The LS Series Linear Stapler and Reloads have application or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The CLC Series Curved Linear Cutter and Reloads is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
The LC Series Linear Cutter and Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses.
The ELC Series Endoscopic Linear Cutter and Single Use Loading Unit have applications in general, abdominal, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.
The proposed device, LS Series Linear Stapler and Reloads is a sterilized and disposable surgical instrument intended to be used in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. It places a double staggered row of titanium staples. It is available in 30 mm, 45 mm, 60 mm and 90 mm staple line length for use in various applications. Three staple sizes (2.5 mm, 3.5 mm, and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings. It has two configurations: (1) LS serials are staplers, and (2) LSC serials are Reloads. Each of them has various specifications.
The proposed device, CLC Series Curved Linear Cutter and Reloads are sterilized and disposable surgical instrument, which has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures. It is mainly suitable for low rectal resection and anastomosis of tissues where manual anastomosis is difficult. It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. It is available in 37mm and 43mm lengths. Two staple sizes (3.8 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings. It has two configurations: (1) CLC serials are staplers, and (2) CLCC serials are reloads. Each of them has various specifications.
The proposed device, LC Series Linear Cutter Stapler and Reloads are sterilized and disposable surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and the creation of anastomoses. It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 60 mm, 80 mm and 100 mm lengths. Three staple sizes (3.8 mm, 4.2mm and 4.5 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 11 times for total 12 firings. It has two configurations: (1) LC serials are staplers, and (2) LCC serials are reloads. Each of them has various specifications.
The proposed device, ELC Series Endoscopic Linear Cutter and Single Use Loading Unit are sterilized and disposable-surgical instrument, which has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. Five staple sizes (2.0mm, 2.5mm, 4.0mm, and 4.8mm) are available to accommodate various tissue thicknesses. Each cartridge could be reloaded no more than 7 times for total 8 firings. It can be adapted for all of the reload sizes available. It has two configurations: (1) ELC-G and ELC-T serials are staplers, and (2) MG and RG serials are cartridges. Each of them has various specifications.
The provided text describes a 510(k) premarket notification for several series of surgical staplers and reloads (LS Series Linear Stapler, CLC Series Curved Linear Cutter, LC Series Linear Cutter, and ELC Series Endoscopic Linear Cutter). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are tied to non-clinical testing performed to show substantial equivalence. The document summarizes performance testing and other evaluations rather than a clinical study with human patients or an AI algorithm's performance.
Here's an analysis based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense for each parameter, but rather compares the proposed device's characteristics and performance to that of a predicate device. The implicit acceptance criterion is that the proposed device must perform "the same" or "similarly" to the predicate device in aspects deemed critical for safety and effectiveness, and any differences must not affect safety and effectiveness.
The non-clinical tests conducted include:
- Performance Testing: Physical Specification, Closed Staple Height Dimensions, Pressure Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair, and Force Required to Fire Stapler.
- Endotoxin Limit
- Package Integrity: Dye penetration tests and seal strength test.
- Shelf Life
Here's a table combining the general performance parameters across the different proposed devices, with the understanding that "Same" implies meeting the implicit acceptance criteria of being equivalent to the predicate device. Where specific values are given for the Proposed Device and "Same" or "Similar" for the Predicate, it means the proposed device meets that value and is considered acceptable in comparison to the predicate.
Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Item | Implicit Acceptance Criteria (Compared to Predicate) | Proposed Device Performance |
|---|---|---|
| General | ||
| Product Code | Must be GDW | GDW |
| Regulation No. | Must be 21 CFR 878.4750 | 21 CFR 878.4750 |
| Class | Must be II | II |
| Intended Use | Must be equivalent to predicate's intended use | Stated as "Same" or equivalent |
| Operation Principle | Must be Manual | Manual |
| Closed Staple Form | Must be "staple form" (Image) | "Image: staple form" (Same) |
| Pressure Resistance after Suturing | $\geq$ 3.6 kPa | $\geq$ 3.6 kPa (Same) |
| Staple Material | Unalloyed Titanium conforms to ASTM F 67-06 | Unalloyed Titanium conforms to ASTM F 67-06 (Same) |
| Stapler Materials | Stainless Steel, Polycarbonate | Stainless Steel, Polycarbonate (Same) |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Irradiation Sterilized, SAL: 10-6 (Same) |
| Endotoxin Limit | 20 EU per Product | 20 EU per Product (Same) |
| Package | Tray with Tyvek Paper | Tray with Tyvek Paper (Same) |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 (Same) |
| Specific to LS Series Linear Stapler | ||
| Safety Mechanism | Safety Release for preventing mis-firing | Safety Release for preventing from mis-firing (Same) |
| Suture Line Length | Similar to predicate | 30, 45, 50, 60, 90 mm |
| Number of Staples | Similar to predicate | 13, 19, 21, 23, 25, 39 |
| Closed Staple Height | Similar to predicate | 1.0, 1.5, 2.0 mm |
| Specific to CLC Series Curved Linear Cutter | ||
| Cutting Mechanism | Curved Knife | Curved Knife (Same) |
| Safety Mechanism | Safety Release for preventing mis-firing | Safety Release for preventing from mis-firing (Same) |
| Cutting Line | Similar to predicate | 37, 43 mm |
| Row Number of Staple | 4 | 4 (Same) |
| Closed Staple Height | Similar to predicate | 1.5, 2.0 mm |
| Hardness (Circular knife) | $\cong$ 380HV0.2 | $\cong$ 380HV0.2 (Same) |
| Specific to LC Series Linear Cutter | ||
| Cutting Mechanism | Linear Knife | Linear Knife (Same) |
| Safety Mechanism | Safety Release for preventing mis-firing | Safety Release for preventing from mis-firing (Same) |
| Suture Length | Similar to predicate | 60, 80, 100 mm |
| Cutting Length | Similar to predicate | 54, 74, 94 mm |
| Number of Staple | Similar to predicate | 64, 84, 104 |
| Closed Staple Height | Similar to predicate | 1.5, 1.8, 2.0 mm |
| Hardness (Circular knife) | $\geq$ 380HV0.2 | $\geq$ 380HV0.2 (Same) |
| Specific to ELC Series Endoscopic Linear Cutter | ||
| Cutting Mechanism | Linear Knife | Linear Knife (Same) |
| Safety Mechanism | Green button for preventing mis-firing | Green button for preventing from mis-firing (Same) |
| Suture Length | Same as predicate | 30, 45, 60 mm |
| Cutting Length | Same as predicate | 26, 41, 56 mm |
| Closed Staple Height | Same as predicate | 0.75, 1.0, 1.5, 1.7, 2.0 mm |
| Hardness (Circular knife) | $\ge$ 380HV0.2 | $\ge$ 380HV0.2 (Same) |
The study that proves the device meets (or is substantially equivalent to) these criteria is the "Non-Clinical Test Conclusion" section, which states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
2. Sample size used for the test set and the data provenance
The document specifies "Non clinical tests were conducted," including "Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair and Force Required to Fire Stapler." It also mentions "Endotoxin Limit," "Package Integrity," and "Shelf Life" tests.
The exact sample sizes for these non-clinical tests are not explicitly stated in the provided text. The data provenance is also not explicitly detailed, but it would have been generated internally by the manufacturer, Touchstone International Medical Science Co., Ltd., likely from their manufacturing and testing facilities. These are generally prospective tests conducted on manufactured devices/lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a non-clinical device submission for surgical staples and cutters. The "ground truth" in this context is established by engineering specifications, material standards (e.g., ASTM F 67-06 for titanium), and performance measurements against those specifications and the predicate device's known performance. There were no human experts establishing a "ground truth" in a diagnostic or clinical sense. The evaluation of test results would be performed by engineers and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is a non-clinical device test for engineering specifications, there is no "adjudication method" involving multiple human readers as would be seen in clinical or image-based AI studies. The data would be analyzed against predetermined engineering specifications and comparison data from the predicate device.
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 submission is for surgical stapling devices, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device evaluation is based on:
- Engineering specifications and design requirements: For parameters like dimensions, materials, and mechanical properties.
- International/Industry Standards: Such as ASTM F 67-06 for titanium.
- Comparison to predicate device performance: The "Same" or "Similar" designations in the comparison tables imply that the predicate device's established performance serves as a benchmark for the proposed device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm, so there is no training set or ground truth establishment for one.
§ 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.