(90 days)
The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Periprosthetic fractures
- Comminuted fractures
- Supracondylar fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions
The NCB Periprosthetic Femur Plate Provisional Instruments are surgically invasive, non-sterile, reusable devices used to determine the suitable implant length during intra-operative planning as part of the implantation of the NCB Periprosthetic Femur Plates.
The provided document describes the Zimmer NCB® Periprosthetic Femur Polyaxial Locking Plate System, specifically an update with new optional provisional instruments. The performance data focuses on non-clinical testing of these provisional instruments.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bending Test | Not explicitly stated, implied to withstand high handling force. | "A bending test was performed to assess the behavior of the Provisionals under high handling force. The acceptance criteria were successfully met." |
| Radiolucency and Physico-chemical Stability (after cleaning/sterilization) | No discernable or significant differences between pre- and post-processing; no evidence of surface changes, etch degradation, material deformation, significant dimensional changes, and/or cracking. | "Radiolucency and the physico-chemical stability of the polyphenylsulfone with barium sulfate material was compared before and after cleaning and sterilization cycles - results showed no discernable or significant differences between pre- and postprocessing. There was no evidence of surface changes, etch degradation, material deformation, significant dimensional changes and/or cracking of the provisional materials. The acceptance criteria were successfully met." |
| Cytotoxicity | No leachable substances released in cytotoxic concentrations. | "Cytotoxicity of the polyphenylsulfone material with barium sulfate was evaluated post-processing. No leachable substances were released in cytotoxic concentrations from the test item. The acceptance criteria were met." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the tests. The document refers to "the Provisionals" and "the polyphenylsulfone material with barium sulfate," implying a representative number of samples were tested.
- Data Provenance: The studies are non-clinical (laboratory-based) and conducted by Zimmer, GmbH (Switzerland). The document does not specify a country of origin for data in the sense of clinical patient data, as no clinical studies were performed. All tests were retrospective in the sense that they were conducted on already manufactured provisional instruments and material.
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 studies are entirely non-clinical performance tests of medical device components and materials. There is no "ground truth" established by human experts in the context of diagnostic or treatment efficacy for these types of engineering and biocompatibility tests. The "ground truth" is based on objective measurements against quantifiable standards or observations by trained laboratory personnel.
4. Adjudication Method for the Test Set
- This information is not applicable for non-clinical performance tests. Adjudication methods are typically relevant for clinical studies or studies involving subjective human interpretation (e.g., image reading).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data and conclusions were not needed for this device." The studies were non-clinical performance evaluations of the provisional instruments and their material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. The device described is a physical medical device (surgical instruments), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- For the Bending Test: The ground truth would be established by the physical resistance and structural integrity of the provisional instruments under defined high handling forces, measured via engineering standards and metrics.
- For Radiolucency and Physico-chemical Stability: The ground truth is objective measurement of material properties (e.g., optical density for radiolucency, visual inspection for surface changes, dimensional measurements, material characterization techniques to detect degradation) before and after sterilization, compared against a baseline.
- For Cytotoxicity: The ground truth is established by standardized biological assays (e.g., ISO 10993-5) that measure the effect of leachable substances on cell cultures at a cellular level, adhering to pass/fail criteria for cytotoxicity.
8. The Sample Size for the Training Set
- This information is not applicable. There is no machine learning or AI component involved in this device or its testing, therefore no "training set" exists.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as in point 8.
§ 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.