(76 days)
Quick-Start Orthopaedic Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.
This document describes the 510(k) premarket notification for the "Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw" by Innovate Orthopaedics Limited. The submission is for a modified version of an existing device, primarily to include MR conditional labeling.
Here's a breakdown of the requested information, where available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Related to MR Safety) | Reported Device Performance |
|---|---|
| Risk of displacement force or torque effects during clinical MR scanning should be low and acceptable. | Results of testing confirmed that the risk of displacement force or torque effects during clinical MR scanning is considered low and acceptable. |
| Potential temperature increase during clinical MR scanning should be established and demonstrate safety. | Results established the potential temperature increase during clinical MR scanning and demonstrate the safety of the Quick-Start Screws in the MR environment within the conditions specified in the Instructions for Use. |
| Image artifact during clinical MR scanning should be established and demonstrate safety/acceptability. | Results established the image artifact during clinical MR scanning and demonstrate the safety of the Quick-Start Screws in the MR environment within the conditions specified in the Instructions for Use. |
| Device complies with FDA guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (May 20, 2021). | Tests for displacement force and torque effects, heating effects, and image artifacts were conducted on three sizes of Quick-Start Screw, in accordance with FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", dated May 20, 2021. |
| Device complies with relevant ASTM standards for MR safety testing (ASTM F2052-21, ASTM F2213-17, ASTM F2182-19, ASTM F2119-07(2013)). | Tests for displacement force and torque effects, heating effects, and image artifacts were conducted on three sizes of Quick-Start Screw, in accordance with ASTM F2052-21, ASTM F2213-17, ASTM F2182-19 and ASTM F2119-07(2013). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: "three sizes of Quick-Start Screw" were tested for MR safety.
- Data Provenance: Not explicitly stated, but based on the nature of the tests (physical testing of devices), it would be proprietary laboratory testing performed by or for the manufacturer. The document doesn't specify if it's retrospective or prospective, but MR safety testing is typically performed prospectively on new or modified devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For MR safety testing, "ground truth" is typically established by adhering to recognized international standards (like ASTM) and FDA guidance, rather than expert consensus on individual test outcomes. The tests themselves provide objective measurements against these predefined criteria.
4. Adjudication Method for the Test Set
This information is not applicable for this type of non-clinical, objective MR safety testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective assessments or interpretations (e.g., image readings) are involved. The MR safety tests involve precise measurements and adherence to specified test protocols.
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
This information is not applicable. This document concerns a physical orthopedic fixation screw, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is not an algorithm or software device. Performance is determined through physical non-clinical testing of the device itself.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the MR safety testing, the "ground truth" is established by adherence to predefined national and international standards and guidance documents. Specifically:
- FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", dated May 20, 2021
- ASTM F2052-21 (Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2213-17 (Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment)
- ASTM F2182-19 (Standard Test Method for Measurement of Radiofrequency Induced Heating Near Passive Implants in the Magnetic Resonance Environment)
- ASTM F2119-07(2013) (Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants)
The results of the physical tests are compared against the acceptance limits and methodologies specified in these standards.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI device that requires a training set. The performance evaluation is based on non-clinical physical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.