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The Bio-Fastak Suture Anchor is intended for fixation of soft tissue to bone. This product is intended for the following indications:

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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

The Bio-Fastak Suture Anchor is manufactured using poly (L, DL-lactide). It is a threaded design with an evelet of braided polyester suture insert molded down the length of the device. The anchor has a hex head, which is seated in a disposable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a tap. Once in place, additional suture may be passed through the eyelet and used to reattach soft tissue to the bone.

This document describes a 510(k) premarket notification for a medical device called the "Arthrex Bio-Fastak Suture Anchor." A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that does not require premarket approval.

Based on the provided text, there is no information present regarding acceptance criteria or a study proving the device meets acceptance criteria related to software performance, AI/ML algorithms, or diagnostic accuracy. This document is for a physical surgical implant (suture anchor), and the FDA's review focuses on its substantial equivalence to predicate devices, material safety, and intended use.

Therefore, I cannot provide the requested information. The document is concerned with:

1. Device Description: What the Bio-Fastak Suture Anchor is made of (poly L, DL-lactide), its design (threaded, eyelet with polyester suture, hex head), and how it's used to reattach soft tissue to bone.
2. Intended Use/Indications: The specific surgical procedures and body parts where the anchor is intended to be used (e.g., Rotator Cuff Repair, Bankart Repair, Achilles Tendon Repair, Bladder Neck Suspension).
3. Substantial Equivalence: The primary basis for FDA clearance, stating that the device has the same intended use and similar technological characteristics (or proven equivalent safety and effectiveness with different characteristics) as legally marketed predicate devices, and raises no new safety or effectiveness questions.
4. Regulatory Classification: The device is classified as Class II, under Product Codes MAI and HWC.
5. FDA Clearance Letter: Official communication from the FDA stating that the device has been reviewed and determined to be substantially equivalent, allowing it to be marketed.

The concept of "acceptance criteria" and "device performance" in this context refers to the physical and biological performance of the implant (e.g., strength, biodegradability, biocompatibility), which would have been assessed through bench testing and potentially animal or clinical studies that are NOT detailed in this summary. The document explicitly states that the "material is well characterized, and has been used in a predicate device with a similar indication," implying that the testing on the material properties and the device's mechanical functions were deemed sufficient based on the established equivalence.

No mention is made of:

• Any software, AI, or diagnostic components.
• Test sets for performance evaluation.
• Experts establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Training set information.

Conclusion: The provided text is a 510(k) summary for a physical medical implant, not a software or AI-driven diagnostic device. Therefore, the questions related to acceptance criteria, study design, and performance metrics for AI/ML or diagnostic accuracy are not applicable to the information contained in this document.

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The FASTak Suture Anchor is intended for fixation of suture to bone. The 11.7mm FASTak is intended for the following uses:

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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Pelvis: Bladder Neck Suspension for female unnary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency

The 7.5mm FASTak is intended for the same uses except Rotator Cuff Repair, Bankart Repair, and SLAP Lesion Repair

The FASTak is a threaded anchor with an eyelet for holding suture. The largest suture size used with the 11.7mm FASTak is a single strand of #2. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of #2 suture (~ 15 lbs.). The pull-out strength of the FASTak in cortical bone, as well as cancellous, is at least 90 Ibs. and thus provides an acceptable factor of safety.

The largest suture size used with the 7.5mm FASTak is a single strand of size 0. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of size 0 suture (~ 10 lbs.). The pull-out strength of the FASTak in cortical bone as well as cancellous is at least 60 lbs. and thus provides an acceptable factor of safety.

In addition to fulfilling the requirements of a suture anchor, the FASTak eliminates the need for predilling. In a single motion, the tissue is grasped, shifted and the FASTak inserted. The result is a technique which is both easier and more reproducible.

The FASTak is made of Titanium 6Al-4V alloy (ASTM F136-92). The biocompatibility of this alloy has been well documented.

Here's an analysis of the provided 510(k) summary regarding the Arthrex FASTak Suture Anchor, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes material and mechanical testing performed on the FASTak Suture Anchor. The study's objective was to demonstrate that the pull-out strength of the FASTak anchor in both cortical and cancellous bone exceeds the tensile strength of the suture it is designed to hold, thus providing an "acceptable factor of safety."

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size (e.g., number of anchors tested) for the pull-out strength tests. It provides average or minimum "at least" pull-out strength values.
• Data Provenance: The document implies laboratory testing (mechanical and material characterization). There is no information provided about the country of origin of the data or whether it was retrospective or prospective. It is assumed to be prospective, specifically designed for this submission.

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

This type of information is not applicable to this submission. The "ground truth" here is objective physical properties (pull-out strength, material composition) determined through mechanical and material science testing, not through expert interpretation of biological data.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the assessment is based on objective physical measurements, not on expert consensus or adjudication of subjective interpretations.

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

This is not applicable. The device is a physical surgical implant (suture anchor), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This is not applicable. The device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for demonstrating compliance with acceptance criteria is:

• Mechanical Testing Results: Direct measurements of pull-out strength using laboratory-controlled tests.
• Material Characterization: Verification of the device's material composition against established standards (Titanium 6Al-4V alloy, ASTM F136-92).
• Suture Tensile Strength: Known industry standards for the tensile strength of specific suture sizes.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model; therefore, there is no "training set."

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

This is not applicable. As there is no training set, there is no ground truth for it to be established.

Ask a specific question about this device

The FASTak Suture Anchor is intended for fixation of suture to bone. This product is intended for use in repairing rotator cuff tears and Bankart lesions.

The FASTak is a self tapping, threaded anchor with an eyelet for holding suture. The largest suture size used with this device is a single strand of #2. Therefore, in order for the anchor to be effective, it must have a pull-out strength greater than the tensile strength of #2 suture (~ 15 lbs.). The pull-out strength of the FASTak in cortical bone as well as cancellous is at least 38 lbs. and thus provides an acceptable factor of safety. In addition to fulfilling the requirements of a suture anchor, the FASTak also offers the advantage of a self tapping design which eliminates the need for predrilling. In a single motion, the tissue is grasped, shifted and the FASTak inserted. The result is a technique which is both easier and more reproducible.

The FASTak is made of Titanium 6Al-4V alloy (ASTM F136-92). The biocompatibility of this alloy has been well documented.

This document describes a 510(k) summary for the Arthrex FASTak Suture Anchor. Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set (e.g., number of anchors tested for pull-out strength). It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to this type of device and study. The "ground truth" for a suture anchor is typically objective mechanical performance (pull-out strength) and material biocompatibility, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" involves objective mechanical testing, not a subjective assessment requiring adjudication.

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

No. An MRMC study is not applicable to this type of device. MRMC studies are typically used in imaging diagnostics where human readers interpret medical images, and the aim is to evaluate how AI assistance impacts their performance. This document concerns a physical implantable device.

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

No. This concept is not applicable to a physical suture anchor. "Standalone performance" usually refers to the accuracy of an AI algorithm operating independently, without human intervention, which is not relevant here.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's primary function (fixation) is objective mechanical testing data (pull-out strength) against a predefined benchmark (tensile strength of #2 suture). For biocompatibility, it relies on documented material properties (ASTM F136-92).

8. Sample Size for the Training Set

This document does not mention a training set. This is because the development and validation of a physical medical device like a suture anchor typically involve engineering design, material selection, mechanical testing, and biocompatibility studies, rather than machine learning models that require training data.

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

This information is not applicable as there is no mention of a training set for a machine learning algorithm.

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