(29 days)
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
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Material Composition | Manufactured from viscose fibers. |
| Shapes and Sizes | Offered in similar shapes and sizes as the predicate device. |
| Indications for Use | Intended for use during surgery to protect nervous tissue, absorb fluids, or stop bleeding during neurological and other general procedures. This is identical to the predicate device K031008. |
| Sterility | Provided sterile or non-sterile (for kit packager). |
| Single Use Only | Designed for single use only. |
| Non-Resterilizable | Should not be resterilized. |
| Suture String | All patties have a suture string attached for ease in count verification. |
| X-ray Detectable Markers | Available with x-ray detectable markers if desired. |
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.
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).