(119 days)
Endo GIA™ Staplers: The Endo GIA™ Staplers 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 and for transection and resection of pancreas.
Endo GIA™ Radial Reload with Tri-Staple™ Technology: The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
DST Series™ GIA™ Staplers: The DST Series™ GIA™ Staplers and the DST Series™ SGIA™ Knifeless Stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The SGIA™ Knifeless stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
DST Series™ TA™ Staplers: The Auto Suture™ TA™ Reloadable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The 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 appropriate single use reload that is available in 30, 45 and 60 mm lengths as well as being available with optional Duet TRS™ staple line reinforcement material and optional curved-tip anvil for reloads with Tri-Staple™ Technology.
The Endo GIA™ Single Use Radial Reload with Tri-Staple™ Technology 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 appropriate single use reload that is available in a 60 mm length only.
The DST Series™ GIA™ Stapler place two double staggered rows of titanium staples and simultaneously divides the tissue between the two double rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in 60, 80 and 100 mm lengths.
The DST Series™ SGIA™ Knifeless Stapler places two double staggered rows of titanium staples. The size of the staples is determined by the selection of a 2.5 mm staple size single use reload available in a 60 mm length only.
The DST Series™ TA™ Stapler places a double staggered row of titanium staples. The size of the staples is determined by the selection of the appropriate single use reload that is available in 30, 45, 60 and 90 mm lengths.
This document is a 510(k) Summary of Safety and Effectiveness for the Endo GIA™ Staplers, DST Series™ GIA™ Staplers, and DST Series™ TA™ Staplers. The primary change highlighted is the inclusion of a specific indication for use in the transection and resection of the pancreas.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for functional performance (e.g., staple line integrity, leak rates, burst pressure). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices and the successful clinical literature review.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is substantially equivalent to predicate devices | "The Endo GIA™ Staplers, DST Series™ GIA™ Staplers and TECHNOLOGICAL DST Series™ TA™ Staplers are each identical to their predicate device." and "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
| Materials are in accordance with ISO Standard 10993-1 | "All components of the Endo GIA™ Staplers, DST Series™ MATERIALS: GIA™ Staplers and DST Series™ TA™ Staplers are comprised of materials, which are in accordance with ISO Standard 10993-1." |
| Clinical application for transection and resection of pancreas is supported | "A clinical literature review was performed to demonstrate and PERFORMANCE DATA. support the clinical application of the Endo GIA™ Staplers, DST Series™ GIA™ Staplers and DST Series™ TA™ Staplers for transection and resection of pancreas." (The outcome of this review is implied to be sufficient for regulatory approval, as the device was deemed substantially equivalent.) |
| Intended Use includes transection/resection of pancreas | The "Indications For Use" section details the specific application of the devices for "transection and resection of pancreas" for all listed stapler types (Endo GIA™ Staplers, DST Series™ GIA™ Staplers, and DST Series™ TA™ Staplers). This is the key performance claim being supported by the literature review and forms the basis of the substantial equivalence for the expanded indication. No specific numerical performance metrics are provided for pancreatic resection, but rather the general applicability is deemed supported. |
Study Details
-
Sample size used for the test set and the data provenance:
The document mentions a "clinical literature review." This implies that the 'test set' was not a de novo, prospectively collected dataset for this specific submission, but rather existing published clinical data. The exact sample size (number of patients or cases) of the literature review is not specified. The data provenance (country of origin, retrospective/prospective) is also not specified, as it would depend on the individual studies included in the review. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not describe a process for establishing ground truth with a specific number of experts for a 'test set' in the traditional sense of an AI/diagnostic device study. The "clinical literature review" relies on the reported outcomes and findings of published studies, where the "ground truth" would have been established by the inherent diagnostic and surgical practices of the medical professionals involved in those studies (e.g., surgeons performing the procedures, pathologists examining resected tissue, follow-up clinicians assessing outcomes). The qualifications of these implicit "experts" from the literature are not detailed but would generally be medical professionals specializing in surgery (abdominal, gynecologic, pediatric, thoracic) and pathology. -
Adjudication method for the test set:
Not applicable in this context. The clinical literature review does not describe an adjudication process for a specific test set. The review synthesizes findings from multiple studies, and any form of "adjudication" would be at the discretion of the original study authors or implicitly through the peer-review process of the medical literature itself. -
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:
Not applicable. This is a surgical device, not a diagnostic AI device. The submission does not describe an MRMC study or any AI assistance. The clinical literature review supports the device's intended use, not the performance of human readers with or without AI. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical surgical stapling device, not a software algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the clinical literature review, the "ground truth" would have been derived from the outcomes data (e.g., successful transection, anastomosis integrity, post-operative complications, patient survival) and potentially pathology results from the surgical procedures described in the reviewed literature. It would be based on the established clinical practices and follow-up prevalent in those studies. -
The sample size for the training set:
Not applicable. This is a medical device, and the "clinical literature review" is not a "training set" in the context of machine learning. The device design and manufacturing process would involve extensive engineering testing and simulations, but the literature review serves to expand the intended use based on existing clinical evidence, not to train an algorithm. -
How the ground truth for the training set was established:
Not applicable, as there is no training set in the AI sense for this device submission.
§ 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.