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510(k) Data Aggregation
(259 days)
X-Fix Line Additions
The Vilex X-Fix is intended for external fixation with the following indications:
- Stabilization of Fractures & Osteotomy
- Adult and Pediatric Leg Lengthening
- Correction of Bone Deformity in Upper & Lower Extremities
The P&C Software is intended to be used as a component of multilateral external fixation system for the indications listed above.
The X-Fix Line Additions, subject of this 510(k) submission, include External Fixation Rings and Footplates, External Fixation Struts, External Fixation Assembly Accessories, and P&C Software. The line additions are manufactured from stainless steel and aluminum materials in various sizes to accommodate patient needs. The X-Fix Line Additions are used with the X-Fix system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the X-Fix Line Additions device, presented in the requested format.
It's important to note that the document describes a 510(k) submission, which aims to demonstrate substantial equivalence to a predicate device rather than strictly proving effectiveness and safety through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the information provided focuses on mechanical testing and software validation, not on clinical performance criteria like sensitivity, specificity, or reader studies.
Acceptance Criteria and Study for X-Fix Line Additions
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|
| Mechanical Performance: Withstanding expected in vivo loading | All testing confirmed that the device is capable of withstanding expected in vivo loading, as per ASTM F1541-02 (Sections A6 and A7). |
| P&C Software Validation: Conformance with FDA guidance | The results of software V&V testing indicate that the software performed as intended, in conformance with FDA guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" dated January 11, 2002. |
| Material Equivalence: Same materials as predicates | Line additions are manufactured from the same materials (stainless steel and aluminum) as the predicate devices. |
| Design/Size Equivalence: Similar to predicates | Line additions are manufactured in similar sizes and designs as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Mechanical Testing: The document does not specify the exact sample size for mechanical testing. It mentions general adherence to ASTM F1541-02 (Sections A6 and A7), which would define the sample size requirements for specific tests.
- Software Validation: The document does not specify the exact sample size (e.g., number of test cases) for software V&V.
- Data Provenance: The data is likely retrospective (meaning performed according to established protocols) and generated internally by Vilex in Tennessee, Inc. (the manufacturer). The country of origin for the data generation would be USA. This is not clinical data, so patient data provenance is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission relied on mechanical engineering and software testing standards, not clinical ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is defined by the stress and strain limits specified in the ASTM standard. For software, the "ground truth" is established by the functional requirements and specifications.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers. This submission focused on mechanical and software-based performance.
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. An MRMC comparative effectiveness study was not conducted. This device is a physical external fixation system and associated P&C software, not an AI-assisted diagnostic or therapeutic tool that would involve human reader performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes (for the P&C Software component). The software verification and validation (V&V) essentially evaluates the algorithm's standalone performance against its intended specifications and functionality. The document states, "The results of software V&V testing indicate that the software performed as intended," implying testing of the algorithm itself. However, it's not "algorithm-only" in an AI sense; it's a piece of software for planning and calculation.
7. The Type of Ground Truth Used
- Mechanical Performance: The ground truth for mechanical testing is based on engineering standards and specifications (e.g., ASTM F1541-02). This means the device must withstand specified forces and conditions without failure.
- Software Performance: The ground truth for software validation is based on predefined software requirements, specifications, and functional tests. The software is verified to perform its intended computational and operational tasks accurately.
8. The Sample Size for the Training Set
- Not Applicable. This device is hardware with associated planning and calculation software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software is developed based on engineering principles and validated, not trained on data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this submission. The "ground truth" for the software's development is its design specification, derived from clinical and engineering principles.
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