(113 days)
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used both in adult and pediatric (adolescent and child) patients.
The Medline UNITE® Calcaneal Fracture Plating System consists of 3 styles of Sinus Tarsi plates (Sinus Tarsi, Sinus Tarsi Offset, and Sinus Tarsi Extension) made from Titanium Alloy (Ti-6Al-4V ELI) and Perimeter plates made from Commercially Pure Titanium. The Sinus Tarsi Offset, and Sinus Tarsi Extension, and Perimeter plates are each offered in small, medium, and large sizes in left and right configurations. The plates can accommodate 2.7mm, 3.5mm and 4.0mm screws. Previously cleared 3.5mm locking and non-locking screws (K151235) that range from 10-60mm in length will be included in the tray with the Medline UNITE® Calcaneal Fracture Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. targeting guide, drill bits
This document is a 510(k) premarket notification for the Medline UNITE® Calcaneal Fracture Plating System. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria through a study involving AI. Therefore, the requested information elements related to AI/algorithm performance and clinical study outcomes cannot be extracted from this document.
The document primarily describes a medical device, its indications for use, and a comparison of its technological characteristics to a predicate device. The performance testing outlined is largely bench testing to demonstrate mechanical equivalence, not clinical effectiveness studies.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit acceptance criteria in a quantitative sense for performance metrics like sensitivity, specificity, or image quality, as it's not and AI device undergoing such validation. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process, where the device must perform equivalently to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bending stiffness equivalent to predicate device (ASTM F382) | The Medline Unite® Calcaneal Plates and the predicate Wright Medical ORTHOLOC® Calcaneal Plates are substantially equivalent in 4-point single cycle bend testing. |
| Bending fatigue equivalent to predicate device (ASTM F382) | Results from this testing demonstrate that the Medline UNITE® Calcaneal Plates are substantially equivalent to the Wright Medical ORTHOLOC® CALC Fracture Plates in bending fatigue. |
2. Sample sized used for the test set and the data provenance
Not applicable. The "test set" in this context refers to physical devices undergoing mechanical testing, not a dataset for an AI algorithm. The document mentions "Single Cycle 4-Point Bend Testing" and "Bending Fatigue Testing," which involve physical samples of the plates. The document does not specify the exact number of plates tested in these bench tests, nor does it specify data provenance as it would for a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for AI algorithms is not relevant here as this is a physical medical device. The "ground truth" for the performance tests is derived from standardized mechanical testing protocols (ASTM F382).
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically for clinical studies where expert consensus is needed. For mechanical testing, the results are objectively measured per established ASTM standards.
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
No. This is not an AI device, and therefore, an MRMC study involving human readers and AI assistance was not performed. The document explicitly states: "Performance Testing (Clinical) This section does not apply. No clinical testing was performed." and "Summary of Clinical Testing Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI device.
7. The type of ground truth used
For the bench testing, the "ground truth" or reference for comparison is the performance of the legally marketed predicate device as measured by the specified ASTM standards.
8. The sample size for the training set
Not applicable. There is no AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm.
§ 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.