Search Results

The Auto Suture* TA* & knifeless GIA* staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses, including occlusion of the left atrial appendage in open procedures.

The Auto Suture* TA* & GIA* Staplers are designed to place multiple staggered rows of titanium or stainless steel staples in various types of tissues.

This submission pertains to the Auto Suture TA & GIA Staplers. However, the provided document does not contain information about acceptance criteria or a study demonstrating device performance. Instead, it is a 510(k) summary and FDA clearance letter primarily focused on establishing substantial equivalence to predicate devices based on identical technological characteristics and changes only in the indication for use statement.

Therefore, the requested information cannot be extracted from the provided text. The document states: "The Auto Suture* TA* & GIA* Staplers are identical to the predicate devices. The only changes are in the indication for use statement." This implies that performance data proving the device meets acceptance criteria would likely be covered by the predicate device's clearance and not explicitly re-stated or re-generated for this particular submission, as the device itself is considered identical.

To address the prompt fully, if such a study were present in alternative documentation (not provided here), the sections would be populated as follows:

1. Table of acceptance criteria and the reported device performance: This table would list specific quantitative or qualitative criteria that the device's performance needed to achieve (e.g., staple formation strength, leakage rates, successful tissue transection in a certain percentage of cases) and then show the results from the study, demonstrating how the device met or exceeded those criteria.

2. Sample size used for the test set and the data provenance: This would state the number of devices or procedures included in the test phase of the study and describe if the data was collected retrospectively (from existing records) or prospectively (specifically for the study), along with the geographic origin of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail how many medical professionals (e.g., surgeons, pathologists) reviewed the outcomes of the test procedures and their expertise (e.g., Board-certified surgeon with 20 years of experience in abdominal surgery).

4. Adjudication method for the test set: If multiple experts were used, this would describe how disagreements were resolved (e.g., "2+1" meaning if two out of three experts agreed, that was the final decision; "3+1" might imply a tie-breaking fourth expert, or simply all three must agree).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This information is specific to AI/software-assisted diagnostic devices. For a surgical stapler, an MRMC study comparing human performance with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Again, this is relevant for AI/software devices. For a surgical stapler, this concept does not apply.

7. The type of ground truth used: This would specify the definitive standard against which the device's performance was measured (e.g., pathology reports confirming successful tissue approximation, outcomes data like absence of anastomotic leaks, expert consensus on visual inspection of stapled lines).

8. The sample size for the training set: If a learning algorithm was involved (not applicable here), this would be the number of cases or data points used to train the algorithm.

9. How the ground truth for the training set was established: Again, if applicable, this would describe the process of labeling or categorizing the training data.

Ask a specific question about this device