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AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intra- articular and extra-articular fractures, and for osteotomies of the distal radius in adults.

The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

The AFFINITY - Variable Angle Distal Radius System is contains a set of titanium plates and screws that are intended to be end-user sterilized. The AFFINITY - Variable Angle Distal Radius System plates are provided in different configurations and are intended to be used in combination with the variable angle drilling guide and the Styloid hole variable angle drill guide to provide the necessary angulation for optimal screw positioning. The system includes Extra-articular plates (intermediate, wide, and narrow), Distal dorso-ulnar and dorso-radial L-plates, Distal ulnar T-plates, and straight Radius styloid plates.

This is a medical device 510(k) summary, not a study of an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not applicable.

The document describes the AFFINITY - Variable Angle Distal Radius System, which is a set of titanium plates and screws for fixing fractures and osteotomies of the distal radius. This is a traditional medical device, not an AI/ML product.

Instead of clinical performance, the summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the non-clinical testing performed, presented in a table format, though it's important to note this does not align with the AI/ML-specific request for acceptance criteria and device performance:

• Annex 1 Static Bend Testing
• Annex 2 Fatigue Bend Testing | Substantial equivalence to predicate device |
  | Mechanical Testing of Screws:
  ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws)
• Annex 1 Torsional Properties
• Annex 2 Driving Torque
• Annex 3 Axial Pullout | Substantial equivalence to predicate device |
  | Biocompatibility Testing:
• ISO 10993-5: Tests for in-vitro cytotoxicity
• ISO 10993-18: Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials.
• XPS investigation for film-forming contaminations
• Detection and Quantification of Bacterial Endotoxins | - no cytotoxic effect
• chemical characterization as per the report
• appropriate surface cleanliness
• no risk of bacterial pyrogenicity |
  | Sterilization Testing:
  Validating steam sterilization method according to ISO 11737-2:2009, ISO 17665-1:2006, ISO 14161:2009. | The results of the validating steam sterilization method show that the implants, accessories, and models can be sterilized to a SAL of 10-6 using the recommended steam sterilization instructions |

Regarding the specific points requested for an AI/ML device:

1. A table of acceptance criteria and the reported device performance: Provided above for non-clinical testing, but not for AI/ML performance.
2. Sample size used for the test set and the data provenance: Not applicable as there is no test set for an AI/ML algorithm. The "test set" for this device refers to physical samples used in mechanical and biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
7. The type of ground truth used: Not applicable. The "ground truth" for this device is established by international standards for material properties, mechanical strength, and biocompatibility.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document describes a traditional mechanical medical device, not an AI/ML product. The evaluation criteria are based on established engineering and biological standards for such devices, demonstrating substantial equivalence to a predicate device rather than AI/ML performance metrics.

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The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

The Modified Distal Radius Plating System consists of Titanium alloy Extra Narrow and Extra Long family of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures and reconstructive surgeries.

The provided text describes a 510(k) submission for a Modified Distal Radius Plating System and focuses on demonstrating substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, many of the requested elements for describing an AI/CAD-based study are not applicable to this document. The document primarily outlines pre-clinical mechanical testing to ensure the new device is comparable to existing ones.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "pre-clinical data including axial load construct testing, 4-point bending testing, evaluation of galvanic corrosion potential and multidirectional screw capability" demonstrated substantial equivalence. Specific quantitative acceptance criteria (e.g., minimum load bearing, maximum corrosion rate) and the exact quantitative results are not provided in this summary.

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

• Sample Size: Not applicable. The "test set" here refers to the physical devices undergoing mechanical and material testing, not a dataset of medical images or patient records. The number of physical implants/constructs tested is not specified in the provided summary.
• Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance relates to laboratory testing of device components.

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

• Not applicable. Ground truth in this context would be defined by engineering specifications and physical measurements, not expert consensus on medical images.

4. Adjudication method for the test set

• Not applicable. This concept is relevant for expert review of clinical data, not for material and mechanical testing.

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, an MRMC comparative effectiveness study was not done. This document pertains to a medical device's physical and material properties, not an AI/CAD system for image interpretation.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance would be derived from engineering specifications, material science standards, and mechanical testing protocols. For example, the load at which a construct fails in axial loading would be the measurable "truth" compared against a specified acceptance load.

8. The sample size for the training set

• Not applicable. This product is a physical implant, not an AI model requiring a training set.

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

• Not applicable. No training set for an AI model.

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