(201 days)
The Medicon Stern-a-Fix Sternal Closure System is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
The Medicon Stern-a-Fix Stermal Closure System consists of titanium plates and 2.4 mm locking and standard bone screws, as well as 2.7 mm emergency screws. All 2.4 mm screws are self- drilling, i.e., a predrilled hole is not required, but may be used if desired. Screws are provided in lengths from 7-15 mm.
The plates are affixed to the sternum using the screws. They include thinner horizontal sections to facilitate quick re-entry.
The provided text describes a medical device, the Medicon Stern-a-Fix Sternal Closure System, and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any AI/software performance.
Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices. The "study" mentioned is a comparative fixation strength study against cerclage wire.
Here's an analysis based on the information provided, explicitly stating where information is missing for your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fixation Strength: | "Significantly greater stability was recorded for the Medicon Stern-a-Fix sternal closure system in all regions of the sternum, particularly at the xyphoid" compared to cerclage wire. |
| (Specific quantitative thresholds for "significantly greater stability" are NOT provided.) | (No specific numerical performance metrics are provided for the Stern-a-Fix system itself beyond the comparative statement.) |
| Biocompatibility: | (Not explicitly mentioned, but implied by material (titanium) and regulatory class. Detailed acceptance criteria and performance data are not in this summary.) |
| Mechanical Properties (e.g., fatigue, tensile strength of components): | (Not explicitly mentioned. These would typically be part of a comprehensive device submission but are not detailed in this summary.) |
| Clinical Outcomes (e.g., reoperation rate, infection rate): | (Not mentioned. The study referenced is a biomechanical comparison, not a clinical outcomes study.) |
| Intended Use Equivalence: | "The Medicon Stern-a-Fix Sternal Closure System is the same as the predicate devices in indicated use, method of rigid bone fixation, operating principle and materials." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document references a study by "Dasika et al" titled "Lower Sternal Reinforcement Improves the Stability of Sternal Closure." However, the sample size for this study is not provided in the given text.
- Data Provenance: Not specified. It's unclear if the study was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. The "ground truth" here relates to biomechanical fixation strength, not diagnostic interpretations from experts. The study likely involved physical testing or simulations, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. This refers to expert consensus in diagnostic studies, which is not what was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This document does not describe a MRMC study or any study where human readers' performance with/without AI assistance was evaluated. The device is a surgical implant, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not applicable. The device is a physical surgical implant, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for the comparison was biomechanical fixation strength (stability) in a model of a sternum, rather than expert consensus, pathology, or outcomes data. This would typically involve objective measurements from mechanical testing.
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI algorithm that requires a training set. The term "training set" is generally used in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no AI algorithm or training set for this physical device.
Summary of Device and Evidence:
The Medicon Stern-a-Fix Sternal Closure System is a physical metallic bone fixation appliance. Its regulatory clearance is based on substantial equivalence to existing predicate devices for its intended use (stabilization and fixation of anterior chest wall fractures). The primary "proof" cited in this 510(k) summary regarding performance is a biomechanical comparison study ("Dasika et al") which found that the Stern-a-Fix system provided "significantly greater stability" than cerclage wire for sternal closure. This study is primarily focused on the physical performance (fixation strength) of the device, and not on diagnostic accuracy, AI performance, or clinical outcomes as might be seen for software or diagnostic devices.
§ 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.