(89 days)
The Bone Plate with Cable's device is indicated for use where wire, cable, or band cerclage is used in combination with bone plates. The Bone Plate with Cable's device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the bone plate.
The Bone Plate with Cable's device consists of a bone plate with transverse holes for passage of multifilament cables. A cable is passed through the transverse bone plate hole, and then through a crimp. The crimp is typically positioned adjacent to the plate. The cable is locked into a tensioning device and tightened which applies compression to the plate and bone. The crimp and cable are then crimped with a crimping tool to lock the cable in place. Excess cable is cut and removed. Additional cables of the same system type maybe applied as required.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pioneer Laboratories Bone Plate with Cables device.
It's important to note that this 510(k) summary is from 1997, and the information presented is typical for the regulatory standards of that era. Modern medical device submissions often include more detailed performance studies and statistical analyses.
Acceptance Criteria and Study for Pioneer Laboratories Bone Plate with Cables Device
Based on the provided 510(k) Summary, the "Bone Plate with Cables" device underwent performance testing to demonstrate substantial equivalence to predicate devices, primarily focusing on mechanical strength and loading capabilities.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Criteria | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Strength | Loading Values (for Cable/Plate System) | "Exceed the loading values for wire systems" and "equivalent to the values of the Pioneer Laboratories Bone Plate with Cerclage Cable's system." | The Bone Plate with Cable's device was found to "exceed the loading values for wire systems" and its loading values were "equivalent to the values of the Pioneer Laboratories Bone Plate with Cerclage Cable's system." |
Observation: The document does not explicitly state numerical acceptance criteria (e.g., "must withstand X Newtons of force"). Instead, the performance is reported relative to existing systems. The "acceptance criteria" are implied to be "at least as good as or better than" the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of plates or cables tested). It refers to "tests of each of the systems."
- Data Provenance: The data is generated from performance testing conducted by the manufacturer, Pioneer Laboratories. The Country of Origin is the USA (where Pioneer Laboratories is based). The study is prospective in the sense that the testing was performed specifically to support the 510(k) submission for this new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for a mechanical device like a bone plate with cables is typically established through engineering principles, material science, and mechanical testing standards. It isn't based on expert consensus on interpretations as would be the case for diagnostic imaging. The "truth" in this context is the physical properties measured in a lab.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human expert assessments (e.g., in clinical trials or image interpretation studies). For mechanical testing, if there were any discrepancies in test results, standard engineering practices for repeatability, reproducibility, and retesting would be employed, not an adjudication process by experts.
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. MRMC studies are typically used to assess the performance of diagnostic imaging devices or software where human readers interpret medical images. This 510(k) is for a mechanical orthopedic implant, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a mechanical implant, not an algorithm or AI system. Its performance is inherent in its physical and mechanical properties, not in an "algorithm only" mode.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance study was based on mechanical testing results and comparison to established performance of predicate devices. The "truth" refers to the measured loading values and the device's ability to withstand forces, as determined by laboratory methods.
8. The Sample Size for the Training Set
This section is not applicable. The device is not an AI/ML algorithm requiring a "training set." Its design and performance are based on engineering principles and material properties, validated through mechanical testing.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated above (not an AI/ML device).
§ 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.