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510(k) Data Aggregation
(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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