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The Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors are indicated to be used for suture or tissue fixation in the elbow, shoulder, hand, wrist, foot, ankle, knee, and hip. Specific indications are listed below:

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

Shoulder: Rotator Cuff Repair, Bankart 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hip: Capsular repair, acetabular labral repair.

The Suture Anchors, manufactured by GM dos Reis Indústria e Comércio Ltda, are anchor-type implants, and are composed of two groups of anchors, manufactured in Titanium Alloy (ASTM F136) and Ultra High Molecular Weight Polyethylene – UHMWPE (which are called ZIP Anchor), that is the same raw material of the suture. The anchors are made available preloaded in a disposable inserter device, composed of a metal rod and a polymeric cable. The implant and disposable inserter devices are unique products and cannot be sold separately.

Implants of the Suture Anchors - GM Reis are classified as surgically invasive, non-absorbable, and non-active implantable medical devices. In addition, the implants, as well as, the inserter device, are for single-use and sold in sterile form - supplied as a sterile kit for ethylene oxide (ETO) according to ISO 11135 - "Preview Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices".

The Suture Anchors - GM Reis is composed of two different groups of anchors:

• HTA – Headless Titanium Anchor.
  • Anchor Diameters: ø1,7 mm; ø2,2 mm; ø2,7 mm; ø3,5 mm and ø5,0 mm
• -ZIP Anchor.
  • Ø0.9mm; Ø1.2mm; Ø1.5mm; Ø1.8mm; Ø1.9mm; Ø2.6mm.

This document is a 510(k) Premarket Notification from the FDA regarding "Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors." It details the device, its intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria for an AI/algorithmic device.

The document discusses non-clinical performance data for the suture anchors themselves (insertion torque, pullout strength, MRI compatibility) to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about a study proving an AI/algorithmic device meets acceptance criteria, which is not what this FDA document is about.

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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 SoftStitch is an implantable suture which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

The Arthrex SoftStitch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears. The Arthrex SoftStitch consists of a suture implant and an implant delivery inserter. The implant is a polyester sheath preloaded on a wax coated barbed suture manufactured from nylon monofilament.

The provided text does not describe an AI/ML device, and therefore the complete information requested in the prompt cannot be extracted. The document is a 510(k) premarket notification for a medical device called "Arthrex SoftStitch," which is an implantable suture retention device. This type of device falls under traditional medical device regulations and does not involve AI or machine learning.

Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set" are not applicable.

Here's the information that can be extracted related to acceptance criteria and performance studies, based on the provided text:

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

The document describes performance testing conducted to demonstrate substantial equivalence to predicate devices rather than specific quantitative acceptance criteria with reported numerical performance values in a direct comparison. The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices through various tests.

2. Sample sized used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for each test. For the "canine functional meniscus implant study," the sample size (number of animals) is not provided.
• Data Provenance:
  • Cyclic pull-out testing: Laboratory testing.
  • Canine functional meniscus implant study: Animal model (canine). No country of origin is specified.
  • Biocompatibility testing: Laboratory testing.
  • Bacterial Endotoxin testing: Laboratory testing.

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

Not applicable. This is a medical device clearance, not an AI/ML diagnostic or prognostic device study that requires expert ground truth establishment for a test set. The "truth" is established through engineering and biocompatibility testing, and animal studies.

4. Adjudication method for the test set

Not applicable. This is a medical device clearance, not an AI/ML study involving human readers or interpretation requiring adjudication.

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

Not applicable. This device is not an AI-assisted diagnostic or prognostic tool.

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

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through:

• Direct physical and mechanical testing: "Cyclic pull-out testing."
• Biocompatibility testing: According to ISO 10993-1:2018 standards.
• In vivo animal studies: "Arthroscopic/histologic imaging from a canine functional meniscus implant study."
• Materia characterization and manufacturing controls: Assessment of product attributes, manufacturing conditions, packaging, sterilization, and shelf-life.
• Pyrogenicity testing: Bacterial endotoxin testing.

8. The sample size for the training set

Not applicable. This is a medical device clearance, not an AI/ML device that uses training sets.

9. How the ground truth for the training set was established

Not applicable. No training set is used for this type of device.

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The FiberTak Button 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, 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
• Hip: Acetabular labral repair
The FiberTak Button is also used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; ACL/PCL repair (minor/major), biceps tendon repar and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The FiberTak Button is an 'all-suture' soft-tissue device constructed from a hollow braid of polyester and two shuttling sutures made of a polyblend of UHMWPE and polyester. The FiberTak Button is preloaded on a disposable inserter and will be sold sterile for single use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FiberTak Button, structured according to your request.

Please note: The provided document is a 510(k) summary for a medical device (FiberTak Button), not a clinical study report for an AI/CADe device. Therefore, many of your requested points related to AI/CADe studies (like multi-reader multi-case studies, expert consensus on images, training sets, etc.) are not applicable to this type of submission. The information below focuses on mechanical and biological performance rather than diagnostic accuracy.

Acceptance Criteria and Device Performance for FiberTak Button (K191426)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample sizes for the tensile testing, biocompatibility testing, or bacterial endotoxin testing. It refers to these as performance data that demonstrate equivalence.

Regarding data provenance: This clinical and regulatory document does not cover the country of origin or whether data was retrospective or prospective in the context of typical AI/CADe studies. These are laboratory and material tests.

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

This question is not applicable to the type of device and testing described. "Ground truth" in this context refers to established standards for material properties and biological response, not expert interpretation of diagnostic images. The ground truth is defined by the specified international standards (ISO 10993-1:2009, EP 2.6.14 / USP ) and comparison to predicate devices, which are themselves held to certain performance levels.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in diagnostic imaging studies. The tests described are objective laboratory measurements, not subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the diagnostic performance of AI-assisted systems in interpreting medical images, which is not the function of the FiberTak Button.

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

No, a standalone performance study in the context of an algorithm or AI system was not done. The FiberTak Button is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests relies on:

• Established standards and specifications: ISO 10993-1:2009 for biocompatibility, EP 2.6.14 / USP for bacterial endotoxin/pyrogen limits.
• Performance of legally marketed predicate devices: For tensile strength, the proposed device's performance was compared to the criteria established by its predicate devices (K181769: Arthrex FiberTak Suture Anchor, K123341: Arthrex Proximal Biceps Button). This establishes a benchmark for clinical safety and effectiveness based on prior device performance.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI algorithm being trained for this device. The term "training set" is typically used in machine learning.

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

This question is not applicable as there is no training set for an AI algorithm for this device.

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