(57 days)
The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
The Sternal Closure System is comprised of bone screw, bone plate and fastener components and instruments for implantation. The plates are offered in a fixed one-piece and a fastenable two-piece style. Bone screws are available in a single diameter having a range of lengths. The interconnecting components come in solid and cable versions and fasten the halves of the two-piece plate.
Here's the information regarding the acceptance criteria and study for the Sternal Closure System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Performance (Static and Dynamic Lateral Distraction) | The Sternal Closure System construct performance is substantially equivalent to the Ethicon Stainless Steel Suture Wire. |
| Mechanical Performance (Static Longitudinal Shear) | The Sternal Closure System construct performance is substantially equivalent to the Ethicon Stainless Steel Suture Wire. |
| Bone Screw Performance (ASTM F543) | The Sternal Closure System screw performance is substantially equivalent to the Biomet Microfixation Sternal Closure System screws. |
| General Technological Characteristics | The Sternal Closure System possesses the same technological characteristics as the predicate devices, including performance, implant grade materials, and basic design. Differences are supported with descriptive information and/or performance data. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a numerical sample size for the "test set" in terms of number of devices tested. It refers to "worst case Sternal Closure System constructs" tested.
- Data Provenance: Not specified in the provided text. The testing was conducted as part of the 510(k) submission, implying a laboratory setting rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this type of device (mechanical fixation system). The "ground truth" here is the physical performance of the device against established engineering standards and predicate device performance, not clinical interpretation by experts.
4. Adjudication Method for the Test Set
- Not applicable. The "adjudication method" concept is typically for clinical data or expert interpretation, not mechanical testing. The results of mechanical tests are objective measurements.
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. This device is a mechanical surgical implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on:
- Mechanical Test Standards: Specifically, ASTM F543 for bone screws.
- Predicate Device Performance: Comparison to the performance of legally marketed predicate devices (Ethicon Stainless Steel Suture Wire and Biomet Microfixation Sternal Closure System screws). The implicit "ground truth" is that the new device should perform at least as well as these established devices.
8. The Sample Size for the Training Set
- Not applicable. This is a mechanical device, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for this type of device.
§ 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.