(65 days)
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudarthrosis of long bones
- Limb lengthening by distraction
- Correction of bony or soft tissue deformities
- Joint arthrodesis
- Infected fractures
- Nonunions
The Smith & Nephew Acute QC Strut and Components consist of multiple sized struts (e.g., X Short, Short, Medium, and Long) and components such as nuts, bands, and washers to build an external fixation construct. The proposed devices incorporate design features similar to those currently incorporated in previously cleared Smith & Nephew SMART Taylor Spatial Frame and ILIZAROV™ External Fixation System. The Acute QC Strut and Components will be manufactured from aluminum, composite, and stainless-steel material, which is identical to that of the predicate devices of the SMART Taylor Spatial Frame System (e.g., K210953, S.E. 07/29/2021).
This document is a 510(k) Premarket Notification for a medical device (Acute QC Strut and Components). The acceptance criteria and supporting studies described in such documents are typically related to proving the substantial equivalence of the new device to existing predicate devices, primarily through engineering performance testing and material compatibility, rather than clinical performance (like improved diagnostic accuracy).
Therefore, the provided text does not contain the information requested regarding acceptance criteria related to a study proving the device meets acceptance criteria through clinical performance metrics, such as sensitivity, specificity, or human reader improvement with AI assistance. This type of information is typically found in submissions for AI/ML-enabled diagnostic devices, not for mechanical orthopedic devices like external fixation systems.
The document primarily focuses on demonstrating:
- Substantial Equivalence: The new device has the same intended use, indications for use, similar design, materials, and performance characteristics as legally marketed predicate devices.
- Bench Testing: Mechanical, biological, and MR safety testing to ensure the device performs as expected and is safe.
Given this, I cannot construct the table and detailed answers about clinical performance studies as the information is not present in the provided text.
However, I can interpret the provided text in the context of what was done for this specific device.
What is present in the document:
-
Acceptance Criteria & Performance (Implicit - Mechanical/Material): The acceptance criteria are implicitly met by demonstrating that the mechanical performance, biological safety, and MR safety of the Acute QC Strut and Components are "substantially equivalent" or do not present "greater risk" than the predicate devices. The document states:
- "The subject Acute QC Struts were determined to not present a greater biological risk than the cleared worst-case representative SMART FX STRUT..."
- "Performance testing was conducted on the subject, implantable devices in comparison against one or more of the previously cleared predicate devices... A review of the mechanical data in the submission indicates that the Acute QC Strut and Components are substantially equivalent to the previously cleared predicate devices."
-
Study That Proves the Device Meets Acceptance Criteria: This was primarily through non-clinical performance testing (bench testing) and comparison to predicate devices, rather than a clinical study involving diagnostic accuracy.
The performance testing reviewed included:
- Fully Reversed Compressive Fatigue Loading of the Construct
- Continuous Compressive Static Loading of the Construct
- Static Compressive Bending Load on the Ball Joint Assembly
- Compressive Fatigue Loading of the Ball Joint Assembly
- Torsional Strength Testing of the Subject Half Pin Washer
- Biological risk assessment (ISO 10993-1: 2018)
- MR safety technical memo comparing to predicate devices.
Based on the provided text, the requested information (related to clinical performance of an AI/ML device) is explicitly not present.
The document states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This confirms that no clinical studies as you've described (e.g., MRMC, standalone AI performance, expert ground truth adjudication) were conducted or deemed necessary for this 510(k) submission.
Therefore, I cannot fill out the requested table or answer the specific questions about clinical performance studies accurately from the provided text.
§ 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.