(90 days)
The easyEndo® Linear Cutting Stapler and Loading Unit for Single Use have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.
The proposed devices, easyEndo® Linear Cutting Stapler and Loading Unit for Single Use, are sterilized and disposable surgical instruments, which have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomoses.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The easyEndo® Linear Cutting Stapler may be reloaded and fired no more than 25 times in a single procedure.
This document does not describe a study proving the device meets acceptance criteria. Instead, it is an FDA 510(k) Premarket Notification summary for the "easyEndo® Linear Cutting Stapler and Loading Unit for Single Use."
The document focuses on establishing substantial equivalence to a predicate device (Endo GIA™ Universal Staplers with Duet TRS™ reloads) rather than detailing performance acceptance criteria and a study to prove they are met in the traditional sense of a clinical trial or performance study against specific metrics.
Here's a breakdown of the information requested, based on the provided text, and highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
The provided document does not present a table of acceptance criteria with corresponding device performance results in a quantitative manner as typically found in a device performance study. Instead, it lists non-clinical tests conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device.
| Acceptance Criteria (Stated as conformance to standards/design) | Reported Device Performance (Implied by "met" or "complies with") |
|---|---|
| Seal strength of flexible barrier materials (ASTM F88/F88M-09) | Complies with standard |
| Detecting seal leaks in porous medical packaging (ASTM 1929-12) | Complies with standard |
| Bacterial Endotoxins Test (USP 37-NF32:2014, ) | Complies with standard |
| Pyrogen Test (USP Rabbit Test) (USP 37-NF32 ) | Complies with standard |
| Biocompatibility (Cytotoxicity, ISO 10993-5) | Complies with standard |
| Biocompatibility (Irritation and skin sensitization, ISO 10993-10) | Complies with standard |
The document also offers a "Substantially Equivalent (SE) Comparison" (Table 1) which compares technological characteristics between the proposed and predicate device. This table does not list acceptance criteria but rather features of the device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document states that "Non clinical tests were conducted," but does not specify sample sizes for these tests or the provenance of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The non-clinical tests described do not involve human expert ground truth establishment; they refer to standard testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As the tests are non-clinical, an adjudication method for ground truth would not be applicable in the same way it would for a clinical study involving subjective assessments.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a surgical stapler, not an AI-assisted diagnostic or treatment device, so such a study would not be applicable. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a mechanical surgical stapler, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned, the "ground truth" is established by the specifications and standardized methods of the referenced ASTM, USP, and ISO standards (e.g., a seal passes if it meets the strength requirement of ASTM F88, a material is biocompatible if it passes the ISO 10993 tests for cytotoxicity, etc.). There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical tests.
8. The sample size for the training set
This question is not applicable as the device is a mechanical surgical stapler, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
This question is not applicable as the device is a mechanical surgical stapler, not an AI/ML algorithm that requires training data.
§ 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.