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The American Electromedics Quik Tymp 1 (QT1) Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

The American Electromedics Quik Tymp 1 (QT1) Tympanometer/Audiometer With Integral Printer is an impedance tympanometer. The American Electromedics Quik Tymp 1 (QT1) Tympanometer with Integral Printer is an impedance tympanometer which has a built-in printer.

I cannot provide the information requested from the text provided because the document is a 510(k) summary and FDA letter regarding substantial equivalence. It does not contain information about acceptance criteria, study details, or performance data for the American Electromedics Quik Tymp 1 (QT1) Tympanometer/Audiometer with Integral Printer. The document focuses on regulatory classification and substantial equivalence to previously marketed devices, rather than a clinical study demonstrating performance against specific criteria.

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The American Electromedics Race Car Tympanometer/ Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

The American Electromedics Race Car Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.

This is a 510(k) premarket notification for a medical device (Tympanometer/Audiometer), which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specified acceptance criteria and human evaluation. The provided text does not contain the detailed information required for the requested output regarding acceptance criteria and a study proving device performance in the context of AI or human reader improvement.

Therefore, I cannot fulfill your request as the necessary data is not present in the provided text. The document describes the device, its intended use, and its classification, and notes that it is substantially equivalent to previously marketed devices (K970279). It does not detail specific performance metrics, clinical trials, or expert-based evaluations in the way an AI-driven diagnostic device might.

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The American Electromedics Race Car Tympanometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

The American Electromedics Race Car Tympanometer With Integral Printer is an impedance tympanometer.

This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and the FDA's response letter, which primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information.

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The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

The American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.

This 510(k) submission for the American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The provided text only includes:

• Manufacturer and Contact Information: American Electromedics Corporation, Ferguson Medical.
• Device Classification and Names: Auditory Impedance Tester, Audiometer, Tympanometer/Audiometer. Proprietary Name: American Electromedics Quik Tymp 2 (QT2) Tympanometer/Audiometer With Integral Printer.
• Substantial Equivalence: Refers to predicate devices: Car Tympanometer With Race Audiometer and Quik Tymp2, and Quik Tymp1, American Electromedics Corporation (K970279).
• Device Description: A combination device functioning as both a tympanometer and an audiometer with a built-in printer.
• Intended Use: "The device is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders."
• Technological Characteristics: Reiteration of the device description.
• FDA Communication: A letter affirming substantial equivalence to pre-amendment devices, outlining regulatory requirements, and permitting marketing.

There is no mention of:

1. Acceptance criteria table or reported device performance.
2. Sample size for test set or data provenance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This submission is concerned with demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a performance study with specific acceptance criteria that the device unequivocally meets. The FDA's letter confirms substantial equivalence, which implies that the device is as safe and effective as its predicate devices, but it does not detail new performance study results or acceptance criteria for this specific submission.

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The device is used to perform pure tone threshold tests.

Not Found

This document is a 510(k) clearance letter from the FDA for the K-15 Audiometer. It indicates that the device has been found substantially equivalent to a predicate device for performing pure tone threshold tests.

The document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Sample size used for a test set or its data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• References to a multi-reader, multi-case (MRMC) comparative effectiveness study, nor effect sizes for human readers with and without AI assistance.
• Information about a standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for a training set.
• How ground truth for a training set was established.

Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory clearance document, not a performance study report.

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Ask a specific question about this device