The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease.
The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.
The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
Disposable Circular Stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm, 28mm, 29mm and 32mm five specifications. The staple is available in 4.5mm and 4.8mm two different heights.
Disposable Endoscopic Linear Cutter Stapler and Unit places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three specifications. Reloads are available in 2.5mm, 4.0mm and 4.8mm four staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.
Disposable Hemorrhoidal Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 32mm, 33mm three specifications. The staple size is 3.8mm. It cannot be reloaded.
Disposable Linear Cutter Staplers and Reload places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm five specifications. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 8 times in a single procedure.
The Disposable Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm four specifications for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 8 times in a single procedure.
The provided document is a 510(k) Summary for various disposable staplers and reload devices. It describes non-clinical tests to verify performance but does not include any information about studies involving acceptance criteria related to AI/human reader performance, ground truth establishment by experts, or any MRMC comparative effectiveness studies.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to medical device regulatory submission for staplers, not AI medical devices.
However, I can provide the following based on the Non-Clinical Test Conclusion section:
1. A table of acceptance criteria and the reported device performance
The document mentions several tests and standards the device complies with, which would imply passing these as acceptance criteria. It doesn't provide specific numerical acceptance criteria or performance metrics for each test, but generally states that the device "met all design specifications" and "complies with the following standards".
| Test/Standard | Reported Device Performance (Implied Acceptance) |
|---|---|
| ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process. | Device complies with the standard. |
| ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity. | Device complies with the standard. |
| ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity | Device complies with the standard. |
| USP42-NF37 Bacterial Endotoxins Tests | Device complies with the standard. |
| ASTM F 88/F88M-15 Standard test method for seal strength of flexible barrier materials; | Device complies with the standard. |
| ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Device complies with the standard. |
| ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Device complies with the standard. |
| Ex-vivo tissue test (porcine stomach and intestine tissue) - Pressure Rest, Closed Staple Dimension Test, Staple Formation Test, Force Required to Fire Stapler Test. | Test results demonstrated the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. |
| Jugular vein test (porcine model) - Burst pressure, closed staple height and staple formation. | Test results demonstrated the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: The ex-vivo and jugular vein tests were conducted on "porcine stomach and intestine tissue" and a "porcine model," respectively. This indicates animal tissue, not human data. The geographical origin of the tests is within "Beijing Biosis Healing Biological Technology Co., Ltd." in China (derived from company address). The tests are described as non-clinical "conducted to verify," implying prospective testing for the 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. There is no mention of experts or ground truth establishment for a test set in the context of human interpretation or AI performance studies. The testing is for medical staplers, not an AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of adjudication methods for a test set, as this document refers to physical device testing rather than expert-based assessments of data.
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
No. This document explicitly states: "No clinical study is included in this submission." Furthermore, the device is a surgical stapler, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a surgical stapler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the ex-vivo and jugular vein tests, the "ground truth" would be the direct measurements and observations of the physical performance characteristics (e.g., staple formation, burst pressure, seal strength) as defined by engineering specifications and relevant standards, demonstrated through the "device met all design specifications" claim. This is physical performance testing, not diagnostic accuracy evaluation.
8. The sample size for the training set
Not applicable. The document describes a physical medical device (stapler), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this document does not describe an AI algorithm or a training set.
§ 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.