(30 days)
The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.
The Orthofix Contours Proximal Humeral Plate (PHP) is a modified version of the Orthofix Titanium Humeral Plating System "LSP", cleared under 510(k) K062920. Like the predicate device, the Orthofix Contours Proximal Humeral Plate (PHP) is a locking titanium plate intended for the treatment of fractures. osteotomies and non-unions of the proximal humerus. The Orthofix Contours Proximal Humeral Plate (PHP) consists of a left and a right plate that has to be used in combination with at least two Diaphyseal Screws, a main locking screw and at least two titanium hexagonal Fine Threaded Screws. In addition titanium/polymeric cerclage wires can be used to achieve further stabilization of the bone fragments. Instrumentation is available for the insertion of the plates and screws. The modifications introduced with the Orthofix Contours Proximal Humeral Plate (PHP) are summarized below: - Dimensional changes, concerning width and central part height of the plate, diameter of some fixation points and lengths of the revision screws. - Sterilization configuration: Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration while the predicate device, Orthofix Titanium Humeral Plating System "LSP" is sold in a non-sterile configuration. - Packaging configuration: as the Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration, the packaging will be modified with respect to the predicate device.
This document describes a 510(k) premarket notification for the Orthofix Contours Proximal Humeral Plate (PHP). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) would.
Therefore, the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test and training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable in this context.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. This document does not describe acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-driven device. It's for a medical implant and focuses on mechanical equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set for clinical performance is mentioned. The study referenced (mechanical testing) would involve physical samples of the device, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth for clinical interpretation by experts is not relevant to this submission for a bone plate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Clinical adjudication methods are not relevant to this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-driven device and no MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" in this context is the mechanical performance standards set by ASTM (American Society for Testing and Materials) for bone plates.
8. The sample size for the training set:
- Not Applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the 510(k) document):
The "study" in this context is mechanical testing to demonstrate substantial equivalence to a predicate device, rather than a clinical trial.
-
Acceptance Criteria (Implicit): The implicit acceptance criteria are that the mechanical strength of the Orthofix Contours Proximal Humeral Plate (PHP) must be equivalent or better than the predicate device, Orthofix Titanium Humeral Plating System "LSP". This is based on specific ASTM standards.
-
Study Description:
- Type of Study: Non-clinical (mechanical) testing.
- Standards Used: The testing was conducted in accordance with ASTM F384-06 (Standard Specification for Metallic Bone Plates) and ASTM F382-99 (Standard Specification for Metallic Bone Plates). These standards specify methods for evaluating the mechanical properties of bone plates.
- Reported Device Performance: "Testing in accordance with ASTM F384-06 and ASTM F382-99 shows the mechanical strength of the Orthofix Contours Proximal Humeral Plate (PHP) to be equivalent or better than the predicate devices." (Page 2, Section 6 and Page 3, Section 7)
- Comparison: The results were compared directly against the mechanical performance of the predicate device, the Orthofix Titanium Humeral Plating System "LSP" (K062920).
- Conclusion: Based on these mechanical test results, alongside similarities in design, materials, and intended uses, Orthofix concluded that the Contours Proximal Humeral Plate (PHP) is substantially equivalent to the predicate device.
Key takeaway for this document: The focus of a 510(k) for a medical implant like a bone plate is primarily on demonstrating substantial equivalence to a previously cleared device through comparisons in design, materials, intended use, and non-clinical performance (like mechanical strength) rather than extensive clinical efficacy or diagnostic performance studies.
§ 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.