(90 days)
The Signia™ stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of the pancreas.
The Signia™ stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.
The Signia™ stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ Technology, has applications 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 the pancreas.
The Signia™ stapler. when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloads preloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.
The Signia™ Stapler is a battery powered microprocessor controlled surgical stapler that provides push-button powered maneuverability and firing of compatible Covidien stapling reloads. The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ Linear Adapter. System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, and Signia™ Single Bay Charger.
The User controls the Signia™ Stapler via button presses on the Handle and receives feedback status and other information from the Handle via its OLED Display, LED indicator and audible annunciator. Pushbutton / Toggle switches on the Handle are provided for:
- Stapling activation: Advancing the Firing Rod / Clamping / Unclamping .
- Left and Right Articulation .
- Clockwise and Counter Clockwise Rotation .
When the appropriate buttons are pressed, the Signia™ Stapler software initiates stapling (firing), articulation or rotation operation by turning on the appropriate motor. The motors have built-in encoders which provide shaft position information. The software controls motor speed and position using encoder pulses. Since it is possible to press multiple keys simultaneously, software must be able to process them and take appropriate actions.
The Signia™ Stapier is compatible with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads, and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges.
The Signia™ Stapler when used with the abovementioned family of Endo GIA™ reloads is a surgical device for stapling and cutting tissues. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, cleaning, sterilization, and use of surgical devices.
This document is a 510(k) premarket notification from the FDA regarding the Covidien Signia™ Stapler, a surgical stapler. It describes the device, its intended use, and the tests performed to demonstrate its substantial equivalence to a predicate device.
There is no information in the provided document about AI implementation, acceptance criteria for AI performance, clinical study results proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.
The document does list various tests performed (Lifecycle Reliability, Cleaning Validation, Aseptic Barrier, Functional Performance, Usability, Biocompatibility, Electrical Safety, EMC/EMI) to show that the Signia™ Stapler is substantially equivalent to a predicate device (iDrive™ Ultra Powered Handle with Endo GIA™ Adapter) based on its technological and performance characteristics, and not based on AI performance or clinical performance data.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving AI device performance, as the document pertains to a traditional medical device (stapler) and its substantial equivalence without mention of AI.
To directly answer your specific points based only on the provided text, many are "Not Applicable" or "Not Provided":
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A table of acceptance criteria and the reported device performance:
- Not Provided. The document states that "Qualitative and quantitative data were obtained and used to compare the Signia™ Stapler to the predicate iDrive Ultra™ Powered Handle with Endo GIA™ Adapter," and that "The design differences were found to not affect safety or performance through applicable design verification activities that showed conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing." However, specific acceptance criteria for these tests or the quantitative performance results are not detailed in this summary. It's focused on "substantial equivalence" to a predicate device without specific performance metrics listed in this public summary.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Provided. The document mentions "Functional Performance Test Bench and Animal" studies but does not specify sample sizes or data provenance (country, retrospective/prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This is a hardware surgical device, not an AI or diagnostic device that requires expert-established ground truth on a test set in the manner described for AI. The "ground truth" would be the engineering specifications and performance capabilities of the device itself and its predicate.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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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 not an AI device. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the context of AI. For a surgical stapler, the ground truth relates to its mechanical and functional performance, safety standards, and equivalence to a legally marketed predicate device. This would typically involve engineering specifications, material properties, mechanical testing results (e.g., staple formation, tissue compression, firing force), and possibly animal studies for functional performance.
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The sample size for the training set:
- Not Applicable. No AI training set is mentioned or implied.
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How the ground truth for the training set was established:
- Not Applicable. No AI training set is mentioned or implied.
In summary, the provided FDA document is a regulatory letter concerning the substantial equivalence of a physical surgical stapler, not an AI-powered medical device. Therefore, the questions related to AI performance, test sets, ground truth establishment by experts, and MRMC studies are not addressed by this document.
§ 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.