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1. Post-Traumatic joint contracture which has resulted in loss of range of motion
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction
6. Correction of bony or soft tissue deformities
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis
9. 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."

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.

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The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:

1. Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
3. Open and closed fracture fixation
4. Pseudoarthrosis of long bones
5. Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)
6. Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
7. Correction of segmental bony or soft tissue defects
8. Joint arthrodesis (not applicable for Smith & Nephew Rail System)
9. Infected fractures or nonunions
10. Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.

The provided text is a 510(k) Premarket Notification for the "Smith & Nephew, Inc. External Fixation Instrumentation." This submission is for surgical instruments, not a device that generates performance metrics in the way an AI diagnostic or therapeutic device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment is not applicable to this type of regulatory submission.

This 510(k) submission establishes substantial equivalence to legally marketed predicate devices based on similarities in:

• Raw materials
• Manufacturing processes
• Sterilization procedures
• Nature of body contact
• Design and function

The FDA's review for this type of device focuses on ensuring these accessory instruments are safe and effective for their intended use alongside the cleared Smith & Nephew External Fixation Systems, and that they are substantially equivalent to existing predicate instruments. It does not involve a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.

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