(56 days)
The OsteoWedge™ Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
The OsteoWedge™ Open Wedge Bone Locking Plate System consists of plates and screws and incorporates a screw-to-plate locking mechanism. The plate is attached to a prepared surface of the involved bone(s) of the foot using six (6) screws for fixation. The plates are available in six (6) wedge sizes. The fully threaded screws are available in 2 diameters, with numerous lengths.
The OsteoWedge™ Opening Wedge Bone Locking System is a medical device used for stabilizing and/or correcting angular deviations in the bones of the foot. Its acceptance was based on demonstrating substantial equivalence to predicate devices, namely the Arthrex, Inc. Low Profile Plate and Screw System and the Darco International, Inc. DACRO Locking Bone Plate System.
Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the OsteoWedge™ system were primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This involves showing that the new device has the same intended use and technological characteristics as the predicate devices, or if it has different technological characteristics, that it does not raise different questions regarding its safety and effectiveness.
The reported device performance is implicitly that it meets the safety and effectiveness profile equivalent to the predicate devices.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | The OsteoWedge™ system must have the same intended use as the predicate devices. This includes the patient population (adult and transitional adolescent patients, 18-21 years old) and the purpose (stabilization and/or correction of angular deviations within an individual bone or between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations). | The OsteoWedge™ system's intended use is for "adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations." This was deemed comparable to the predicates, which are also used for stabilization and fixation in foot bones. Although OsteoWedge has a narrower indication (foot only) compared to some predicates (hand, feet, wrist, ankles, fingers, and toes), this difference was not considered to raise new questions of safety or effectiveness. |
| Technological Characteristics Equivalence | The device should share similar technological characteristics with the predicate devices, including materials, design principles, screw-to-plate locking mechanisms, and provision as non-sterile for cleaning and sterilization. Deviations in size should be justified not to impact safety or effectiveness negatively. | Materials: All devices are made of the "same materials." |
| Sterilization: All devices are "provided non sterile for cleaning and sterilization prior to use." | ||
| Function/Mechanism: All devices are for "fixation & stabilization" and incorporate a screw-to-plate locking mechanism. | ||
| Size: The OsteoWedge™ has "slightly larger 'wedge size'" than the predicate devices, but this was justified as leading to "narrower 'indications for use'" and not raising new safety/effectiveness questions. | ||
| Safety and Effectiveness | The device must not raise different questions regarding its safety and effectiveness compared to the predicate devices. This is typically supported by non-clinical performance testing. | Non-Clinical Testing: The following tests were performed: |
- Bend Testing (Static Four Point Bending & Dynamic Four Point Bending)
- Bending Strength
- Torsion Testing
- Self-Tapping Performance
- Axial Pullout Testing
- Insertion and Removal Testing
- Cleaning and Sterilization Testing
Conclusion: The submission states that "the differences between the OsteoWedge™ Opening Wedge Bone Locking Plate System and the predicate devices do not raise any questions regarding its safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a "test set" in the context of clinical data or patient samples. The submission relies on non-clinical (bench) testing to support substantial equivalence.
- Sample Size for Test Set: Not applicable in the context of clinical data. The sample sizes would refer to the number of devices or components tested during the non-clinical mechanical and sterilization tests, but these specific numbers are not provided in the summary.
- Data Provenance: Not applicable for clinical data. The non-clinical testing was conducted to evaluate the device's physical properties and performance against engineering standards. The location or specific context of these non-clinical tests is not detailed beyond being "performed to support substantial equivalence."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission did not rely on clinical data, expert consensus, or ground truth established by medical experts for a "test set" to prove device performance in a diagnostic or clinical efficacy manner. The assessment was based on engineering and performance characteristics relative to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical "test set" requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Clinical trial or testing was not required for the OsteoWedge™ Opening Wedge Bone Locking System." Since no clinical trials were done, an MRMC study was certainly not performed, and therefore, an effect size of human readers with AI assistance is not relevant.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical bone plate system, not an AI algorithm or diagnostic tool. The concept of "standalone performance" for an algorithm or human-in-the-loop performance is not applicable to this type of medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" refers to established engineering standards, material properties, and mechanical performance metrics (e.g., bending strength, torsion resistance, pullout strength). These are objective, measurable physical properties, not clinical outcomes or expert interpretations.
8. The Sample Size for the Training Set
Not applicable. This device is hardware and does not involve AI or machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, this question is irrelevant to the device submission.
§ 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.