(29 days)
The Smith & Nephew Spatialframe.com software is intended to be used as component of multilateral external fixation systems that are indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; 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; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.
Subject of this Special 510(k) premarket notification is the Smith & Nephew Spatialframe.com version 4.1 Software. The subject device is a web-based software component of a multilateral external fixation system that is intended for fracture fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the software is designed to be used to assist the physician in adjusting the external fixator frame by creating a patient adjustment schedule. The Spatialframe.com software receives inputs measurements taken by the physician and produces outputs recommending adjustments to the fixator that define a correction path for the deformity.
The provided document describes the Smith & Nephew Spatialframe.com Software version 4.1, a web-based software component for multilateral external fixation systems. It states that software verification and validation testing was completed in line with FDA's guidance document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (as per submission) |
|---|---|
| Software Validation | - Software Installation Qualification Protocol completed. |
- Software Operational Qualification Protocol completed.
- Software Performance Qualification Protocol completed. |
| Functional Performance | "The results of the testing indicate that the software will perform as intended." |
| Safety and Effectiveness | "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject device." |
2. Sample size used for the test set and the data provenance:
The document does not specify a sample size for a "test set" in the context of clinical or diagnostic performance. The testing described relates to software validation activities (Installation, Operational, Performance Qualification) rather than evaluation of diagnostic or predictive accuracy on a dataset of patient cases. There is no information provided about data provenance (e.g., country of origin, retrospective or prospective data) because no clinical data or patient datasets were used for performance evaluation in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission states, "Clinical data was not needed to support the safety and effectiveness of the subject device." The software validation outlined does not involve establishing ground truth from expert consensus on medical cases.
4. Adjudication method for the test set:
This information is not applicable as no test set requiring expert adjudication was used.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is software designed to assist physicians in adjusting an external fixator frame by creating an adjustment schedule, not a diagnostic AI tool that human readers would interpret.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance evaluation in the context of diagnostic accuracy was not explicitly described or presented. The software's "performance as intended" refers to its functional operation as a calculation and recommendation tool based on physician inputs, not its ability to standalone diagnose or interpret medical images.
7. The type of ground truth used:
Ground truth in the medical diagnostic sense (e.g., pathology, outcomes data, expert consensus on patient cases) was not used. The "ground truth" for the software's performance was its adherence to specified functional requirements and its ability to correctly process inputs and generate outputs according to its design, as assessed during software qualification protocols.
8. The sample size for the training set:
A training set, in the context of machine learning or AI models, was not mentioned or applicable to this submission. The software described is a rule-based or algorithmic tool for calculating adjustment schedules, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there was no training set for a machine learning model.
§ 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.