(42 days)
The Auto Suture™ ENDO GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The Auto Suture™ ENDO GIA™ Stapler places two, triple- staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm 3.5 mm or 4.8 mm single-use loading unit (SULU). The ENDO GIA™ Stapler will accommodate any of the single-use loading units that are available in 30 mm, 45 mm and 60 mm sizes.
The provided text describes a 510(k) submission for the Auto Suture™ ENDO GIA™ Stapler. This is a surgical stapling device, not an AI or imaging device, so many of the requested categories related to AI performance, imaging, and ground truth establishment are not applicable.
Here's an analysis based on the information provided for this specific medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" in the format typically seen for AI/software devices (e.g., minimum sensitivity, specificity). Instead, for this surgical stapler, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and supporting the expanded indication through performance data.
The "performance data" section indicates:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is substantially equivalent to a predicate device. | Device is identical to the predicate device (Auto Suture™ ENDO GIA™ Stapler). |
| Materials are biocompatible. | All components are comprised of materials in accordance with ISO Standard 10993-1. |
| Supported new indication for use on liver tissue. | In-vivo animal tests performed to support inclusion of the specific liver indication. |
| Clinical application for liver resection and transection supported. | Clinical literature search performed to demonstrate and support the clinical application. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size in the document. The performance data section vaguely mentions "in-vivo animal tests" and a "clinical literature search."
- Data Provenance:
- In-vivo animal tests: The country of origin is not specified, nor is whether this data was retrospective or prospective. It is implied to be prospective testing for the K061095 submission.
- Clinical literature search: This would involve existing published data, likely from various countries and methodologies (retrospective/prospective, depending on the individual studies included). The specifics are not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This category is not applicable for this type of medical device submission. The "ground truth" for a surgical stapler's performance is typically established through observable clinical outcomes, tissue integrity, and successful procedural results, not through expert consensus on image interpretation. The submission discusses animal testing and literature review, which are forms of performance data, not expert-adjudicated ground truth as understood in AI/imaging studies.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., images) to establish a consensus ground truth. For animal testing and clinical literature review, the "adjudication" is inherent in the study design and clinical assessments, rather than a separate expert-consensus process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This is not applicable. MRMC studies are specific to evaluating imaging devices or AI algorithms that assist human readers in interpreting medical images. The Auto Suture™ ENDO GIA™ Stapler is a physical surgical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This question pertains to AI algorithms.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the evidence used to validate the device's performance for the new indication. It includes:
- In-vivo animal test results: Direct observation and assessment of the stapler's performance in living tissue (likely related to staple line integrity, hemostasis, tissue healing, etc.).
- Clinical literature: Published evidence of the device's or similar devices' performance and safety when used in liver resection/transection. This could include pathology reports, surgical outcomes, patient follow-up data, etc., as documented in the literature.
8. The Sample Size for the Training Set
This is not applicable. "Training set" refers to data used to train an AI algorithm. For a physical medical device, there is no AI training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
§ 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.