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The ICONN Campbell Interference Screw System is intended for fixation of tissue, including ligament or tendon to bone for the following indications:

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis.

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist, Lateral Epicondylitis repair.

The ICONN Campbell Interference Screws (various part numbers) are sterile (gamma irradiation), single use implantable devices available in two materials: Solvay's Zeniva®ZA-600L polyetheretherketone (PEEK) or Ti 6Al-4 ELI (Grade 23) and is intended for fixation of tissue, including ligament or tendon to bone. The screws are available in multiple sizes ranging from diameters of Ø6mm - Ø12mm in 1mm increments. The Ø6mm screw is available only in 20mm long, the Ø7mm - Ø10mm screws are available in 20mm and 25mm lengths, and the Ø11mm and Ø12mm screws are available in 25mm lengths only.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the ICONN Campbell Interference Screw:

1. Table of Acceptance Criteria and Reported Device Performance

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The ICONN Revolution Knotless Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

The ICONN Revolution Knotless Suture Anchor (P/N 350000) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in one size (Diameter x Length): 5mm x 23mm. The implants with attached disposable inserter are supplied sterile and the instrument is supplied Non-Sterile and is to be sterilized in the ICONN instrument tray prior to surgery. The disposable inserter is made out of 17-4 stainless steel and the reusable driver is made out of 17-4 stainless steel (shaft) and silicone (handle). All anchors are intended to be used with the supplied #2 sutures and/or 1.5mm ICONN TetherTape, both made from Ultra High Molecular Weight Polyethylene (UHMWPE). The sutures/tape are supplied sterile, are packaged individually, and are single strands measuring 36/38 inches in length.

The provided text is a 510(k) summary for the ICONN Revolution Knotless Suture Anchor, a medical device. It describes the device, its intended use, and comparative studies against a predicate device to establish substantial equivalence for FDA clearance. The summary does not provide information about an AI/algorithm-based device as requested in the original prompt. Therefore, I cannot extract the specific details you've asked for regarding acceptance criteria and an AI study.

However, I can provide the available information related to the device's performance testing and acceptance criteria as described in the document, which are related to its mechanical and biocompatibility properties, not AI performance.

Here's a breakdown of the information that is available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions performance testing but does not present a formal table of "acceptance criteria" with specific numerical targets alongside "reported device performance." Instead, it states the following regarding the outcomes of the performance tests:

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The ICONN Answer II Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. Specific indications are as follows: Shoulder Indications: Rotator Cuff Repairs, Biceps Tenodesis Foot/Ankle Indications: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

The ICONN Answer II Suture Anchor (P/N's 147501 and 155001) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-600L polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in two sizes (Diameter x Length): 4.75mm x 16mm and 5.5mm x 16mm.

The provided text is a 510(k) summary for the ICONN Answer II Suture Anchor, a medical device. It describes performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about studies involving AI or human readers for diagnostic purposes.

Therefore, I cannot fulfill your request for information related to:

• A study proving the device meets acceptance criteria using an AI system.
• Number of experts establishing ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Sample size and ground truth for training set.

The document focuses on mechanical and biocompatibility testing for a physical medical device (suture anchor), not a diagnostic AI system.

Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and performance, as appropriate for a physical implantable device:

Description of Device Testing and Acceptance Criteria

The ICONN Answer II Suture Anchor underwent performance testing to demonstrate its safety and effectiveness, and substantial equivalence to its predicate device (Arthrex PEEK Corkscrew FT (K061665)). The tests focused on mechanical properties, biocompatibility, and sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

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The ICONN Square Suture Anchor System is intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The system is designed for use in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee for the following indications:

Hip Indications: Capsule Repair, Acetabular Labrum Reattachment

Shoulder Indications: Capsular Stabilization, Bankart Repair, Anterior Shoulder Instability, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Acromioclavicular Separation Repair, Rotator Cuff Repair, Biceps Tenodesis.

Foot/Ankle Indications: Hallux Valgus Repair, Medial or Lateral Instability Repair/Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair/Reconstruction, Bunionectomy.

Elbow. Wrist, and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Knee: Extra Capsular Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Patellar Realignment and Tendon Repair, Vastus Medialis Obliquous Advancement, Iliotibial Band Tenodesis.

The ICONN Square 2.5MM Suture Anchors (P/N 125000) are sterile (gamma irradiation), single use implantable devices made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The anchors are available in one size (Width x Length): 2.5mm x 7.95mm and can be used as a knotted or knotless anchor.

This document is related to a 510(k) premarket notification for a medical device, specifically the ICONN Square 2.5MM Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm or diagnostic device. Therefore, many of the requested elements for an AI-based device's acceptance criteria and study proving its performance (like sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

The "acceptance criteria" for this device are based on its mechanical performance relative to predicate devices, ensuring it is at least as safe and effective.

Here's the information extracted from the provided text as it relates to the mechanical device, with an explanation of why certain AI-specific questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this mechanical device, "acceptance criteria" are embodied by demonstrating performance that is "similarly or better than the predicates or within acceptable ranges for the intended use."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact number of units tested for "anchor displacement after cyclic loading," "ultimate anchor pull-out," or "insertion testing." It refers to "side by side mechanical testing."
• Data Provenance: The testing was conducted in a laboratory setting as part of the premarket notification process for the manufacturer (ICONN Orthopedics, LLC). It is not clinical data from patients or a specific country of origin in the way an AI study would entail. It's not retrospective or prospective clinical data but rather engineering test data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This is a mechanical device, not an AI algorithm requiring expert interpretation to establish a "ground truth" for diagnostic purposes. The "ground truth" here is objective mechanical measurements (e.g., force, displacement).

4. Adjudication Method for the Test Set

• Not Applicable. This concept applies to human interpretation of data where disagreements need resolution. Mechanical testing results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not Applicable. An MRMC study is for evaluating the impact of a new diagnostic technology (often AI) on human reader performance. This device is a surgical implant.

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

• In a sense, yes, for mechanical performance. The "standalone" performance here refers to the device's intrinsic mechanical properties (pull-out strength, displacement) in a test environment, independent of a surgical outcome. However, this is not an "algorithm" and does not relate to human-computer interaction.

7. The Type of Ground Truth Used

• Mechanical Measurement and Engineering Standards: The ground truth for this device's performance is derived from established mechanical testing standards and comparison to the performance characteristics of predicate devices. The FDA's "Draft Guidance Document for Testing Bone Anchor Devices (April 20, 1996)" was used for guidance.
• Biocompatibility: Demonstrated through equivalence to a predicate device (ICONN Answer Suture Anchor, K132724) which presumably had its biocompatibility established.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, no training set was used.

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