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510(k) Data Aggregation
(141 days)
XLO Brand of Locking Distal Humerus Plating System
The XLO Brand of Locking Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
The system is indicated for use in adult patients only. All implants are for single use only.
The XLO Brand of Locking Distal Humerus Plating System consists of various shape and sizes of plates featuring compression and locking or non-locking holes, full threaded-cortical, locking or non-locking & self-tapping screws. The XLO Brand of Locking Distal Humerus Plating System consists of the following implants:
- Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, Left & Right
- Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, With Lateral Support Left & Right
- 3.5mm cortical screw
- 2.7mm locking screw
- 3.5mm locking screw
The aforementioned plates are used with cortical screws & locking Screws.
These bone plates are generally designed on the basis of the bone contour and anatomy.
The plates and screws are fabricated from titanium-alloy (Ti-6Al-4V).
These implants are sold non-sterile, the products have to be sterilized prior to use.
The provided text is a 510(k) summary for the XLO Brand of Locking Distal Humerus Plating System. This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant (bone plates and screws), not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories about AI performance studies, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to performance criteria outlined in FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws. The specific numerical acceptance criteria are not explicitly stated in the provided text, but the reported performance is that the device "conform[s] to the performance criteria outlined in [FDA guidance documents]."
| Acceptance Criteria (Reference) | Reported Device Performance (XLO Brand of Locking Distal Humerus Plating System) |
|---|---|
| Performance criteria outlined in FDA guidance document, "Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" (for Static Four Point Bend Test per ASTM F382) | Test results conform to the performance criteria. |
| Performance criteria outlined in FDA guidance document, “Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway" (for Torsional Strength, Driving Torque, Removal Torque, and Axial Pull-out Strength per ASTM F543) | Results conform to the performance criteria. |
2. Sample size used for the test set and the data provenance:
This information is not explicitly provided. For mechanical testing of physical orthopedic implants, sample sizes are typically determined by specific ASTM standards (e.g., ASTM F382, ASTM F543) and validation protocols, rather than "test sets" in the AI/SaMD sense. The data provenance would be from laboratory mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a physical device, and its "performance" is evaluated through mechanical engineering tests against established standards, not through clinical interpretation or expert ground truth.
4. Adjudication method for the test set:
Not applicable. Mechanical tests have objective pass/fail criteria based on measured physical properties.
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 is not an AI/SaMD device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/SaMD device.
7. The type of ground truth used:
The "ground truth" for this device's performance is objective mechanical engineering data compared against established industry standards (ASTM F382, ASTM F543) and FDA guidance documents.
8. The sample size for the training set:
Not applicable. This is not an AI/SaMD device and does not involve a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/SaMD device and does not involve a training set or its associated ground truth establishment.
Summary of Applicable Information from the Document:
- Device Type: Physical Metallic Bone Fixation Appliances and Accessories (Bone Plates and Screws).
- Study Type: Non-clinical (benchtop) mechanical testing and material standards compliance.
- Standards Used:
- Material: ASTM F136 (Wrought Titanium-6Aluminium-4Vanadium ELI Alloy for surgical implant applications).
- Performance: ASTM F382 (Static Four Point Bend Test for plates), ASTM F543 (Torsional Strength, Driving Torque, Removal Torque, Axial Pull-out Strength for screws).
- Performance Comparison: Test results were compared to performance criteria outlined in FDA guidance documents: "Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway."
- Conclusion: The device's test results conform to the specified performance criteria, and the material complies with the relevant standard, justifying its safety and effectiveness.
- Clinical Data: "Clinical data and conclusions were not needed for these devices to demonstrate substantial equivalence to the predicate devices."
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