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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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The indications for use for each product cleared under 510(K) remains the same. The only difference in the product is that it will now be available sterile.

Small Fragment Plates and Screws: Used as an aid to the healing of volar rim fractures of the distal radius. Used as an aid to the treatment of certain types of fractures involving small fragments. Specifically: - Cortical fragments large and strong enough to allow application of the device with fixation to an adjacent stable cortex of cortical bone. - An intraarticular fragment large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. - A combination of the above

Tension Band Wire: Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, medial malleolus, lateral malleolus, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of the injury.

TriMed Bearing Plate: TriMed Volar Bearing Plate: 1. Fixation of fractures or non-unions of the distal radius 2. Osteotomies of the distal radius to correct malunion.

TriMed Ulnar Osteotomy Plate: The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

TriMed Bone Plates: The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

TriMed Tenodesis Cross Screw and Interference Screw: The TriMed Tenodesis Cross Screw and Interference Screw are intended to be used as an aid for fixation of soft tissue grafts to bone. Specific indications for use include: Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon Transfer in the hand and wrist. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruciton, Tendon Transfers in the foot and ankle.

TriMed Suture Bead: The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment. The TriMed Suture Bead is not indicated for use within intra-articular sites.

The products cleared in the 510(K)'s listed above will now be provided sterile by TriMed, Inc. No other changes have been made to the devices. Sterilization, packaging, aging and shipping validations have proven that the product can reach the end user while maintaining a sterility assurance level of 10-6.

The provided document is a 510(k) summary for the TriMed Sterile Product. It states that the product is a sterile version of previously cleared TriMed devices and does not include any studies or performance data related to AI/ML device performance or clinical outcomes.

Therefore, I cannot answer the questions regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, or any aspects of a comparative effectiveness study. The document explicitly states:

"The products cleared in the 510(K)'s listed above will now be provided sterile by TriMed, Inc. No other changes have been made to the devices. Sterilization, packaging, aging and shipping validations have proven that the product can reach the end user while maintaining a sterility assurance level of 10-6."

This indicates that the focus of this 510(k) is solely on the sterility of existing devices, not on new functionality or a new AI/ML algorithm.

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