(93 days)
EarCheck Pro 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 instrument is designed for use by doctors and other medical professionals on children from 6 months to young adult.
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Here's a breakdown of the acceptance criteria and study information for the EarCheck Pro 10.0, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for sensitivity, specificity, PPV, and NPV. Instead, it presents the "Summary of Clinical Performance Data" as factual results from the Validation Study, with the implication that these results met or exceeded the device's diagnostic performance specifications.
| Metric | Reported Device Performance (EarCheck Pro) |
|---|---|
| Sensitivity | 0.67 |
| Specificity | 0.87 |
| PPV (20%) | 0.57 |
| NPV (20%) | 0.91 |
The document also mentions that:
- "The Validation Study demonstrated that the EarCheck Pro was substantially equivalent to predicate devices - the Acoustic Reflectometer and Tympanometer in its ability to function as a diagnostic instrument."
- "Kappa statistic calculations also demonstrated statistically significant diagnostic concordance between the EarCheck Pro and Acoustic Reflectometer, and between the EarCheck Pro and the Tympanometer."
- "The Validation Study demonstrated that the EarCheck Pro meets or exceeds its diagnostic performance specifications (those specifications being levels of MEE risk associated with various ranges of EarCheck Pro angle readings)."
- "The EarCheck Pro is able to generate reproducible readings on the same ears, as demonstrated by Kappa statistic calculations that showed excellent reproducibility between serial readings."
- "The Validation Study demonstrated that the EarCheck Pro did not exhibit any actual or potential safety hazards in the testing of both ears, twice in over 500 patients."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: "over 500 study subjects" (tested in both ears, twice). So, over 1000 ear measurements/data points.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is implied to be prospective as it's a "Validation Study" involving "study subjects."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the given text. The document refers to "diagnostic information that indicates a subject's risk of having middle ear effusion (MEE)" and comparison to "predicate devices," suggesting a clinical diagnosis as the ground truth, but the specifics of who made that diagnosis and their qualifications are absent.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with vs. without AI assistance was not done. The study focuses on the standalone performance and equivalence of the device itself compared to predicate devices. The EarCheck Pro is described as an "instrument" for medical professionals, not explicitly an AI system designed to assist human readers in a comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Yes, a standalone study was done. The provided performance metrics (sensitivity, specificity, PPV, NPV) are for the "EarCheck Pro" itself, indicating its standalone diagnostic capability in identifying middle ear fluid.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The text implies that the ground truth for middle ear effusion (MEE) was established through clinical diagnosis, likely using established diagnostic methods. It refers to the device's ability to indicate MEE risk and compares this to "predicate devices" (Acoustic Reflectometer and Tympanometer), which are also diagnostic instruments for middle ear conditions. The explicit method for establishing this ground truth (e.g., specific clinical examination, direct visualization, or a gold standard procedure) is not detailed. It is highly likely based on an expert clinical assessment, potentially corroborated by the predicate devices.
8. The Sample Size for the Training Set
- The document describes a "Validation Study." It does not mention a separate training set or its sample size. This suggests that the listed performance metrics are from a validation/test set, and details about a development or training phase are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
- Since a training set is not mentioned, the method for establishing its ground truth is also not provided.
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<970685
MAY 28 1997 510(k) Summary of Safety and Effectiveness for EarCheck Pro 10.0
Indications for Use:
EarCheck Pro 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 instrument is designed for use by doctors and other medical professionals on children from 6 months to young adult.
Summary of Clinical Performance Data:
The EarCheck Pro was tested in both ears of over 500 study subjects in the Validation Study. In summary, the Validation Study demonstrated that the EarCheck Pro can appropriately provide diagnostic information that indicates a subject's risk of having middle ear effusion (MEE). Sensitivity, specificity, positive predictive value, and negative predictive value calculations demonstrated the EarCheck Pro's ability to appropriately indicate a subject's risk of MEE.
| Sensitivity | Specificity | PPV(20%) | NPV(20%) | |
|---|---|---|---|---|
| EarCheck Pro | 0.67 | 0.87 | 0.57 | 0.91 |
EarCheck Pro Sensitivity, Specificity, PPV, and NPV Table 10.1:
The Validation Study demonstrated that the EarCheck Pro was substantially equivalent to predicate devices - the Acoustic Reflectometer and Tympanometer in its ability to function as a diagnostic instrument.
Kappa statistic calculations also demonstrated statistically significant diagnostic concordance between the EarCheck Pro and Acoustic Reflectometer, and between the EarCheck Pro and the Tympanometer.
Furthermore, the Validation Study demonstrated that the EarCheck Pro meets or exceeds its diagnostic performance specifications (those specifications being levels of MEE risk associated with various ranges of EarCheck Pro angle readings).
The EarCheck Pro is able to generate reproducible readings on the same ears, as demonstrated by Kappa statistic calculations that showed excellent reproducibility between serial readings.
Finally, the Validation Study demonstrated that the EarCheck Pro did not exhibit any actual or potential safety hazards in the testing of both ears, twice in over 500 patients.
Technical Specifications:
- . 7.0 in, H x 2.75 in, W x 2.5 in, D (169 mm x 87 mm Dimensions:
- x 87 mm) Weight: 6.2 oz (174 g) (With Batteries) .
- Measuring Range: 1.8 kHz to 4.4 kHz
- 80 dB SPL (± 6 dB) Sound Volume:
- 0.2 second sweep Sound Duration:
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.
1-4-
- Display:
- Display Hold Time:
- Power:
Battery Symbol: . - .
- . .
- .
- Battery Life:
Alight Niki Tiemel:
Alight Niki Tiemelia Kure
Aligabi Ministralian Paris Ministration Suidential Aliani Marian Marian Marian Marian Siorage Storage Storage . - .
- . Range:
Relative Humidity
Storage Range:
LCD Display 10 sec. Two AA Alkaline Batteries Low Battery.
Approximately 3 months.
Error Indicator.
+50°F to +95°F (15°C to 35°C).
<75%
-4°F to 122°F (-20°C to +50°C).
<85%
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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Rockville MD 20850
Food and Orug Administration 9200 Corporate Boulevard
MAY 28 1997
Sandra Kimball Vice President of Medical and Regulatory Affairs MDI Instruments, Inc. 200 Unicorn Park Drive Woburn, MA 01801
Re: K970685 EarCheck Pro Dated: March 31, 1997 Received: April 3, 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 desemined 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 Amendances 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 registerion, I isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device in be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 through 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(x) premarket assification. 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 vite diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please ontact 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 yours,
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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i ol Page
5 10(k) Number (il known): K970685 .
Devicc Name:_ EarCheck Pro
Indications I-or Usc:
8.0 Statement of Indications for Use
8.1 Indications For Use
EarCheck Pro 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 instrument is designed for use by doctors and other medical professionals on children from 6 months to young adult.
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Concurrence of CORH, Office of Device Evaluation (ODE)
Prescription Lise X
(Pe 21 CFR 801.109!
OR
Over-The-Counter Vor...
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K970685
§ 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.