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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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ACAM® 5 is intended as an aid in diagnosing hearing loss and fitting of hearing aids. The device consists of an audiometer that can be used individually or with the other ACAM modules for performing Real Ear Measurements (REM), Hearing Instrument Test (HIT) and loudness scaling. ACAM 5 should be used by persons trained in audiology on patients of any age who are able to understand the basic principles of the test method when explained by the operator.

ACAM® 5 is an audiometer with optional components for performing Real Ear Measurements (REM) Hearing Instrument Testing (HIT) and loudness scaling. It is intended to aid trained audiologists and hearing aid professionals in the diagnosis of hearing loss and the fitting of hearing aids. As a part of the REM and HIT modules ACAM performs several kinds of signal analysis including root mean squared (RMS), fast Fourier transformation (FFT) and percentile analysis (PA). ACAM® 5 gives an audiologist the ability to use one or any combination of the diagnostic tools recommended by the National Acoustics Laboratory (NAL) and Dr. Richard Seewald (DSL-IO).

Available ACAM® 5 hardware consists of an audiometer with a modular control unit for peripheral components, which include a large or small hearing instrument test box and an in sity ear probe for real ear measurement. Headphones for audiometry, bone conduction and loudness scaling. loudspeakers, a microphone and an interrupter switch are available for use with the audiometer.

ACAM®'s operational software meets the international software standards established by the Hearing Instruments Software Manufacturers Association (HIMSA) and the speech recognition standards (ISTS, International Speech Test Signals) established by the-European Hearing Instrument Manufacturers Association (EHIMA).

The ACAM® 5 system meets or exceeds the following international standards: IEC 60645, ISO 8253, ISO 16832, ANSI S3.6, ANSI S3.22, EN 60118-0, EN 60118-7, DIN IEC 60118-15, ISO 12124, ANSI S3.43

ACAM® 5 should be operated by individuals with education and training in the field of audiology such as audiologists, hearing aid dispensers, health care and school nurses and ear nose and throat specialists.

Here's a summary of the acceptance criteria and the study details for the ACAM 5 Audiometer System based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACAM® 5 Audiometer System are primarily based on compliance with established international and national standards for audiometers and hearing instrument analyzers. The document presents a comparison to a predicate device (Siemens Unity 2 with HIA and Probe) to demonstrate substantial equivalence, rather than a direct performance study with a specific set of acceptance metrics for diagnostic accuracy.

The reported device performance, in terms of meeting these standards, is stated as "in compliance with the requirements of the international consensus standards shown below."

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

The document does not describe a clinical performance study involving human subjects or a specific test set for evaluation of diagnostic accuracy. The "test set" in this context refers to the rigorous testing against engineering and clinical performance standards.

• Sample Size for Test Set: Not applicable in the context of human subject data. The testing involved physical device measurements against specified standard requirements.
• Data Provenance: Not applicable for human subject data. The "provenance" of the compliance data comes from internal testing and validation against international and national standards by the manufacturer. The location of the manufacturer (Germany) suggests the testing likely occurred in Germany or by an accredited European testing body. The document states it was subjected to electrical safety and EMC testing and performance specifications.

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

Not applicable. Ground truth, in the sense of expert consensus on patient diagnoses or conditions, is not described as part of this submission. The "ground truth" for the device's technical specifications and performance is the requirements set forth in the various international and national standards. These standards are established by expert bodies in the field of audiology and medical device safety/performance.

4. Adjudication Method for the Test Set

Not applicable. Since there isn't a human-read or AI-interpreted test set with subjective outcomes needing adjudication, this section is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This submission focuses on demonstrating substantial equivalence to a predicate device (Siemens Unity 2) based on technical characteristics and compliance with recognized standards. It is not an AI-assisted diagnostic device, so a study on human readers' improvement with AI assistance is not relevant.

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

Yes, in a way. The "performance test data" discussed are essentially standalone evaluations of the device's adherence to technical standards. The system itself is an audiometer, and its performance (e.g., accuracy of frequency output, intensity output, signal distortion) is evaluated independently against engineering specifications as defined by the standards (e.g., ANSI S3.6-2004 for audiometers). This is not an "algorithm only" in the modern AI sense, but rather a standalone device performance check.

7. The Type of Ground Truth Used

The "ground truth" used is defined by the technical specifications and requirements outlined in recognized international and national standards for audiometers and hearing instrument analyzers. The device's performance parameters (e.g., frequency accuracy, intensity accuracy, stimulus distortion) are compared against the limits and criteria specified in these standards (e.g., IEC 60645, ANSI S3.6, etc.).

8. The Sample Size for the Training Set

Not applicable. This device is an audiometer, not an AI/machine learning algorithm that requires a training set of data.

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

Not applicable, as no training set is described for this device.

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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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The AC440 system is intended to be used for the detection and diagnosis of suspected hearing loss.

The HIT440 system is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. These two devices can either be sold individually or together in the same housing. The HIT440 system may also be used with other approved Hearing aid test chambers

Not Found

This is an FDA 510(k) clearance letter for an audiometer and hearing aid calibrator system. As such, it does not contain the detailed study information typically found in a clinical trial report or a comprehensive regulatory submission. The document focuses on the regulatory determination of substantial equivalence to a predicate device, rather than detailed acceptance criteria and performance data from a specific study.

Therefore, I cannot provide the requested information from this document. To answer your questions, I would need access to the actual 510(k) summary or the full regulatory submission, which would contain the performance data and methodology used to demonstrate substantial equivalence.

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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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