
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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 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), please contact the Office of Compliance at (301) 827-8910. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting 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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Eclipse System 510k Notification
Image /page/2/Picture/1 description: The image shows a logo for "interacoustics". The logo features a globe-like design with lines representing longitude and latitude. The word "interacoustics" is written in a sans-serif font across the center of the globe. The logo is black and white.
Indications for Use
510(k) Number (if known):
Device Name: TEOAE25, EP15 or EP25, or the combination of systems
Indications For Use:
The Interacoustics EP systems, EP15 and EP25, are intended to assist in the r the interdoodotios and diagnosis of ear disorders on human beings. evaluation, documentation and the automatic recording of ABR waveforms makes it
EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it EF 15/2013 a 2 channon ADA and the manual programmability options well suited for waverom baood occorning and and and and specific threshold test to operating room applications and cochlear implant tests.
operating foom applications and over over of the Auditory Brainstem Response The E. 1915 a bacil unk allowing of the ABR and earlier and later potentials.
The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli.
Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Doll of these byotone are of paist and other health professionals concerned with measuring auditory functions.
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)
Use
Prescription Use (Per 21 CFR 801.109)
Larrilu
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
Author Eivind Christensen
Page 1 of
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.