(30 days)
Endo GIA™ reinforced reload with Tri-Staple™ Technology 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. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.
The Endo GIA™ Reinforced Reload with Tri-Staple™ Technology places two, triple-staggered rows of titanium staples with a reinforcement material and simultaneously divides the tissue and the reinforcement material between the two, triple-staggered rows. The absorbable staple line reinforcement material, comprised of a synthetic polyester composed of pure alvcolide, will be secured to the anvil and cartridge sides of the reload with four synthetic absorbable sutures. The size of the staples is determined by the selection of the 3.0-4.0 mm or 4.0-5.0 mm Reload. The Endo GIA™ Reinforced Reload with Tri-Staple™ Technology is only available in the articulating 45 mm and 60 mm length cartridges with the 3.0-4.0 mm or 4.0-5.0 mm staples, respectively.
The provided document is a 510(k) summary for a surgical stapler device (Endo GIA™ Reinforced Reload with Tri-Staple™ Technology). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for an AI/diagnostic device would.
Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of medical device submission (a surgical stapler reload) and are not present in the provided text.
However, I can extract the relevant information regarding performance data and what serves as "acceptance criteria" for demonstrating substantial equivalence for this device.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this device are implicitly tied to demonstrating performance comparable to the predicate device in specific bench and animal tests, ensuring safety and effectiveness. The document lists the types of tests performed; the success in these tests constitutes meeting the "acceptance criteria" for substantial equivalence. The document states that the results "demonstrate that the subject device... is substantially equivalent to the predicate device(s)."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrate safe and effective performance as intended. | Bench and animal performance evaluations were completed to verify that the device is safe and effective and performs as intended. |
| Prove substantial equivalence to predicate devices. | Performance tests (In Vitro and In Vivo) were conducted. The results demonstrated substantial equivalence to the predicate device(s) regarding stapling and staple line reinforcement technologies. |
| Biocompatibility in accordance with ISO Standard 10993-1. | All components are comprised of materials in accordance with ISO Standard 10993-1. Biocompatibility testing was performed. |
| Satisfactory In Vitro performance for specific parameters. | Performed tests: Insertion/removal force, Firing force, Retraction force, Staple formation, iDrive Ultra testing, Twek Pull apart, Sequential firings, Perpendicular firings, L-shaped firings. (Implicitly, the results of these tests were satisfactory for demonstrating equivalence). |
| Satisfactory In Vivo performance for specific parameters. | Performed tests: Atraumatic reload, Free bleed time, Air leaks, Burst, Additional firings. (Implicitly, the results of these tests were satisfactory for demonstrating equivalence). |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary. The tests are benchtop (in vitro) and animal (in vivo) performance evaluations.
- Data Provenance: Not specified, but generally, such tests would be conducted by the manufacturer (Covidien llc) in their own labs or contract research organizations. These are prospective evaluations conducted specifically for this submission.
3. 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 surgical stapler, not a diagnostic device requiring expert interpretation for ground truth. Performance is assessed through objective physical and biological measurements in bench and animal studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- Not Applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For a surgical stapler, "ground truth" would relate to objective physical and biological parameters such as staple formation, tissue integrity, leak rates, burst pressure, and biocompatibility, as measured by standardized testing methods and instrumentation. The "truth" is established by the validated measurement methods themselves, not by expert consensus on an image or pathology.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a "training set." The device is evaluated based on its physical and biological performance characteristics.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.