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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 Arthrex FibuLock Nail is intended for use in the fixation of fibula fractures and osteotomies.

The Arthrex FibuLock Nail is used in the Fibula Repair System cleared under K160069. It is a stainless steel implant used with stainless steel bone screws for the fixation of fibula fractures and osteotomies. The Arthrex FibuLock Nail can be used with existing FDA cleared Arthrex Low Profile Cortical Screws (K141478, K143139 and K143614), Arthrex TightRope Syndesmosis Devices (K043248) and instrumentation required for the fixation of fibula fractures and osteotomies.

The provided text describes the Arthrex FibuLock Nail, its predicate device, and the basis for its 510(k) clearance. However, it does not contain information related to acceptance criteria, human reader studies (MRMC), standalone algorithm performance, or ground truth establishment for a study proving device performance in the context of AI/ML.

The "Performance Data" section briefly mentions "Worst-Case Cross-Section Comparison" and "Axial pullout and torsion comparison testing," which are mechanical performance tests typical for orthopedic implants, not studies involving AI or human readers for diagnostic tasks.

Therefore, many of the requested details, particularly those pertaining to AI/ML device evaluation, cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

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

• Test Set Sample Size: Not applicable. This document describes mechanical testing for an orthopedic implant, not a study with a "test set" of patient data for diagnostic or predictive purposes.
• Data Provenance: Not applicable. The "data" refers to mechanical test results, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert diagnosis, pathology) is not relevant for the mechanical testing described.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No. This document does not mention any MRMC studies or human reader performance.

6. If a standalone (algorithm only) performance study was done:

• No. This document describes a physical medical device (an intramedullary nail), not an algorithm or AI system.

7. The type of ground truth used:

• Not applicable. The relevant "ground truth" for this device would be its mechanical properties meeting engineering specifications, which is assessed through direct mechanical testing, not expert consensus or histopathology.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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