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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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The Arthrex Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
• Shoulder: Rotator Cuff Repairs, 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/Tendon Repair, Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
• Hip: Capsular Repair, acetabular labral repair.

The Arthrex 3.9mm Corkscrew is a partially threaded suture anchor pre-loaded with Arthrex Suture on a disposable inserter. The anchor is manufactured from either PLLA/BTCP or PEEK and is offered sterile, single use.

The provided document is a 510(k) summary for a medical device (Arthrex 3.9mm Corkscrew Suture Anchor) and does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance. Instead, it describes:

1. Device Description and Intended Use: The device is a suture anchor used for soft tissue fixation to bone in various anatomical locations and procedures.
2. Comparison to Predicate Device: The submission is a line extension to an existing cleared device (K173788: Arthrex Corkscrew FT) and a reference device (K082810: Arthrex BioComposite Anchors).
3. Performance Data (Non-AI/ML specific): The data presented refers to mechanical (pull-out) and biocompatibility testing, along with bacterial endotoxin testing. This is standard for a mechanical implant and not related to AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The information provided pertains to a traditional medical device submission, not an AI/ML diagnostic or assistive technology.

If you have a document describing an AI/ML device study, please provide that, and I will do my best to answer your questions.

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The Arthrex SwiveLock 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:
• 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, Mid-foot reconstruction, Metatarsal Ligament Repair, Tendon Repair, Bunionectomy
• 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 or Radial Collateral Ligament Reconstruction
• · Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondy.itis Repair
  · Hip: Capsular Repair, Acetabular labral repair

The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

This document describes the FDA clearance for the Arthrex SwiveLock Anchor. As such, the information provided focuses on the regulatory review process and the basis for substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of a medical device against specific acceptance criteria.

Therefore, the specific information requested in your prompt regarding acceptance criteria and a study to prove the device meets these criteria (including sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not present in the provided text.

The document primarily states:

• Performance Data: "Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor met the criteria established by the predicate device and that the anchor was successfully inserted into the bone substitute. Geometric analysis and Load vs Degradation Time comparison was conducted to demonstrate that the expected degradation and pull out strength of the proposed anchor is not a new worst case over the predicate and referenced predicate devices. Bacterial endotoxin per USP , USP , FDA Guidance for Industry Pyrogen & Endotoxin Testing and EP 2.6.14 was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that mechanical and biocompatibility tests were performed, and the results were compared against established criteria or predicate device performance. However, it does not provide the quantitative acceptance criteria, the specific methodology of these tests (e.g., number of samples tested, blinding, etc.), or details of a study meeting the criteria you've outlined for clinical performance or an AI/human-in-the-loop system.

In summary, the provided text from the FDA 510(k) clearance letter and summary does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria in the context of an AI-driven or diagnostic device. This document pertains to a mechanical surgical implant, and the assessment for such a device is typically based on mechanical properties, biocompatibility, and substantial equivalence to existing devices, rather than the types of performance metrics and study designs common for AI/human reader studies.

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The Arthrex SwiveLock Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repairs, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
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 or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, acetabular labral repair

The SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. FiberWire suture may also be provided with the device.

The provided 510(k) summary (K101823) describes the Arthrex SwiveLock Anchors, a medical device intended for fixing suture (soft tissue) to bone in various anatomical regions. The device is seeking substantial equivalence to previously marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the Arthrex SwiveLock Anchors are based on demonstrating substantial equivalence to existing predicate devices. Since this is an equivalence submission, specific quantitative acceptance criteria for absolute performance metrics are not explicitly stated in the summary. Instead, the performance is compared against the known performance of the predicate devices.

The study aimed to demonstrate that the SwiveLock Anchors perform comparably to the predicate devices in terms of:

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

The document does not explicitly state the specific sample sizes for each test mentioned (degradation, mechanical pull-out, insertion, animal testing). It only refers to "data" for each category.

The data provenance is not specified. It is an industry standard to conduct these tests in a controlled laboratory environment or animal models. Neither the country of origin nor whether the data is retrospective or prospective is mentioned.

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

This information is not applicable to this type of 510(k) submission. Establishing "ground truth" by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is involved. For a mechanical device like a suture anchor, the "truth" is established through physical and biological testing against established standards or predicate device performance.

4. Adjudication Method:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts in diagnostic studies, which is not relevant for the mechanical and biological testing of a suture anchor.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is evaluated.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through physical and biological testing methodologies. This includes:

• Degradation data: Measuring the breakdown of biomaterials over time.
• Mechanical pull-out (tensile) testing data: Quantifying the force required to pull the anchor out of bone, adhering to engineering standards.
• Insertion testing data: Assessing the ease and characteristics of device insertion.
• Animal testing data: Observing the biological response (histology), in-vivo pull-out strength, and imaging of the device in a living system.

The "truth" is rooted in the physical and biological properties and performance of the device as measured by these tests, compared against the known performance of predicate devices.

8. Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The Arthrex SwiveLock Anchor is a mechanical device, not an AI or algorithm-driven system.

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

This information is not applicable for the reasons stated above.

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