(90 days)
The Smith & Nephew ENDOBUTTON DIRECT Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL).
The ENDOBUTTON DIRECT is a machined titanium implant designed to provide cortical fixation in the repair of tendons and ligaments. The design of the ENDOBUTTON DIRECT allows for the device to be endoscopically delivered from a single access point. The harvested graft is looped through the closed portion of the ENDOBUTTON DIRECT and by pulling on a lead suture attached to the top of the ENDOBUTTON DIRECT the construct is moved through the tunnel. The trailing suture located distal to the graft is then used to flip the device into position, lying flat across the tunnel opening on top of the femoral cortex.
The provided text is for a 510(k) Summary for a medical device called the "Smith & Nephew ENDOBUTTON DIRECT." This document focuses on demonstrating substantial equivalence to a predicate device, not on demonstrating performance against specific acceptance criteria through a clinical study involving human readers or AI.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not applicable or available in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The 510(k) Summary for the ENDOBUTTON DIRECT does not present acceptance criteria for device performance in the way described (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device (Smith & Nephew Endobutton CL, K980155) in terms of design, materials, function, and intended use.
The "performance" described is limited to:
| Acceptance Criteria Type | Reported Device Performance | Comments |
|---|---|---|
| Bench Top Testing (Tensile Testing) | Differences in the new device and the predicate device do not raise any new issues of safety and efficacy. | No specific numerical acceptance criteria or performance values (e.g., tensile strength in Newtons) are provided. The statement indicates a qualitative assessment of equivalence. |
| Material Equivalence | Button material is the same as the predicate device. | Demonstrates equivalence, not specific performance metrics against an acceptance criterion. |
| Design Equivalence | Similar design to the predicate device, allowing for endoscopic delivery and flipping into position. | Focuses on functional similarity to the predicate, not performance against pre-defined acceptance criteria. |
| Function Equivalence | Provides cortical fixation in the repair of tendons and ligaments, similar to the predicate. | Equivalence in intended functional outcome. |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. No "test set" in the context of imaging or AI performance is mentioned. The performance testing was bench-top tensile testing. The sample size for this testing is not specified, nor is the provenance of any "data" as it pertains to human or AI performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not Applicable. Ground truth, in the context of expert consensus, is not relevant for this device's regulatory submission, which relies on bench-top mechanical testing and comparison to a predicate device.
4. Adjudication Method
Not Applicable. No adjudication method is mentioned as there is no "test set" requiring expert review or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew Endobutton CL, cleared in K980155. The bench top testing included tensile testing..." There is no mention of an MRMC study, human readers, or AI assistance.
6. Standalone (Algorithm Only) Performance Study
No. This is a mechanical fixation device, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. Type of Ground Truth Used
Not Applicable. The "ground truth" for this device's regulatory submission is based on the performance of the predicate device and engineering principles demonstrated through bench-top testing (e.g., tensile strength, material properties). It's not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices.
8. Sample Size for the Training Set
Not Applicable. This is a mechanical device, not an AI system. There is no concept of a "training set" in this submission.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this question is not relevant.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.