(245 days)
The Nextremity Solutions CalcShift™ Displacement Calcaneal Osteotomy System is indicated for osteotomies, nonunions, malunions, revisions, fusions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy.
The CalcShift Displacement Calcaneal Osteotomy System is a foot and ankle plate and screw system consisting of a plate and screw implants. The plate is 1.6mm thick, 19.75mm long, and 11.5mm wide. The plate has 4 screw holes. The system provides locking and non-locking screws that are 3.5mm in diameter and range in length from 10mm to 70mm. The system includes cannulated compression screws and cannulated stability screws that are 5.0mm in diameter and range from 30mm to 100mm in length. The plate and screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
This document is a 510(k) premarket notification for a medical device called the CalcShift™ Displacement Calcaneal Osteotomy System. It details the device's indications for use, description, and the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices. Crucially, the document explicitly states that clinical testing was not necessary for this device. Therefore, a study proving the device meets acceptance criteria, as defined by a clinical study with an AI component, was not performed or submitted for this specific 510(k) clearance.
Given this, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance (as these are typically derived from clinical study outcomes)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size regarding human reader improvement with AI assistance
- Whether a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document's "Non-Clinical Testing" section describes mechanical tests performed on the device (e.g., axial pullout strength, torque to failure, 4-point bend tests) to ensure its performance and safety are comparable to existing predicate devices. The acceptance criteria for this device are therefore primarily based on these mechanical test results meeting established ASTM standards (ASTM F543-17 and ASTM F382) and demonstrating substantial equivalence to the predicate devices in terms of strength and adequacy for intended use.
In summary, this 510(k) relies on non-clinical bench testing for device acceptance, not clinical testing, and definitely not a study involving AI performance or human-in-the-loop evaluation as would be typical for an AI/ML medical device.
§ 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.