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Quick-Start Screws are indicated for interference fixation of 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 grafts in ligament reconstruction procedures such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions. 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 document is a 510(k) clearance letter from the FDA for a medical device called "Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw." This type of document primarily confirms substantial equivalence to a predicate device and does not contain the detailed study information typically found in a clinical trial report or a comprehensive premarket submission that would elaborate on acceptance criteria and performance data for AI/ML-based devices.

The document discusses the physical characteristics and intended use of the orthopedic screws, with a focus on demonstrating equivalence to an already cleared predicate device (K231819). It mentions "bench testing" to support the use of the screws with synthetic grafts but does not provide specific performance metrics, sample sizes, or details about the methodology (e.g., ground truth establishment, expert adjudication) that would be relevant to an AI/ML-based device's validation.

Therefore, the information required to answer your request about acceptance criteria and study details for an AI/ML device is not present in the provided text. The document describes a traditional medical device (orthopedic screws) and its regulatory clearance process, not an AI/ML-driven diagnostic or therapeutic system.

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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

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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