(133 days)
The Disposable End-to-end Anastomosis Circular Stapler has applications throughout the alimentary tract for the creation of end-to end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
The Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and for transection and resection and resection of pancreas.
The Linear Cutting Stapler and Single Use Loading Unit has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection and creation of anastomosis. The stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection of pancreas.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
Disposable End-to-end Anastomosis 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 and 31mm three specifications. The staple size is 4.8 mm.
Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit places two, triple-staggered rows of progressive or equal titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in staple sizes 2mm-3mm, 3mm-4mm, 2.5mm, 4.0mm. 4.8mm to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.
Linear Cutting Stapler and Single Use Loading Unit places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. 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 7 times for a total 8 firings in a single procedure.
Disposable Hemorrhoidal Circular Stapler is a set of instrument 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 is available in 33mm one specification. The staple size is 4.5mm. It cannot be reloaded.
This document is a 510(k) Summary for premarket notification of several surgical staplers. It focuses on demonstrating Substantial Equivalence (SE) to legally marketed predicate devices, rather than proving a device meets specific acceptance criteria in a clinical study or demonstrating an improvement in human reader performance with AI assistance.
Therefore, most of the information requested in your prompt (e.g., acceptance criteria for a study, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, training set specifics) cannot be extracted from this document, as it describes a different type of regulatory submission process.
The document primarily outlines non-clinical testing to establish technical equivalence and mentions no clinical studies were performed for this submission.
Here's what can be extracted based on the provided text, and where your requested information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the sense of clinical performance thresholds or a pre-defined set of performance metrics for human-in-the-loop or standalone AI. Instead, it describes non-clinical test conclusions verifying design specifications and substantial equivalence to predicate devices. The "reported device performance" is essentially that the device met these design specifications and performed comparably to predicate devices in bench tests.
Non-Clinical Test Conclusions and Performance (Staplers)
| Test Category | Acceptance/Conclusion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conforms to ISO 10993-1, -5, -10 standards. | Device materials are biocompatible (e.g., non-cytotoxic, non-irritating, non-sensitizing). |
| Sterilization | Conforms to ISO 11137-2 (Radiation) and ISO 11135 (Ethylene Oxide) standards. | Device can be effectively sterilized and maintain sterility. |
| Packaging Integrity | Conforms to ASTM F 88/F88M-09 (Seal Strength) and ASTM F1929-12 (Dye Penetration). | Packaging maintains seal integrity to protect the sterile device. |
| Endotoxin Limit | Meets specified endotoxin limit (20 EU). | Device has low endotoxin levels as required. |
| Bench Test (Swine tissue) | Demonstrated Substantial Equivalence to predicate devices. Includes: Pressure Resistance Test, Closed Staple Height Test, Staple Formation Test, Force Required to Fire Stapler Test. | Proposed devices performed comparably to predicate devices in these tests. For example, Closed Staple Height and Closed Staple Form were found to be "Same" or very similar to predicate devices, and force required to fire was suitable. (Specific numerical performance data like exact pressure resistance values are not provided in this summary, only the conclusion of 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 for the bench tests. It says "Bench test was conducted on swine stomach and intestine tissue," but the number of samples or animals is not provided.
- Data Provenance: The bench tests involved "swine stomach and intestine tissue." The manufacturer is Chongqing Qmi Surgical Co., Ltd. in China. The location where the bench tests were performed is not explicitly stated beyond "Non clinical tests were conducted," but it's implied to be part of the manufacturer's testing or a contracted lab. The data would be considered prospective as it's generated 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 submission relies on non-clinical bench testing to demonstrate the physical and functional performance of the staplers against defined engineering specifications and comparison to predicate devices, not on human expert interpretation of medical images or records. Therefore, "ground truth" as typically defined for AI/diagnostic studies (e.g., expert consensus, pathology) is not established by human experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3. This is not a study requiring human adjudication for ground truth.
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 MRMC study was done. This document is for a surgical stapler, not an AI device. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (surgical stapler), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical bench tests, "ground truth" would be the engineering specifications and physical properties of the stapler and the tissue tests. For example, "Closed staple height" is a measurable physical attribute, not a subjective interpretation. Comparison to predicate device performance also serves as a benchmark for equivalence.
8. The sample size for the training set
- Not applicable. This device is a surgical stapler, not an AI/machine learning model. There is no "training set."
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.