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Primus Hearing Instrument Test Unit (PHITU):
The Primus Hearing Instrument Test Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
The Primus Hearing Instrument Test Unit is intended to give an objective indication of the characteristics of a Hearing Aid, by visualizing a signal recorded in the test coupler with reference information such as target curves in order to make adjustments of the Hearing Instrument settings.

• The Primus Hearing Instrument Test Unit is indicated for technical quality inspection of hearing instruments with no clients involved.

Primus Fitting Unit (PFU):
The Primus Fitting Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.

• The Primus Fitting Unit is intended for hearing test.
• The Primus Fitting Unit with stated accessories is indicated for non-continuous, noninvasive air and optionally bone conduction and speech audiometric testing in quiet office and sound treated environments.
• The Primus Fitting Unit is indicated for non-continuous real-ear measurements at the ear drum by means of noninvasive external ear canal insertion of a probe tube in quiet office environments.
• Finally the system can be used to present hearing instrument related sound examples through headsets or loudspeakers.
• The Primus Fitting Unit is indicated for use with both pediatric and adult age groups.
• The Primus Fitting Unit is not indicated as a sole means of diagnostics.

The Primus Fitting System is a PC operated system that contains Primus Hearing Instrument Test unit (PHITU) for Hearing Instrument testing (HIT), Primus Fitting Unit (PFU) for Audiometry (AUD) and Real Ear measurement (REM). The Primus Fitting System is operated from a dedicated software application installed on a standard Windows operating system. The Primus Fitting system can either be sold individually (PHITU or PFU) or together (PHITU and PFU).
The Primus software solution operates within the NOAH framework, as well as stand-alone. On-top diagrams and control panels make it easy to use simultaneously with the proprietary hearing instrument fitting systems of your choice. The stand-alone client data files hold all historical session information, and makes fittings away from the office very easy.

Audiometry (AUD):
Primus AUD is a PC based audiometry module providing a wide range of possibilities within pure tone audiometry, bone conduction audiometry and speech audiometry including inserts probe and industry standard headsets with an option of high frequency testing.

Real Ear Measurements (REM):
Primus REM offers classic Real Ear Measurements as well as comprehensive Speech Mapping measurements, where all measurements include high frequency testing. The measurements are supported by a large sound library including technical sounds, daily life sounds, speech signals and dialogue. The Primus REM module contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear.
The classic Real Ear Measurements, which can be performed by Primus REM, include: Unaided, Occluded and Aided Response as well as Insertion Gain. Toggling between SPL and Gain shows the response measurements in gain view.
The PFU hardware is powered by a USB connection from the PC and a medical grade power supply (for extended sound pressure) and can be placed at the most convenient working place.

Hearing Instrument Testing (HIT):
Primus HIT offers full featured technical measurements for testing and troubleshooting hearing instruments. The test can be run as an automatic test sequence in accordance with European and American standards. The Primus HIT unit module contains of 2 microphones (one for measuring and one for reference) and various couplers for hearing aid testing.
The PHITU hardware is powered by a USB connection from the PC and can be placed at the most convenient working place.

The submission describes the Auditdata Primus Fitting System, which consists of the Primus Hearing Instrument Test Unit (PHITU) and the Primus Fitting Unit (PFU). The device is intended for professionals to perform hearing instrument testing, audiometry, and real ear measurements.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance metrics. Instead, it relies on demonstrating compliance with recognized industry standards. The reported "performance" is implicitly achieving compliance with these standards.

2. Sample Size Used for the Test Set and Data Provenance:

The submission explicitly states that "non-clinical performance testing" was conducted. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily device-centric, focusing on the functionality and measurement accuracy of the Primus Fitting System itself against established technical standards, rather than patient- or human-subject data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the involvement of experts to establish a "ground truth" for a test set in the context of diagnostic accuracy or clinical decision-making. The testing described focuses on the technical performance of the device against industry standards, where the "ground truth" is typically defined by the precise measurement requirements and specifications within those standards.

4. Adjudication Method for the Test Set:

Given that there is no mention of a human-interpreted test set or diagnostic accuracy evaluation, there is no information provided on an adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The device is a measurement and testing system, not an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The studies described are standalone performance evaluations of the device itself (PHITU and PFU). The tests assess the accuracy and compliance of the device's measurements and functionalities according to established technical standards (e.g., ANSI, IEC). The device operates as an instrument, and its performance is evaluated based on its ability to accurately perform those instrumental functions.

7. Type of Ground Truth Used:

The ground truth used for the testing is primarily the specifications and requirements defined within the referenced industry standards (e.g., ANSI S3.6, ANSI S3.22, ANSI S3.46, IEC 60118-7, EN 61669). The "ground truth" for this type of device, which measures acoustic properties and performs audiometry, is the accurate and precise adherence to these technical benchmarks. It does not involve expert consensus on medical conditions, pathology results, or clinical outcomes data in the typical sense of a diagnostic AI device.

8. Sample Size for the Training Set:

The submission does not mention a "training set" as the device is not described as utilizing machine learning or artificial intelligence in a way that would require a distinct training phase. Its operation is based on conventional electronic circuit design, digital signal processing, and software logic.

9. How the Ground Truth for the Training Set was Established:

Since there is no mention of a training set, there is no information on how ground truth for a training set was established.

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