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The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computer-based testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.

The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computerbased testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.

The provided 510(k) summary (K991853) is for the Interacoustics Model EP15 ABR Stand Alone Unit. Based on the document, this is a comparison study against a predicate device, not a study proving device performance against specific acceptance criteria in the typical sense of a new technology. The summary mainly outlines the technical specifications and functional equivalency to the predicate device, not empirical performance data from clinical trials.

Therefore, many of the requested fields regarding acceptance criteria, study sample sizes, expert involvement, and ground truth are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process for this device focuses on demonstrating substantial equivalence to a legally marketed predicate device.

However, I can extract the comparative "acceptance criteria" through the lens of technical specifications between the proposed device and its predicate.

1. Table of Acceptance Criteria (as inferred from comparison to predicate) and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the proposed device, Interacoustics Model EP15 ABR, is either identical to or has equivalent or superior specifications compared to the predicate device, ICS Medical Corp. Chartr EP System, for key functional and safety aspects. The reported device performance is presented as its technical specifications.

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The Interacoustics AZ26 Clinical Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

Our device, the Model AZ26 Clinical Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

The Interacoustics Model AZ26 Clinical Impedance Audiometer (K990652) is deemed substantially equivalent to the Interacoustics Clinical Impedance Audiometer Model AZ26 (predicate device) and thus meets its acceptance criteria by complying with relevant performance and safety standards.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the device's compliance with established performance and safety standards, and its similarity to the predicate device. The performance is reported through comparison with the predicate device and explicit statements of compliance with standards.

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

The document specifies the device is "in compliance with the following performance and safety standards" (listed above) and provides a "Comparison of the Interacoustics Model AZ26 Clinical Impedance Audiometer and the Interacoustics Clinical Impedance Audiometer Model AZ26". This suggests that the "testing" for acceptance was based on device specifications and adherence to recognized industry standards, rather than a clinical trial with a specific "test set" of patients or data.

Therefore, there is no explicit sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set mentioned in this 510(k) summary, as it is a predicate-based submission relying on technical equivalence and compliance with standards.

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

There is no mention of experts establishing ground truth for a test set, as the submission appears to rely on technical specifications and adherence to established industry standards for audiometric and impedance devices rather than a clinical ground truth established by experts.

4. Adjudication method for the test set

As there is no identified "test set" or clinical study described in the provided document, there is no adjudication method mentioned.

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

The document does not describe an MRMC comparative effectiveness study, nor does it involve AI assistance. This device is a measurement instrument (audiometer), not an AI-powered diagnostic aid for human readers.

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

This question is not applicable as the device is a clinical impedance audiometer, not an algorithm. Its performance is inherent to its design and calibration, not a standalone algorithmic output.

7. The type of ground truth used

The "ground truth" for this device's acceptance is its compliance with established international and national performance and safety standards (e.g., ANSI S 3.6-1996, IEC 645-1-1992 for audiometers; ANSI S 3.39-1987, IEC 1027-1991 for impedance; IEC 601-1-1988 for general safety). Additionally, the device demonstrated substantial equivalence to a legally marketed predicate device based on feature comparison. The performance parameters detailed in the comparison table essentially serve as the "ground truth" for its technical specifications matching or exceeding the predicate.

8. The sample size for the training set

This question is not applicable. The device is an electroacoustic test instrument, not a machine learning model. Therefore, there is no concept of a "training set" for its development or validation.

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

This question is not applicable as there is no training set for this type of device.

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The Interacoustics AT22t Automatic Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

The Interacoustics AT22t Automatic Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

The provided text describes a 510(k) premarket notification for the Interacoustics AT22t Automatic Impedance Audiometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo study to prove safety and effectiveness against specific acceptance criteria.

Therefore, the information you requested regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided document.

The document primarily provides:

• Device Description: The Interacoustics AT22t Automatic Impedance Audiometer is an electroacoustic test instrument for diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders, featuring tympanometry, acoustic reflex, and air conduction audiometry.
• Predicate Device: Interacoustics Automatic Impedance Audiometer.
• Comparison Table: A comparison showcasing the similarities and differences between the new device (AT22t) and the predicate device, emphasizing identical indications for use and similar technical specifications.
• Safety and Effectiveness: A statement that the device complies with specific performance and safety standards (Audiometer: ANSI 3.6-1989 IEC 645-1-1992 Type 4; Impedance: ANSI 3.39-1987 IEC 1027-1991 Type 2; Safety: IEC 601-1-1988). This compliance indicates that the device meets established industry standards, which serve as a form of acceptance criteria in regulated environments, but it's not data from a specific study to prove novel performance.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. Table of acceptance criteria and reported device performance: The document lists compliance with standards (e.g., ANSI, IEC) as the basis for safety and effectiveness. It does not present a table of specific measurable acceptance criteria with corresponding performance statistics from a study.
2. Sample size used for the test set and data provenance: No information on a test set, sample size, or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such test set or ground truth establishment is described.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported. The device is a diagnostic instrument, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.
6. Standalone (algorithm-only) performance: Not applicable, as this is a physical audiometer, not an algorithm.
7. Type of ground truth used: Not applicable, as no study requiring ground truth is described.
8. Sample size for the training set: Not applicable, as the device is not an AI/ML model that undergoes a training phase.
9. How the ground truth for the training set was established: Not applicable.

In essence, the 510(k) pathway demonstrates equivalence, not novel performance, and therefore does not typically include detailed clinical study data of the kind requested for an AI/ML device. The "proof" of the device meeting "acceptance criteria" here is its adherence to existing, recognized performance and safety standards for impedance audiometers.

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The Interacoustics MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of now sible otologic disorders.

Our device, the Model MT10 Handheld Impedance Audiometer is an easy to use handheld diagnostic middle ear analyzer that is well suited for providing quick and reliable results in both diagnostic and screening settings. The tympanometry test features a user selectable extended pressure range that is capable of -600daPa. Four ipsilateral reflexes at different frequencies may be tested at each ear. Reflex testing operates either at a user defined fixed level or uses an automatic intensity search function. It assists in the diagnosis of possible otologic disorders.

The provided text describes the Interacoustics Model MT10 Handheld Impedance Audiometer and its similarity to a predicate device, the Grason Stadler GSI-37 Auto Tymp, for the purpose of 510(k) clearance.

However, the document does not contain information about specific "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the device, nor does it detail a study that proves the device meets such criteria. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device based on technical specifications and adherence to relevant standards.

Therefore, many of the requested sections about acceptance criteria, device performance, and details of a performance study cannot be filled from the provided text.

Here's an attempt to answer the questions based on the available information:

Acceptance Criteria and Device Performance

The submission does not specify quantitative acceptance criteria in terms of clinical performance metrics, nor does it present detailed study results in that format. The "acceptance criteria" in this context appear to be compliance with established performance and safety standards, and demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and 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)

The document does not describe a clinical or performance study with a test set of data or human subjects. The submission relies on technical comparisons and adherence to standards rather than clinical data for demonstrating substantial equivalence.

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

Not applicable, as no clinical test set requiring ground truth established by experts is described.

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

Not applicable, as no clinical test set requiring adjudication is described.

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 impedance audiometer, providing objective measurements, not an AI-assisted diagnostic tool that would involve human readers interpreting results in conjunction with AI.

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

This is an impedance audiometer providing objective measurements. The concept of "standalone algorithm performance" as typically applied to AI/imaging diagnostics does not directly apply here. The device itself performs the measurements. Its "standalone" performance is dictated by its technical specifications and adherence to standards, which are detailed in the comparison table.

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

Not applicable, as no clinical performance study with defined ground truth is described. The "ground truth" for this type of device's regulatory submission is its capability to meet technical specifications and established standards, and its equivalence to a predicate device in performing its intended function.

8. The sample size for the training set

Not applicable, as this device would not typically involve a "training set" in the context of machine learning or AI.

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

Not applicable, for the same reasons as above.

Summary of Device Approval Approach:

The provided 510(k) summary indicates that the Interacoustics Model MT10 Handheld Impedance Audiometer received clearance based on:

• Substantial Equivalence: Demonstrating that it is as safe and effective as a legally marketed predicate device (Grason Stadler GSI-37 Auto Tymp) through a comparison of technical specifications and indications for use.
• Compliance with Standards: Meeting recognized national and international performance and safety standards (IEC 1027-1995, ANSI 3.60 -1989, ANSI 3.60-1985, Safety IEC 601-1-1988).
• CE Mark Approval: The device was also approved for Medical CE-marking, indicating compliance with European safety and performance requirements.

The document does not detail any clinical performance studies that might involve patient data, expert interpretations, or statistical measurements of accuracy, sensitivity, or specificity.

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The Interacoustics Model AD229 Diagnostic Audiometer is indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Because of its master hearing aid capability this device is also indicated for simulating a hearing aid during audiometric testing thus it may help in the selection and adjustment of a patient's hearing aid.

The Interacoustics Model AD229 Diagnostic Audiometer is an electroacoustic device that produces controlled levels of test tones and signals. The unit employs digital readouts and includes an external power supply that contains an isolation transformer. The tones and sound signals are directed to the patient by means of the following transducers: TDH39 Audiometric Headset (standard); EAR-Tone 3A Insert Phones (optional); and B71 Bone Conductor (standard). This device also has master hearing aid capability and utilizes either the TDH39 Headset or the Ear-Tone 3A Insert Phones for the acoustical outputs.

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of the requested details are not available in the provided text.

Here is the information that can be extracted or reasonably inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against recognized performance and safety standards, which serve as its "acceptance criteria" for basic functionality and safety. The reported device performance is its compliance with these standards.

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

This information is not provided in the 510(k) summary. The summary focuses on compliance with standards and comparison to a predicate device, not a clinical study on a specific test set of data.

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

This information is not provided. As this is a medical device (audiometer) and not an AI/software device requiring human interpretation of results, the concept of "ground truth" established by experts in the context of a test set for diagnostic accuracy does not directly apply here. The device itself generates the "result" (e.g., hearing thresholds).

4. Adjudication Method for the Test Set

This information is not provided. This concept is not relevant for the type of device and submission described.

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

This information is not provided. An MRMC study is not applicable to an audiometer, which is a diagnostic tool used by a clinician to measure hearing, not an AI system that interprets images or data requiring human-in-the-loop assistance.

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

This information is not provided. The device is an electroacoustic device that measures hearing; it's not an "algorithm only" device in the context of typical AI/software. Its performance is inherent in its measurement capabilities, which are assessed against standards.

7. The Type of Ground Truth Used

The "ground truth" for an audiometer is its ability to accurately and reliably produce and measure sound levels and frequencies according to established audiological standards. Therefore, the "ground truth" would be established by compliance with scientific and engineering standards (IEC 645-1-1991 Type 2, ANSI 3.6-1996 Type 2), verified through calibration and performance testing.

8. The Sample Size for the Training Set

This information is not provided. Audiometers are not typically developed using "training sets" in the way AI/Machine Learning models are. Their design and calibration are based on physical principles and established audiological standards.

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

This information is not provided and is not applicable for this type of medical device submission.

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The Interacoustics Model AD226 Diagnostic Audiometer is indicated for use in The Interacoustics Model AB220 Diagnostic and assisting in the diagnosis of possible otologic disorders.

The interacoustics Model AD226 Diagnostic Audiometer is an electroacoustics instrument that produces and as a diagnectic hostring electroacousiic test instrument until processible stallegic disording tones and signals intended for acc in conductions of possible otologic disorders.

This 510(k) summary describes a traditional medical device (an audiometer) and not an AI/ML powered device. As such, many of the requested fields are not applicable or cannot be extracted from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through comparison of physical and functional characteristics, and compliance with established performance standards.

Here's the information that can be extracted, with explanations for the missing fields:

Acceptance Criteria and Device Performance

The acceptance criteria for the Interacoustics Model AD226 Diagnostic Audiometer are primarily based on its compliance with established performance and safety standards, and its similarity in function and intended use to a legally marketed predicate device.

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

(See table above)

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

• Not applicable for this type of device submission. This 510(k) is for a hardware medical device (an audiometer), not an AI/ML algorithm. The "test set" in this context refers to the device itself being tested for compliance with standards, not a dataset of patient information. The submission does not describe clinical trials or data analysis that would require a patient-based test set.

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 applicable. Ground truth generation by experts is relevant for AI/ML models that interpret medical images or signals. For a diagnostic audiometer, performance is established through calibration and adherence to established physical and electrical standards, not through expert-labeled patient data as described in the prompt.

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

• Not applicable. Adjudication methods are used in studies involving human interpretation of data, often in the context of clinical trials for AI/ML devices. This submission focuses on the device's technical specifications and compliance with engineering 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. An MRMC study is relevant for evaluating the impact of AI on human reader performance. This submission is for a standalone diagnostic audiometer and does not involve AI assistance for human readers.

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

• Not applicable in the context of AI/ML. The "standalone" performance here refers to the device operating independently, measuring auditory responses. However, this is not an AI/ML algorithm being evaluated in isolation. The document describes the device's inherent capability to produce and analyze electroacoustic signals for diagnostic purposes.

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

• Not applicable in the AI/ML sense. The "ground truth" for an audiometer's performance is its accurate production of calibrated sounds and its ability to consistently measure auditory thresholds as per established audiology principles and standards (e.g., ANSI 3.6-1989). This is verified through physical calibration and testing against reference equipment, not against clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML system, so there is no "training set" of data.

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

• Not applicable. As there is no training set, there is no ground truth establishment process for it.

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