(40 days)
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held auditory test instrument designed to evoke or stimulate the generation of distortion product otoacoustic emissions (DPOAEs), utilizing pure-tone stimulus presentation, for the purpose of determining the presence of cochlear function in adults, children and infants.
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held device designed to provide an objective measure of outer hair cell function through the measurement of otoacoustic emissions (OAEs). The ERO.SCAN system has both receivers and microphone built into the screener. The DSP board is housed in a hand-held device.
The provided text describes a 510(k) premarket notification for the ERO•SCAN Otoacoustic Emissions Test Instrument, seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical trials that establish device performance against specific acceptance criteria.
Therefore, the document does not contain information about explicit acceptance criteria in the form of performance metrics (like sensitivity, specificity, accuracy) with corresponding acceptance thresholds, nor does it detail a study designed to prove the device meets such criteria through a traditional clinical validation process. Instead, it focuses on comparing the technological characteristics of the ERO•SCAN device to its predicate, the Etymotic Research Cub Dis Otoacoustic Emissions Test Instrument.
However, we can infer "accepted" performance characteristics by examining the "Performance Characteristics" listed for both the predicate and the ERO•SCAN device in the comparison table, as these are implicitly deemed acceptable for an Otoacoustic Emissions Test Instrument.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly the performance characteristics of the predicate device. The "reported device performance" is the ERO•SCAN's characteristics.
| Characteristic | Predicate Device (Cub 'Dis System) Performance (Implicit Acceptance Criteria) | ERO•SCAN Device Performance (Reported Device Performance) |
|---|---|---|
| Noise Floor | 0 dB SPL @ 1 kHz | 0 dB SPL @ 1 kHz |
| Frequency Range | 500 Hz – 8 kHz | 2 kHz – 5 kHz |
| Stimulus Intensity Range | 40 – 70 dB SPL | 45 – 65 dB SPL |
| Maximum Output | ≤ 90 dB SPL | ≤ 90 dB SPL |
Note: The differences in Frequency Range and Stimulus Intensity Range between the predicate and the ERO•SCAN describe variations in their technical specifications, which are deemed acceptable for the intended use through the substantial equivalence argument, rather than being "failures" to meet a criterion. The core functionality and safety aspects (like maximum output) are maintained or improved.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study with a test set of patient data. The substantial equivalence argument is based on a technical comparison of device specifications and principles of operation.
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 applicable. No clinical test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set is described.
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. This device is an Otoacoustic Emissions Test Instrument, a diagnostic tool, not an AI-assisted interpretation system for human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone instrument for measuring otoacoustic emissions. Its performance is inherent to its design and technical specifications, which are compared to the predicate. It's not an "algorithm only" in the sense of a software-based AI interpreting data externally. The "Software algorithms are essentially equivalent" to the predicate, implying that the underlying computational methods for processing signals are similar or the same as an already accepted device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device and submission, the "ground truth" for demonstrating safety and effectiveness implicitly relies on the established safety and effectiveness of the predicate device. The comparison focuses on technical and functional equivalence, ensuring the new device operates on the same principles and provides similar, safe, and effective measurements. There isn't a "ground truth" derived from patient outcomes or expert consensus specifically for validating the ERO•SCAN's diagnostic accuracy in the way a new imaging algorithm might be evaluated.
8. The sample size for the training set
Not applicable. This document describes a medical device seeking substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This document describes a medical device seeking substantial equivalence, not a machine learning model requiring a training set.
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Image /page/0/Picture/1 description: The image shows the logo for Etymotic Research. The logo consists of the letters 'E' and 'R' combined into a single graphic on the left, with the registered trademark symbol above and to the right of the graphic. To the right of the graphic is the text 'ETYMOTIC RESEARCH' in all capital letters.
61 Martin Lane Elk Grove Village, Illinois 60007 (847) 228-0006 (847) 228-6836 Fax
MAR 2 3 1998
February 9, 1998
ERO.SCAN Otoacoustic Emissions Test Instrument
SUMMARY OF SAFETY AND EFFECTIVENESS
| Classification Name: | Audiometer |
|---|---|
| Common/Usual Name: | Otoacoustic Emissions Test Instrument |
| Proprietary Name: | ERO•SCAN Otoacoustic Emissions Test Instrument |
| Establishment Registration: | 1450042 |
| Classification: | Panel 77, Procode EWO Classification 874.1050, Class II |
Steve Iseberg Contact Person:
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held device designed to provide an objective measure of outer hair cell function through the measurement of otoacoustic emissions (OAEs). This device is substantially equivalent to the marketed Etymotic Research Cub Dis Otoacoustic Emissions Test Instrument, 510(k) No. K930553, September 29, 1993.
Substantial equivalence of the ERO•SCAN instrument to Etymotic Research Cub5Dis predicate device referenced above is based on the following:
- The intended use of the ERO●SCAN device and the predicate test instrument is to . determine cochlear function by measuring distortion product otoacoustic emissions (DPOAEs) utilizing pure-tone stimulus presentation in adults, children and infants.
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ETYMOTIC RESEARCH
61 Martin Lane Elk Grove Village, Illinois 60007 (847) 228-0006 (847) 228-6836 Fax
- The ERO.SCAN device is manufactured and delivered completely assembled to . the health care professional using materials and techniques widely used by other manufacturers of devices as with the predicate device.
- The ERO.SCAN instrument is battery powered, whereas the predicate device . utilizes AC power to the DSP board and two 9-volt batteries for powering the preamplifier.
- . Patient safety is preserved in both the ERO.SCAN and predicate devices. There is no direct electrical connection to the patient when using the ERO.SCAN unit. The predicate Cub Dis system, if used as intended, provides isolation with the plastic eartips so that there is no path for electrical conductance to the patient.
- The Ear Probe System ERO®SCAN components are similar to those incorporated . in the predicate device, however the physical construction is not the same. The ERO.SCAN system has both receivers and microphone built into the screener. The probe assembly for the predicate Cub-Dis system connects to an external preamplifier that connects to a PC computer-installed DSP board.
- Regarding hardware configurations, the DSP board hardware is housed inside a . PC computer for the predicate device. whereas the ERO.SCAN DSP board is housed in a hand-held device.
- Software algorithms are essentially equivalent for both the ERO.SCAN and ● predicate devices.
- The parameters and principles of the signal processing are essentially the same in both systems with regard to stimulus duration, the use of signal averaging and Fourier transforms, and the fi/f2. fixed ratio of 1.2.
- . The maximum sound level output of the ERO.SCAN Otoacoustic Emissions Test Instrument remains below +90 dB SPL throughout the audible frequency range of 20-20 kHz, which is equal to or less than that of the predicate device.
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இ ETYMOTIC RESEARCH
61 Martin Lane Elk Grove Village, Illinois 60007 (847) 228-0006 (847) 228-6836 Fax
The following comparison is provided as a summary of the technological characteristics relative to the ERO•SCAN Otoacoustic Emission Test Instrument and the predicate Etymotic Research Cub Dis Otoacoustic Emissions Test Instrument upon which the determination of substantial equivalence is based.
| Characteristic | Cub 'Dis System | ERO•SCAN Device |
|---|---|---|
| Intended Use | Auditory test instrument designed toevoke or stimulate the generation ofotoacoustic emissions for the purpose ofdetermining the presence of cochlearfunction in adults, children and infants. | SAME |
| HardwareDesign | DSP board hardware is housed in a PCcomputer. The probe assembly isconnected to an external preamplifier thatattaches to connections on the board. | DSP board housed in a hand-helddevice. |
| Software andEffectiveness | Software verification and validation is inaccordance with FDA guidelines forcomputer controlled medical devices. QAprocedures are adhered to and test resultsdemonstrate that both systemspecifications and function requirementsare met to perform DPOAEmeasurements. | SAME |
| Energy Source | AC power to DSP board with 9-voltbattery power to preamplifier. | (4) 1.5v AA Batteries |
| Ear ProbeSystem | External probe system housing 2microphones and 2 speakers. | Microphone and receivers areintegrated in the hand-heldscreener. |
| PerformanceCharacteristics | Noise Floor: 0 dB SPL @ 1 kHzFrequency Range: 500 Hz – 8 kHzStimulus Intensity Range:40 – 70 dB SPLMaximum Output: ≤90 dB SPL | Noise Floor: 0 dB SPL @ 1 kHzFrequency Range: 2 kHz – 5 kHzStimulus Intensity Range:45 – 65 dB SPLMaximum Output: ≤90 dB SPL |
| Safety | The predicate Cub 'Dis system, if used asintended, provides electrical isolation withthe plastic eartips so that there is no pathfor electrical conductance to the patient.Max. output <90 dB SPL. | No electrical connection to thepatient. Max. output <90 dBSPL. |
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1998
Krista M. Buckles, M.A., CCC-A. RAC Consultant Etymotic Research 61 Martin Lane Elk Grove Village, Illinois 60007
Re:
K980533 ERO-SCAN Otoacoustic Emissions Test Instrument . Dated: February 9, 1998 Received: February 11, 1998 Regulatory class: II 21 CFR 874.1050/Procode: 77 EWO
Dear Mr. Buckles:
We have reviewed your Section 510/k) notification of intent to market the device 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 probleming against misbranding and adulteration.
If your device is classified (see above) into either class III (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 Feleral Regulations, Title 21, Parts 800 to 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.ida.gov/cdr/dsmaldsmam.html".
Sincerely yours,
Kiliani Yin
Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN): ERO.SCAN Otoacoustic Emissions Test Instrument DEVICE NAME:
INDICATIONS FOR USE:
The ERO.SCAN Otoacoustic Emissions Test Instrument is a hand-held auditory test instrument designed to evoke or stimulate the generation of distortion product otoacoustic emissions (DPOAEs), utilizing pure-tone stimulus presentation, for the purpose of determining the presence of cochlear function in adults, children and infants.
Otoacoustic emissions are low-level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing process. Available evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAEs is an indication that the outer hair cells are viable. Clinical evidence indicates that these emissions normally occur with normal hearing or, at most, mild hearing loss (usually 30-40 dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.
(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
Over - The - Counter - Use (Optional Format 1-2-96)
David W. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, E and Radiological 510(k) Number
§ 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.