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510(k) Data Aggregation
(75 days)
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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