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The Knotless AC Repair Devices are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The Knotless AC Repair Devices are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
The Knotless AC Repair Devices with distal clavicle plate button are intended for use with Arthrex clavicle plates for clavicle indications and may not be used alone.

The subject devices are suture constructs configured with one or two metal buttons made of titanium or stainless steel. The nonabsorbable suture is made of UHMWPE. Some of the subject devices are compatible with the Clavicle Fracture plates cleared under K112437.

The provide FDA 510(k) summary describes the Arthrex Knotless AC Repair Devices, which are indicated as adjuncts in fracture repair and for fixation during syndesmotic trauma. The submission aims to demonstrate substantial equivalence to a predicate device, K052776: Arthrex TightRope Acromioclavicular (AC) Device, and refers to several other devices (K112437, K143139, K123341, K202581, K112990) as reference devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Demonstrated that modifications do not negatively impact mechanical strength compared to the predicate device. This implies specific thresholds for ultimate load and cyclic displacement.	Ultimate load testing and cyclic displacement were performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength. (No specific numerical values or direct acceptance "pass/fail" stated, but the conclusion of non-negative impact implies acceptance.)
   Device meets pyrogen limit specifications.	Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. (Implies meeting the standard, thus acceptance.)
   Device is safe for use in an MR environment, specifically regarding: magnetic field induced displacement force, radiofrequency induced heating, and image artifact. (Based on standards: FDA guidance, ASTM F2052, ASTM F2119, ASTM F2182).	MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, and ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging. (Implies that the testing demonstrated compliance with these standards, meaning the device met the safety criteria for MRI, thus acceptance.)
   Overall, the device is substantially equivalent to the predicate, with differences being minor and not raising questions concerning safety and effectiveness.	"The Arthrex Knotless AC Repair Devices are substantially equivalent to the predicate in which the basic design features and intended use are the same. Any differences between the subject device and the predicate device are considered minor and do not raise questions concerning safety and effectiveness." (This is the overarching conclusion of the submission.)

2. Sample size for the test set and data provenance:

   • The document mentions "ultimate load testing and cyclic displacement," "bacterial endotoxin" testing, and "MRI force, torque, and image artifact testing." However, it does not specify the sample sizes (e.g., number of devices tested) for any of these tests.
   • Data provenance is not explicitly stated. These are laboratory tests, so the "country of origin of the data" would likely be the location of the testing facility, which is not provided. The tests are prospective in nature, as they are conducted specifically for this submission.

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

   • This document describes mechanical, biocompatibility, and MRI compatibility testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth. Therefore, this information is not applicable to this type of submission.

4. Adjudication method for the test set:

   • Similar to point 3, this is not applicable as the studies are physical/chemical device tests, not involving human interpretation or clinical 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:

   • This is not applicable. The submission is for a physical medical device (suture button), not an AI-powered diagnostic tool.

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

   • This is not applicable. The device is a physical implant, not a software algorithm.

7. The type of ground truth used:

   • For the mechanical tests, the "ground truth" would be the physical properties and performance characteristics of the predicate device, against which the subject device's mechanical performance is compared. Performance standards (e.g., ISO, ASTM) and established biological limits (e.g., pyrogen limits per EP/USP) serve as the "ground truth" or acceptance criteria for biocompatibility and MRI compatibility. Pathology or outcomes data are not relevant for this type of testing.

8. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is a physical device, not an AI/machine learning model.

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

   • This is not applicable as there is no training set.

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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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The JuggerKnot Soft Anchors are intended for soft tissue to bone fixation for the following indications:

Shoulder: Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction. Deltoid repair, Rotator cuff tear repair, Biceps tenodesis, Pectoralis major repair

Foot and Ankle: Medial/lateral repair and reconstruction, mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

Elbow: Ulnar or radial collateral ligament reconstruction. Lateral epicondylitis repair. Biceps tendon reattachment

Knee: Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure, Medial Patellofemoral Ligament (MPFL) repair or reconstruction, Quadriceps tendon repair

Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Hip: Acetabular labral repair, Proximal hamstring repair

The JuggerKnot Self-Punching Soft Anchors are intended for soft tissue to bone fixation for the following indications:

Shoulder: Rotator cuff tear repair

Foot and Ankle: Achilles tendon repair

The JuggerKnot Soft Anchors consists of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.

The provided text is a 510(k) premarket notification for the "JuggerKnot Soft Anchors" and "JuggerKnot Self-Punching Soft Anchor" for soft tissue to bone fixation. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with defined performance metrics.

Therefore, much of the requested information (like a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, and detailed ground truth methodology) is not available in the provided document. The document describes a comparison to a predicate device, not a standalone performance study against pre-defined acceptance criteria.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The document describes a comparison to a predicate device, not performance against pre-defined acceptance criteria. The performance data is stated as:

"The test results indicate that the JuggerKnot Soft Anchors achieved statistically equivalent or greater pullout strength to the predicate device and would be functional within their intended use."

The acceptance criterion, by inference, was demonstrating "statistically equivalent or greater pullout strength" compared to the predicate.

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

The document mentions "non-clinical laboratory testing was performed to verify the fixation strength... as compared to the predicate JuggerKnot Soft Anchors (K110145)". However, the sample size for this test set is not specified. The data provenance is also not specified, though it is a non-clinical laboratory test, implying it was conducted as part of the device development and testing process.

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

This information is not applicable/not provided as the "test set" described is a mechanical pullout strength test, not an evaluation by human experts requiring ground truth establishment in the traditional sense of clinical or image-based studies.

4. Adjudication method for the test set

This information is not applicable/not provided for the same reasons as #3.

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

No, a multi-reader multi-case comparative effectiveness study was not conducted or reported. This document pertains to a medical device for soft tissue fixation, not an AI-assisted diagnostic tool.

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

This refers to an "algorithm-only" performance, which is a concept for AI/software devices. The JuggerKnot Soft Anchors are physical medical devices. The performance testing was a standalone mechanical test of the physical device's pullout strength, compared to a predicate device.

7. The type of ground truth used

The "ground truth" for the mechanical pullout strength test was the measured pullout strength values obtained during the laboratory testing. This is a direct measurement of a physical property, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not an AI algorithm that requires a "training set" in the context of machine learning.

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

This information is not applicable/not provided for the same reasons as #8.

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