(268 days)
The MicroCutter XCHANGE® 30 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatic surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
The MicroCutter XCHANGE® 30 is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The size of the White Cartridge staple is compatible with tissue that can be easily compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
Here's a breakdown of the acceptance criteria and study information for the Cardica MicroCutter XCHANGE® 30, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, for the tissue burst pressure tests, the acceptance is implied by demonstrating "no statistical difference" compared to the predicate device. For the animal studies, the acceptance is based on an "uncomplicated 5-week postoperative course" and "unremarkable" histological evaluation with "no demonstrable difference between the two groups."
Therefore, the table below reflects the reported performance relative to the predicate, rather than explicit numerical acceptance criteria.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance and Comparison to Predicate |
|---|---|---|
| Bench Testing | ||
| Tissue Burst Pressure (White Cartridge in Porcine Carotid Artery) | Substantially equivalent to predicate device (implied: no statistically significant difference in burst pressure performance compared to the Ethicon PROXIMATE Vascular Linear Cutter 55). | No statistical difference, p>0.05 when compared to the (primary) predicate device, Ethicon PROXIMATE Vascular Linear Cutter 55 (K020779). The document states "Not Available" for the secondary predicate, Ethicon ENDOPATH ETS-Flex45 Endoscopic Linear Cutters (K002398) for this test. |
| Tissue Burst Pressure (White Cartridge in Porcine Jugular Vein) | Substantially equivalent to predicate device (implied: no statistically significant difference in burst pressure performance compared to the Ethicon PROXIMATE Vascular Linear Cutter 55). | No statistical difference, p>0.05 when compared to the (primary) predicate device, Ethicon PROXIMATE Vascular Linear Cutter 55 (K020779). The document states "Not Available" for the secondary predicate, Ethicon ENDOPATH ETS-Flex45 Endoscopic Linear Cutters (K002398) for this test. |
| Chronic Animal Studies | ||
| Postoperative Course | Uncomplicated 5-week postoperative course, no signs of postoperative bleeding or infection, and unremarkable vascular/ureter stumps. Histological evaluation shows no demonstrable difference between subject and predicate device. | All animals had an uncomplicated 5-week postoperative course and were euthanized after a second terminal surgery. The vascular and ureter stumps were all unremarkable without any signs of postoperative bleeding or infection. The histologic evaluation was also unremarkable and showed no demonstrable difference between the two groups. |
| Endpoints | Met the defined study endpoints. | The endpoints of the studies were met. |
2. Sample Size and Data Provenance for Test Set (Bench Testing & Animal Studies)
-
Bench Testing:
- Sample Size: Not explicitly stated in the provided text for the bench testing. The results are described generally as "Tissue Burst pressure testing was conducted."
- Data Provenance: Porcine carotid artery and porcine jugular vein were used, indicating animal tissue (ex vivo) for these specific tests. The country of origin is not specified, but it's likely a controlled laboratory environment. This is prospective data generation for the purpose of the 510(k).
-
Chronic Animal Studies:
- Sample Size: Not explicitly stated as a number of animals per group, but it involved two studies: "a study in which unilateral nephrectomies were performed and a study in which unilateral lobectomies were performed." "All animals" had an uncomplicated course, implying the sample size was sufficient for the study's conclusions.
- Data Provenance: The studies were "chronic animal studies," meaning conducted in vivo on live animals. The type of animal (e.g., porcine, canine) is not specified. The country of origin is not specified. This is prospective data generation.
3. Number of Experts and Qualifications for Ground Truth for Test Set
- Not Applicable. The described studies are performance tests (bench and animal), not diagnostic or image-based studies requiring human expert interpretation as ground truth. The "ground truth" (or outcome assessment) was based on direct physiological measurements (burst pressure), macroscopic observation (postoperative course, stump condition), and microscopic histological evaluation. These evaluations would typically be performed by trained technicians, veterinarians, and pathologists, but they are not "experts" in the context of establishing diagnostic ground truth from images or clinical data.
4. Adjudication Method for Test Set
- Not Applicable. As mentioned above, the studies are performance tests and do not involve human interpretation or adjudication in the manner of, for example, multiple readers assessing medical images. Outcomes are based on objective measurements and pathological/histological findings.
5. MRMC Comparative Effectiveness Study
- No. The provided document describes bench testing and chronic animal studies, not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers and AI assistance. The device is a surgical stapler, not an AI-powered diagnostic tool.
6. Standalone Performance (Algorithm Only)
- No. The device is a surgical stapler. This concept primarily applies to AI/software as a medical device (SaMD) where an algorithm's performance is evaluated independently of human interaction.
7. Type of Ground Truth Used
- Bench Testing: Direct physical measurements (e.g., burst pressure) under controlled laboratory conditions, and comparison to a legally marketed predicate device.
- Chronic Animal Studies:
- Macroscopic observation: Postoperative course assessment (complications, bleeding, infection), visual inspection of vascular and ureter stumps.
- Microscopic evaluation: Histological assessment of tissue.
- Comparison of these outcomes between the subject device and the predicate device.
8. Sample Size for the Training Set
- Not Applicable. This device is a mechanical surgical stapler. There is no AI or machine learning component that would require a "training set" in the conventional sense. The "development" or "training" of the device involves engineering design, material selection, and iterative physical testing, not data-driven algorithm training.
9. How Ground Truth for Training Set Was Established
- Not Applicable. As there is no AI/ML component, there is no "training set" or ground truth for it. The design and validation relied on established engineering principles, material science, and pre-clinical testing against known performance benchmarks from predicate devices.
§ 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.