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510(k) Data Aggregation
(72 days)
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
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.
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(75 days)
TEMPFIX EXTERNAL FIXATION SYSTEM
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures of the distal femur, proximal tibia or distal tibia where soft tissue injury precludes the use of other fracture treatments.
The TempFix External Fixation System is intended to be non-weight bearing.
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 and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.
The provided text describes the TempFix™ External Fixation System, a medical device. Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Stiffness | The TempFix constructs were stiffer than predicate devices (Howmedica Hoffman II, Immedica/Zimmer Transfx). |
| Load to Failure | The TempFix constructs had a higher load to failure than predicate devices (Howmedica Hoffman II, Immedica/Zimmer Transfx). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the mechanical tests. The data provenance is not specified beyond being "simulated clinical use," implying laboratory testing. The country of origin of the data is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a mechanical fixation system, and its performance is evaluated through biomechanical testing, not through expert interpretation of medical images or patient outcomes in the test set.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation is based on objective mechanical measurements, not subjective expert judgment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC study or the involvement of human readers in assessing the device's performance. The device is a physical fixation system, not an AI or diagnostic tool that would typically involve human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device's mechanical properties. The document states: "When tested to simulate clinical use, the TempFix constructs were stiffer and had a higher load to failure than either the Howmedica Hoffman II constructs or the Immedica / Zimmer Transfx constructs." This describes the device's performance in isolation during simulated use.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was based on biomechanical measurements (stiffness and load to failure) under simulated clinical use conditions.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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