(144 days)
The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, and/or creation of anastomoses in small and large intestine as well as 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 staple (blue; 3.5mm) is compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on demonstrating substantial equivalence to predicate devices and meeting design specifications through various tests. The primary acceptance criterion highlighted in the provided text for clinical performance is non-inferiority related to adverse events.
| Acceptance Criteria (Primary Clinical) | Reported Device Performance |
|---|---|
| Non-inferiority of composite related severe adverse event rate (composite of infection, leakage, bleeding, and strictures) compared to historical control in comparable open and laparoscopic procedures. | One (1) composite severe adverse event (composite of infection (non-dermal), leakage, bleeding, and strictures) related to the MicroCutter XCHANGE 30 System was reported in 153 patients (0.65%). The exact upper 95% confidence limit for this rate is 3.59%. The primary endpoint was met, indicating non-inferiority to the composite historical control. |
Additional Performance Data (Non-Clinical/Bench Testing - not explicitly "acceptance criteria" but included to show general compliance)
| Area of Performance | Reported Device Performance Summary (Met Design Specifications/Passed) |
|---|---|
| Integrity of Staple Line | Confirmed via dimensional analysis, visual inspection, and burst pressure testing. |
| Dimensional Tests | Confirmed attributes for shaft diameter, jaw aperture, clamp gap, articulation angle, and staple line length. |
| Ergonomics | Confirmed device ergonomics and usability for cartridge load/unload force, force to articulate, force to deploy, force to reset device, and torque required to rotate device. |
| Safety | Confirmed the strength of the deploy lockout safety mechanism. |
| Functionality | Confirmed device features for the clamp system, deployment system, and articulation. |
| Reliability | Demonstrated that device performance does not degrade within the indicated number of clinical deployments. |
| Packaging Validation | Passed in accordance with ASTM D4169. |
| Sterilization | Passed in accordance with ISO11137-2. |
| Bioburden | Passed in accordance with ANSI/AAMI/ISO 11737-1:1995. |
| Shelf Life | Passed in accordance with ASTM F1980. |
| Biocompatibility | Completed and passed in accordance with ISO 10993-1 requirements (Cytotoxicity, Intracutaneous Reactivity, Hemolysis, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogen, Coagulation, Thromboresistance). |
| Tissue Leak Pressure (Bench & Animal) | No statistical difference (p>0.05) compared to predicate (implied, as it states "No statistical difference p>0.05", but doesn't explicitly name the predicate in this line). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 160 subjects were enrolled, and 423 deployments were performed. 153 patients were included in the primary endpoint calculation.
- Data Provenance: The study was a "prospective, open label, multi-center study" meaning the data was collected specifically for this study in real-time or as events occurred. While the document does not explicitly state the country of origin, the FDA 510(k) submission context implies it would be relevant to US regulatory standards, and the manufacturer is based in Redwood City, California. The "MicroCutter European Trial I (METI)" mentioned under clinical performance suggests an international origin, but it specifically states "The Cardica MicroCutter in Surgical Stapling" for METI, and the results are cited as "Non-inferior to composite historical control." The main clinical study described appears to be for this specific submission and is referenced as "clinical study information" without explicit geographic limitation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical adverse events. The adverse event rate was compared to a "composite severe adverse event rate... derived from a comprehensive analysis of the medical literature," implying a benchmark from existing published data rather than a newly established expert consensus on the test set.
For the non-clinical and bench tests, it's reasonable to infer that qualified engineers and technicians performed the tests against established design specifications and industry standards, but specific expert qualifications for "ground truth" are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (like 2+1 or 3+1) for the clinical adverse events. The events were "reported," and it states that "One (1) composite severe adverse event... related to the MicroCutter XCHANGE 30 System was reported." This suggests a direct reporting and classification of events rather than an independent adjudication process among multiple reviewers for the study itself, though standard clinical trial practices would involve physician assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The clinical study performed was a direct assessment of the device's performance against a historical control for adverse event rates, not a comparison of human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a surgical stapler, not an AI algorithm. Therefore, the concept of a "standalone algorithm only" performance study is not applicable. The performance studies evaluate the physical device's function.
7. Type of Ground Truth Used
- Clinical Study: The "ground truth" for the clinical study's primary endpoint regarding adverse events was a composite historical control derived from a comprehensive analysis of the medical literature for comparable open and laparoscopic procedures.
- Non-Clinical/Bench Testing: The ground truth for these tests would be based on established design specifications, industry standards (e.g., ASTM, ISO), and performance criteria for surgical staplers.
8. Sample Size for the Training Set
This product is a mechanical surgical stapler, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The design specifications and manufacturing processes are developed through engineering and material science principles.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" for this type of device. The "ground truth" for the device's design and manufacturing would be established through engineering design principles, material science, regulatory requirements, and established industry best practices for medical device development.
§ 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.