(28 days)
The autosuture™ Circular EEA™ Staplers have application 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 autosuture™ Circular EEA™ family of staplers place a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
This document is a 510(k) summary for a surgical stapler, not a study evaluating an AI-powered device. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not present in the provided text.
The document focuses on demonstrating substantial equivalence of the new stapler to a predicate device, which is a regulatory pathway for medical devices that are similar to devices already on the market. It does not involve clinical studies or performance evaluations intended for AI devices.
However, I can extract the following relevant information:
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in the way one would for an AI device's performance (e.g., a specific sensitivity or specificity threshold). Instead, it states that the device was deemed "substantially equivalent" to its predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | In-vitro and in-vivo tests were performed to verify that the modified autosuture™ EEA™ stapler is substantially equivalent to the predicate device. |
| Compliance with ISO 10993-1 | All components are comprised of materials in accordance with ISO Standard 10993-1. |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "in-vitro and in-vivo tests," but does not provide details on the number of samples or subjects used in these tests.
- Data Provenance: Not specified. It's likely these tests were conducted internally or by a contracted lab, but the country of origin or whether they were retrospective/prospective is not mentioned.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The "ground truth" for a surgical stapler involves mechanical and biological performance, not interpretive tasks requiring expert radiologists or similar specialists.
4. Adjudication Method for Test Set:
Not applicable. This concept is relevant for reconciling discrepancies among human readers or between human and AI interpretations, which is not the nature of this device's evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is for evaluating the impact of AI on human reader performance, which doesn't apply to a surgical stapler.
6. Standalone Performance Study:
A standalone performance evaluation (in-vitro and in-vivo tests) was conducted for the device itself to verify substantial equivalence. However, this is not a standalone algorithm performance in the context of AI.
7. Type of Ground Truth Used:
The "ground truth" would have been established through a combination of:
- Engineering measurements (e.g., staple formation, anastomotic strength).
- Biological observations (e.g., tissue healing, leak rates) in animal models (for in-vivo tests).
8. Sample Size for Training Set:
Not applicable. This device is a mechanical surgical stapler, not an AI algorithm, so there is no training set in the AI sense.
9. How Ground Truth for Training Set Was Established:
Not applicable (as above).
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.