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The intended use of the OtoStat DPOAE Measurement is to determine the presence of cochlear function.

The intended use of the OtoStat MEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies.

The intended use of the OtoStat DPOAE+MEPA is to determine the presence of cochlear and middle ear functions and to assist in differential diagnosis between cochlear and middle ear dysfunctions.

The OtoStat MEPA system measures various acoustic properties of the ear, namely power reflectance, power absorbance, transmittance, wideband immittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear.

The OtoStat is a small portable handheld audiometric measurement device for measuring either DPOAE (distortion product otoacoustic emission), MEPA (middle ear power analysis), or both, where DPOAE is for evaluating cochlear function and MEPA for middle and outer ear status. Both MEPA and DPOAE measurements present acoustic stimulus into the ear canal via the loudspeakers in the acoustic ear probe, then record the complex pressure frequency responses via the microphone in the same acoustic ear probe. The responses are then analyzed and displayed against relevant normative data with recommended pass/refer indication for the trained user to determine the cochlear and middle ear status and for differential diagnosis.

Here's a breakdown of the acceptance criteria and study information for the Mimosa Acoustics OtoStat DPOAE+MEPA, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided 510(k) summary does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective). The evaluations were primarily nonclinical performance evaluations and benchmarking against predicate devices.

3. Number of Experts and Qualifications

The document does not mention the use of experts to establish ground truth for any test set. The evaluation relied on direct comparison against predicate devices and compliance with technical standards.

4. Adjudication Method

No adjudication method is described, as the evaluation was not based on expert review of diagnostic classifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission focuses on direct technical equivalence to predicate devices and adherence to safety standards, not on improvement in human reader performance with AI assistance. This device is an audiometric measurement device, not an AI-powered diagnostic tool requiring human interpretation.

6. Standalone Performance Study

The evaluation described is essentially a standalone performance assessment in the context of comparing its functionality against predicate devices and demonstrating compliance with safety standards. However, it's not a "standalone performance study" in the sense of evaluating a novel AI algorithm's diagnostic accuracy. The study aims to show that the OtoStat's measurements are consistent with and comparable to the predicate devices.

7. Type of Ground Truth Used

The "ground truth" for this submission appears to be the performance and specifications of the predicate devices and adherence to recognized consensus standards (like IEC 60601-1 for safety). The nonclinical performance evaluations were conducted by "comparing their functionality against CUB®DIS-DIS-DPOAE and HearID MEPA Measurement Systems."

8. Sample Size for the Training Set

No information is provided regarding a "training set" as this device does not appear to utilize machine learning or AI in a way that requires a separate training phase. The device measures acoustic responses and analyzes them based on established physiological principles and normative data.

9. How Ground Truth for the Training Set Was Established

As no training set is indicated, no ground truth establishment for a training set is described.

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The intended use of the HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer is to characterize inner-ear status and to assist in diagnosing inner-ear pathologies.

The HearID+TE system measures various acoustic properties of the inner ear, namely otoacoustic emission sound pressure level, signal-to-noise ratio, and reproducibility. These three properties may be measured within prescribed frequency bands or wideband. These measures allow for the evaluation of the functional condition of the inner ear, assuming a normal middle and outer ear. The HearID+TE system is suitable for all populations, including newborn infants. The HearID+TE system is to be used by trained personnel only.

HearID Transient-Evoked Otoacoustic Emission Analyzer (HearID+TE, T2001, and T2K)

This document is a 510(k) premarket notification for the "HearID+TE Transient-Evoked Otoacoustic Emissions Analyzer." It is a regulatory clearance letter and "Indications for Use" statement, not a study report detailing acceptance criteria and performance. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated from the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided from the given text. This document does not contain acceptance criteria for device performance nor reported performance metrics. It primarily addresses the regulatory clearance of the device based on substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided from the given text. The document does not describe any specific test set, sample sizes, or data provenance from a study.

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 from the given text. The document does not describe any test set or ground truth establishment process involving experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided from the given text. The document does not describe any test set or adjudication method.

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

• Cannot be provided from the given text. The device described (an otoacoustic emission analyzer) is a diagnostic tool, not an AI-assisted reading system for humans. The document does not describe any MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• The device itself is a standalone diagnostic tool. The "Indications for Use" states it "measures various acoustic properties of the inner ear" and is "to be used by trained personnel only." This implies it provides measurements and results directly, rather than assisting a human in interpreting other data. However, the document does not detail a specific "standalone performance study" in terms of methodology or results.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Cannot be provided from the given text. The document does not describe how ground truth was established for any performance evaluation. The device is intended to "characterize inner-ear status and to assist in diagnosing inner-ear pathologies" based on its measurements, implying its output is directly related to the condition being assessed, rather than being compared to an external ground truth in this document.

8. The sample size for the training set

• Cannot be provided from the given text. The document does not describe a training set or a machine learning/AI model.

9. How the ground truth for the training set was established

• Cannot be provided from the given text. As above, no training set or ground truth establishment is described.

Summary: The provided text is a regulatory clearance letter, specifically a 510(k) premarket notification decision. It affirms that the device is "substantially equivalent" to legally marketed predicate devices. It discusses the device's intended use and regulatory classifications but does not contain the detailed technical study data, acceptance criteria, or performance results typically found in a clinical study report or a more comprehensive technical submission.

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The intended use of the HearID-wbMEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies. The HearID-wbMEPA system measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The devices are suitable for all populations including new-born infants. The devices are to be used by trained personnel only.

The HearID system comes in two versions: HearID_b-wbMEPA, and HearID_e-wbMEPA, where the difference is the variation of the hardware platform.

The provided text is a 510(k) premarket notification approval letter for the HearID Wideband Middle Ear Power Analyzer. It confirms that the device is substantially equivalent to a legally marketed predicate device.

*However, this document does not contain any information regarding specific acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or details about comparative effectiveness studies.

The letter focuses on regulatory approval based on substantial equivalence, rather than detailing the results of performance studies against predefined acceptance criteria. To provide the requested information, a different document, such as the actual 510(k) submission or a clinical study report, would be necessary.

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The intended use of The CUB®DIS II™ DPOAE Measurement System is to determine the presence of cochlear function.

The CUBEDIS II TM DPOAE Measurement system is designed to provide acoustic stimuli for, and rapid clinical measurement and evaluation of, odd order distortion product tones generated by the cochlea and measured in the ear canal, at the audiometric frequencies (or other frequencies, as desired), between 500 through 8,000 Hz with no known artifacts, a low noise floor system, and a high signal-to-noise ratio.

Here's a summary of the provided text regarding the CUBEDIS II™ DPOAE Measurement System, structured according to your requested categories.

Based on the provided K981460 510(k) Summary, the regulatory submission focuses on demonstrating substantial equivalence to a predicate device (Etymotic Research CUBEDIS™ Otoacoustic Emission). The information provided does not include a formal acceptance criteria table, nor a detailed study that proves the device meets specific performance criteria in a clinical sense. Instead, the document highlights technical comparisons and regulatory compliance.

Here's an attempt to interpret and present the available information in the requested format, with significant limitations due to the nature of the provided document:

Acceptance Criteria and Device Performance (Interpreted from Technical Comparison)

The document doesn't explicitly state "acceptance criteria" but rather provides a technical comparison between the CUBEDIS II™ and its predicate device, the Ariel_DSP16+. The implicit acceptance criterion is that the performance of the CUBEDIS II™ should be comparable or better than the predicate device across critical technical specifications.

Note on Interpretation: The discrepancies in "Instantaneous Dynamic Range - Line Inputs" and "Full Scale Input/Output Voltage" between the devices would typically warrant further explanation in a comprehensive submission. However, in the context of a 510(k) for substantial equivalence, the overall functionality and safety are key. The improved "Total Harmonic Distortion" and "Total Dynamic Range" in other areas might offset these differences for the intended use.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The provided document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The comparison appears to be purely based on technical specifications and characteristics of the hardware. This is typical for a 510(k) for a device like this, where the focus is on a technical comparison to a predicate, rather than new clinical effectiveness studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention any experts or a ground truth establishment process related to a clinical test set. The ground truth for the device's technical specifications would be engineering measurements.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • No adjudication method is mentioned as there's no clinical test set described.

4. 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:

   • No MRMC or comparative effectiveness study involving human readers/AI assistance is mentioned. This device is an Otoacoustic Emissions Test Instrument, which directly measures physiological responses, not an AI-assisted diagnostic tool requiring human interpretation improvement studies.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is an instrument to measure physical phenomena, not an "algorithm" in the AI sense. Its primary function is to provide acoustic stimuli and measure responses.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the technical comparison, the "ground truth" implicitly refers to the established technical specifications and performance characteristics of both the predicate device and the new device, measured through standard engineering tests. There's no clinical ground truth (like pathology or outcomes data) mentioned in this submission summary. The intended use "to determine the presence of cochlear function" implies that the device's output is the diagnostic information, which then a clinician interprets.

7. The sample size for the training set:

   • N/A. This document describes a medical device for physiological measurement, not a machine learning model. Therefore, there is no "training set."

8. How the ground truth for the training set was established:

   • N/A, as there is no training set.

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