(66 days)
KLS-Martin Sternal Plating System is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures.
KLS - Martin Sternal Plating System consists of plates having a thickness of 1.0mm to 3.0mm and screws having a diameter of 2.3mm to 3.2mm.
The KLS-Martin Sternal Plating System is a Class II device intended for stabilization and fixation of anterior chest wall fractures, including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in a dedicated table format. However, it establishes substantial equivalence and superiority based on specific biomechanical performance compared to a predicate device and cerclage wires.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent in strength to the Lorenz Sternal Closure System with Modular Screws (K011079). | The KLS-Martin Sternal Plating System's plates and screws were asserted to be "substantially equivalent in strength to the Lorenz Sternal Closure System with Modular Screws (K011079)." |
| Superiority to sternum wiring (cerclage wires) in terms of fixation strength, stiffness, and lower lateral displacement. | Clinical studies supporting superiority of sternal plating over wiring were cited (Sargent et al., Cheng et al., Buchman et al.). |
| In the Ozaki et al. study (Phase II), "sterna fixed with rigid custom titanium 'H' plates [KLS-Martin prototype] showed a greater stiffness and a lower lateral displacement when compared with sterna fixed with stainless steel cerclage wires." | |
| Biomechanically superior to wire fixation. | The Ozaki et al. study concluded: "... this study has led to the development of a rigid Sternal Plating System that is biomechanically superior to wire fixation." |
2. Sample Size Used for the Test Set and Data Provenance
Only one specific study with biomechanical testing is detailed: "Biomechanical Study of Sternal Closure Using Rigid Fixation Techniques in Human Cadavers. Ozaki et al.".
- Sample Size: Not explicitly stated for the cadaver tests in the provided text.
- Data Provenance: Human cadavers were used for the biomechanical study. The location or institution where the study was conducted is not specified beyond listing "Ozaki et al.". The study appears to be retrospective in the sense that existing systems were compared, but the testing itself was prospective on the cadaveric samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device's acceptance is based on biomechanical testing and comparison to predicate devices, not on a diagnostic accuracy study requiring expert adjudication of "ground truth" in the traditional sense of medical image analysis. Therefore, this question is not directly applicable. The "ground truth" here is the physical measurement of strength, stiffness, and displacement.
4. Adjudication Method for the Test Set
Not applicable. The biomechanical study involved quantitative measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided document concerns a Sternal Plating System, which is a surgical implant, not an AI or imaging device that would typically undergo MRMC studies. The "clinical studies" mentioned (Sargent et al., Cheng et al., Buchman et al.) refer to studies on sternal plating in general versus wiring, not a specific MRMC study comparing human performance with and without this particular device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical surgical device, not an algorithm.
7. The Type of Ground Truth Used
For the Ozaki et al. biomechanical study, the "ground truth" was established through physical biomechanical measurements of stiffness and lateral displacement on human cadavers. For the overall claim of substantial equivalence, it was based on comparison of performance data against predicate devices and clinical literature assessment.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above.
§ 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.