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Aesculap's Neuro Patties are intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures.

Aesculap's Neuro Patties are rectangular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions, with widths from 4mm to 70mm and lengths from 6mm to 150mm. The material used for the patties is natural woven cotton fiber, this material is available in either a tight weave (neurosorb 4 or 6) or a more open gauze-like weave (neurosorb 75). The neurosorb 4 material consists of 4 layers while neurosorb 6 is constructed with 6 layers, the layers provide different levels of absorbency for surgeon preference. All pattles have a suture string attached for ease in count verification, they are also available with x-ray detectable markers if desired. The patties are packaged 10 per card in either single size sets or in procedure (indication) sets with a variety of sizes. These devices are for single use only and should not be resterilized.

The provided text is a 510(k) Premarket Notification for the Aesculap Neuro Patties, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, the input does not contain the information needed to fill out all the requested sections of your query. This device is a cottonoid pattie, which is a low-risk device where performance is typically assessed by material properties and comparison to existing similar devices, not through a clinical trial with performance metrics like sensitivity, specificity, etc.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The implicit "acceptance criteria" here is substantial equivalence to the predicate devices.
• Reported Device Performance: No quantitative performance metrics (like sensitivity, specificity, F1-score, etc.) are reported. The document describes the device's physical characteristics and intended use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Not applicable. This document describes a medical device for surgical use, not an AI/software device that undergoes testing on a "test set" of data in the typical sense. There is no mention of a test set, data provenance, or a study that uses such a set.

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

• Not applicable. No test set or ground truth in the context of AI/ML evaluation is mentioned.

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

• Not applicable. No test set or related adjudication process is 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:

• No. This is a physical medical device (cottonoid patties), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant and not mentioned.

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

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

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

• Not applicable. There is no "ground truth" as a reference standard for performance evaluation in the context of this type of device submission. The assessment is based on material properties, manufacturing controls, and comparison to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. No training set is mentioned as this is not an AI/ML device.

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

• Not applicable. No training set or ground truth for it is mentioned.

In summary: The provided 510(k) document is for a Class II physical medical device (Aesculap Neuro Patties) and focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or studies in the context of AI/ML or diagnostic performance (e.g., sensitivity, specificity, test sets, ground truth establishment, MRMC studies) because such evaluations are not typically required or relevant for this type of device.

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