(387 days)
Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges).
Microware Bone Plates and Bone Screws Accessories:
- The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
- The spherical washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. In addition, it can be applicable on the insertion at acute angles.
- The spiked washer is used for ligament reattachment or fixation.
- The support screw is anchored in cancellous bone by its thread. It supports the countersink head of a cannulated screw in cancellous bone.
The added devices do not change the original intended use, material, label, and package. The added devices with changes are described as follows:
- Added cortex, cancellous, and shaft screws are designed with self-tapping flutes and are easier to insert into the bone than non-self-tapping screws.
- Added cortex screws 1.5 and 2.0mm are designed with a cruciform recess and can be applied with a cruciform tool.
- Added screws of all sizes are designed with a hexalobular socket and they can improve torque transmission to facilitate easy insertion and removal.
- Added cannulaed screws extend diameter specification with 6.5, 4.5, 4.0, 3.0 and 2.4mm.
- Added implants include the round washer, spherical washer, spiked washer, and support screw which can be used with or without other implants.
- Added screws extend length specifications.
The provided document is a 510(k) summary for PREDICATE DEVICES, not a study that proves a device meets specific acceptance criteria. This submission is to establish substantial equivalence for Microware Bone Plates and Bone Screws to existing predicate devices. Therefore, a detailed study with acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance metrics as specified in your request are not included.
However, I can extract the information related to the performance testing demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of formal acceptance criteria and quantitative performance metrics as might be found in a clinical study for an AI/diagnostic device, this 510(k) submission relies on performance testing to demonstrate substantial equivalence to predicate devices. The acceptance criterion is implicitly that the new device's performance in these tests is comparable to or better than the predicate devices, thereby ensuring it is as safe and effective.
| Performance Test | Reported Device Performance |
|---|---|
| Axial Pullout | Demonstrated substantial equivalence to predicate devices. |
| Self-Tapping Performance | Demonstrated substantial equivalence to predicate devices. |
| Driving Torque | Demonstrated substantial equivalence to predicate devices. |
| Torsional Properties | Demonstrated substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a 510(k) submission for orthopedic implants, not a clinical study involving a test set of data. The "test set" here refers to the physical devices undergoing mechanical performance testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is for mechanical device performance, not for establishing ground truth on medical diagnoses.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is typically done for diagnostic devices, particularly those involving human interpretation, to compare human performance with and without AI assistance. This document is for orthopedic implants.
6. Standalone Performance Study
Yes, in a sense. The performance testing (axial pullout, self-tapping performance, driving torque, torsional properties) characterizes the standalone physical and mechanical properties of the device itself. This is done without human-in-the-loop for the test execution.
7. Type of Ground Truth Used
The "ground truth" for the mechanical performance testing would be established by standardized testing methods and material science principles, comparing the new device's properties against established benchmarks and the predicate devices' known characteristics. It's not "expert consensus, pathology, or outcomes data" in a clinical sense.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm being developed or "trained" in this context. The "training set" would implicitly refer to the design, manufacturing, and quality control processes that lead to the final device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI algorithm. The device's design and manufacturing rely on engineering specifications, material standards (e.g., stainless steel and titanium alloy), and adherence to good manufacturing practices, all aimed at producing a safe and effective implant.
§ 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.