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The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and diagnosis of ear disorders on human beings. EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it well suited for waveform based screening and the manual programmability options allow for comprehensive clinical use ranging from frequency specific threshold test to operating room applications and cochlear implant tests. The EP15 is a basic unit allowing only recording of the Auditory Brainstem Response (ABR), while the EP25 allows recording of the ABR and earlier and later potentials.

The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli.

Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Neurology specialties, Audiologist and other health professionals concerned with measuring auditory functions.

The EP15 and EP25 systems measure auditory brainstem responses picked up by skin electrodes and amplified by a pre amplifier. The data acquisition of the ABR recordings takes place from the surface electrodes mounted at specific recording points on the patient. The analogue ABR recordings are amplified in the external preamplifier connected to the electrodes. The amplified analogue ABR recordings are converted into a digital signal in the ADC (Analog to Digital Converter) inside the Eclipse. The digital ABR recordings undergo data processing handled by the PC to improve the ABR-recordings. The ABR-recordings are displayed on the monitor for the operator, for further examination and diagnosis. All ABR recordings are stored on the Laptop / Desktop computer hard drive for later examination and diagnosis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Interacoustics EP15/EP25 device:

This 510(k) summary describes a modification to an existing medical device, the Interacoustics Eclipse EP15/EP25. As such, the acceptance criteria and study focus on demonstrating that the modified device is as safe and effective as, or better than, the predicate device, rather than a de novo validation of a completely new device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail format related to performance metrics like sensitivity, specificity, or accuracy for a diagnostic task. Instead, the acceptance criteria are implicitly met by demonstrating that the modified device functions correctly and equivalently (or better) than the predicate across various technical aspects.

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

The document does not provide specific sample sizes for any of the bench tests or validations mentioned. It describes "bench testing" and "validation," which typically refer to internal engineering and quality assurance tests rather than clinical studies on patient populations.

Regarding data provenance: All tests described appear to be internal, prospective bench tests conducted by Interacoustics. There is no mention of data from a specific country of origin or whether it was retrospective or prospective in a clinical sense.

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

The document does not mention the use of experts to establish ground truth for the test set. The validation seems to rely on comparing the output of the modified device against mathematically predicted outputs or expected results from the predicate device (e.g., electrical consistency, predicted results for Bayesian weighting).

4. Adjudication Method for the Test Set:

There is no mention of an adjudication method. Since the validation primarily involves technical bench testing and comparison against expected outputs, rather than clinical interpretation by multiple human readers, an adjudication method is not applicable in this context.

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 comparative effectiveness study was not done. The device (EP15/EP25) is an audiometer that measures auditory brainstem responses and evoked potentials. It assists in evaluation and diagnosis but is not an AI-driven image analysis or decision support system that would typically undergo MRMC studies to assess the impact of AI assistance on human reader performance. Its enhancements are in signal processing and stimulus generation, not AI interpretation.

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

The "tests" section describes validation activities, which could be considered analogous to standalone testing for the specific new features. For example:

• "The usefulness of the EABR protocol setup has been validated with a positive result."
• "The correct implementation of the new stimuli... have been verified through bench testing which provided the expected results. The generated electrical output was consistent with the mathematically predicted output."
• "The correct implementation of the Bayesian weighting and low pass filtering has also been verified through bench testing and the results were as predicted."

These statements indicate that the algorithmic and functional aspects of the new features were tested independently to ensure they performed as intended, without direct human intervention in the measurement process itself. However, the device's overall intended use still involves human operators for diagnosis and interpretation.

7. The Type of Ground Truth Used:

The ground truth for the technical validations was primarily:

• Mathematically predicted output: For the new stimuli (chirp, NB chirp, click from wave file), the generated electrical output was compared to mathematically predicted output.
• Expected results/Predicted results: For Bayesian weighting and low pass filtering, the results were compared to what was "predicted."
• Lack of abnormal behavior: For Windows Vista® compatibility, the ground truth was the absence of unexpected errors or malfunctions.

There's no mention of pathology, expert consensus on clinical cases, or outcomes data as ground truth because the validation focused on the technical correctness of feature implementation, not diagnostic accuracy in a clinical population.

8. The Sample Size for the Training Set:

The document does not provide any information about a training set. This is expected as the document describes a traditional medical device (audiometer) update, not a machine learning or AI-driven system that would typically involve distinct training and test sets in the context of model development.

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

Not applicable, as no training set is mentioned or implied for this device modification.

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The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.

Titan IMP440 consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite and Titan IMP440 module). The measurements are controlled by the handheld unit. Titan IMP440 is going to be offered as 3 configurations that will support screening, diagnostic and clinic users. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system. Titan IMP440 is an impedance product based on a hardware platform named Titan Platform. It uses a cabinet named Titan but may use any other cabinets as long as it meets the requirement of the platform. Other products will in the future be developed to the Titan platform and submitted as required and thereby become a part of the Titan System Family as Titan IMP440. A connection box named Titan Shoulder Box enables different types of accessories to the hardware platform.

The provided text is a 510(k) summary for the Interacoustics Titan IMP440 device, which is an auditory impedance tester. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it focuses on comparing the new device's technological characteristics and performance to an existing, cleared device, rather than conducting a full clinical study with acceptance criteria, sample sizes, and expert validation in the way a novel AI/ML device might.

Therefore, many of the requested categories (e.g., sample size for training/test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, specific acceptance criteria with reported performance, ground truth types) are NOT applicable to this type of regulatory submission as it appears from the provided text.

Based on the information given, here's what can be extracted:

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

The document states: "The performance data indicated that the Titan Impedance System meets all specified requirements, and is substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., accuracy thresholds, precision ranges) are not detailed in this summary. The "specified requirements" likely refer to internal design specifications and relevant industry standards for auditory impedance testers, but these are not enumerated here.

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

Not applicable. This 510(k) summary does not describe a clinical study with a specific test set, sample size, or data provenance in the context of an AI/ML device. The "performance data" likely refers to engineering tests and comparisons against the predicate device's specifications.

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

Not applicable. This is not a clinical study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable.

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 Titan IMP440 is an electroacoustic test instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting results with or without AI assistance.

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

Not applicable. The device is a diagnostic instrument, not an algorithm, and its performance is inherently standalone in generating measurement data for a clinician to interpret.

7. The type of ground truth used

Not applicable in the typical sense of a clinical study or AI/ML validation. For an impedance system, "ground truth" would be the physically accurate measurement of the auditory system's impedance. The document implies that the device's measurements are accurate enough to be considered substantially equivalent to the predicate device, which is already an accepted method for obtaining such "ground truth" in routine clinical use.

8. The sample size for the training set

Not applicable. This device does not use machine learning, so there is no training set.

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

Not applicable.

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The Interacoustics EP systems, EP15 and EP25, are intended to assist in the evaluation, documentation and the automatic recording of ABR waveforms makes it EP15/25 is a 2 channel ABR and the automatic recording of ABR waveforms makes it EF 15/2013 a 2 channon ADA and the manual programmability options well suited for waverom baood occorning and and and and specific threshold test to operating room applications and cochlear implant tests. operating foom applications and over over of the Auditory Brainstem Response The E. 1915 a bacil unk allowing of the ABR and earlier and later potentials. The Interacoustics TEOAE25 system is intended for determining Cochlear function using Transient Evoked Otoaccoustic Emission click stimuli. Both of these systems are of particular interest to Ear, Nose, and Throat doctors, Doll of these byotone are of paist and other health professionals concerned with measuring auditory functions.

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I'm sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for the Interacoustics Eclipse system.

The document is a 510(k) premarket notification letter from the FDA to Interacoustics AS, indicating that the device is substantially equivalent to legally marketed predicate devices. It lists the trade/device name, regulation numbers, and indications for use.

Specifically, it lacks the following information that would be needed to answer your questions:

• A table of acceptance criteria and reported device performance: The document confirms the FDA found the device "substantially equivalent" but does not detail specific performance metrics or acceptance criteria used in a study.
• Sample sizes used for the test set and data provenance: No information on test sets, sample sizes, or data origin (country, retrospective/prospective).
• Number of experts and their qualifications for ground truth: No mention of experts or their roles in establishing ground truth.
• Adjudication method for the test set: Not discussed.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No indication that such a study was performed or any effect sizes.
• Standalone algorithm performance: The document describes the system's intended use in diagnosis and evaluation, implying human interaction, but doesn't detail standalone algorithm performance.
• Type of ground truth used: Not specified.
• Sample size for the training set: Not mentioned.
• How ground truth for the training set was established: Not mentioned.

The document primarily addresses the regulatory approval process (510(k) clearance) based on substantial equivalence to predicate devices, rather than a detailed clinical study report with specific performance metrics and study methodologies.

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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

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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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