(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.
§ 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.