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The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.

The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation.

This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.

The patient group includes all ages and sexes.

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This document describes a 510(k) premarket notification for the DPOAE20, Eclipse audiometer system. The information provided is very limited in terms of what is typically included in a study proving device performance against acceptance criteria. There is no specific study described in the provided text that outlines acceptance criteria and corresponding device performance metrics.

However, based on the nature of a 510(k) submission, we can infer some general aspects and note the absence of detailed information for most of your requested points.

Here's an analysis based on the provided text, highlighting what is not available and what can be inferred:

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

• Not Available: The document does not provide a table of acceptance criteria or reported device performance metrics. For an audiometer, typical performance criteria might include accuracy of stimulus presentation (frequency, intensity), sensitivity, specificity, and reliability of OAE detection.

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

• Not Available: No information regarding the sample size used for any test set or the provenance of data (country, retrospective/prospective) is provided.

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 Available: The document does not mention any expert review process or ground truth establishment for a test set.

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

• Not Available: No adjudication method is 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

• Not Applicable/Not Available: This device is an audiometer for DPOAE (Distortion Product Otoacoustic Emission) measurements. It is a diagnostic tool, not an AI-assisted interpretation device that would involve "human readers" in the context of improving interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device.

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

• Inferred (Standalone Functionality): The DPOAE20 system is described as a device that "records and processes" the OAE response and "then displayed on the computer screen for evaluation." This implies that the device itself performs the measurement and initial processing stand-alone to generate the OAE data. While human interpretation ("evaluation") is required, the core function of generating the OAE response is standalone. No specific "standalone performance study" details are provided, but the device's function is inherently standalone in its data acquisition and processing steps.

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

• Not Available/Implied Clinical Standard: For an audiometer like this, the "ground truth" for its performance would typically be established by comparing its measurements to established clinical standards for DPOAE acquisition and potentially against other validated audiometric tests or objective measures of hearing function. No specific ground truth method is detailed in this document.

8. The sample size for the training set

• Not Available: No information about a training set or its sample size is provided. This type of device (an audiometer) typically relies on engineering validation and calibration against known acoustic standards rather than machine learning training sets.

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

• Not Available/Applicable: As there's no mention of a training set, there's no information on how its ground truth would be established.

Summary:

This 510(k) submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, as opposed to providing a detailed clinical study report with acceptance criteria and performance data against those criteria. The provided text primarily establishes the device's identity, its indications for use, and the regulatory decision for market clearance. It does not contain the specific study details you've requested. For such information, one would typically need to review the full 510(k) submission or associated clinical validation reports if they were part of the submission.

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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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TEOAE25 is an accessory to the EP15 or EP25 platform and provides the ability to test the cochlea functions of infants, children and adults in hospitals, nurseries, ENT clinics or audiology offices. It measures the amount of otoacoustic emission (OAE) present in the ear after a stimulus, and it allows a trained operator to get objective information about the cochlea function.

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The provided text is a 510(k) clearance letter from the FDA for a device called TEOAE25, an accessory to the EP15 or EP25 platform used to test cochlea functions.

While the document confirms that the device has been reviewed and found "substantially equivalent" to legally marketed predicate devices, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria and device performance studies.

The letter focuses on regulatory approval based on equivalence, not on a detailed breakdown of performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from this document.

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The Interacoustics Audio Traveller AA222 is intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.

The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.

This is a regulatory letter from the FDA, approving the Interacoustics Audiotraveller, Model AA222. The letter does not contain a detailed study report with acceptance criteria and device performance results. Therefore, I cannot provide most of the requested information based solely on the provided text.

Here's what I can infer and what is explicitly stated:

Information from the document:

• Trade/Device Name: Audiotraveller, Model AA222
• Regulation Number: 21 CFR 874.1090
• Regulation Name: Auditory Impedance Tester
• Regulatory Class: Class II
• Product Code: ETY
• Intended Use: For use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The AA222 is a combination of audiometer and tympanometer.

Limitations:

The provided document is an FDA clearance letter based on a 510(k) submission. A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive new clinical trials with detailed acceptance criteria and performance studies as might be seen for a PMA (Premarket Approval) device or for novel technologies.

Therefore, the document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used, training set sample size, or how ground truth was established for the training set.

The FDA's decision is based on a review of the submitter's assertion that the device is substantially equivalent to a predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. The specific data supporting such a claim would be in the 510(k) submission itself, not in the FDA's clearance letter.

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