(89 days)
The MicroCutter 5/80 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatric 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 size of the Dextera MicroCutter 5/80TM Blue Reload and Dextera MicroCutter 5/80™ Blue Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the Dextera MicroCutter 5/80™ White Reload and Dextera MicroCutter 5/80TM White Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.0mm. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The Dextera MicroCutter 5/80™ Reloads are deployed using the Dextera MicroCutter 5/80™ Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.
This document is a 510(k) premarket notification for a medical device, specifically surgical stapler reloads (Dextera MicroCutter 5/80™), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against acceptance criteria in the way a new, novel AI/software medical device might.
Therefore, the information requested to describe "the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software medical device is largely not present in this document.
However, I can extract the available relevant information and highlight what is missing based on your request.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of explicit acceptance criteria with corresponding performance metrics in a pass/fail format, as might be found for a software device. Instead, it lists types of bench tests performed.
| Acceptance Criteria (Implicit from Tests) | Reported Device Performance |
|---|---|
| Proper staple formation | "Bench testing, including staple forming and release, ... was performed." (Implied successful formation) |
| Secure staple release | "Bench testing, including staple forming and release, ... was performed." (Implied successful release) |
| Appropriate cartridge loading force | "cartridge loading force... was performed." (Implied within acceptable limits) |
| Appropriate cartridge unloading force | "cartridge unloading force... was performed." (Implied within acceptable limits) |
| Sufficient cartridge boss strength | "cartridge boss strength... was performed." (Implied sufficient strength) |
| Secure cartridge retention | "cartridge retention during and outside of deployment... was performed." (Implied secure retention) |
| Correct dimensions | "dimensional inspection... was performed." (Implied conformity to specifications) |
| Leak/burst pressure integrity | "leak/burst pressure testing... was performed." (Implied meeting pressure integrity requirements) |
| Correct staple form height | "staple form height... was performed." (Implied correct height) |
| Appropriate deployment force | "deployment force... was performed." (Implied within acceptable limits) |
| Overall performance | "The results demonstrated that the subject devices perform as intended and are substantially equivalent to the predicate devices." (General conclusion of meeting requirements) |
Missing Information: Specific quantitative acceptance criteria (e.g., "loading force must be X-Y Newtons") and the precise measured performance values are not provided.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only states "Bench testing... was performed." The number of reloads or test specimens used for each type of test is not detailed.
- Data Provenance: The testing was conducted by Cardica, Inc. (the device manufacturer) as part of their 510(k) submission. It's not relevant in this context to speak of "country of origin of the data" or "retrospective or prospective" as these terms typically apply to clinical studies involving human or animal subjects, or retrospective analysis of medical records for AI/software devices. For bench testing, it refers to internal laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device and study. The "ground truth" for mechanical integrity, staple formation, etc., is established directly by physical measurements and engineering standards, not by expert interpretation.
4. Adjudication method for the test set
This is not applicable to this type of device and study. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human reviewers (e.g., radiologists, pathologists) when establishing ground truth for complex interpretations, typically in AI/software device studies. Bench testing relies on objective measurements.
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 to this type of device and study. An MRMC study is relevant for AI-assisted diagnostic or therapeutic decision-making devices where human reader performance is a key metric. This medical device (surgical stapler reloads) is a surgical tool, not an AI/software diagnostic or assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI/software medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation in this 510(k) submission is based on:
- Engineering specifications and standards: For measurements like dimensions, forces, and heights.
- Physical properties and integrity: For tests like leak/burst pressure and staple formation.
- Comparison to predicate device performance: The ultimate conclusion is often that the new device performs "as intended" and is "substantially equivalent" to the predicate, implying it meets the same functional requirements.
8. The sample size for the training set
This is not applicable as this is not an AI/Software medical device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/Software medical device that uses a training set.
§ 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.