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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.

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.

Ask a specific question about this device

The ETS 45, ETS-Flex45, and Compact-Flex 45 reprocessed, reloadable Endoscopic Linear Cutters are intended for transection, resection and/or anastomosis. These instruments have applications in open and minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic and pediatric surgery. The ETS Flex 45, ETS 45 and ETS Compact Flex 45 device can be used with staple line or tissue buttressing materials such as bovine pericardium.

The ETS and ETS-Flex (articulating) reprocessed, reloadable Endoscopic Linear Cutters (35mm) have applications in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses.

SterilMed's reprocessed Ethicon ETS Linear Cutter is a sterile, single patient use device. It delivers two double-staggered or two triple-staggered rows of staples while simultaneously dividing the tissue between the rows of staples. An articulation lever on the ETS-Flex Linear Cutter enables bilateral movement of the instrument jaws. These devices are reloadable linear cutters that allow for a maximum of 8 firings in a single surgical procedure.

Note: Only the linear cutter is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.

The provided text does not contain detailed acceptance criteria for a device, nor does it describe a specific study that proves the device meets such criteria. Instead, the document is a 510(k) summary for the reprocessing of Ethicon ETS Endoscopic Linear Cutters, demonstrating substantial equivalence to predicate devices. It outlines the device description, intended use, and general functional and safety testing, but lacks the specific performance metrics and study details requested.

Therefore, I cannot provide the requested information in the structured table and numbered points. The document states:

"Representative samples of reprocessed Linear Cutters are tested to demonstrate appropriate functional characteristics. Process validation testing is performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced."

This indicates that testing was performed, but the specifics of acceptance criteria and the results of a study designed to prove these criteria are met are not included in the provided text.

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