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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.

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