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The Arthrex Double Loaded Knotless FiberTak® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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 (Except Canada)
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair (Except Canada)

The Arthrex Double Loaded Knotless FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip. The Arthrex Double Loaded Knotless FiberTak Suture Anchor is a sterile, single use implant device constructed from a hollow braid of polyester (sheath) preloaded on an inserter with a double loaded suture component composed of UHMWPE and polyester.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device: the "Arthrex Double Loaded Knotless FiberTak® Suture Anchor." This document describes a surgical implant and its intended uses, asserting its substantial equivalence to a previously cleared device. It does not describe an AI/machine learning device, nor does it contain information about acceptance criteria or a study that proves an AI device meets acceptance criteria.

The information you are requesting, such as ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies, are concepts applicable to AI/ML device evaluations, particularly for diagnostic imaging or assistive technologies. Since this document describes a physical surgical implant (a suture anchor), these concepts are not relevant to its regulatory submission.

Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The document explicitly states the "Performance Data" is "Cyclic pull-out testing was conducted on the proposed devices submitted in this Special 510(k). The test data demonstrates that the proposed devices perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." This type of testing is standard for mechanical implants, not AI.

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The Arthrex Self Punching SwiveLock® Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in skeletally mature pediatric and adult patients. Specifically, rotator cuff repair.

The proposed Arthrex Self Punching SwiveLock® Suture Anchors are fully threaded suture anchors comprised of a PEEK eyelet and a hollow anchor body preassembled on a disposable inserter. The anchor body is manufactured from either PLLA/βTCP or PEEK. The Arthrex Self Punching SwiveLock® Suture Anchor is intended to be used for suture (soft tissue) fixation to the bone in the shoulder.

The document describes the Arthrex Self Punching SwiveLock® Suture Anchors and its substantial equivalence to a predicate device. It briefly mentions performance data but lacks the detailed information requested for acceptance criteria and a comprehensive study description.

Here's a breakdown of the available information and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific quantitative acceptance criteria for "pull-out and insertion testing" and the actual numerical results of the device performance are not provided.

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

• Sample size for the test set: Not specified. The document only states "all samples."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• This information is not applicable as the study described is a performance/mechanical test, not one involving expert review of data for ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable for a mechanical performance test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a MRMC comparative effectiveness study was not done. The study described is a mechanical performance test.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical medical device (suture anchor), not an algorithm or AI system.

7. Type of Ground Truth Used

• For the mechanical performance study, the "ground truth" would be the physical measurements obtained from pull-out and insertion testing, compared against pre-defined engineering or performance specifications. The document indicates these were met.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. (See point 8).

Summary of the Study:

The provided text indicates that Arthrex Inc. performed "Pull-out and insertion testing" on the proposed Arthrex Self Punching SwiveLock® Suture Anchors and a predicate device (K191226: Arthrex SwiveLock Suture Anchor). The purpose of this testing was to demonstrate substantial equivalence to the predicate device. The results reported state that "The acceptance criteria were met for all samples, demonstrating substantial equivalence to the predicate." This suggests that the mechanical performance of the new device in terms of its ability to be inserted and its pull-out strength was comparable and within acceptable limits when compared to the established predicate device. However, the specific details of these acceptance criteria and the quantitative performance data are not included in this document.

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The Arthrex Knotless FiberTak Biceps Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
•Hand Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
•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, Gluteal Tendon Repair.

The proposed Arthrex Knotless FiberTak Biceps Suture Anchor is an "all-suture" soft tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hallow braid of polyester with pre-loaded suture components composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and is sold sterile single use.

Here's a breakdown of the acceptance criteria and the study information for the Arthrex Knotless FiberTak Biceps Suture Anchor, based on the provided text:

Device: Arthrex Knotless FiberTak Biceps Suture Anchor

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a "Special 510(k)" submission for a line extension, meaning the device is being compared to a very similar predicate device. Therefore, the acceptance criteria here are primarily demonstrating equivalent performance to the predicate device in specific areas, rather than meeting absolute numerical thresholds for an entirely new device.

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

• Sample Size: The document does not explicitly state the sample size for the "Cyclic Pull-out testing" or "Biocompatibility testing."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory testing conducted by the manufacturer, Arthrex Inc.

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

This type of information is generally not applicable to mechanical or biocompatibility testing for a medical device like a suture anchor. "Ground truth" in this context would be established by standardized testing protocols and measurements, not expert consensus on interpretations of data.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this involves laboratory performance testing against engineering and biological standards, not subjective interpretations requiring adjudication.

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

No. An MRMC study is not relevant for this type of device (a suture anchor). MRMC studies are typically used for diagnostic devices (e.g., imaging AI) to assess how much human performance (e.g., radiologists' diagnostic accuracy) improves with AI assistance. This device is a surgical implant.

6. Standalone (Algorithm Only) Performance Study

No. This is not an algorithmic or AI-based device. It is a physical medical implant.

7. Type of Ground Truth Used

• Mechanical Strength/Stiffness: Ground truth is based on established engineering principles and measurements from standardized pull-out and cyclic loading tests, primarily for comparison against the predicate device.
• Biocompatibility: Ground truth is established by recognized biocompatibility standards and specific tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993.
• Pyrogenicity: Ground truth is established by pharmacopeial standards (EP 2.6.14/USP ) for bacterial endotoxin limits.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Arthrex self-punching PushLock suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder: Shoulder: Rotator Cuff Repair

The Arthrex Self-Punching PushLock Anchor is a push-in, fully threaded barbed suture anchor comprised of a PEEK Optima eyelet and a hollow anchor body pre-assembled on a disposable inserter. The anchor body is made of either PLLA/βTCP or PEEK Optima. The Arthrex Self-Punching PushLock Anchor is intended to be used for suture (soft tissue) fixation to bone in the shoulder.

The provided FDA 510(k) summary is for a medical device called the "Arthrex Self-Punching PushLock Suture Anchor". This document does not include information about AI/ML device performance or clinical studies in the context of diagnostic accuracy, which is what your questions are geared towards.

The performance data summarized in this document relates to the mechanical properties, shelf-life, MR safety, and pyrogenicity of a physical medical device (suture anchor), not the performance of an AI model. Therefore, I cannot extract the information required for your questions (acceptance criteria, study design for AI models, expert ground truth, etc.) from this document.

The document states:

• Performance Data: "Ultimate load testing and insertion testing was performed on the subject device and compared to the predicate device cleared under K101679 to demonstrate that the modifications do not negatively impact mechanical strength." It also mentions shelf-life and MR safety.

This means the acceptance criteria and study proving it, in this context, would be based on engineering and biocompatibility standards, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC as evaluated for AI models.

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