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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 SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis Capsulolabral Reconstruction, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulo labral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy

Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75 SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL Repair/Reconstruction(3.9 SwiveLock Only)

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

Elbow: Biceps Tendon Reattachment, Unar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair

Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 – 5.5 mm PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only).

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 an anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor, which seeks to obtain pediatric indications and an extended shelf life for an existing device. It largely focuses on mechanical testing, a review of clinical literature, and real-world data to demonstrate substantial equivalence to predicate devices, rather than an AI-powered device's performance study.

Therefore, many of the requested details regarding acceptance criteria for an AI device, specific study methodologies (like MRMC, standalone AI performance), ground truth establishment for AI training/testing, expert qualifications, and adjudication methods are not present in the provided document. The document details testing for a physical medical device (suture anchor).

However, I can extract information related to the performance data and the "study" (testing) that was done to support the submission for the physical device.

Acceptance Criteria and Device Performance (Based on Provided Text)

The "acceptance criteria" here refer to the standards the physical device needed to meet to demonstrate substantial equivalence, particularly concerning the proposed modifications (pediatric indication, extended shelf life).

Study Details (Based on Provided Text)

1. Sample sized used for the test set and the data provenance:

• Mechanical Testing: Not explicitly stated (e.g., number of anchors tested), but it was performed on the "subject device" and "predicate device." No geographical provenance is specified.
• Clinical Literature: The text states "Clinical literature was provided on the subject devices involving the proposed patient population of skeletally mature pediatric patients." The number of studies or patients is not specified. It's a retrospective review of existing data.
• Real World Data/Evidence: "Real World Data/Evidence is provided from the Surgical Outcomes System registry." The sample size (number of patients) is not specified, but it compares "patients less than 22 years of age versus patients greater than 22 years of age." The provenance of this registry data (e.g., country of origin) is not specified. This is retrospective data.

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

• This concept is not applicable here as the "ground truth" for a physical medical device's performance primarily comes from engineering and clinical outcome data, not expert consensus on image interpretation. For the clinical literature review and RWD, the "truth" is established by the clinical outcomes themselves, as documented in studies and registries.

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

• This concept applies to interpreting complex data, typically images or clinical scenarios, often for AI or diagnostic devices. It is not relevant to the mechanical/biological testing or the clinical literature/RWD review described for this physical medical device.

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 study type is for evaluating reader performance with and without AI assistance for diagnostic or prognostic devices. It is not relevant for a physical medical device like a suture anchor.

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

• No. This applies to AI algorithms. Not relevant for this physical medical device.

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

• Mechanical Testing: Ground truth established through direct physical measurement and engineering standards (e.g., force applied, displacement measured).
• Pyrogenicity Testing: Ground truth established by laboratory assay results meeting specified pyrogen limits.
• Clinical Literature/Real World Data: Ground truth is clinical outcomes data (e.g., success of repair, complications, patient outcomes), as documented in published literature and registries.

7. The sample size for the training set:

• Not applicable in the context of this device. This pertains to machine learning models. This submission is for a physical medical device.

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

• Not applicable. This pertains to machine learning models. This submission is for a physical medical device.

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The Arthrex FastThread Interference Screws are intended to be used for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; specifically,

Shoulder: Rotator Cuff Repair, Bankart 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, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Posterior Cruciate Ligament Repair, MPFL Repair/Reconstruction

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

The Arthrex FastThread Interference Screw is a cannulated, fully threaded, bioabsorbable interference screw, manufactured from PLDLA, Biphasic Calcium Phosphate and hydroxyapatite (HA). The screws measure 6-12 mm in diameter and 20-30 mm in length.

The provided document is a 510(k) Summary for a medical device, the Arthrex FastThread Interference Screw. It outlines the device's indications for use, its comparison to predicate devices, and the performance data submitted for its clearance.

However, the information provided does not contain details about acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for an AI/ML-based medical device study.

Instead, this document describes the regulatory submission for a physical, implantable medical device (an interference screw) and its mechanical and biological performance data. The "Performance Data" section specifically states:

• "Mechanical testing demonstrated that the pull-out strength of the proposed Arthrex FastThread Interference Screw met the acceptance criterion established by K201749 for MPFL repair/reconstruction."
• "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that the acceptance criteria and study proving the device meets them are related to the physical properties and safety of the implantable screw, not to the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML device performance from this document. The questions posed in your prompt (e.g., "Number of experts used to establish the ground truth", "Adjudication method", "MRMC comparative effectiveness study", "Standalone performance", "Training set ground truth") are relevant to the evaluation of AI/ML software as a medical device, which is not what this document describes.

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The Arthrex SwiveLock Suture 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 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/Tendon Repair and Bunionectomy.

. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only).

• . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or 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 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.

The provided text is a 510(k) Summary for the Arthrex SwiveLock Suture Anchor, a medical device for orthopedic fixation. It describes the device, its intended use, and its equivalence to a predicate device. This document is a regulatory submission to the FDA, not a study report on the performance of an AI/ML powered device, therefore, it does not contain the requested information about acceptance criteria and a study proving an AI device meets them.

The sections you've asked for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in documents related to the validation and performance evaluation of AI/ML software as a medical device (SaMD). This 510(k) is for a physical medical device (suture anchor) and focuses on demonstrating substantial equivalence through mechanical testing and biocompatibility.

Therefore, I cannot extract the requested information from the provided text.

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