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The Amplivox Otowave is designed for use by trained operators in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders associated with the functioning of the middle ear. The instrument performs two types of measurement: Tympanometry is used to measure the compliance of the tympanic membrane and middle ear at a fixed frequency over a range of pressures. Reflex tests are used to measure stapedial reflexes. The Otowave measures ipsilateral reflexes and, when selected, reflex measurement is automatically carried out after a tympanogram is taken.

This is a hand held portable tympanometer. It features: Automatic measurement of ear canal volume, tympanic compliance peak, placement . of the peak and the gradient. . Automatic detection of stapedial reflexes. . Up to 30, dual-ear patient tests can be stored in non-volatile memory. 9 . Configurable settings for user preferences, held in non-volatile memory. . Printout via an infrared link to a thermal printer. . Transfer to Windows XP via an infrared IrDA link for storage and display using . NOAH..

The Amplivox Otowave 102 Hand Held Portable Tympanometer (K081841) was cleared based on substantial equivalence to predicate devices, rather than meeting specific performance acceptance criteria from a clinical study. The provided document does not contain an acceptance criteria table or a detailed study demonstrating device performance against such criteria.

Instead, the submission focuses on the device's intended use, description, and comparison to legally marketed predicate devices (K925585, GSI 38 AUTO TYMP LUCAS GRASON-STADLER, INC. and K060885 the Maico MI 44 Tympanometer) to establish substantial equivalence.

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

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

This information is not provided in the given document. The submission states: "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." However, it does not detail specific acceptance criteria or quantitative performance metrics from these tests.

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

This information is not provided in the given document. The document mentions "bench, user, and standards testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).

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 in the given document. The clearance relies on substantial equivalence, not on the establishment of ground truth by experts for a specific test set.

4. Adjudication method for the test set

This information is not provided in the given document.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided document. The device is a diagnostic instrument, not an AI-assisted diagnostic tool for human readers; therefore, this type of study would not be applicable or expected in this context.

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

The device is a standalone tympanometer. Its performance would inherently be "algorithm only" as it provides automated measurements. However, no specific study detailing its standalone performance with quantitative results is provided. The comparison is made against predicate devices, implying similar performance characteristics.

7. The type of ground truth used

This information is not explicitly stated in the provided document. Given that the device performs measurements for the "detection of possible otologic disorders," the implied 'ground truth' in a clinical setting would likely be established through clinical diagnosis by medical professionals (e.g., ENT specialists, audiologists) or potentially through pathology/imaging in more severe cases. However, no specific ground truth method for the pre-market testing is described.

8. The sample size for the training set

This information is not provided in the given document. The device is a traditional medical instrument, not an AI/machine learning system, so the concept of a "training set" in that context does not apply.

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

This information is not provided in the given document, as it is not an AI/machine learning device requiring a training set with established ground truth.

Summary of what is available from the document regarding acceptance criteria and study:

The submission for the Amplivox Otowave 102 Hand Held Portable Tympanometer (K081841) focuses on demonstrating substantial equivalence to existing predicate devices (K925585, GSI 38 AUTO TYMP LUCAS GRASON-STADLER, INC. and K060885 the Maico MI 44 Tympanometer).

The evidence for this substantial equivalence is primarily based on:

• Intended Use Compatibility: The intended use of the Otowave 102 is highly similar to that of the predicate devices.
• Technological Characteristics: The device performs similar measurements (Tympanometry and Reflex tests) as the predicate devices. Differences noted are primarily in form factor (handheld vs. desktop) and power source (battery-operated vs. AC).
• Safety and Effectiveness Claims: The document states, "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." However, no detailed reports, specific results, or quantitative acceptance criteria from these tests are provided. The "standards testing" refers to adherence to safety standards like UL and IEC 60601-1, which would involve meeting predefined benchmarks for electrical and mechanical safety.

In essence, the "acceptance criteria" here are implicitly met by demonstrating that the new device is comparable in function, safety, and effectiveness to devices already cleared for market. The study, if one could call it that, is a comparative assessment against predicate devices supported by general "bench, user, and standards testing" without specific details on methodologies or results in the provided document.

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