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The Arthrex FiberTak 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 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
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Arthrex 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 anchor is constructed from a hollow braided sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The sutures components are made of ultra-high molecular weight polyethylene yarns or a polyblend of UHMWPE and polyester yarns. The anchor is preloaded on a disposable inserter and provided sterile for single use.

The provided text is a 510(k) summary for a medical device (Arthrex FiberTak Suture Anchor). It describes the device, its intended use, and a comparison to predicate devices, but does not contain information about an AI/ML-driven medical device or a study involving human readers, ground truth establishment by experts, or MRMC studies.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study design for AI/ML performance, sample sizes for AI/ML test/training sets, expert consensus, or human reader performance.

The "Performance Data" section only mentions:

• "Cyclic pull-out testing was conducted on the proposed devices and submitted in this Traditional 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 refers to mechanical and biocompatibility testing of the suture anchor, not performance of an AI/ML system.

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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 Stryker Omega PEEK Knotless Anchor System is intended to bone fixation in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip.

It is indicated for use 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 and Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair

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

Elbow: Biceps Tendon Reattachment, Temis Elbow Repair, Unar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capular Repair, Acetabular Labral Repair

The Stryker Omega PEEK Knotless Anchor System consists of poly-ether-ether-ketone ("PEEK") cannulated screws with a separate PEEK eyelet. The anchor system is designed for insertion of the eyelet and screw into bone either directly or by using instrumentation for creation of a pilot hole. Alternatively, screws may be used without the eyelet for suture fixation in a pre-drilled pilot hole by means of a cannulated screwdriver. Screws and eyelets may be provided either preloaded on respective disposable screwdrivers and inserters, or separately for manual loading. A suture threader is included with the eyelet inserter to facilitate loading of suture through the eyelet. Anchor systems are provided sterile and are packaged in single-use sterile barrier systems (SBS) that include one or more screws with or without eyelets.

The provided document describes the predicate device and the modifications made to the original device. It indicates that benchtop testing was conducted to evaluate the performance characteristics of the modified device. However, it does not contain specific acceptance criteria values, reported device performance metrics against those criteria, or details regarding a study that explicitly "proves" the device meets acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here is a summary of what can be extracted or inferred based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states:

• "Ultimate tensile strength (UTS) and insertion testing were performed to assess the proposed eyelet modification"
• "cyclic displacement testing was performed to demonstrate that the displacement of the modified Omega anchors is within a clinically acceptable range for meniscal root repair."
• "The modified Omega anchors demonstrated equivalent pull-out strength to the Predicate A devices and equivalent displacement to the Predicate B devices, and no new issues of safety and effectiveness were identified."

However, specific numerical acceptance criteria (e.g., "UTS must be > X Newtons") and the actual reported performance values (e.g., "Achieved UTS = Y Newtons") are not provided in the text. The term "equivalent" is used, indicating a comparative assessment, but the quantitative details are missing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document only mentions "Non-clinical benchtop testing was conducted."
• Data Provenance: The document describes benchtop testing, implying laboratory data. No country of origin is specified for the data, nor is it classified as retrospective or prospective (as it's bench testing, these terms are less applicable).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable as the study described is non-clinical benchtop testing, not a clinical study involving experts establishing ground truth for diagnostic accuracy.

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

• This information is not applicable as the study described is non-clinical benchtop testing.

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 information is not applicable. The device is an orthopedic anchor system, not an AI/imaging diagnostic device that would typically undergo MRMC studies.

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

• This information is not applicable. The device is an orthopedic anchor system.

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

• For the benchtop testing, the "ground truth" would be engineering specifications and established test methodologies (e.g., ISO standards for biocompatibility, material science principles for strength and displacement). No human expert consensus or pathology is involved in this type of testing.

8. The sample size for the training set

• This information is not applicable. There is no "training set" as this is a physical medical device undergoing benchtop performance testing, not a machine learning model.

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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