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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 rectanqular fluid absorption pads for use during neurological and/or general procedures. The devices are available in a variety of dimensions and sizes. The neuro patties are manufactured from either a cotton or viscose fibers. All patties 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 provided sterile or non-sterile (for kit packager), single use only, and should not be resterilized.

The provided document K062406 describes a 510(k) premarket notification for "Aesculap Neuro Patties" (Neurosorb Premium). This device is a neurosurgical paddie, and the submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies against specific acceptance criteria.

Therefore, many of the requested categories (e.g., acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable or not explicitly detailed in this type of submission.

Here's an analysis based on the provided text, acknowledging the limitations for a 510(k) submission for a cottonoid paddie:

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

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

• Sample Size for Test Set: Not applicable or not specified. This submission is for establishing substantial equivalence for a Class II medical device (Neurosurgical paddie) based on comparison to a predicate device, rather than a clinical performance study with a test set.
• Data Provenance: Not applicable. Performance data from a clinical test set is not explicitly provided or referenced as the basis for this 510(k) clearance. The provenance of the predicate device (Aesculap Neuro Patties K031008) is that it was legally marketed.

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

• Not applicable. No clinical test set requiring expert ground truth establishment is described in this submission.

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

• Not applicable. 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

• Not applicable. This device is a physical medical device (neurosurgical paddie), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI performance improvement are not relevant.

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

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

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

• Not applicable. For this type of 510(k) submission, the "ground truth" is primarily based on the equivalence to the legally marketed predicate device and compliance with general controls and recognized safety/performance attributes for such devices (e.g., material biocompatibility, sterility, absorption capacity, which would have been established during the development and clearance of the predicate).
  • The "study" that proves the device meets (implicit) acceptance criteria is the comparison to the predicate device. The claim is that the "Neurosorb Premium Pattie will be offered in similar in shapes and sized as the predicate devices. The Neurosorb Premium Paddie is manufactured from viscose, which is the same material as the existing predicate device."

8. The sample size for the training set

• Not applicable. No training set is described for this device.

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

• Not applicable. No training set or associated ground truth establishment is described.

Summary of the "Study" for this K062406 Submission:

The provided document describes a substantial equivalence claim rather than a "study" in the typical sense of a clinical trial or performance evaluation. The "study" that proves the device meets the (implied) acceptance criteria is the comparison to the predicate device, Aesculap Neuro Patties (K031008).

The basis for this substantial equivalence is stated as:

• The material (viscose) is the same as the predicate.
• The shapes and sizes will be similar to the predicate.
• The indications for use are identical to the predicate: "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."

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the fundamental technological characteristics and indications for use with a previously cleared device, implying similar safety and effectiveness. No new clinical performance or efficacy studies are detailed in this 510(k) summary because the device is a simple, well-understood product type with a clear predicate.

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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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