(72 days)
Existing indications cleared in K021933:
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures and correction of bony or soft tissue defects or deformities.
When used without adjunctive support, the TempFix External Fixation System is intended to be nonweight bearing.
DePuy also sceks the following additional indications:
The TempFix External Fixation System is MR safe when specific safety guidelines are followed relative to the use of 1.5-Tesla MR systems, only.
The TempFix External Fixation System consists of components that can be assembled to provide multiple degrees of freedom for positioning implantable threaded fixation pins on either side of a fracture or deformity. The unique frame materials provide radiolucent viewing of the fracture and are lightweight for patient comfort. The components are preassembled in kits with three basic frame configurations: a knee frame, a half pin ankle frame, a 400 mm bar, and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.
The provided text from the 510(k) submission (K043113) for the TempFix™ External Fixation System, MR Safe, does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, or information about sample sizes, ground truth establishment, or expert involvement for a clinical study.
Instead, this submission primarily focuses on establishing "MR safety" for the device based on material conformance to standards and comparison to previously cleared devices. The document does not describe a clinical performance study with the types of metrics requested (e.g., sensitivity, specificity, accuracy) that would apply to an AI/algorithm-based device.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here is an attempt to address what can be extracted:
Device Acceptance Criteria and Performance (Based on MR Safety Claim)
The "acceptance criteria" here would relate to the device's ability to be considered "MR Safe" according to relevant standards and FDA guidance, rather than clinical performance metrics like diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Conformance |
|---|---|---|
| MR Safety | Conformance to standards included in Section I under E. Materials (These specific standards are not detailed in the provided text). | The submission asserts the device is "MR safe when specific guidelines are followed relative to the use of 1.5-Tesla MR systems, only." The basis is material conformance and comparison to predicate devices, implying the materials used meet the safety requirements. |
Missing Information (Not available in the provided text):
- Specific quantitative metrics for MR safety (e.g., temperature rise limits, artifact size limits, force/torque limits) and actual measured values. The document only states "conformance of the material to the standards," but doesn't list the standards or the test results.
2. Sample size used for the test set and the data provenance
Not applicable. This was not a data-driven clinical performance study evaluating an algorithm or AI. The assessment was based on material characterization and potentially bench testing for MR safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of clinical performance (e.g., disease presence) was not established for this submission. The "ground truth" for MR safety would be derived from physical measurements and adherence to engineering standards.
4. Adjudication method for the test set
Not applicable. There was no test set requiring expert adjudication in the context of a clinical performance study for an algorithm.
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
Not applicable. This submission is for an external fixation device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the MR safety claim, the "ground truth" would be established by:
- Physical properties and composition of the device materials.
- Results from standardized bench tests (e.g., for magnetic force, torque, heating, artifact) according to relevant industry standards (though these specific tests and their results are not detailed in the provided text).
8. The sample size for the training set
Not applicable. There was no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
Summary based on given document:
The 510(k) submission K043113 primarily seeks to add an "MR Safe" claim to the existing TempFix™ External Fixation System. This claim is based on the conformance of the device's materials to established (but unspecified in the provided text) MR safety standards, and comparison to predicate devices that have already been cleared for MR safety. It is not a submission for a software, AI, or diagnostic device, and therefore the criteria for clinical performance studies as typically understood for such devices are not relevant here and thus, not present in the document.
§ 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.