(77 days)
The Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.
The Audioscreener OAE+ABR is a Otoacoustic Emissions and Audiotory Brainstem Response testing device to be used in the evaluation of hearing function. This device is essentially the Audioscreener OAE+ABR unit with additional software required to perform a Transient Evoked OAE in addition to the Distortion Product OAE test.
The provided document is a 510(k) Premarket Notification summary for the AUDIOscreener OAE+ABR device. It primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to various safety and performance standards.
Based on the provided text, there is no specific acceptance criteria table or a study described that proves the device meets specific performance acceptance criteria in the manner an AI/ML clinical study would.
This 510(k) submission does not detail a clinical performance study with acceptance criteria, sample sizes, ground truth establishment, or expert adjudication that would be typical for evaluating the diagnostic accuracy of a new AI/ML device.
Here's an analysis based on the information provided, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not describe specific clinical performance acceptance criteria and reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for the AUDIOscreener OAE+ABR. The submission focuses on demonstrating substantial equivalence to a predicate device (K001058) and compliance with safety and electrical performance standards.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No distinct "test set" for evaluating clinical performance is described. The submission focuses on substantial equivalence to a predicate device and compliance with physical and electrical standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical "ground truth" establishment by experts is described for a performance study.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned as there is no described clinical performance test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC comparative effectiveness study is not mentioned. This type of study is more relevant for diagnostic imaging or interpretation devices where human readers' performance with and without AI assistance is evaluated.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the device described. The AUDIOscreener OAE+ABR is an instrument that performs objective physiological tests (OAE and ABR) to screen for hearing loss. It is not an AI algorithm making diagnostic interpretations independently. Its "performance" would relate to its ability to accurately measure OAEs and ABRs and to appropriately classify results (pass/refer) based on predefined physiological thresholds, which are typically established through scientific literature and clinical practice, not through a standalone algorithm study in this context.
7. The Type of Ground Truth Used
Not applicable in the context of a diagnostic accuracy study. The "ground truth" for OAE and ABR tests is typically defined by the physiological presence or absence of a response within certain parameters, often correlated with behavioral audiometry. However, the 510(k) does not describe a study to establish this.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Document's Approach to Acceptance Criteria and Study:
The 510(k) summary for the AUDIOscreener OAE+ABR primarily relies on:
- Predicate Device Equivalence: Stating that the device is "similar in its intended use to predicate devices and existing methodologies" (specifically mentioning K001058).
- Compliance with Standards: Listing adherence to various international (UL, CSA, IEC) and national (ANSI, FDA guidance) safety and performance standards for medical electrical equipment, audiometers, and evoked response equipment. These standards themselves contain specifications that could be considered "acceptance criteria" for the physical and electrical performance of the device, rather than its clinical diagnostic accuracy in a study setting.
The absence of a detailed clinical performance study with acceptance criteria, sample sizes, and ground truth establishment indicates that the review focused on the device's technical specifications, safety, and functional equivalence to already marketed devices, rather than a de novo clinical validation of its diagnostic accuracy as one might see for novel AI/ML diagnostics.
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KO 24205
Premarket Notification [510(k)] Summary MAR 0 7 2003
SUBMITTED BY: Everest Biomedical Instruments Co. 16690 Swingley Ridge Rd. Suite 140 Chesterfield. MO 63017 V: 636-519-7770 F: 636-519-7991
CONTACT PERSON: Randall J. Krohn
DATE OF PREPARATION December 19, 2002
TRADE NAME: AUDIOscreener OAE+ABR
COMMON NAME: Otoacoustic Emissions Test Instrument / Evoked Response Auditory Stimulator
CLASSIFICATION NAME: Audiometer (per 21 CFR section 874.1050) Panel 77 Product Code EWO
Evoked Response Auditory Stimulator (per 21 CFR section 882.1900) Panel 84 Product Code GWJ
PREDICATE DEVICES: Kedly Audioscreener OAE+ABR (K001058)
DEVICE DESCRIPTION:
The Audioscreener OAE+ABR is a Otoacoustic Emissions and Audiotory Brainstem Response testing device to be used in the evaluation of hearing function. This device is essentially the Audioscreener OAE+ABR unit with additional software required to perform a Transient Evoked OAE in addition to the Distortion Product OAE test.
INTENDED USE:
The Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.
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TECHNOLOGICAL CHARACTERISTICS:
The Audioscreener OAE+ABR is similar in its intended use to predicate devices and existing methodologies. In addition, the device complies with the following safety and performance standards as applicable to its classification:
UL 2601-1 Medical Electrical Equipment Part 1: General Requirements for Safety 18 ed. 1997-10
CSA 22.2 No. 601.1 Medical Electrical Equipment Part 1: General Requirements for Safety-M90
IEC60601-1-2 Medical Electrical Equipment Part 1: General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests 1st ed. 1993-04
ANSI S3.6 Specification for Audiometers (sections 4-10 as applicable) 1996
IEC 60601-2-40 Particular Requirements for the Safety of Electromyographs and Evoked Response Equipment (1998-02)
FDA Electroencephalograph Devices Guidance for 510(k) Content Draft Document Version 1.0 November 3, 1997
IEC 645-3 Audiometers Part 3: Auditory Test Signals of Short Duration for Audiometric and Neuro-Otological Purposes (1994-10)
IEC 60601-2-26 Particular Requirements for the Safety of Electroencephalographs (1994-04)
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head facing right, composed of three curved lines that suggest depth and dimension. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
MAR 0 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Everest Biomedical Instruments Co. c/o Randall J. Krohn VP Engineering - Neuro Products 16690 Swingley Ridge Rd Suite 140 Chesterfield, MO 63017
Re: K024205
Trade/Device Name: AUDIOscreener OAE+ABR Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: December 19, 2002 Received: December 20, 2002
Dear Mr. Krohn:
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 - Randall J. Krohn
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) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
A. halyi Rosenthal
A. Ralph Rosenthal, 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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Page 1 of 1
510(k) Number (if known):
Audioscreener OAE+ABR Device Name:
Indications for Use:
The Audioscreener OAE+ABR may be used for patients of all ages, from newborn infants through adults. The Distortion Product Otoacoustic Emissions, Transient Evoked Otoacoustic Emissions, and Auditory Brainstem Response tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Veena Abrol
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K024305
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 3-10-98)
§ 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.