(29 days)
EarCheck Acoustic Reflectometer is an advanced medical instrument which accurately deflects 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 Acoustic Reflectometer is an advanced medical instrument.
This appears to be an FDA 510(k) clearance letter for the EarCheck Acoustic Reflectometer, and as such, it primarily focuses on establishing "substantial equivalence" to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test/training, number of experts, adjudication, MRMC study, standalone performance, and ground truth methodologies) cannot be extracted directly from this document. The document confirms the device's classification and its intended use, but not the specific clinical trial data that would demonstrate its performance against predefined criteria.
Here's what can be inferred or explicitly stated based on the provided text, with the understanding that the detailed study information is not present in this 510(k) summary:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided directly from this document. The 510(k) process focuses on substantial equivalence, implying that the device performs similarly to a legally marketed predicate device. This document does not contain a table with specific performance metrics (e.g., sensitivity, specificity) or predefined acceptance criteria for those metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided directly from this document. This information would typically be found in a clinical study report submitted as part of the 510(k), but it is not detailed in the clearance letter itself.
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)
- Cannot be provided directly from this document. This level of detail on ground truth establishment is not included in the FDA's clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided directly from this document. This information is typically part of a detailed clinical study protocol, which is not present here.
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
- Highly unlikely for this type of device and submission, and not mentioned. The EarCheck Acoustic Reflectometer is described as an "advanced medical instrument" to "accurately deflects the presence of middle ear fluid" for home use by parents. It's an assistive diagnostic tool, not an AI-powered image interpretation system that typically undergoes MRMC studies comparing human readers with and without AI assistance. The concept of "human readers improve with AI" doesn't directly apply here, as the device provides a direct measurement/indication, rather than interpreting complex medical images for human review.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is designed for standalone use by parents/caregivers. The "device performance" is its standalone performance in detecting middle ear fluid. The document states its purpose is to "assist parents in determining when to seek medical attention," implying that the device provides a direct output for interpretation by the user. However, specific performance metrics for this standalone use are not provided in this letter.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided directly from this document. For a device detecting middle ear fluid, ground truth would likely involve formal otoscopic examination by a clinician, potentially with tympanometry or other objective measures as part of a reference standard. However, the specific methodology is not detailed here.
8. The sample size for the training set
- Cannot be provided directly from this document. This information is part of the engineering and development validation, not typically in the clearance letter.
9. How the ground truth for the training set was established
- Cannot be provided directly from this document. Similar to the test set, the methodology for establishing ground truth during development and training would be in the device's design control documentation, not in this FDA summary.
Summary based on the provided text:
This document is an FDA 510(k) clearance letter for the EarCheck Acoustic Reflectometer. It confirms the device's substantial equivalence to a predicate device, allowing it to be marketed.
- Intended Use: Accurately detects the presence of middle ear fluid (otitis media with effusion) in children from 6 months to young adult. Intended for home use by parents and caregivers to assist in determining when to seek medical attention.
- Regulatory Classification: Class II, Product Code ETY.
- Regulatory Pathway: 510(k) premarket notification, indicating substantial equivalence to a legally marketed predicate device.
Key takeaway: The document confirms the legal marketing approval and intended use but does not provide the detailed study data, acceptance criteria, or performance results that would be found in a comprehensive clinical study report. Those details would have been part of the 510(k) submission reviewed by the FDA but are not publically available in this letter.
§ 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.