(28 days)
The WishBone Bone Plate and Screw System is used for pediatric and adult patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotion of deformity or arthrodesis.
Indications for use include fractures of the clavicle, scapula, humerus, ulna, radius, middle hand, metacarpals, pelvis acetabulum, femur, fibula, tibia, metatarsals and middle foot bones, and treatment of the calcaneus.
The purpose of this subject 510(k) is to introduce 4.0mm diameter cannulated screws and washers to the bone plate and screw system cleared under K180736.
This document describes a 510(k) premarket notification for the WishBone Medical Plate and Screw System. It is a submission for an orthopedic device, specifically bone plates and screws.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The submission refers to acceptance criteria, but doesn't explicitly state a table with quantitative values for each criterion and the device's performance against them. Instead, it indicates that the device met certain standards.
| Acceptance Criterion (Reference) | Reported Device Performance |
|---|---|
| Predicted Shear Failure: Performance criteria for pullout strength defined within the FDA guidance document "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway". | Confirmed pullout strength met performance criteria defined within the FDA guidance document. |
| Torsional Strength: Compared torsional strength of the screw shafts to legally marketed predicate cannulated screws per ASTM F543-17. | Torsional strength of the screw shafts was compared to predicate cannulated screws. (Implied that it met or was comparable to the predicate, as a conclusion of substantial equivalence was reached). |
| Breaking Torque of 4.0mm Cannulated Screws at the Hexalobe Drive Feature: Torsional yield strength as defined in the FDA guidance document. | Confirmed the screw head meets the torsional yield strength as defined in the FDA guidance document. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of number of screws or plates tested. The document mentions "Engineering analysis and mechanical testing," but does not provide specific sample numbers for these tests.
- Data Provenance: The studies were non-clinical engineering and mechanical tests performed to demonstrate compliance with standards (ASTM F543-17) and FDA guidance documents. This indicates the testing was likely conducted in a controlled lab environment. There is no information regarding country of origin for the data, nor whether it was retrospective or prospective, as these terms typically apply to clinical studies.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable as the studies were non-clinical mechanical tests, not clinical studies involving human patients or expert interpretation of medical data (like imaging). Therefore, no "ground truth" derived from expert consensus was required for this particular submission.
4. Adjudication Method for the Test Set
This information is not applicable as the studies were non-clinical mechanical tests. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies where multiple experts evaluate cases and discrepancies need to be resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/radiology devices where human readers' performance with and without AI assistance is evaluated. The WishBone Medical Plate and Screw System is a physical orthopedic implant, not an AI diagnostic or assistive device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (in the context of an algorithm's performance without human interaction) was not done. This is because the device in question is a physical medical implant, not an algorithm or AI software.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by industry standards (ASTM F543-17) and performance criteria defined within FDA guidance documents for metallic bone screws and washers. These define the expected mechanical properties and failure limits.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical implant, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.