(90 days)
EarCheck is an advanced medical instrument which accurately detects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The device is intended to assist parents in determining when to seek medical attention. The instrument is designed for use in the home by parents and other caregivers on children from 6 months to young adult.
EarCheck determines the condition of the middle ear by measuring the response of the ear drum to a sound stimulus. Using a built-in microphone, EarCheck registers the intensity of different frequencies of reflected sound waves to detect the absence or presence of fluid in the middle ear.
The instrument analyzes the mechanical resonance characteristic of the ear drum, indicating the condition of the ear by measuring the Spectral Gradient angle of the ear drum's resonance curve. In a normal ear, the ear drum has full freedom of motion, producing a shallow wide Spectral Gradient angle. When fluid is present, the motion of the ear drum is restricted and a narrower Spectral Gradient angle results. The determination of the absence or presence of middle ear fluid is displayed in one of five levels on the instrument.
The provided 510(k) summary for the EarCheck device offers limited details regarding specific acceptance criteria and the methodology of the proving study. However, based on the information provided, here is an attempt to structure the answer according to your request.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Diagnostic Accuracy: Ability to accurately detect Middle Ear Effusion (MEE) | "accurately detects the presence of middle ear fluid" and "appropriately provide information that indicates a subject's risk of having middle ear effusion (MEE)." |
| Substantial Equivalence: Performance comparable to predicate device | "substantially equivalent to the predicate device - the EarCheck Pro - in its performance." and "statistically significant diagnostic concordance between the EarCheck and the EarCheck Pro." |
| Consistency with Labeling: Performance aligns with stated indications for use | "the diagnostic performance of the EarCheck is consistent with its labeling." |
| Reproducibility: Consistent readings on the same ears | "EarCheck is able to generate reproducible readings on the same ears." |
| Safety: No actual or potential safety hazards | "EarCheck did not exhibit any actual or potential safety hazards in the testing of both ears, twice in over 500 patients." |
| Usability (Home Use): Consumers can take accurate readings, interpret them, and take appropriate action. | "consumers can take accurate readings, interpret the readings, and take appropriate action." and "the EarCheck can be appropriately used in the home to monitor middle ear health." |
| Performance in presence of earwax: Comparable to predicate and tympanometer | "the EarCheck performance is comparable to that of the EarCheck Pro and the tympanometer in the presence of earwax." |
| Human Factors: Design and instructions are appropriate | "the EarCheck's human factors design and instructions for use are appropriate." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Over 500 study subjects. The study tested both ears of each subject, twice.
- Data Provenance: Not specified in the provided text. It does not mention the country of origin or whether the study was retrospective or prospective.
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)
The document does not explicitly state how ground truth for the test set was established, nor does it mention the number or qualifications of experts involved in this process. However, given the nature of the device (detecting middle ear fluid), it is highly likely that diagnosis by an ENT specialist or pediatrician (possibly using otoscopy or tympanometry) would have served as the clinical reference standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for establishing ground truth or resolving discrepancies in readings.
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
The document mentions "Clinical studies demonstrated statistically significant diagnostic concordance between the EarCheck and the EarCheck Pro." This suggests a comparative study between the new device and a predicate. However, it does not describe an MRMC study involving human readers with and without AI assistance. The EarCheck is presented as a standalone diagnostic tool for parental use, not as an AI-assisted diagnostic aid for clinicians. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the study described for the EarCheck is a standalone performance study. The device itself analyzes the mechanical resonance characteristics and displays the determination of middle ear fluid absence or presence. The "Validation Study" assessed the device's ability to "appropriately provide information" and its "diagnostic performance," implying evaluation of the device's output itself. The indication for use specifically states it is "intended to assist parents in determining when to seek medical attention," implying the device's output is directly interpreted by the user without expert intervention as part of its primary function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for the "Validation Study." However, for detecting middle ear effusion, the typical clinical reference standard would be clinical diagnosis by a physician (e.g., otoscopy by an ENT or pediatrician) often supplemented by tympanometry. The statement "EarCheck was substantially equivalent to the predicate device - the EarCheck Pro - in its performance" suggests that the predicate device or its established diagnostic approach might have informed the de-facto ground truth.
8. The sample size for the training set
The document does not provide any information about a training set since this device predates the common paradigm of AI/ML development that explicitly uses training and test sets in the modern sense. The "Validation Study" described pertains to the evaluation of the device as a whole.
9. How the ground truth for the training set was established
As no training set is mentioned in the provided text, information on how its ground truth was established is also not available.
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510(k) Summary (as per 21CFR807.92)
August 13, 1997
Submitter and Contact Person:
AUG 1 8 1997
Sandra Kimball Vice President, Medical and Regulatory Affairs MDI Instruments, Inc. 200 Unicorn Park Drive Woburn, MA 01801 617-935-0150 617-935-8139 fax
Trade Name:
EarCheck
Common Name:
Acoustic Reflectometer
Classification Name:
Auditory Impedance Tester (as per 21CFR874.1090)
Predicate Devices:
MDI EarCheck Pro (K970685)
Description of Device:
EarCheck determines the condition of the middle ear by measuring the response of the ear drum to a sound stimulus. Using a built-in microphone, EarCheck registers the intensity of different frequencies of reflected sound waves to detect the absence or presence of fluid in the middle ear.
The instrument analyzes the mechanical resonance characteristic of the ear drum, indicating the condition of the ear by measuring the Spectral Gradient angle of the ear drum's resonance curve. In a normal ear, the ear drum has full freedom of motion, producing a shallow wide Spectral Gradient angle. When fluid is present, the motion of the ear drum is restricted and a narrower Spectral Gradient angle results. The determination of the absence or presence of middle ear fluid is displayed in one of five levels on the instrument.
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Indications for Use:
EarCheck is an advanced medical instrument which accurately detects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The device is intended to assist parents in determining when to seek medical attention. The instrument is designed for use in the home by parents and other caregivers on children from 6 months to young adult.
Summary of Clinical Performance Data:
The EarCheck was tested in both ears of over 500 study subjects in the Validation Study. In summary, the Validation Study demonstrated that the EarCheck can appropriately provide information that indicates a subject's risk of having middle ear effusion (MEE). The Validation Study also demonstrated that the EarCheck was substantially equivalent to the predicate device - the EarCheck Pro - in its performance.
Clinical studies demonstrated statistically significant diagnostic concordance between the EarCheck and the EarCheck Pro.
Furthermore, the Validation Study demonstrated that the diagnostic performance of the EarCheck is consistent with its labeling.
Clinical studies demonstrated that the EarCheck is able to generate reproducible readings on the same ears.
Finally, the Validation Study demonstrated that the EarCheck did not exhibit any actual or potential safety hazards in the testing of both ears, twice in over 500 patients.
Other studies demonstrated that: consumers can take accurate readings, interpret the readings, and take appropriate action; the EarCheck can be appropriately used in the home to monitor middle ear health; the EarCheck performance is comparable to that of the EarCheck Pro and the tympanometer in the presence of earwax; and the EarCheck's human factors design and instructions for use are appropriate.
Technical Specifications:
| Dimensions: | 7.0 in, H x 2.75 in, W x 2.5 in, D(169 mm x 87 mm x 87 mm) |
|---|---|
| Weight: | 6.2 oz (174 g) (With Batteries) |
| Measuring Range: | 1.8 kHz to 4.4 kHz |
| Sound Volume: | 80 dB SPL (+ 6 dB) |
| Sound Duration: | 0.2 second sweep |
| Display: | LCD Display |
| Display Hold Time: | 10 sec. |
| Power: | Two AA Alkaline Batteries |
| Battery Symbol: | Low Battery. |
| Battery Life: | Approximately 1000 readings in 4 months |
| High Noise Level: | Error Indicator. |
| Ambient Temperature | |
| Operating Range: | +50°F to +95°F (15°C to 35°C). |
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| • Relative HumidityOperating Range: | <75% |
|---|---|
| • Storage TemperatureRange: | -4°F to 122°F (-20°C to +50°C). |
| • Relative HumidityStorage Range: | <85% |
. . . . . . .
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized human figure with three profiles overlapping each other. The text "DEPARTMENT OF H & HS" is arranged in a circular fashion around the figure. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sandra Kimball Vice President, Medical and Regulatory Affairs MDI Instruments, Inc. 200 Unicorn Park Drive Woburn, MAir 01801 i
Re: K971859
AUG 1 8 1997
EarCheck Auditory Impedance Tester Dated: August 4, 1997 Received: August 7, 1997 Regulatory Class: II 21 CFR 874.1090/Procode: 77 ETY
Dear Ms. Kimball:
We have reviewed your Section 510(k) notification of intent to market the device referenced above 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 prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 531 through 542 of the Act for devices under 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.fda.gov/cdrh/dsmamain.html".
Sincerely vours
h.J. lian Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological 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):_K971859
Device Name:FarCheck
Indications For Use:
EarCheck is an advanced medical instrument which accurately detects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The device is intended to assist parents in determining when to seek medical The instrument is designed for use in the home by attention. parents and other caregivers on children from 6 months to young adult.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number
Prescription Use (Pe- 21 CFR 801.109) OR
Over-The-Counter Use_$\checkmark$
(Optional Format 1-2-96)
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.