(179 days)
The KITE Distal Fibula Kit is indicated for:
- Diaphyseal and metaphyseal fractures of the distal fibula
- Intra and extra articular fractures of the distal fibula
- Non-unions of the distal fibula
The KITE Distal Fibula Kit is intended for the stabilization of distal lateral and posterior fibular fractures including those of the diaphysis and metaphysis and intra-articular fractures. The system is comprised of various plates and screws which allow it to be customized to a patient's anatomy and fracture pattern. The plate is secured in place via autolocking and cortical screws.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KITE Distal Fibula Kit, formatted as requested:
KITE Distal Fibula Kit Acceptance Criteria and Study Analysis
Below is a summary of the acceptance criteria and the studies performed to demonstrate the device meets these criteria, based solely on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria Source | Reported Device Performance |
|---|---|---|
| Plates | ||
| Static 4-point Bending | ASTM F382-17 Annex A1 and "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Screws | ||
| Torsional Test | ASTM F543-17 and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Insertion & Removal Test | ASTM F543-17 and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Pullout Test | ASTM F543-17 and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Self-Tapping Test | ASTM F543-17 and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Sterility/Biocompatibility | ||
| LAL Testing | FDA Guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff" issued January 21, 2016 | Testing was performed according to the guidance. (Specific results like endotoxin levels or pass/fail not explicitly stated but implied success for clearance) |
Notes on Reported Performance: The summary states that performance data "demonstrates alignment" or "demonstrate substantial equivalence" and "demonstrate alignment acceptance criteria," indicating that the device met the specified criteria. However, explicit quantitative results for each test (e.g., specific bending strength values, torque values, pullout forces) are not provided in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes bench testing for mechanical properties and sterility, not clinical testing with human subjects or patient data. Therefore, the concepts of "test set" in terms of patient data, data provenance, and retrospective/prospective studies are not applicable here.
- Sample Size for Mechanical Testing: The specific number of plates or screws tested for each mechanical test (e.g., how many plates for 4-point bending, how many screws for torsional tests) is not specified in the provided summary.
- Data Provenance: Not applicable as it's mechanical bench testing, not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for mechanical and sterility testing is established by the specified ASTM standards and FDA guidance documents, which define the testing methodology and acceptance criteria. This does not involve human expert adjudication of results in the way clinical image analysis or diagnostic studies would.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1 consensus. The tests are either pass/fail based on objective mechanical properties or sterility criteria defined in standards and guidance documents.
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. This type of study is typically performed for diagnostic devices (e.g., AI for medical imaging) to assess the impact of AI assistance on human reader performance. The KITE Distal Fibula Kit is a bone fixation appliance, and its clearance is based on mechanical performance and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a bone fixation kit, not an algorithm or AI-based diagnostic tool. The performance studies described are for the physical components of the kit.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Mechanical Standards: ASTM F382-17 (for plates) and ASTM F543-17 (for screws). These standards define the methods for measuring specific mechanical properties.
- FDA Guidance Documents: "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" for mechanical performance, and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff" for LAL testing. These documents define the acceptance criteria that demonstrate safety and performance for these types of devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical medical implant.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/machine learning algorithm, there is no ground truth to establish for it.
§ 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.