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Nasopore® Ear is a fragmentable ear packing and is indicated for use in patients, undergoing outer ear surgery, as a space occupying stent to separate and prevent adhesions between mucosal surfaces; to help control minimal bleeding, following ear surgery, by tamponade effect and blood absorption.

Nasopore® Ear is composed of a bioresorbable poly(DL-lactide-co-sscription caprolactone) urethane that fragments within several days after insertion in the outer ear, whereafter it is drained from the cavity. The type of Nasopore® Ear is indicated on the label. Nasopore® Ear is packed in a blister closed by a medical paper lid. Nasopore® Ear is indicated for single-use.

The provided text describes the 510(k) summary for the Nasopore® Ear device, focusing on its substantial equivalence to predicate devices rather than a standalone performance study with specific acceptance criteria and detailed device performance metrics.

Therefore, many of the requested details about acceptance criteria, a specific study proving it, sample sizes, expert involvement, and ground truth establishment are not available in the provided document. The submission relies on demonstrating substantial equivalence based on the device's material composition and intended use being similar to existing cleared devices, rather than an independent performance study with defined acceptance criteria.

Here's a breakdown of what can be gleaned from the text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not set numerical acceptance criteria for the Nasopore® Ear device's performance in a clinical study. Instead, it relies on demonstrating substantial equivalence to predicate devices (Invotec Ear Tampon (Wick) w/String and Nasopore® Nasal Dressing). The "performance data" mentioned refers to design verification tests (in vitro degradation and shelf life), which are engineering tests, not clinical performance metrics against specific acceptance criteria.

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

• Sample Size: Not applicable/Not mentioned. The document does not describe a clinical test set with human or animal subjects for performance evaluation against specific criteria.
• Data Provenance: Not applicable/Not mentioned for a clinical test set. The "performance data" mentioned (in vitro degradation, shelf life testing) would typically be conducted in a lab setting.

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/Not mentioned. No test set requiring expert ground truth is described.
• Qualifications of Experts: Not applicable/Not mentioned.

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

• Adjudication Method: Not applicable/Not mentioned. No clinical test set requiring adjudication is described.

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 is not an AI-assisted device. The Nasopore® Ear is a physical medical device.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

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

• Type of Ground Truth: Not applicable for a typical clinical performance study. The "ground truth" for the claims in this submission is the established safety and effectiveness of the predicate devices and the physical/chemical properties verified by design tests.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not mentioned. This is not an AI device that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

In summary, the 510(k) submission for Nasopore® Ear relies on a demonstration of "substantial equivalence" to legally marketed predicate devices, rather than a de novo clinical performance study with explicit acceptance criteria. The performance data mentioned (in vitro degradation, shelf life) are design verification tests, not clinical performance metrics. The underlying rationale is that if the new device is made of the same material, uses the same manufacturing process, and is intended for a similar use as a previously cleared device, then its safety and effectiveness are considered substantially equivalent.

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The Invotec Ear Tampon ( wick ) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.

Invotec Ear Tampon (Wick) w/String

The provided documentation pertains to a 510(k) premarket notification for an Invotec Ear Tampon (Wick) w/String and does not contain information about acceptance criteria, device performance metrics, or study details typically associated with demonstrating performance against such criteria for a novel device, especially one involving AI or complex analytical methods.

The document is a letter from the FDA to Invotec International, Inc., confirming that their Ear Tampon (Wick) w/String is substantially equivalent to a legally marketed predicate device. This determination is based on the device's indications for use: "as an ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing."

Since this is a 510(k) clearance for a relatively simple medical device (an ear tampon/wick) where substantial equivalence to a predicate device is the basis for market clearance, a detailed study proving performance against specific acceptance criteria, as one would find for an AI-powered diagnostic device, is not presented or required in this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as existing, similar devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not part of the provided FDA 510(k) clearance letter.

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