(73 days)
- 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 segmental bony or soft tissue defects
- Joint arthrodesis
- Infected fractures or nonunions
The Taylor Spatial Frame Spatialframe.com V5.0 includes a mobile app which is a mobile medical device that aids in the communication between a patient/caregiver and physician. The Taylor Spatial Frame external fixator relies on existing Spatialframe.com software to generate a treatment schedule for limb restoration. The new Taylor Spatial Frame mobile app (iADJUST) will allow the prescribed schedule (currently provided in paper form) to be available and viewable to the patient on a mobile device. Feedback information related to schedule adherence will be available to the physician.
No changes to the hardware of the fixation device will result from the addition of the mobile app. No changes to the treatment schedule or core functionality of Spatialframe.com software will result from the addition of the mobile app.
The provided text describes the Spatialframe.com V5.0 device, which is a mobile app designed to aid in communication between patients/caregivers and physicians regarding limb restoration treatment schedules. It's an extension of the existing Spatialframe.com software.
Based on the provided text, a detailed study proving the device meets acceptance criteria, including specific metrics and performance results, is not present. The submission primarily focuses on establishing "substantial equivalence" of the new mobile app (iADJUST) to its predicate devices.
Here's a breakdown of the requested information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in a way that would typically be seen for a new diagnostic or AI-driven device. The key acceptance criterion appears to be "software validation has been documented to ensure that the information displayed on the mobile medical app is accurate."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy of information displayed on the mobile medical app | "Software validation has been documented to ensure that the information displayed on the mobile medical app is accurate." |
| No changes to existing treatment software algorithm functionality | "No other changes to the existing treatment software algorithm (spatialframe.com) are included in this submission." |
| Substantially equivalent to predicate in performance and tech characteristics | "has been fully validated to ensure that it is substantially equivalent to the existing Spatialframe.com software in performance and technological characteristics." |
2. Sample size used for the test set and the data provenance
The document does not mention a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The validation described is for the software displaying information, not for a clinical outcome or diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device would likely be the correctness of data transfer and display from the existing Spatialframe.com software, not a clinical diagnosis or interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is typically used for clinical endpoints or diagnostic accuracy studies, which are not described here.
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 MRMC study was mentioned. The device is a communication tool for treatment schedules, not a diagnostic or interpretative AI tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a "mobile medical device that aids in the communication...". While it has software, its primary function is to facilitate communication of an existing treatment schedule. A "standalone" performance in the sense of an AI algorithm making independent decisions or interpretations is not described. Its standalone performance would be its ability to accurately display the prescribed schedule.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the software validation appears to be the existing, established treatment schedule generated by the Spatialframe.com software and the correct display of this information on the mobile app. It's about data integrity and display accuracy, not clinical ground truth in the traditional sense.
8. The sample size for the training set
Not applicable. This device is not described as a machine learning or AI model trained on a dataset. It is an application that presents pre-existing treatment schedules.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning model is described.
§ 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.