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The GN Otometrics Insert Earphones are accessories to the GN Otometrics Audiometers and Chartr EP Auditory Evoked Response systems. The GN Otometrics Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

The GN Otometrics Insert Earphones are transducers that convert electrical stimulus, provided by GN Otometrics Audiometers and GN Otometrics Auditory Evoked Response Stimulators, into acoustic stimulus, which is then coupled to the patient's ears. They are comprised of five sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Speaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.

The provided text describes a 510(k) submission for the GN Otometrics Insert Earphones, focusing on its substantial equivalence to a predicate device, the Etymotic Research ER-3 Insert Earphones. As such, the study described is a non-clinical performance and comparison study, rather than a clinical trial with human subjects using the AI device.

Here's an analysis of the provided information relative to your requested categories:

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

Note: The document states that "Substantial equivalence to the Etymotic Research ER-3 Insert Earphones (510(k) #K930003) was based on non-clinical performance testing of the acoustic and electrical parameters as specified in the ANSI/ASA S 3.6-2004, Specification for Audiometers." While the specific numerical performance results for the GN Otometrics device are not explicitly listed in this summary, the FDA's clearance implies that these criteria were met and demonstrated to be substantially equivalent to the predicate device, which itself met these criteria.

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

This was a non-clinical performance study. Therefore, the concept of "test set" and "data provenance" in the context of human data does not directly apply. The testing would have involved physical units of the GN Otometrics Insert Earphones being subjected to various acoustic and electrical measurements in a laboratory setting. No information on the specific number of units tested is provided in this summary.

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)

This being a non-clinical performance study, "ground truth" was established based on engineering specifications and adherence to the ANSI/ASA S 3.6-2004 standard. No human experts were involved in establishing "ground truth" in the way they would be for medical image interpretation or clinical outcomes. The "experts" would be the engineers and technicians conducting the performance tests and comparing the results against the standard and predicate device's characteristics.

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

Not applicable, as this was a non-clinical performance study and did not involve human interpretation or adjudication. The comparison was based on objective physical measurements and engineering specifications.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an accessory for auditory stimulus delivery, not an AI-powered diagnostic tool requiring human reader interpretation.

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

Yes, in a sense, a "standalone" non-clinical performance study was conducted. The performance of the GN Otometrics Insert Earphones was evaluated on its own merits against the specified acoustic and electrical parameters and in comparison to the predicate device's characteristics. There is no "algorithm" in the sense of AI; it's a physical device.

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

The "ground truth" for this non-clinical study was the adherence to established engineering specifications and the performance characteristics of the legally marketed predicate device (Etymotic Research ER-3 Insert Earphones, K930003) as defined by the ANSI/ASA S 3.6-2004 standard for audiological equipment.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

Not applicable. As above, this is a physical medical device, not an AI algorithm.

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