Search Results

The Auto Suture* Premium Plus CEEA* Disposable Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.

The Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler is a single patient use device which places a double staggered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis.

This 510(k) submission (K024275) for the Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler focuses on the substantial equivalence of the device to a legally marketed predicate device. As such, it does not include the detailed performance study information typically found in submissions for novel devices or AI-powered systems.

Therefore, many of the requested categories regarding acceptance criteria, study design, and ground truth are not applicable to this specific submission. This document primarily confirms the device's intended use, materials, and substantial equivalence to existing implantable staples.

Here's the breakdown of what can be gleaned from the provided text:

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

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 summary does not describe a performance study with a test set. The substantial equivalence determination is based on a comparison to predicate devices, not on a new clinical or performance study that would involve a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. There is no mention of a test set requiring expert-established ground truth in this submission.

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

• Not applicable. No test set 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 surgical stapler, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

• Not applicable. This device is a manual surgical tool, not an algorithm.

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

• Not applicable. As this is a substantial equivalence determination for a medical device (surgical stapler), the "ground truth" concept in the context of diagnostic or AI performance studies isn't directly relevant. The assessment revolves around whether the device performs as safely and effectively as its predicates based on its design, materials, and intended use.

8. The sample size for the training set

• Not applicable. There is no "training set" as this device is not an AI algorithm.

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

• Not applicable. No training set is involved.

Ask a specific question about this device

The Auto Suture* Premium Plus CEEA* Disposable Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The Auto Suture* PREMIUM PLUS CEEA* Disposable Stapler is a single patient use device which places a double staggered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis.

This looks like a 510(k) premarket notification for a surgical stapler, which is a physical medical device and not an AI/ML powered device. As such, the requested information (acceptance criteria and study details related to AI/ML device performance) is not applicable to this submission.

Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluation.

Ask a specific question about this device

Ask a specific question about this device