(270 days)
The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The proposed devices, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU), are sterilized and disposable surgical instruments, which have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and billiary structures. It places four or six rows of titanium staples and simultaneously divides the tissue from central line. The Endoscopic Linear Cutter Staplers can be adapted for all of the SULU sizes available, and they may be reloaded and fired no more than 10 times in a single procedure. The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Endoscopic Linear Cutting Staplers with Single Use Loading Units:
This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It is not a clinical study report that would typically describe detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies as you requested. The "study" here refers to non-clinical bench testing for substantial equivalence, not a clinical trial or AI algorithm validation.
Therefore, many of your requested items are not applicable (NA) or not explicitly stated in this type of regulatory submission.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance
The provided text describes a "Substantial Equivalence (SE) Conclusion" based on a comparison to a predicate device, rather than explicit numerical acceptance criteria for a new clinical performance study. The reported performance is that the proposed device is "Substantially Equivalent" to the predicate device in terms of safety and effectiveness, based on meeting similar technological characteristics and passing non-clinical tests.
| Item | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Proposed Device Performance |
|---|---|---|
| Intended Use | Must be same as predicate. | Applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. May be used for transection and resection of liver substance, hepatic vasculature and biliary structures. (Same as Predicate) |
| Product Code | Must be same as predicate (GDW). | GDW (Same as Predicate) |
| Regulation Number | Must be same as predicate (21 CFR 878.4750). | 21 CFR 878.4750 (Same as Predicate) |
| Class | Must be same as predicate (II). | II (Same as Predicate) |
| Cutting Mechanism | Must be same as predicate (Linear). | Linear (Same as Predicate) |
| Operation Principle | Must be same as predicate (Manual). | Manual (Same as Predicate) |
| Safety Mechanism | Must be same as predicate. | Green button for preventing from mis-firing. (Same as Predicate) |
| Suture Length | Must be similar to predicate. | 46, 61 mm (Similar to Predicate) |
| Closed Staples Height | Must be same as predicate. | 0.75, 1.0, 1.5, 2.0 mm (Same as Predicate) |
| Closed Staples Form | Must be same as predicate. | Image: staple form (Same as Predicate) |
| Staple Material | Must be same as predicate (Unalloyed Titanium conforms to ASTM F 67-06). | Unalloyed Titanium conforms to ASTM F 67-06 (Same as Predicate) |
| Stapler Materials | Must be same as predicate (Stainless Steel). | Stainless Steel (Same as Predicate) |
| Sterilization | Must be similar to predicate. | Irradiation Sterilized, SAL: 10-6 (Similar to Predicate) |
| Overall Safety & Effectiveness | Must be demonstrably equivalent to predicate. | Determined to be Substantially Equivalent to predicate (K120179). (Meets Criteria) |
| Non-Clinical Design Specifications | All design specifications must be met. | All design specifications met through Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing. (Meets Criteria) |
Study Details (as inferable from the provided text)
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 for Test Set: Not specified. The "test set" here refers to units of the device subjected to non-clinical bench testing. The number of devices tested for "Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing" is not detailed.
- Data Provenance: Not specified. These are non-clinical bench tests; geographical origin of data is typically less relevant than for clinical studies. The manufacturer is Nanjing Maidixin Medical Device Company, LTD (China), suggesting the testing likely occurred there or through a contract lab.
- Retrospective/Prospective: NA. This classification typically applies to clinical studies.
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)
- NA. This document describes non-clinical engineering and performance testing, not evaluation by medical experts to establish a "ground truth" for diagnostic or clinical outcome data. The "ground truth" here is objective measurement results from bench tests compared to design specifications or predicate device characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- NA. Adjudication methods are relevant for clinical studies or image interpretation, not for bench testing of a stapler.
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
- NA. This type of study is for AI-powered diagnostic or assistive devices, which this stapler is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- NA. This device does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on objective engineering and laboratory measurements (e.g., staple height, material composition, sterilization levels, physical performance metrics like cutting force or staple formation) and the established characteristics of the legally marketed predicate device.
8. The sample size for the training set
- NA. This device does not use machine learning, so there is no training set. The "design specifications" could be considered the "training" for the device's manufacturing and testing.
9. How the ground truth for the training set was established
- NA. Not applicable as there is no training set in the context of an AI/ML algorithm. The "ground truth" for the device's design and manufacturing standards would have been established through engineering principles, regulatory standards (e.g., ASTM F67-06 for titanium), and comparison to existing, proven devices (the predicate).
§ 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.