(121 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
Subject of this premarket notification is the SMART Taylor Spatial Frame. The proposed devices incorporate design features similar to those currently incorporated on previously cleared Smith & Nephew multilateral external fixation systems. The SMART Taylor Spatial Frame consists of full or partial rings, telescoping struts other fixation accessories made from aluminum and stainless steel materials. The system also includes a web-based software component designed for use in assisting physicians creating fixator adjustment schedules and mobile app.
The provided text describes a 510(k) premarket notification for the "SMART Taylor Spatial Frame," a metallic bone fixation appliance and accessories. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through engineering and software testing. It does not contain information about a study involving human readers or AI performance metrics.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance criteria related to AI performance or human reader improvements.
- Reported device performance against such criteria.
- Sample size used for the test set or data provenance for a clinical study comparing AI to human readers.
- Number of experts and their qualifications used to establish ground truth for a clinical study.
- Adjudication method for a clinical study.
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size of AI assistance.
- Standalone algorithm performance study details.
- Type of ground truth (expert consensus, pathology, outcomes data, etc.) for a clinical study comparing AI to human readers.
- Sample size for the training set of an AI algorithm.
- How ground truth for the training set was established for an AI algorithm.
The document does mention software verification and validation, but this refers to the software component of the device itself (for assisting physicians in creating fixator adjustment schedules and a mobile app), not an AI algorithm performing diagnostic or assistive tasks in a clinical setting in the way typically discussed in AI/ML medical device submissions.
The "Summary of Pre-Clinical Testing" section mentions:
- Construct and frame component testing: Per ASTM F1541 "Standard Specification and Test Methods for External Skeletal Fixation Devices."
- Magnetic resonance imaging (MRI) compatibility testing: As per FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," December 11, 2014.
- Software Verification and Validation: Per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005, and "General Principles of Software Validation" dated January 11, 2002.
However, these are engineering and software validation tests for the physical device and its associated software, not AI performance studies as requested in the prompt.
§ 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.