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The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction
• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair,
Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament
Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of
Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits,
Digital Tendon Transfers
• 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, Patellar Tendon Repair, Posterior Oblique Ligament Repair,
Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular Repair, Acetabular Labral repair

The Arthrex Knotless SutureTak Anchor is a non-absorbable, "tap-in" suture anchor with a ribbed profile and a proximally placed external suture eyelet. The anchor is manufactured of Polyetheretherketone (PEEK) and is preloaded with Arthrex Suture and is offered preassembled on a driver. The anchor was originally cleared under K120155 for indications in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.

This document describes the Arthrex Knotless SutureTak Anchor, a medical device. Here's an analysis of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the pull-out test.
The provenance of the data (country of origin, retrospective/prospective) is also not specified. It is an in-vitro performance test.

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

This information is not applicable. The study involves performance testing of the device's mechanical and biological properties, not a diagnostic or AI-driven evaluation that requires expert ground truth assessment.

4. Adjudication Method

This information is not applicable for this type of device performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a medical device (suture anchor) and not an AI-driven diagnostic tool. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

For the pull-out test, the "ground truth" is established by the performance of the chosen predicate device (DePUY Mitek VERSALOK Anchor), against which the Arthrex Knotless SutureTak Anchor is compared for statistical equivalence.

For the pyrogenicity test, the "ground truth" is defined by the pyrogen limit specifications outlined in EP 2.6.14/USP .

8. Sample Size for the Training Set

This information is not applicable. This is a medical device, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for this device.

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The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tend Transfers
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, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral repair

The Arthrex Knotless SutureTak Anchor is a tap-in ribbed suture anchor comprised of PEEK material and preloaded with UHMWPE looped suture and assembled to an insertion device. The proposed anchor is being offered in a 3 mm diameter.

The provided text describes the Arthrex Knotless SutureTak Anchor and its substantial equivalence to predicate devices, focusing on its intended use and mechanical properties. However, it does not contain the detailed information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/software device submission.

The document primarily focuses on regulatory clearance for a physical medical device (an anchor) and relies on mechanical testing for performance. There is no mention of an algorithm, AI, or human reader performance.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: While the document mentions "established minimum acceptance criteria for tensile (pull-out) strength," it does not provide the specific criteria values or the reported performance data in a table format.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device submission which focuses on mechanical testing, not a "test set" in the context of an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical anchor's mechanical performance is typically established through laboratory testing following engineering standards, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set: Not applicable.
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, as this is a physical device, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" would be the results obtained from standardized mechanical tests.
8. The sample size for the training set: Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance:

The document states:

• "The mechanical testing demonstrates that the proposed device meets or exceeds the established minimum acceptance criteria for tensile (pull-out) strength for the desired indications."

This indicates that mechanical testing was performed, and the device's performance in terms of tensile (pull-out) strength met predefined criteria. However, the specific values for these criteria and the results are not detailed in the provided text.

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