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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.

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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

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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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.

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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