(35 days)
The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement 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 billary structures.
The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement place 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 3.5 mm or 4.8 mm Single Use Loading Unit (SULU). The ENDO GIA™ UNIVERSAL Single Use Loading Units (SULUs) with Staple Line Reinforcement are only available in the straight and articulating 45 mm and 60 mm length cartridges with the 3.5 mm or 4.8 mm staples. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each SULU undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. Studies indicate that the staple line reinforcement material can be expected to retain measurable mechanical strength through 14 days and absorption should be complete between 90 and 110 days.
The provided text describes a 510(k) summary for the Autosuture™ ENDO GIA™ Surgical Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement. However, it does not include information about specific acceptance criteria or an explicit study that proves the device meets those criteria in the context of a typical AI/software device evaluation.
The document mainly focuses on the device description, intended use, technological characteristics, and material safety. It states: "Performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units with Staple Line Reinforcement are safe and effective and perform as intended." This is a general statement and does not provide the detailed information requested regarding specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement, which are typical for studies assessing AI device performance.
Therefore, I cannot provide the requested information from the given text. The text does not contain:
- A table of acceptance criteria and reported device performance: No specific performance metrics or acceptance thresholds are listed.
- Sample size used for the test set and data provenance: No information on the number of cases or the origin of data used for performance evaluation.
- Number of experts used to establish ground truth and their qualifications: No mention of expert involvement in establishing ground truth.
- Adjudication method for the test set: Not applicable as no ground truth creation process is described.
- MRMC comparative effectiveness study: The document does not describe a study involving human readers with or without AI assistance.
- Standalone (algorithm only) performance: This device is a surgical stapler, not an AI algorithm, so standalone algorithm performance is not applicable in the usual sense. Its performance is inherent to its mechanical function and material properties.
- Type of ground truth used: Not applicable as it's a physical device and not an AI interpreting data. The "ground truth" for a physical device would relate to its mechanical integrity and biological interaction, which is assessed through various engineering and biocompatibility tests.
- Sample size for the training set: Not applicable as this is a physical device, not an AI system that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason.
The "performance evaluations" mentioned in the document likely refer to laboratory testing, mechanical robustness tests, biocompatibility assessments, and potentially animal studies, which are standard for surgical devices, rather than clinical studies involving human readers or AI algorithms that would generate the kind of data you're asking for.
§ 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.