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The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.

The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use. The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise. The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.

The provided text is a 510(k) summary for the Otodynamics Otoport, an Otoacoustic emission analyzer. This document focuses on demonstrating substantial equivalence to a predicate device and lacks specific information regarding acceptance criteria and the detailed study results that would typically be presented in a clinical trial report.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and study methodologies are not available in the provided document.

Here's what can be extracted and what is missing:

Description of the Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a new study. Instead, it presents a comparison table showing the specifications of the new device (Otodynamics Otoport) against two predicate devices (Otodynamics ILO2088 Echocheck and Otodynamics ILO292 DP EchoportPlus). The implication is that the Otodynamics Otoport is acceptable because its specifications are comparable to or exceed those of the legally marketed predicate devices.

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)

• Not provided. The document is a 510(k) summary focused on substantial equivalence through device specifications, not a clinical study report. There is no mention of a "test set" in the context of clinical performance evaluation with a specific sample size.

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)

• Not provided. Since there's no described "test set" for performance evaluation, there's no mention of experts establishing ground truth.

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

• Not provided. Not applicable as there is no described test set or ground truth establishment process.

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

• Not applicable. This device is an Otoacoustic emission analyzer, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in interpretation in the typical sense for an MRMC study. It measures physiological responses.

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

• Not explicitly stated in these terms. The "study" presented here is a comparison of technical specifications to predicate devices to establish substantial equivalence. The device itself operates independently to generate OAE measurements. Its performance is demonstrated by meeting the functional specifications comparable to the predicate devices.

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

• Not provided. For this type of device (a measurement tool), "ground truth" would typically refer to the accuracy of its physical measurements against a known standard (e.g., sound pressure level, frequency response against calibrated equipment). The document implies that the device's measurement capabilities are accurate and comparable to the predicate.

8. The sample size for the training set

• Not applicable. This device is hardware-based with signal processing, not a machine learning/AI model that requires a "training set" in the conventional sense.

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

• Not applicable. As above, no training set is described.

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