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The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone.

This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the VariAx 2 Distal Radius System. This line extension consists of anatomically pre-contoured plates for the treatment of simple and complex fractures of the distal radius, together with specialized instrumentation. All new plates are manufactured from CP Ti Grade 2 (Type II anodization) and are available in different sizes and left/right versions. The plates will be provided both non-sterile and sterile-packaged. They will use the well-established SmartLock technology to allow variable angle screw locking. The plates can be used with non-locking and locking VariAx 2 T8 screws. The VariAx 2 T8 screws have been previously cleared under K191412.

The provided text is an FDA 510(k) clearance letter for the Stryker VariAx 2 Distal Radius System. This document does not contain information about software performance, AI algorithms, or any type of study that would involve acceptance criteria for an AI/software device.

The document discusses a physical medical device (bone fixation plates and screws) and primarily relies on non-clinical performance data comparing the new device to previously cleared predicate devices. The performance data listed (engineering assessment, biomechanical tests, MR safety assessment, packaging tests, biocompatibility) are all related to the physical properties and safety of the implantable hardware, not software or AI performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them, as the provided input does not describe such a study or device.

To fulfill your request, you would need to provide a document related to the clearance of a software as a medical device (SaMD) or a device that incorporates an AI/ML component.

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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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