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The Ear Pressure Relief Device is indicated for the treative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing loss. The Ear Pressure Reliever provides a method of ventilating the middle ear by momentarily increasing the air pressure in the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.

The Ear Pressure Relief Device is designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes. For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Ear Pressure Relief Device is activated by pressing and holding the adjustment button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear. Ear Pressure Relief Device is provided non-sterile, and is designed for reuse with a single patient.

The provided FDA 510(k) summary for the "Ear Pressure Relief Device (ER813B)" does not contain the level of detail typically found in a study focused on establishing acceptance criteria and proving device performance for an AI/ML-driven device. This document describes a physical medical device that appears to operate without AI or complex algorithms.

However, I can extract the information relevant to what I understand you’re asking for, aligning it with the structure you provided, even if some categories are not directly applicable to this type of device.

Key takeaway: This medical device clearance is based on substantial equivalence to a predicate device, primarily demonstrated through bench testing for physical performance, electrical safety, EMC, and biocompatibility, rather than a clinical study with human readers or AI performance metrics.

Here's the analysis based on the provided document:

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

Since this is a physical medical device and not an AI/ML diagnostic tool, the "acceptance criteria" are based on engineering specifications and regulatory compliance rather than diagnostic performance metrics like sensitivity, specificity, or AUC. The reported device performance is a confirmation that these specifications were met through bench testing.

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

• Sample Size: Not applicable in the context of a "test set" for an AI/ML algorithm or a clinical trial. The testing involved physical units of the device for bench, electrical, EMC, and biocompatibility tests. The document doesn't specify the number of physical units tested, but these are typically small numbers (e.g., 3-5 units for bench tests, relevant samples for biocompatibility).
• Data Provenance: The tests (bench, electrical, EMC, biocompatibility) were conducted on the "Ear Pressure Relief Device (ER813B)" itself. The document does not specify the origin of the samples if different from the manufacturing site (Ningbo Albert Novosino Co., Ltd., China). The tests are prospective in the sense that they are conducted on newly manufactured devices to verify performance against design specifications.

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

Not applicable to this type of device. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this physical medical device. The "ground truth" here is adherence to engineering specifications and regulatory standards, verified by testing specialists and accredited labs.

4. Adjudication method for the test set

Not applicable. There was no "adjudication method" involving multiple experts for a diagnostic task. Testing involves objective measurements against predefined engineering specifications and regulatory standards.

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. This device is a standalone physical product, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study was not performed, nor is there any mention of human readers or AI assistance.

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

No. This device is a physical product for direct patient use to relieve ear pressure, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is adherence to engineering specifications (e.g., air pressure range, flow rate, dimensions), biocompatibility standards, electrical safety standards, and electromagnetic compatibility (EMC) standards. These are objective, measurable criteria.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth established for one.

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The Eustachi is indicated for the treatment of negative middle ear pressure.

Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing, and hearing loss. The Eustachi provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.

The Eustachi device is a battery-operated device designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes. For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Eustachi device is activated by pressing and holding the power button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear.

Eustachi is provided non-sterile, and is designed for reuse with a single patient.

The provided text describes the Eustachi Ear Pressure Relief Device (K203754) and its substantial equivalence to a predicate device. However, it does not include typical acceptance criteria tables or detailed study results that would be used to demonstrate device performance against specific metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance. This type of information is generally found in studies for diagnostic devices or AI-powered medical devices.

The Eustachi device is a non-AI, mechanical device for relieving negative middle ear pressure. Therefore, the information requested regarding AI performance, expert ground truth, MRMC studies, or training set details is not applicable to this device submission.

Here's a breakdown of the available information regarding acceptance criteria and performance studies, addressing as many of the requested points as possible given the nature of the device:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the way one might expect for a diagnostic or AI device. Instead, "acceptance criteria" are implied by compliance with various standards and successful completion of specific tests. The "reported device performance" is the successful demonstration of this compliance and functionality.

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The EarPopper is indicated for the treatment of negative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing and hearing loss. The EarPopper provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.

The EarPopper is a non-surgical, non-drug related treatment for middle ear pressure problems such as:

• . Middle ear fluid (Otitis Media with Effusion)
• Eustachian Tube Dysfunction
• . Temporary hearing loss
• Ear pain and pressure caused by air travel .
• . Ear fullness caused by colds, allergies, sinusitis

The provided 510(k) summary for the EarPopper device (K073401) is a premarket notification for substantial equivalence, not a clinical study proving performance against acceptance criteria in the typical sense of a diagnostic device.

Instead of an acceptance criteria table and device performance, the document provides a comparison of characteristics between the EarPopper and its predicate devices (Earclear, Politzer Bag, Otovent) to demonstrate substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence rather than a study validating specific performance metrics against pre-defined acceptance criteria, the document does not contain a "table of acceptance criteria and reported device performance" in the traditional sense for a diagnostic device.

Instead, the submission demonstrates equivalence by comparing the EarPopper's characteristics to those of its predicate devices. The "SUMMARY of EQUIVALENCE" table serves this purpose by showing that the EarPopper's intended use, patient use, principle of operation, mode of operation, major components, and air pressure output are sufficiently similar to the legally marketed predicate devices.

Outcome: The FDA determined that the EarPopper is substantially equivalent to the predicate devices, indicating that its performance and safety are comparable.

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

The provided 510(k) summary does not describe a clinical study with a test set as it pertains to diagnostic accuracy or clinical effectiveness. The submission focuses on demonstrating substantial equivalence based on technological characteristics and intended use. Therefore, no information on sample size or data provenance (country, retrospective/prospective) is provided in this context.

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

Since a clinical effectiveness study with a test set and ground truth establishment is not detailed in this 510(k) summary, no information is available regarding the number or qualifications of experts for establishing ground truth.

4. Adjudication Method for the Test Set

As no clinical study with a test set is described, there is no adjudication method 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

This device (EarPopper) is a non-surgical, non-drug treatment device for middle ear pressure problems, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable and not mentioned in the document.

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

Similarly, since the EarPopper is a physical, non-AI treatment device, a standalone algorithm performance study is not applicable and not described.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

As this is a 510(k) submission for substantial equivalence based on technological characteristics and intended use, and not a performance study that requires a "ground truth" to validate diagnostic accuracy, no type of ground truth is mentioned or used in this document.

8. The Sample Size for the Training Set

No training set is referenced as no machine learning algorithm development or validation is being described.

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

Not applicable, as no training set or ground truth establishment for an algorithm is described.

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