(35 days)
The Disposable Circular Stapler has application throughout the alimentary tract for end to-end, end-to-side and side-to-side anastomoses.
The disposable circular stapler is preloaded with two staggered rows of 26mm titanium staples in both inner and outer circles. After the deploying of the instrument, the circular knife blade inside the instrument can cut off excess tissue automatically to create a circular anastomosis. The instrument is fired by squeezing the trigger handle firmly as far as it will go. The size of the anastomosis site is determined by the diameter of the selected circular knife blade.
The provided text is a 510(k) summary for a medical device (Disposable Circular Stapler, YH-26) and focuses on establishing substantial equivalence to a predicate device. It does not describe an AI/ML device or a study that evaluates its performance against acceptance criteria in the typical sense of AI model metrics (like AUC, sensitivity, specificity).
Therefore, I cannot extract the information required for an AI/ML device as per your request related to:
- A table of acceptance criteria and reported device performance (in terms of AI metrics)
- Sample sizes and data provenance for test sets
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study
- Standalone performance
- Type of ground truth used (for AI)
- Sample size for training set
- How ground truth for the training set was established
However, I can describe the acceptance criteria and study that proves the device meets its acceptance criteria based on the provided document, which is a regulatory submission for a traditional medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Tests/Standards | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11 | Successfully passed all tests. |
| Sterilization & Packaging | ISO 11137-1:2006, ISO 11137-2:2006, ISO 11737-1:2006, ISO 11737-2:2009, ISO 11607-1:2006, ASTM F1980-07, ASTM F88/F88M-09, ASTM D3078-02 (2008) | Products successfully passed all tests, ensuring sterility for a 3-year shelf life. |
| Functional Equivalence (Staple Performance) | Bench testing based on predicate device performance and standards: ISO 5832-2:1999 (Unalloyed Titanium for surgery) & ASTM F67-06 (Unalloyed Titanium for Surgical Implant Applications) | Energy to deliver and remove staples was consistent with the predicate device. Stated "no appreciable differences in the energy needed to insert or extract the staples" despite staple size difference. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the bench testing, biocompatibility testing, or sterility testing. It describes these as "bench testing," "biocompatibility testing," and "sterility testing" without detailing the number of units or samples used in each test.
The data provenance is from laboratory and bench tests conducted by or for Changzhou City Zhiye Medical Devices Institute Co., Ltd. (China). The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study did not involve human experts establishing "ground truth" in the context of diagnostic interpretation. The "ground truth" for this device focused on objective engineering, material, and biological safety standards. The "experts" would be the scientists, engineers, and microbiologists conducting and evaluating the tests against established international and ASTM standards.
4. Adjudication method for the test set
Not applicable. The tests performed are objective measurements against defined standards, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI tools that assist human interpretation, not for mechanical surgical staplers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical surgical instrument, not an algorithm or AI. Its performance is inherent to its design and manufacturing, tested objectively, and always used by a human surgeon ("human-in-the-loop" in a different sense).
7. The type of ground truth used
The "ground truth" for this device was established based on:
- Pre-defined international standards (e.g., ISO, ASTM) for materials, biocompatibility, and sterilization.
- Predicate device performance characteristics for functional aspects like staple insertion/extraction energy.
- Objective measurements and laboratory assays.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, this question is irrelevant to the provided document.
§ 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.