(56 days)
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
- Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
- Arthrodesis of the foot, wrist and elbow.
- Small and long bone osteotomies.
- Fracture fixation of small bones, small bone fragments and long bones.
Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
- Fixation of fractures in long bones and long bone fragments.
- Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
- Arthrodesis and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
- Slipped capital femoral epiphysis
- Pediatric femoral neck fractures
- Tibial plateau fractures
- SI joint disruptions
- Intercondylar femur fractures
- Subtalar arthrodesis
- Fixation of pelvis and iliosacral joint.
The Biomet Cannulated Screw System consists of bone screws, associated washers, which are manufactured from Titanium-6 Aluminum-4 Vanadium (Ti-6AL-4V), and corresponding instruments are used to aid in the alignment and stabilization of fractures to the skeletal system.
Here's an analysis of the provided text regarding the Biomet Cannulated Screw System's acceptance criteria and study proving its efficacy:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by Predicate Devices) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Design similar to predicate devices | Similar design to predicate devices. |
| Dimensions similar to predicate devices | Similar dimensions to predicate devices. |
| Material identical/similar to predicate devices | Fabricated from Ti-6Al-4V alloy per ASTM F136 (a commonly used material in orthopedic implants and used in predicate devices K082874, K903810, K926047, K872859). |
| Meets mechanical standards (ASTM F543) | Performed torsional, axial pullout, and driving torque mechanical tests per ASTM F543. Results indicate substantial equivalence to legally marketed devices. |
| Safe and effective performance | No new issues of safety or efficacy have been raised. Results indicate the device will perform within the intended use. |
| MRI compatibility/justification | MRI justification performed. |
| Cadaver evaluation | Cadaver evaluation performed. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. The evidence for substantial equivalence is based on non-clinical performance testing (mechanical tests, cadaver evaluation, MRI justification) and comparison to predicate devices, rather than a clinical "test set" in the context of human data.
The data provenance is non-clinical (laboratory and cadaveric testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as there was no clinical "test set" in the traditional sense that required expert interpretation for ground truth. The evaluation focused on material properties, mechanical performance, and design equivalence to established predicate devices.
4. Adjudication Method for the Test Set
This is not applicable as there was no clinical "test set" requiring adjudication or multi-reader reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information: None provided as a basis for substantial equivalence." This indicates that no clinical studies, including MRMC studies, were performed to compare the performance of human readers with and without AI assistance for this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. The device is a physical medical implant (a cannulated screw system), not an AI algorithm. Therefore, a standalone performance study for an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established through:
- Engineering specifications and standards: Adherence to ASTM F136 (material) and ASTM F543 (mechanical testing).
- Performance of predicate devices: The Biomet Cannulated Screw System's characteristics (design, dimensions, material) and performance were compared to those of legally marketed predicate devices, which implicitly serve as the "ground truth" for acceptable safety and effectiveness.
- Non-clinical testing results: Specifically, the outcomes of torsional, axial pullout, and driving torque mechanical tests, and MRI justification, demonstrated "substantial equivalence."
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device (cannulated screw system), there is no 'training set' in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above (not an AI/ML device).
§ 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.