Search Results

Shoulder

• Rotator Cuff Repair
• · Bankart Repair
• · SLAP Lesion Repair
• · Biceps Tenodesis
• · Acormio-Clavicular Separation Repair
• · Deltoid Repair
• Capsular Shift or Capsulolabral Reconstruction

Hand and 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

Foot and 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
• Illiotibial band tenodesis reconstruction
• Patellar ligament/tendon repair

The BoneCam Suture Anchor Delivery Systems are for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The BoneCam Suture Anchor Delivery System consists of a single anchor with integrated multiple suture attachment. The anchors are provided loaded on individual inserters with integrated sutures with or without needles, sterile (EtO), for single use only. The BoneCam Suture Anchor Delivery Systems have a shelf life of 2 years. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).

Here's a breakdown of the acceptance criteria and study information for the Valeris Medical Inc. Bonecam Suture Anchor, based on the provided document:

This document is a 510(k) summary for a medical device (Bonecam Suture Anchor), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel AI performance. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable (N/A) for this type of submission.

Acceptance Criteria and Device Performance (Not applicable for AI performance in this document)

This document does not provide specific acceptance criteria or reported performance for an AI-powered device. Instead, it focuses on demonstrating the substantial equivalence of the Bonecam Suture Anchor to a predicate device, K152255, by comparing their technological characteristics and performing bench testing.

Study Information

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

   • Sample Size: Not specified for human subject data. For bench testing: "Axial Pull-Out per ASTM F543-17 testing was conducted..." The exact number of samples tested is not provided in this summary but would be detailed in the full test report.
   • Data Provenance: N/A for human subject data. For bench testing, it's laboratory testing for mechanical performance characteristics of the device materials.

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

   • Number of Experts: N/A (No clinical study involving expert ground truth determination is described).
   • Qualifications of Experts: N/A

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A (No clinical study requiring adjudication is described).

4. 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 medical device (suture anchor) submission, not an AI device. Therefore, no MRMC study or AI assistance improvement effect size is mentioned or applicable.

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

   • No. This is a medical device, not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A (No AI algorithm or clinical endpoint requiring ground truth is described). For the mechanical testing, the "ground truth" would be the measured physical properties according to the ASTM standard.

7. The sample size for the training set:

   • N/A (No AI algorithm training set is mentioned).

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

   • N/A (No AI algorithm training set is mentioned).

Summary of Relevant Information from the Document:

• Device Name: Bonecam Suture Anchor
• Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K152255) for approval to market.
• Key Comparisons for Substantial Equivalence:
  • Intended Use/Indications for Use: Identical to predicate device.
  • Materials: Similar (both Solvay ZENIVA PEEK), with the subject device offering additional configurations (ZA-600, ZA-600 CF30 PEEK) and an additional UHMWPE suture manufacturer.
  • Design Features: Same general design as the predicate, with an additional suture port for more options.
  • Sterilization and Shelf-Life: Identical (sterile (EtO), 2-year shelf life).
  • Biocompatibility: Established according to ISO 10993-1.
• Performance Data: "Axial Pull-Out per ASTM F543-17 testing was conducted to confirm the material additive did not introduce any new risk." This bench test demonstrates mechanical performance, but specific results or acceptance criteria are not detailed in this summary.
• Conclusion: The subject device is considered substantially equivalent to the predicate device, and safe and effective for its intended use, based on the documented comparisons and performance testing.

Ask a specific question about this device

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.

Ask a specific question about this device