(93 days)
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No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-driven devices (e.g., training/test sets for model development, AUC for classification models). The performance metrics and study descriptions are consistent with traditional medical device validation.
No
The device is described as an "advanced medical instrument which accurately detects the presence of middle ear fluid," indicating its primary function is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the device "accurately detects the presence of middle ear fluid", which is a diagnostic function. Furthermore, the "Summary of Performance Studies" explicitly mentions that the device "can appropriately provide diagnostic information" and "function as a diagnostic instrument."
No
The description refers to the device as an "advanced medical instrument" and mentions "angle readings," which strongly suggests a physical hardware component is involved in taking measurements, not just software processing.
Based on the provided information, the EarCheck Pro is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The EarCheck Pro is described as an "advanced medical instrument" that "accurately detects the presence of middle ear fluid". This suggests it interacts directly with the patient's ear to gather information, rather than analyzing a biological sample (like blood, urine, or tissue) that has been removed from the body.
- The description focuses on direct measurement. The device appears to be measuring something within the ear itself (likely acoustic properties related to the presence of fluid), not performing a test on a sample.
- The intended use is direct patient assessment. The device is designed for use by medical professionals "on children" to detect middle ear fluid. This is a direct diagnostic assessment of the patient.
Therefore, the EarCheck Pro falls under the category of a medical device used for diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
77 ETY
Device Description
EarCheck Pro is an advanced medical instrument with the following 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 Life: Approximately 3 months.
- Error Indicator.
- Operating Range: +50°F to +95°F (15°C to 35°C), 500 study subjects
Key results: 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. 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.
Key Metrics
| Sensitivity | Specificity | PPV (20%) | NPV (20%) | |
|---|---|---|---|---|
| EarCheck Pro | 0.67 | 0.87 | 0.57 | 0.91 |
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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