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The Amplivox Otowave 202 is designed for use by trained operators (audiologists, general practitioners, hearing aid dispensers, and child health professionals) in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders in the general population associated with the functioning of the middle ear. The instrument performs two types of measurement: Tympanometry is used to measure 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.

The Otowave 202 relies heavily on long-established practice in the clinical area of middle-ear measurements, and implements tympanometer functionality in a small desk-top device that may be powered from the mains (via a d.c. adapter) or by internal batteries. Stimuli are applied to the patient by means of a probe mounted on a flexible connecting lead for ease of use (especially with neonates) and additional contralateral stimuli are available if required via a separate plug-in transducer. Operation is via an intuitive menu-driven user interface, with test data displayed on the integral screen and capable of download to a PC via a USB connection and to a printer via an infrared communications (IrDA) interface. Tympanometers work by measuring the admittance of the tympanic membrane while the pressure in the ear canal is varied. The admittance is at a maximum when the air pressure across the tympanic membrane is balanced.

The provided document is a 510(k) premarket notification for the Amplivox Otowave 202 Portable Tympanometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical trial for efficacy. Therefore, much of the information typically found in an acceptance criteria study (e.g., sample sizes for test sets, expert-established ground truth, MRMC studies) is not applicable or not explicitly provided in the context of this regulatory submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The document presents a comparison of the Amplivox Otowave 202 to its predicate device, the Amplivox Otowave 102 (K081841). The "acceptance criteria" are implied by the specifications of the predicate device and the new device's ability to meet or exceed those specifications, as well as adherence to relevant industry standards.

Table of Acceptance Criteria and Reported Device Performance (as derived from the comparison table and testing summaries):

Study Details (Based on available information)

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

• Sample Size: Not applicable. This submission relies on substantial equivalence through bench testing and adherence to standards, not human subject testing for performance.
• Data Provenance: Not applicable for performance testing in humans. Bench testing was performed on the device itself.

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

• Number of Experts: Not applicable. Ground truth for device performance was established against engineering specifications and international standards, not clinical expert consensus on patient data.
• Qualifications of Experts: Not applicable in the context of human data. The "experts" would be the engineers and regulatory specialists ensuring compliance with the technical standards and testing protocols.

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

• Adjudication Method: Not applicable. This is not a study involving human evaluations or interpretations requiring adjudication.

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:

• MRMC Study: No. This device is not an AI-powered diagnostic tool requiring human reader studies. It's a medical measurement device.

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

• Standalone Performance: Yes, in the sense that the device's technical specifications and performance against physical standards (e.g., probe tone accuracy, pressure range) were tested without human interpretation of clinical outcomes. The document states: "Bench performance testing: Measurements were carried out with an Otowave 202 tympanometer to confirm that it satisfies the requirements of ANSI S3.39-1987/IEC60645."

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

• Type of Ground Truth: The ground truth for this device's performance is established by engineering/technical standards and specifications (e.g., IEC 60601-1, EN 60601-1-2, EN60645-5, ANSI S3.39-1987) for medical electrical equipment, EMC, and tympanometers, as well as the specifications of the predicate device.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device does not employ machine learning or AI models that require a training set of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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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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