(24 days)
The Ethicon Endo-Surgery® 5mm Laparoscopic Multi-Feed Stapler has application for use in a variety of minimally invasive procedures for approximation of tissue.
The Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler is a sterile, single patient use instrument designed for use with a 5mm diameter trocar. The device places rectangular titanium staples. The staple opens to a tip to tip width of about 6.1mm (0.240 inches). Closed staple dimensions are approximately 5.5 mm x 6.1 mm (0.215 inches x 0.242 inches). The instrument shaft is 5.5mm (0.218 inches) in diameter and 457mm (18 inches) long and contains about 40 staples.
The provided text describes a 510(k) premarket notification for a new surgical stapler. The submission focuses on demonstrating substantial equivalence to a predicate device through performance data, not on establishing acceptance criteria and conducting a study to prove a device meets those criteria in the context of AI/machine learning.
Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device submission.
Here's an analysis based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific quantitative acceptance criteria (e.g., specific staple strength, deployment accuracy rates) that the device must meet, nor does it present device performance data in a detailed, quantified table format suitable for head-to-head comparison against such criteria.
The "Performance Data" section generally states: "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device performs as intended." This is a qualitative statement of intent and outcome, not a presentation of specific criteria and corresponding results.
2. Sample sized used for the test set and the data provenance
Not applicable. This is a traditional medical device submission primarily focused on mechanical performance and biocompatibility, not an AI/machine learning device submission involving test sets of data. The "bench testing and preclinical laboratory evaluations" likely involved a certain number of devices or staple deployments, but these numbers are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This concept of "experts establishing ground truth for a test set" is relevant to AI/ML where human expertise is used to label data. For a surgical stapler, "ground truth" would be established through engineering specifications, material science, and observed mechanical performance.
4. Adjudication method
Not applicable. Adjudication methods (like 2+1 or 3+1) are used in AI/ML studies to resolve discrepancies in expert labeling of data. This is not relevant to a surgical stapler's performance evaluation as described.
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
Not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the performance of an AI algorithm alone. The device is a surgical stapler, not an algorithm.
7. The type of ground truth used
For a surgical stapler, the "ground truth" would implicitly be defined by:
- Engineering Specifications: Designed dimensions, material properties, force requirements for staple formation and deployment.
- Biocompatibility Standards: Compliance with ISO 10993-1.
- Functional Performance Expectations: The ability to approximate tissue effectively, ensure proper staple formation, and preclude unintended failure modes.
- "Pathology" in the context of a stapler might relate to post-stapling tissue analysis, but not as the primary "ground truth" for proving the stapler itself works. "Outcomes data" would be from clinical use, not the bench and preclinical studies described here.
8. The sample size for the training set
Not applicable. This concept is for AI/ML models. The "design and development were predicated on use of technology currently used in Ethicon Endo-Surgery manual stapler devices," which could be considered analogous to a "training" history or experience base, but not a quantifiable data set in the AI sense.
9. How the ground truth for the training set was established
Not applicable. Similarly, the "ground truth" for the "training set" (if we consider previous stapler designs as training) would be established through the accumulated engineering knowledge, testing data, and clinical experience with those existing devices.
Summary based on the provided document:
The Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler's acceptance criteria and proof of meeting them are described in terms of a substantial equivalence pathway to a predicate device (Ethicon, Inc. ENDOPATH Disposable Endoscopic Multifeed (EMS) Stapler K913469).
The study that proves the device meets "acceptance criteria" (which are not explicitly detailed in the document as quantitative metrics but are implied by safe and effective surgical stapler performance) is the "Bench testing and preclinical laboratory evaluations". These evaluations were performed to demonstrate that the device performs as intended and that its new features "do not raise any new issues relating to safety and effectiveness" compared to the predicate device. Additionally, device materials were evaluated for biocompatibility and comply with the requirements of ISO 10993-1.
The document indicates that this data supports the conclusion that the new stapler is substantially equivalent to the predicate device. No specific quantitative performance metrics, sample sizes for detailed testing, or expert reviews for data labeling are provided in this summary.
§ 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.