(21 days)
The Autosuture™ Endo GIA™ Staplers with Endo GIA™ Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection. transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology when used with the Endo GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. For the Tan reload, the staple sizes are 2.0, 2.5, and 3.0 mm for use in vascular and medium thick tissue. The Tan Reloads are available in 30mm. 45mm and 60mm staple line lengths as well as curved-tip anvil configurations. Tri-Staple™ Technology means that each of the two triple-staggered rows has a stepped configuration whereby the staples in the outer row are a taller height than the staples in the middle row which in turn are a taller height than the staples in the inner row. The size of the staples is determined by the selection of the appropriate single use Reload.
The provided text describes a 510(k) premarket notification for a surgical stapler reload. The focus of this submission is a change in the upper range of the tissue thickness compression contraindication from 1.5 mm to 1.8 mm for the Autosuture™ Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
Key Takeaways from the Document:
- Device: Autosuture™ Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology (used with the Autosuture™ Endo GIA™ Stapler).
- Change: Modified contraindication for tissue thickness, increasing the upper limit from 1.5 mm to 1.8 mm.
- Purpose of Study: To demonstrate that the device is safe and effective and performs as intended with the new tissue thickness range.
- Tests Conducted: Bench tests (staple formation) and in vivo tests (staple formation, hemostasis, burst strength).
- Regulatory Context: This is a 510(k) submission, meaning the device is seeking substantial equivalence to a legally marketed predicate device. The change is a labeling modification.
1. Table of Acceptance Criteria and Reported Device Performance
Based solely on the provided text, the acceptance criteria are implicitly related to the performance characteristics evaluated in the study. The actual numerical acceptance criteria (e.g., minimum burst strength, specific hemostasis metrics) are not detailed in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Bench Tests: | |
| Proper Staple Formation within the revised tissue thickness range | Bench tests were performed to evaluate staple formation, demonstrating safe and effective performance. |
| In Vivo Tests: | |
| Proper Staple Formation within the revised tissue thickness range | In vivo tests were performed to evaluate staple formation, demonstrating safe and effective performance. |
| Adequate Hemostasis within the revised tissue thickness range | In vivo tests were performed to evaluate hemostasis, demonstrating safe and effective performance. |
| Adequate Burst Strength within the revised tissue thickness range | In vivo tests were performed to evaluate burst strength, demonstrating safe and effective performance. |
| Biocompatibility | All components are comprised of materials in accordance with ISO Standard 10993-1. |
| Overall Safety and Effectiveness | Bench and in vivo performance evaluations were conducted to demonstrate that the device is safe and effective and performs as intended. |
Important Note: The document states that these tests were conducted to demonstrate safety and effectiveness and "performed as intended," implying the acceptance criteria were met. However, the specific quantitative criteria (e.g., "burst strength must exceed X psi") are not explicitly stated in this high-level summary.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "bench tests" and "in vivo tests" but does not provide the number of samples, animals, or tests conducted.
- Data Provenance:
- Country of origin: Not specified.
- Retrospective or prospective: The tests ("bench tests were performed," "in vivo tests were performed") suggest a prospective study design, as they were conducted to support the labeling modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This device is a surgical stapler reload. "Ground truth" in the context of expert review for diagnostic imaging or similar AI applications is not relevant here. The performance is assessed through objective physical and biological tests (staple formation, hemostasis, burst strength). The analysis of these tests would be conducted by qualified engineers and scientists, but the concept of "ground truth" established by a panel of medical experts is not directly applicable to a mechanical device performance study.
4. Adjudication Method for the Test Set
- Not Applicable. As explained above, for a mechanical device performance study, an adjudication method for test set ground truth is not typically used. The data from the bench and in vivo tests would be analyzed according to predefined protocols and statistical methods.
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 not an AI-assisted diagnostic device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical surgical device, not an algorithm.
7. The Type of Ground Truth Used
- The concept of "ground truth" as a reference standard for diagnostic accuracy (e.g., pathology, expert consensus) is not directly applicable here.
- Instead, the "ground truth" or reference for evaluating performance would be derived from:
- Engineering specifications and standards: For staple formation (geometric precision, integrity).
- Physiological measurements: For hemostasis (e.g., absence of bleeding, blood loss quantification).
- Biomechanical testing standards: For burst strength (e.g., pressure at which the staple line fails).
- ISO Standard 10993-1: For biocompatibility.
8. The Sample Size for the Training Set
- Not Applicable. This is a mechanical device, not a machine learning model. Therefore, there is no "training set." The device design and manufacturing processes are developed through engineering principles, prototyping, and testing, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no "training set" for a mechanical device, there is no ground truth to establish for it.
§ 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.