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510(k) Data Aggregation
(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.
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(139 days)
Quick-Start 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 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.
The provided text describes the performance data for the Quick-Start Screws in a 510(k) summary submitted to the FDA. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Biophysical Performance (Comparative) | |
| Ease of engagement with bone tunnel and initial insertion | The Quick-Start Screw was found to be easier to engage with the bone tunnel and initially insert than the comparative device. |
| Immediate postsurgical fixation strength | The Quick-Start Screw achieved similar immediate postsurgical fixation strength compared to the comparative device. |
| ASTM Standards (Bench Testing) | |
| Torsional strength (ASTM F543) | The Quick-Start Orthopaedic Fixation Screws meet the performance-based requirements outlined by the FDA. (Implies compliance with ASTM F543 parameters, specific values not provided in the summary.) |
| Driving torque (ASTM F543) | The Quick-Start Orthopaedic Fixation Screws meet the performance-based requirements outlined by the FDA. (Implies compliance with ASTM F543 parameters, specific values not provided in the summary.) |
| Axial pullout strength | The Quick-Start Orthopaedic Fixation Screws meet the performance-based requirements outlined by the FDA. (Implies compliance with relevant ASTM standards, specific values not provided in the summary.) |
| Endotoxin Level (LAL Test) | |
| Meets acceptance criteria at 20 endotoxin units per device | Testing demonstrates that the subject devices meet the acceptance criteria at 20 endotoxin units per device in accordance with USP for medical devices which are not in contact with cerebrospinal fluid. |
| Biocompatibility (ISO 10993-1) | |
| Biocompatible for permanent contact (>30 days) | The Quick Start Screws were determined to be biocompatible per International standard: ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing and FDA Guidance Document: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1": Evaluation and Testing within a risk management process... categorized as an implant device with permanent contact (>30 days) to tissue or bone. (Implies compliance with ISO 10993-1 requirements for this category). |
| Sterility (Co60 gamma irradiation) | |
| Sterility Assurance Level (SAL) 10-6 | The Quick Start screws are provided sterile (SAL 10-6) by means of Co60 gamma irradiation. |
| Shelf Life | |
| 5-year shelf life | The Quick Start Screws have a 5 year shelf life. (Implies testing was conducted to support this claim, though the specific study details are not provided in this summary. This would typically involve accelerated aging studies or real-time studies to demonstrate maintenance of sterility and material properties over the claimed period.) |
2. Sample Size Used for the Test Set and Data Provenance
-
Comparative Biophysical Performance Study:
- Sample Size: 10 fresh-frozen human cadaveric knees.
- Data Provenance: Retrospective (cadaveric tissue implies specimens were obtained from previously deceased individuals), likely from a country with cadaver donation programs. The document does not specify the country of origin.
-
ASTM Standards Testing, Endotoxin, Biocompatibility, Sterility:
- Sample Size: Not explicitly stated for bench testing, endotoxin, biocompatibility, or sterility. These tests typically involve a statistically relevant number of samples for each specific test, but the exact count is not detailed in this summary.
- Data Provenance: Not explicitly stated, but typically these are laboratory-based tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the given text. The studies described are primarily performance and bench testing, not image-based diagnostic studies that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided as the studies are primarily objective performance tests of the device itself (e.g., insertion ease, fixation strength, material properties) rather than studies that require human interpretation and adjudication of a dataset.
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 provided and is not applicable. The device is an orthopedic fixation screw, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not provided and is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
- Comparative Biophysical Performance Study: The ground truth for this study was direct physical measurement and observation of the device's interaction with cadaveric bone (e.g., ease of insertion, immediate fixation strength) in comparison to a predicate device.
- ASTM Standards Testing: The ground truth was defined by established engineering and material science standards (e.g., ASTM F543) and measured physical properties of the screw (torsional strength, driving torque, axial pullout strength).
- Endotoxin Testing: The ground truth was the quantitative measurement of endotoxin levels against a specified USP acceptance limit.
- Biocompatibility Testing: The ground truth was biological response assessment against the criteria outlined in ISO 10993-1.
- Sterility Testing: The ground truth was the absence of viable microorganisms to a specified SAL (verified through standard sterility testing methods).
8. The Sample Size for the Training Set
- This information is not provided and is not applicable. As a physical medical device, there is no "training set" in the context of an AI/ML algorithm. The "training" for the device's design and manufacturing processes would be related to engineering iterative design and testing, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided and is not applicable for the reasons stated in point 8.
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