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The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:
shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

The provided text is an FDA 510(k) clearance letter for a medical device called "Fix2Lock" (a bone anchor). This type of document primarily focuses on establishing substantial equivalence to a predicate device based on non-clinical performance data (bench tests). It does not contain information about clinical studies involving human patients, human readers (e.g., radiologists interpreting images), or AI algorithms for diagnostic purposes.

Therefore, I cannot provide details on:

• Acceptance criteria related to AI performance (e.g., sensitivity, specificity).
• Sample sizes for test sets or data provenance for AI.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for AI test sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone AI performance.
• Training set details for AI.

The document discusses bench testing to demonstrate the device's mechanical and material properties, and sterility, compared to existing standards and a predicate device.

Here's the information that can be extracted relevant to the performance and acceptance criteria for this specific type of medical device, which is a bone anchor, not an AI diagnostic tool:

Acceptance Criteria and Study for the Fix2Lock Device

The acceptance criteria and supporting studies for the Fix2Lock device are based on non-clinical (bench) testing, primarily to demonstrate that the device meets established material and mechanical performance standards and is substantially equivalent to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• The document does not specify the exact sample sizes (number of units) used for each bench test. However, it indicates that "Bench tests were conducted to verify that the subject device met all design specifications."
• Data Provenance: Not applicable in the human patient context. The data is from laboratory bench testing of the physical medical device. The sponsor is OSTEONIC Co., Ltd. from Korea, South. The testing would have been conducted by or for the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for this type of device is established through compliance with recognized consensus standards (e.g., ASTM, ISO) and comparison of physical/mechanical properties to a predicate device via laboratory testing, not through expert human interpretation of data like in an AI study.

4. Adjudication method for the test set:

• Not applicable. Bench tests have objective, measurable endpoints based on engineering and material science principles, not subjective interpretation requiring adjudication.

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. This is a physical medical device (bone anchor), not an AI diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This applies to AI algorithms, not physical implanted devices.

7. The type of ground truth used:

• The "ground truth" for this device is compliance with established engineering, material, and sterilization standards (ASTM and ISO standards) and demonstration of equivalent performance characteristics (material, mechanical, sterilization properties) compared to a legally marketed predicate device through objective bench testing.

8. The sample size for the training set:

• Not applicable. There is no AI training set for this physical device.

9. How the ground truth for the training set was established:

• Not applicable. There is no AI training set.

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The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

The furnished document is an FDA 510(k) Premarket Notification for the medical device "Fix2Lock". This document is a clearance letter, not a study report for an AI/ML medical device. It pertains to a bone fixation screw and its substantial equivalence to predicate devices, not an AI-powered diagnostic or assistive technology.

Therefore, the document does not contain the information requested in the prompt regarding:

• Acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Types of ground truth.
• How ground truth for training data was established.

The document discusses non-clinical bench tests to verify the subject device's design specifications and compliance with various ASTM and ISO standards for materials, mechanical performance, sterilization, and packaging. This is for a physical implantable device, not a software algorithm.

Ask a specific question about this device