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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 ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.

This document is a 510(k) Summary for the ANTHEM™ Fracture System, a medical device. Based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on AI/algorithm performance, nor is there any mention of an AI device. The document explicitly describes the ANTHEM™ Fracture System as a system of "plates and screws designed to be used for internal bone fixation."

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to AI/algorithmic accuracy.
• Sample size and data provenance for an AI test set.
• Number of experts and qualifications for AI ground truthing.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone AI performance.
• Type of ground truth used for AI.
• Sample size for training set for AI.
• How ground truth for a training set was established for AI.

The document focuses on the mechanical and material performance of bone fixation devices, not on diagnostic or AI-driven performance.

Here's a summary of the performance data that is mentioned in the document, which pertains to the physical device itself:

1. Acceptance Criteria and Reported Device Performance (for the physical device):

• Acceptance Criteria (Implicit Standard Performance): The device's performance was evaluated in accordance with recognized ASTM standards for bone fixation devices. This implies that the device had to meet performance benchmarks defined by these standards to demonstrate substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated (e.g., "minimum bending strength of X N-m"), the adherence to these standards serves as the implicit acceptance criteria for mechanical performance.
• Reported Device Performance:
  • Tests Conducted: Engineering analysis, bending strength tests (for plates and screws), pullout strength tests (for screws), and insertion/removal torque tests (for screws).
  • Outcome: "Performance data demonstrates substantial equivalence to the predicate devices."
  • Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011 to ensure sterility or low endotoxin levels.

2. Sample Size and Data Provenance (for the physical device testing):

• The document does not specify the sample sizes used for the mechanical performance tests (e.g., how many plates or screws were tested for bending strength).
• The data provenance is not mentioned (e.g., where the tests were conducted, whether the materials were from specific batches, etc.).

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

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done...:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

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

• Not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the physical device, "ground truth" would be the objective measurements obtained from standardized mechanical tests (e.g., actual force at failure, actual torque values) against the requirements of the ASTM standards.

8. The sample size for the training set:

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

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

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

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