(28 days)
The SurgASSIST™ Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-toside, and side-to-side anastomoses.
The SurqASSIST™ System with Circular Stapler Digital Loading Units® (DLUs) offers computer mediated steering and stapling. The DLUs contain implantable, titanium staples and integral cutting blades. The DLUs are used to anastomose tubular structures by applying a double staggered circular row of staples through the tissue. The staples form to controlled closed conditions to secure the lavers of tissue together. The DLUs also cut away the excess tissue at a controlled diameter inside the ring of staples. The Circular Stapler DLUs are available in the following four sizes: 21 mm, 25 mm, 29 mm, and 33 mm. The DLU is supplied sterilized and ready for use upon removal from its packaging.
The provided text is a summary of a 510(k) premarket notification for a medical device called the SurgASSIST™ Circular Stapler Digital Loading Units®. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria, performance metrics, and a full statistical analysis. As such, much of the requested information regarding study design, sample sizes, and ground truth establishment is not present in the provided text.
Based on the available information, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes material and design specifications that align with the predicate device, implying that meeting these specifications serves as the "acceptance criteria" for substantial equivalence. The "reported device performance" is implicitly that the device is functionally equivalent to the predicate, even with modifications. No specific quantitative performance metrics or acceptance thresholds are provided in this summary.
| Feature / Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Intended Use | Same as predicate device (K003277 and K920752) |
| Contraindications | Same as predicate device (K003277 and K920752) |
| FDA Class (System) | Class II (Same as predicate devices) |
| Sizes | 21 mm, 25 mm, 29 mm, 33 mm (Same as predicate devices) |
| Staple Shape | B-Shaped (Same as predicate devices) |
| Closed Staple Height | Approximately 1.5 mm - 2.3 mm (Similar to predicate K003277, within range of K920752) |
| Staple Material | ASTM F-67 Unalloyed Titanium (Same as predicate devices) |
| Knife Material | Stainless steel (Same as predicate devices) |
| DLU Materials | Polymeric materials, surgical grade stainless steels, adhesives, and lubricants (Same as predicate devices) |
| Cutting Mechanism | Circular Knife (Same as predicate devices) |
| DLU Internal Power | None (Same as predicate K003277, different from K920752) |
| Power | Electrically powered via a remote Power Console (Same as predicate K003277, different from K920752) |
| Software Containing Digital Information | Yes, memory module (Same as predicate K003277, different from K920752) |
| How Supplied | Sterile - Single Patient Use (Same as predicate devices) |
| Safety Mechanism | Will not deploy until within appropriate range for desired closed staple height (Same as predicate K003277, superior to K920752) |
| Insertion Mechanism | Flexible, steerable (Same as predicate K003277, different from K920752) |
| Method of Sterilization | Ethylene Oxide Gas (ETO) (Same as predicate K003277, different from K920752) |
| Packaging | Blister Tray with Tyvek Lid (Same as predicate devices) |
| Modification: Latching Mechanism Failure Prevention | Improved engagement of latch fingers due to spline tube and trocar modification (Addresses root cause of recall for predicate K003277) |
2. Sample size used for the test set and the data provenance:
The provided document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on comparing the modified device's design and materials to its predicate, and addressing a specific design modification (latching mechanism). It does not present data from an independent clinical or lab study as might be found for a novel device. The "study" here is primarily a design verification and validation against specified engineering standards and a comparison with the predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. As this is a 510(k) submission for a modification to an existing device, the "ground truth" for comparison is primarily the performance and characteristics of the predicate devices and the resolution of a known issue.
4. Adjudication method for the test set:
This information is not provided in the document.
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 device is a surgical stapler, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a surgical stapler. It has "computer mediated steering and stapling" and has "software containing digital information," but it is a physical surgical instrument. It is not an algorithm that performs actions "standalone" in the sense of an AI model without human intervention. The software likely manages the device's mechanical functions where a human is operating the system. Therefore, a standalone algorithm performance study as typically understood for AI is not applicable.
7. The type of ground truth used:
Given this is a physical medical device, the "ground truth" for its performance would typically involve:
- Engineering specifications and test standards: Ensuring the staples form correctly, the cutting blade functions, and the latching mechanism is secure under various conditions.
- Bench testing/ex-vivo models: Testing on tissue surrogates or cadaveric tissue to verify mechanical performance.
- Animal studies (potentially): To evaluate in-vivo performance for prior versions or if significant changes were made.
- Clinical experience & predicate device performance: The "ground truth" for safety and effectiveness is largely established by the performance of the predicate devices and the ability of the modified device to meet similar performance criteria, especially in resolving the known latching mechanism issue.
The document implicitly uses the performance and safety profile of the predicate devices as the primary "ground truth" for substantial equivalence. The modification addressed a specific failure mode in the predicate, so successful mitigation of that failure mode through design changes would be part of the "ground truth" demonstration.
8. The sample size for the training set:
This information is not provided and is not applicable in the context of this device and submission type. "Training set" typically refers to data used to train machine learning models. This device is a mechanical stapler with integrated software, not an AI/ML model in the typical sense.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable.
§ 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.