(98 days)
The Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.
The Emerge Medical Cannulated Bone Screw set consists of various size bone screws. The screws are available in a variety of sizes differing in diameter, overall length and threaded length. The screws are machined from 316 L stainless steel or titanium alloy. Each screw is cannulated with a hole through the center for use with appropriately sized guide wires. The screw heads have various configurations which mate with commonly used drivers. No specialized instruments are required for placement of the screws. The screws have mating washers which can be slipped over the shaft of the screw and fit under the screw head. The screws are used with generic instruments commonly available to orthopedic surgeons. The devices are provided both in non-sterile or in sterile packages as preferred by the user.
The provided text describes the "Emerge Medical - Cannulated Screw Fixation System (K102343)" and details its substantial equivalence to predicate devices. It focuses on the mechanical performance of the screws rather than the performance of an AI/ML-driven device. As such, many of the requested categories related to AI/ML device evaluation (like expert adjudication, MRMC studies, standalone algorithm performance, and ground truth creation for training/test sets) are not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria related to the device's physical performance and how it was proven to meet those criteria.
Description of the Acceptance Criteria and Study for the Emerge Medical Cannulated Screw Fixation System (K102343)
The Emerge Medical Cannulated Screw Fixation System is a Class II medical device intended for bone fixation. Its acceptance criteria and performance evaluation were based on demonstrating substantial equivalence to predicate devices through mechanical testing and material characteristics, rather than an AI/ML-driven performance study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Screw Torsional Strength (Recognized Consensus Standard) | Shown to be substantially equivalent to predicate screws. |
| Screw Axial Pullout (Recognized Consensus Standard) | Shown to be substantially equivalent to predicate screws. | |
| Screw Driving and Removal Torque (Recognized Consensus Standard) | Shown to be substantially equivalent to predicate screws. | |
| Material Biocompatibility | Use of 316L stainless steel or titanium alloy | Materials "commonly used for orthopedic implants and have a long history of biocompatibility." |
| Design Similarity | Similar design to predicate devices | "Similar designs" to predicate devices. |
| Indications for Use | Aligned with predicate devices | "Similar indications" to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for each mechanical test (e.g., number of screws tested for torsional strength, pullout, etc.). The provenance of the data is from non-clinical bench testing performed by the manufacturer, Emerge Medical, to demonstrate substantial equivalence. No information on country of origin or whether it was retrospective/prospective is applicable as it's a materials/mechanical stress test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the evaluation involved mechanical testing against recognized consensus standards and comparison to predicate devices, not expert human interpretation for a diagnostic or AI/ML-driven task.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI/ML system on human reader performance, which is not applicable to a bone screw fixation system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI/ML algorithm. The "standalone" performance here refers to the physical attributes of the screw itself as tested in a lab.
7. The Type of Ground Truth Used:
The "ground truth" for this device's acceptance was established by:
- Recognized consensus standards: The mechanical tests (Torsional Strength, Axial Pullout, Driving and Removal Torque) were performed against these established standards.
- Performance of legally marketed predicate devices: The Emerge Medical screws were deemed "substantially equivalent" when compared to the performance of predicate devices such as the Synthes Cannulated Screw System (various K-numbers provided). This means the predicate device performance implicitly served as a benchmark for what was acceptable.
8. The Sample Size for the Training Set:
This concept is not applicable as there is no "training set" in the context of a physical device like a bone screw.
9. How the Ground Truth for the Training Set Was Established:
This concept is not applicable for the same reasons as point 8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.