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Valeris BoneCam Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

Shoulder Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acormio-Clavicular Separation Repair Deltoid Repair Capisular 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 Posterior Oblique Ligament Repair Iliotibial Band Tenodesis Reconstruction Patellar Ligament/Tendon Repair

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

Hip Capsular Repair Acetabular Labral Repair

The BoneCam Suture Anchor Delivery Systems are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, hip, and hand/wrist procedures. These anchors consist of anchors with integrated suture attachment. The Anchors are provided loaded on individual inserters with integrated UHMWPE sutures. Sterile, for single use only. Anchor implants are made from either a titanium alloy (6AI4V ELI) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers. Anchors range in size from 2.9mm to 3.3mm in diameter and 6mm to 10mm in length.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "BoneCam Suture Anchor". It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance against a specific study for an AI/CADe device.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/CADe system. The performance data mentioned refers to mechanical testing of a physical suture anchor, not an AI algorithm.

Specifically, the following points from your request cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria for an AI/CADe device, nor reported performance based on such criteria. It mentions "Axial Pull-Out per ASTM F543-13 testing confirmed that the Subject device performed as intended with #2, 2-0, 3-0, and 4-0 sutures in G20 PU foam and in G40 PU foam for #2 sutures." This is mechanical performance for a physical device, not an algorithm.
2. Sample size used for the test set and the data provenance: Not applicable for an AI test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI test set.
4. Adjudication method: Not applicable for an AI test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as this is a physical device, not an AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical device, not an AI.
7. The type of ground truth used: Not applicable for an AI test set.
8. The sample size for the training set: Not applicable for an AI training set.
9. How the ground truth for the training set was established: Not applicable for an AI training set.

The document is a regulatory approval for a physical medical device (suture anchor), not a software/AI device.

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