(364 days)
Mirus™ Circular Stapler has application throughout the alimentary tract for end to end, end to side and side to side anastomoses.
Mirus™ Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses.
Mirus™ Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Mirus™ Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures.
The Mirus™ Circular Stapler are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver double staggered concentric rows of staples on the outside of the cut line. The circular stapler is available in diameter of the staple line from 24mm, 25mm, 26mm, 29mm, 32mm or 34mm stapler. The device has a detachable anvil that allows the surgeon to place the anvil in the desired location. Mirus™ Circular Stapler is preloaded with Staples.
Mirus™ Linear Cutter stapler and the Reload have two groups of staple lines in the target area, both of which are composed of a double row of titanium staples interlaced with each other and automatically cut the tissues between the two groups of staple lines when suturing. There are three suturing lengths of 60mm, 80mm and 100mm. The cartridge/ reload for Mirus™ Linear Cutter are supplied separately.
Mirus™ Hemorrhoids Circular Stapler is a set of instruments that places a circular row of titanium staples (double staggered) while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired. The Mirus™ Hemorrhoid circular stapler is preloaded with staples.
Mirus™ Linear Stapler places a double staggered row of titanium Staples. They are available in 30mm, 45mm, 60mm and 90mm staple line length. The cartridge/ reload for Mirus™ Linear stapler are supplied separately
This FDA 510(k) clearance document outlines the substantial equivalence of the "Mirus Family of Surgical Staplers" to predicate devices, thus it doesn't contain a detailed clinical study with specific acceptance criteria and performance metrics typically found for AI/ML devices.
However, based on the provided text, we can infer the types of acceptance criteria used for this medical device (surgical staplers) and the nature of the "study" (preclinical performance testing) that demonstrates these criteria are met.
Here's an analysis structured per your request, with the understanding that specific numerical performance metrics are not given for acceptance criteria in this document, but rather a qualitative assessment of equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred from document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Functional Performance | - Visual Appearance (absence of defects) | Demonstrated substantial equivalence to predicates. |
| - Dimensional Measurement (conformance to specifications) | Demonstrated substantial equivalence to predicates. | |
| - Open Staple Height (conformance to specifications) | Demonstrated substantial equivalence to predicates. | |
| - Closed Staple Height (conformance to specifications) | Demonstrated substantial equivalence to predicates. | |
| - Staple Formation Test (proper staple crimping) | Demonstrated substantial equivalence to predicates. | |
| - Staple Line Integrity and Staple Formation (adequate sealing/closure) | Demonstrated substantial equivalence to predicates. | |
| - Pressure Resistance Test (withstand internal pressure) | Demonstrated substantial equivalence to predicates. | |
| - Force to Fire (ease of operation) | Demonstrated substantial equivalence to predicates. | |
| Biocompatibility | Absence of adverse biological reactions (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, genotoxicity, subchronic systemic toxicity, implantation effects) | All identified tests were performed and met the requirements outlined in ISO 10993-1 and FDA guidance. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 | Validated as per ISO 11135 using an overkill (half-cycle) method. EtO residuals met ISO 10993-7. |
| Packaging & Shelf Life | - Package integrity throughout shelf life | Validated as per ISO 11607. |
| - Shelf life validity | Validated as per ICH Q1A (R2) & ISO 11607. | |
| - Performance of aged samples | Performance testing on aged samples demonstrated continued satisfactory operation. | |
| - Ability to withstand transportation stresses | Transportation Study as per ASTM D 999 & ASTM D 5276 was conducted. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each performance test. It states "Simulated use testing was performed utilizing each device of the Mirus™ family of surgical staplers," implying that representative samples of each stapler type were tested.
- Test Set Sample Size: Not explicitly stated numerically for each test. Implied to be representative samples of each of the four device types (Circular, Linear Cutter, Hemorrhoidal Circular, Linear Stapler).
- Data Provenance: Preclinical / bench testing data generated by the manufacturer (M/s. Meril Endo Surgery Private Limited). The document does not specify country of origin for the test data generation itself, but the manufacturer is based in Gujarat, India. This generally implies retrospective testing performed to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this document. The "ground truth" for mechanical device performance tests is based on objective measurements against engineering specifications and international standards (e.g., staple height measurements, force measurements, chemical analyses for biocompatibility). It does not involve human expert interpretation in the same way an AI/ML diagnostic device would.
4. Adjudication method for the test set
This is not applicable as it refers to a consensus method for expert review, which is not relevant for preclinical mechanical performance and biocompatibility testing of this nature. All tests were conducted against pre-defined, objective criteria in relevant standards.
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
This is not applicable. This document describes the clearance of surgical staplers, which are mechanical medical devices, not AI/ML-assisted diagnostic tools. Therefore, MRMC studies and "human readers" interpreting AI output are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a mechanical surgical stapler, not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the preclinical performance tests is established by:
- Engineering specifications for dimensional, force, and staple formation characteristics.
- International standards (e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, ISO 11607 for packaging) which define acceptable limits and testing methodologies.
8. The sample size for the training set
This is not applicable. As a mechanical device, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above. There is no training set for this type of device.
§ 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.