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.

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Apollo Medial, Medial with Needles, and Apollo XT Suture Anchor:
Shoulder

• · Rotator Cuff Repair
• · Bankart Repair
• · SLAP Lesion Repair
• · Biceps Tenodesis
• · Acromio-Clavicular Separation Repair
• · Deltoid Repair
• · Capisular Shift or Capsulolabral Reconstruction
  Foot/Ankle
• · Lateral Stabilization
• · Medial Stabilization
• · Achilles Tendon Repair
  Knee
• · Medial Collateral Ligament Repair
• · Lateral Collateral Ligament Repair
• · Posterior Oblique Ligament Repair
• · Illiotibial Band Tenodesis
  Elbow
• · Biceps Tendon Reattachment
• · Ulnar or Radial Collateral Ligament Reconstruction
  Hip
• · Capsular Repair
• · Acetabular Labral Repair

Apollo Knotless Anchor:
Shoulder

• · Rotator Cuff Repair
• · Bankart Repair
• · SLAP Lesion Repair
• · Biceps Tenodesis
• · Acromio-Clavicular Separation Repair
• · Deltoid Repair
• · Capisular Shift or Capsulolabral Reconstruction
  Wrist/Hand
• · Scapholunate Ligament Reconstruction
• · Ulnar/Radial Collament Reconstruction
  Foot/Ankle
• · Lateral Stabilization
• · Medial Stabilization
• · Achilles Tendon Repair/Reconstruction
• · Hallux Valgus Reconstruction
• · Mid- and Forefoot Reconstruction
  Elbow
• · Biceps Tendon Reconstruction
• · Ulnar or Radial Collateral Ligament Reconstruction
• · Lateral Epicondylitis Repair (PEEK Anchor Only)
  Knee
• · Medial Collateral Ligament Repair
• · Lateral Collateral Ligament Repair
• · Posterior Oblique Ligament Repair
• · Joint Capsule Closure
• · Iliotibial Band Tenodesis
• · Patellar Ligament/Tendon Repair

The Apollo Medial Suture Anchor, Medial with Needles, XT Suture Anchor, Knotless 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, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only. Implants are fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026).

The provided document describes a 510(k) premarket notification for the Apollo Suture Anchor System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study involving human readers or AI.

Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and human-in-the-loop performance are not applicable to this type of regulatory submission and are not found in the provided text.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, AUC for AI, or improvement in human reader performance). Instead, it relies on demonstrating equivalence through various engineering and material tests.

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

This document describes a 510(k) submission based on bench testing (e.g., mechanical, biocompatibility) and comparison to a predicate device, not a clinical test set with patient data for an AI/device performance study. Therefore, there's no "test set" in the context of a dataset of patient cases. The "samples" would refer to the physical devices or materials used for the specified laboratory tests. The provenance is internal testing by Valeris Medical.

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

Not applicable. As this is not an AI or diagnostic device that requires expert review of clinical images/data for ground truth.

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

Not applicable. No clinical case adjudication process described.

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:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this type of device lies in:

• Material properties and standards: e.g., ASTM F2026 for PEEK, ISO 10993-1 for biocompatibility, ASTM F543-17 for mechanical testing.
• Predicate device's established performance: The predicate's prior clearance serves as a benchmark for safety and effectiveness.
• Laboratory test results: Measuring physical properties like pull-out strength and endotoxin levels against pre-defined specifications.

8. The sample size for the training set:

Not applicable. This is not an machine learning/AI device requiring a training set.

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

Not applicable.

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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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The Apollo Suture Anchors and Titan Screws are indicated for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are intended for use in the following procedures:
Indications - Apollo Medial Suture Anchor and Apollo XT Suture Anchors: 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), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair).
Indications - Apollo Labral Suture Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction), Wrist (Scapholunate Ligament Reconstruction), Elbow (Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction), Hip (Capsular Repair, Acetabular Labral Repair), Knee (Extracapsular Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis Reconstruction, Patellar Ligament/Tendon Repair, Vastus Medialis Obliquus Muscle Advancement).
Indications - Apollo Lateral Anchor: Shoulder (Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction), Wrist/Hand (Scapholunate Ligament Reconstruction, Ulnar/Radial Collateral Ligament Reconstruction), Foot/Ankle (Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Mid and Forefoot Reconstruction), Elbow (Biceps Tendon Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (PEEK Anchor Only)), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Joint Capsule Closure, Iliotibial Band Tenodesis, Patellar Ligament/Tendon Repair).
Indications –Interference Screws: The Titan Interference Screws are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameter of 9 mm or less and a length of 23 mm or less are also intended for the use in the following procedures: Knee (ACL repairs, PCL repairs, Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis oliquous advancement), Iliotibial band tenodesis), Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus, Tendon transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon transfers).
Indications –Titan Mini-Interference Screws: The Titan Mini-Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. The Mini-Interference Screws are intended to provide soft tissue reattachment (i.e. fixation of ligament and tendon graft tissue). See below for specific indications. Shoulder (Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift of capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus reconstruction, Medial stabilization, Lateral stabilization, Achilles Tendon Repair, Midfoot reconstructions, Metatarsal ligament repair, Bunionectomy, Flexor Hullucis Longus for Achilles Tendon reconstruction, Tendon transfers in the foot and ankle), Knee (Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair), Elbow (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction), Wrist and Hand (Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometalcarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon transfer in the hand/wrist, Lateral Epicondylitis repair).

Apollo Family: The Apollo Medial Suture Anchor, XT Suture Anchor, Lateral Anchor, and Labral Suture Anchor are delivery systems for anchors for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. These anchors consist of cannulated anchors with integrated suture attachment or separate suture punch eyelet. The Anchors are provided loaded on individual inserters with and without integrated sutures, sterile, for single use only.
Titan Family: The Titan Interference and Mini-Interference Screws are interference screws for use in fixation of ligament, tendon, bone, or soft tissue to bone in knee, shoulder, foot/ankle, elbow, and hand/wrist procedures. The screws are provided sterile, for single use only.
Screw and anchor implants are made from either a titanium alloy (6AI4V) per ASTM F136, or PEEK (Zeniva ZA-500) per ASTM F2026 from Solvay Advanced Polymers.

Here's a breakdown of the requested information based on the provided text.

This document is a 510(k) premarket notification for a medical device called the "Apollo Suture Anchor System and Titan Screws." It's primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study of its performance in a clinical setting against a gold standard.

Therefore, the typical acceptance criteria and study data associated with AI/software devices (e.g., sensitivity, specificity, clinical outcome measures) are not directly applicable or present in this type of regulatory submission. This submission focuses on demonstrating the device is as safe and effective as a previously cleared device.

However, I can extract the relevant information regarding performance testing that was done to support the safety and effectiveness for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are not numerical thresholds for clinical performance or diagnostic accuracy. Instead, the acceptance criterion for this 510(k) submission is that the modified device performs comparably to the predicate device and that the modifications (adding a 3rd suture portal) do not introduce new risks. The reported device performance is that this comparison was confirmed through mechanical testing.

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

• Sample Size: Not explicitly stated as a number of devices or cases. The testing conducted was "Axial Pull-Out and Insertion Torque per ASTM F543-7 testing." ASTM F543-7 is a standard test method, but the specific number of samples tested by Valeris Medical is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective). This refers to mechanical testing data.

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

Not applicable. This device is a surgical implant (suture anchor and screws). The "ground truth" for its performance is assessed via engineering and mechanical testing standards (ASTM F543-7) rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes. The testing here is mechanical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This document does not describe an AI/software device or a clinical study involving human readers.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this context is established by validated mechanical testing standards (ASTM F543-7). This standard provides methods for determining the axial pull-out and insertion torque of metallic bone screws. The goal was to show that the modified device's performance aligned with these established standards and did not significantly differ from the predicate device.

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

Summary of the Study Discussed in the Document:

The study described is a performance testing study.

• Purpose: To confirm that a modification (addition of a 3rd suture portal) to the Apollo Suture Anchor System and Titan Screws did not introduce new risks compared to the predicate device.
• Methodology: Axial Pull-Out and Insertion Torque testing was conducted according to ASTM F543-7.
• Conclusion: The testing confirmed that the modification did not introduce any new risks, supporting the substantial equivalence of the subject device to the predicate device (K133036).

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