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The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.

AURICAL HIT is designed for Hearing Instrument Testing and Coupler-Based Fitting. AURICAL HIT connects via USB to a computer running the OTOsuite software. With the OTOsuite HIT Module one can perform traditional hearing instrument testing according to either the ANSI or IEC test protocols, and obtain a consistent picture of every hearing instrument, regardless of manufacturer or type. With the OTOsuite PMM Module one can perform Probe Microphone Measurements in a coupler for pre-programming and pre-fitting hearing instruments without the client being present. It is easy to position hearing instruments on snap-on couplers inside the AURICAL HIT test chamber and it is easy to access the hearing instruments in the test chamber during test without disturbing the test setup. The battery pill types are recognized automatically, and the reference microphone ensures reliable positioning in the test chamber.

The document provided describes the Aurical HIT Type 1082, a hearing aid calibrator. The evaluation involved non-clinical performance testing against established standards, rather than studies involving human participants or complex AI algorithms. Therefore, many of the requested categories are not applicable.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "non-clinical performance testing of the device against the applicable parameters specified in the following standards: ANSI S3.22: 2003, and IEC 60118-7:2005." This indicates bench testing of the device's physical and functional characteristics.

• Test set sample size: Not applicable in the context of human data. The "sample" here refers to the device itself and its components undergoing tests according to industry standards.
• Data provenance: Not applicable. The data is generated from performance testing of the manufactured device in a controlled lab environment according to specified international standards. It is not from a clinical population or geographical region.

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

Not applicable. The "ground truth" for this device is defined by the objective performance parameters outlined in the referenced ANSI and IEC standards for hearing aid calibrators. There is no mention of expert consensus being used to establish these fundamental technical standards.

4. Adjudication Method for the Test Set:

Not applicable. As the testing involves objective measurement against established technical standards, adjudication by experts is not described or required.

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. The device is a hearing aid calibrator, a piece of diagnostic equipment, not an AI system designed to assist human "readers" (e.g., radiologists, pathologists). Therefore, MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a hardware device with accompanying software for instrument control and data acquisition, not a standalone algorithm or AI. The performance tested is the device's ability to precisely measure and present acoustic/magnetic stimuli as per the established technical standards.

7. The Type of Ground Truth Used:

The ground truth used is based on technical specifications and performance requirements defined by international standards:

• ANSI S3.22: 2003 (American National Standard for Hearing Aid Characteristics)
• IEC 60118-7: 2005 (International Electrotechnical Commission standard for Hearing Aids - Part 7: Measurement of the performance characteristics of hearing aids for quality inspection purposes)
• IEC 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use)
• IEC 61326-1 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements)

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning system that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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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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Type 1053 FreeFit is intended for audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals. The intended use is that the user is able to visualize the amplified signal recorded in the ear(s) of persons with a hearing loss together with reference information such as target curves in order for the user to have an objective basis for adjusting the Hearing Instrument settings.

The GN Otometrics Type 1053 FreeFit is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from selfcontained software modules installed on a common software platform. The following applications are available: Real ear measurement system (i.e., audio fitting system) and Simulator system.

As a real ear measurement system, the Type 1053 FreeFit plays calibrated sound files and measures the sound pressure level in the ear canal. The difference between the measured sound level outside the ear and in the ear canal gives the gain from the hearing aid. This allows for adjusting hearing aids and demonstrating hearing aid features like noise suppression. The Type 1053 FreeFit system also shows target curves that the hearing aid dispenser can use as guidelines for adjusting the hearing aid.

The real ear measurement system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC (i.e., OTOsuite Probe Microphone Measurements (PMM)) and hardware for connection to a PC. The neckset is connected to the PC via a Bluetooth radio link (i.e. no physical connection to the PC).

The FreeFit Neckset is the actual measuring device. It contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear. Digital signal processing in form of Fast Fourier Transformations takes place inside the device and the obtained frequency spectra are transmitted to the OTOsuite via Bluetooth. The microphones measuring outside the ear are used for calibrating the sound level. Measurements inside the ear canal (near the eardrum) are conducted with a biocompatible silicone tube guiding the sound waves to the microphone. And the probes contain an o-ring also in biocompatible material for fastening at the ear (pinna).

The FreeFit Charger is used to charge the FreeFit neckset via an inductive coil system. The charger includes a power adaptor connected to mains and providing DC input to the charger stand.

OTOsuite PMM is a software platform required for measuring with the Type 1053 FreeFit, displaying the results and controlling the played sound files and levels. OTOsuite runs on most windows based PCs.

The Type 1053 FreeFit also has the capability to act as a hearing loss simulator and a hearing instrument simulator. These applications are commonly used to demonstrate the level of hearing loss suffered by a patient and the degree to which that loss can be overcome by use of a hearing instrument.

The simulator consists of software for installation on a PC (i.e., OTOsuite Counseling and Simulation (C&S)) and hardware for connection to a PC (i.e., headphones).

OTOsuite C&S is a software application that is required for simulating hearing loss and hearing instruments as part of the counseling process.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define specific numerical acceptance criteria for the Type 1053 FreeFit device in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device (SpeechLink 100 Type 1053) and compliance with various established international and national standards.

Therefore, the table will reflect the general nature of the "acceptance" as described in the document, which primarily focuses on demonstrating equivalence and compliance rather than specific performance thresholds.

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

The document does not specify a sample size for any "test set" in the context of patient data or clinical trials. The testing described is primarily non-clinical, involving comparisons against a predicate device and compliance with technical standards.

• Sample Size for Test Set: Not applicable / Not specified for patient or clinical data. The "test set" here refers to the device itself being tested in a laboratory setting for compliance with standards.
• Data Provenance: Not applicable for patient or clinical data. The data provenance relates to engineering and testing against technical standards.

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

This information is not applicable as the document describes non-clinical performance data and compliance with technical standards for a sound measurement system, not a diagnostic or AI-driven system that would require expert-established ground truth from patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable for the reasons stated above. There's no mention of human adjudication in the context of device performance testing against technical standards.

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, and therefore, there is no information on the effect size of human readers improving with or without AI assistance. The device described is a Real Ear Measurement System, which is a tool for audiologists to measure sound pressure levels, not an AI diagnostic or interpretive tool for "readers" to analyze cases.

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

The document describes the device as a "PC-based system that contains hardware and software." The "FreeFit Neckset is the actual measuring device," and "Digital signal processing... takes place inside the device." The "OTOsuite PMM is a software platform required for measuring... displaying the results and controlling the played sound files and levels."

This strongly suggests a standalone performance assessment was indeed central to verifying compliance with standards. The device's ability to accurately measure sound pressure levels and perform signal processing (Fast Fourier Transformations) and calculate gain curves without human intervention in the measurement process itself is the core of its function. The "improved calibration scheme" leading to "significantly greater measurement accuracy" is a direct measure of its standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance testing is defined by established technical standards and methods for acoustical measurement. Specifically:

• ANSI S3.46-1997: "Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids." This standard dictates how real-ear measurements should be performed and what constitutes accurate measurement.
• EN/IEC 61669: "Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids." Similar to ANSI S3.46, this standard provides a framework for accurate acoustical measurements.

The device's performance is gauged against the requirements and specifications outlined in these standards, which serve as the "ground truth" for its functional accuracy.

8. The Sample Size for the Training Set

Not Applicable. The Type 1053 FreeFit is a measurement device that performs digital signal processing based on established acoustical principles. It is not an AI/ML device that requires a "training set" in the conventional sense to learn patterns or make predictions. Its "learning" is based on its engineering design and adherence to scientific principles.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As established in point 8, there is no training set in the context of AI/ML. The "ground truth" for the device's design and operation is rooted in the principles of electroacoustics and signal processing, validated by compliance with relevant international and national standards.

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This device performs electro-acoustical, telecoil, and battery current measurements of hearing aids.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the FONIX 8000 Hearing Aid Test System, which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general controls but does not include details on specific acceptance criteria, study methodologies, or performance results.

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The Unity 2 HIA and Probe are intended to be used as a system to: (1) perform Real Ear Measurement; (2) get an objective indication of the characteristics of a hearing aid; and (3) assist in the adjustment of hearing aids while in use by the patient. It is used by ENTprofessionals and in clinics for hearing aid fitting.

Siemens Unity 2 HIA and Probe (for use with Siemens Unity 2 System)

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is an FDA 510(k) clearance letter for the Siemens Unity 2 HIA and Probe, indicating it has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested table or details about a study.

The document only states the "Indications For Use" for the device, which are:

1. Perform Real Ear Measurement.
2. Get an objective indication of the characteristics of a hearing aid.
3. Assist in the adjustment of hearing aids while in use by the patient.

It also mentions that the device is used by ENT professionals and in clinics for hearing aid fitting.

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The SpeechLink 100 is a hearing aid calibrator and analysis system that is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid.

The SpeechLink is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from self-contained software modules installed on a common software platform. The following applications are available: Audio fitting system and Simulator system.

The fitting system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC and hardware for connection to a PC. The neckset is connected to the PC via a Bluetooth radio link, i.e. no physical connection to the PC.

The simulator consists of software for installation on a PC and hardware for connection to a PC.

The provided document outlines the acceptance criteria and a study demonstrating the SpeechLink 100 type 1053 device's performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state a specific numerical sample size for the test set. It refers to "Speech mapping recordings" being measured, implying multiple recordings were taken.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.

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

• Not applicable. The study compares the device's measurements against a predicate device and a technical standard and does not involve human expert interpretation of results to establish ground truth in the traditional sense of medical image analysis or diagnosis.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, the comparison is against a predicate device's measurements and technical standard tolerances, not against adjudicated expert opinions.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study compares the device against another device and a technical standard, not human readers with and without AI assistance.

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

• Yes, a standalone performance assessment was conducted. The study directly compares the measurements from the SpeechLink 100 with those from the Audioscan Verifit VF-1, and assesses its compliance with a technical standard. This is an evaluation of the device's (or its underlying algorithm's) performance in generating measurements without human intervention in the measurement process itself.

7. Type of Ground Truth Used:

• The ground truth in this context is established by:
  • The measurements obtained from the predicate device (Audioscan Verifit VF-1).
  • The tolerances defined by the IEC 61669 (2001-01) Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids standard.

8. Sample Size for the Training Set:

• Not applicable. The provided document details a performance study comparing the device to a predicate and a standard, not a machine learning model's training process.

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

• Not applicable. The provided document details a performance study comparing the device to a predicate and a standard, not a machine learning model's training process.

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The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing.

REM440, (for use with Thor Platform System Products)

The provided text is a 510(k) substantial equivalence letter from the FDA for the Interacoustics REM440 device, a hearing aid analyzer. It does not contain the detailed information necessary to answer the questions about acceptance criteria and study design.

Specifically, the document states:

• Device Name: REM440
• Regulation Number/Name: 21 CFR 874.3310 / Hearing Aid Analyzer
• Indications For Use: "The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing."
• Date of Decision: April 29, 2005 (corrected from an earlier letter of the same date).
• 510(k) Number: K050496

However, it does not contain any information regarding:

1. Acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance studies.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter is a regulatory document confirming substantial equivalence to a predicate device, which allows the device to be marketed. It does not elaborate on the specific technical or clinical studies that may have been submitted in the original 510(k) application to demonstrate this equivalence. To find that information, one would typically need to review the full 510(k) submission summary or other related technical documentation, which is not provided in the given text.

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"Otogram" can perform the functions of:
Pure tone and speech audiometer, 1.
Impedance audiometer (tympanometry, acoustic reflex), and 2.
Distortion product otoacoustic emissions analyzer. 3.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, a Impedance Instrument, and a DPOAE Instrument. The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC. The device performs comprehensive audiometry; tympanometry, acoustic reflex; and otoacoustic emissions. Additional features include manual audiometer and NOAH v.3 compliant (hearing aid fitting software). Available in multiple languages, including English, Spanish, Russian, Mandarin, Vietnamese, and Korean.

The provided text describes the regulatory submission for the Tympany Otogram device and its comparison to predicate devices, focusing on substantial equivalence rather than a study proving the device meets specific acceptance criteria in a clinical performance sense.

Therefore, many of the requested elements (like sample size for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and type of ground truth) either do not apply directly to this type of submission or are not detailed in the provided information. This document is a 510(k) summary, which focuses on demonstrating equivalence to existing legally marketed devices based on technical characteristics and intended use, often supported by bench and user testing rather than extensive clinical trials with human subjects.

Here's an attempt to answer the questions based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in the format of specific quantitative thresholds to be met. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing technical characteristics. The "reported device performance" is essentially the detailed technical specifications of the Otogram and its comparison to the predicate devices.

The table below reconstructs the comparison from the provided Substantial Equivalence Chart as effectively serving the role of demonstrating performance relative to established benchmarks (the predicate devices). The implied "acceptance criterion" for each characteristic is that the Otogram's performance/specification is comparable to or within acceptable ranges of the predicate devices.

The study proving the device meets these criteria is described as "bench, user, and laboratory testing" (Section 5. and 7.). These tests indicate that the new device is "as safe and effective as the predicate device," thus demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "bench, user, and laboratory testing" but does not quantify the sample size (e.g., number of devices tested, number of users, number of measurements).
• Data Provenance: Not specified. It's internal company testing ("Tympany Inc."). There is no indication of country of origin or whether the testing was retrospective or prospective in detail, although "user testing" implies prospective interaction with the device.

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

Not applicable/Not specified. This is a technical medical device, and the "ground truth" for its performance is typically established by comparing its physical outputs (e.g., sound frequencies, pressure measurements) against calibrated standards and predicate devices, rather than expert consensus on a diagnosis for a test set. The submission focuses on technical performance and safety.

4. Adjudication method for the test set

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers evaluate cases and their agreement needs to be resolved. This document describes bench and user testing of a medical device's technical specifications and safety, not an evaluation of diagnostic accuracy by human readers.

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. This type of study (MRMC, AI assistance) is not mentioned and is typically associated with diagnostic algorithms or imaging interpretation, which is not the primary focus of this device's regulatory submission. The Otogram is a measurement device.

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

Not applicable for this device in the context of "algorithm only." The performance of the device itself (its hardware and embedded software) was tested, implying a "standalone" evaluation of its technical capabilities against its specifications and predicate devices. However, this is not in the context of an "AI algorithm." The device's operation is "computer-controlled" (Section 4), but the submission focuses on its measurement functions, not on a standalone diagnostic algorithm.

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

The "ground truth" for the device's technical performance would be established by calibrated standards and the specifications of predicate devices. For example, to verify "Probe tone frequency: 226 Hz, +/- 3%", the device's output would be measured against a known, highly accurate frequency standard. For safety, compliance with standards like EN 60601-1 is the ground truth. There's no mention of patient-specific "outcomes data" or "pathology" as ground truth for this type of device submission.

8. The sample size for the training set

Not applicable. The device described (Otogram) is an audiometer, impedance instrument, and DPOAE instrument. It is a measurement device, not an AI/machine learning model that requires a "training set" in the conventional sense.

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

Not applicable (as established in point 8).

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The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient. If the patient wears a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter for the Fonix, Model 7000 hearing aid calibrator and analysis system, indicating that the FDA has found it substantially equivalent to a legally marketed predicate device. It briefly mentions the device's indications for use but does not delve into detailed performance metrics or studies.

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The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.

The Audioscan® Verifit™ is a hearing aid analysis system. The system is integrated with a hearing test chamber physically separated from the display/control unit. Signal processing and analysis is carried out digitally, with the exception of the microphone preamplifiers and output amplifiers. It includes a fluorescent backlit active color display, thermal line printer, and various connectors for peripherals and microphones. It has two stimulus channels and two measurement channels. The hearing aid test chamber has a working space of 8" x 5" x 1.5" (approx.), two 2" x 3" Independent speakers, and induction coils for Telephone Magnetic Field Simulator and a 20 cm diameter test loop. It also includes a battery simulator. The real-ear measurement component has two 2" x 3" ducted ports speakers and a Silicone 1.0mm diameter x 75mm probe microphone tube.

Acceptance Criteria and Device Performance for Audioscan® Verifit™ Model VF-1

This document outlines the acceptance criteria and the reported performance of the Audioscan® Verifit™ Model VF-1, a hearing aid analysis system. The information is derived from the provided 510(k) summary (K012306).

1. Table of Acceptance Criteria and Reported Device Performance

The Audioscan® Verifit™ Model VF-1 demonstrates compliance with established industry standards and its predicate device (Audioscan® Real Ear Measurement System RMS00, K884046/A) across various performance characteristics. The acceptance criteria for this device are implicitly derived from these standards and the performance of the predicate device.

Key Performance Standards Conformance:

• ANSI S3.46-1997, Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
• ANSI S3.22-1996, Specification of Hearing Aid Characteristics
• IEC 60601-1, EN60601-1, UL-2601, UL 544 (Safety Standards)
• Food and Drug Administration radiation safety performance standards

The following table compares key characteristics between the Audioscan® Verifit™ Model VF-1 and its predicate device, Audioscan® Real Ear Measurement System RMS00. The "Acceptance Criteria" are understood to be meeting or exceeding the predicate device's performance, as well as conforming to the cited ANSI, IEC, and UL standards.

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