Search Results

The Arthrex Patella SuturePlates are manufactured from titanium alloy conforming to ASTM F136. The plates are 1.6 mm thick in a semi-contoured, mesh-like design. The plates are available in Arrow, Star and Star Pole configurations. Each plate provides locking screw fixation along with suture holes for fixation of the surrounding soft tissue to the plate. The Arthrex Patella SuturePlates are intended to be used with existing FDA cleared Arthrex screws. The Arthrex Patella SuturePlates are sold sterile and non-sterile and are single use.

AI/ML Overview

The acceptance criteria and study detailed in the provided document pertain to the Arthrex Patella SuturePlates, a medical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.

This document describes the premarket notification for a Class II metallic bone fixation appliance, and the studies focus on demonstrating its substantial equivalence to previously cleared predicate devices through biomechanical, MRI safety, and biocompatibility testing. The "performance" being evaluated is essentially the physical and biological compatibility of the device.

However, I will extract the relevant information that is present in the document.

Acceptance Criteria and Reported Device Performance for Arthrex Patella SuturePlates

Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are related to established engineering and biological standards and comparison to a predicate device, rather than diagnostic performance metrics.

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Biomechanical Performance	Demonstrate statistical equivalence to predicate devices (K201677, K170547) in:	The submitted mechanical testing data demonstrates that the ultimate tensile strength, stiffness, cyclic fatigue, bending strength, and bending structural stiffness of the proposed device is substantially equivalent to that of the predicate devices for the desired indications.
	- Ultimate Tensile Strength	Met (statistical equivalence shown)
	- Stiffness	Met (statistical equivalence shown)
	- Cyclic Fatigue	Met (statistical equivalence shown)
	- Bending Strength	Met (statistical equivalence shown)
	- Bending Structural Stiffness	Met (statistical equivalence shown)
	Testing methods: Tensile and cyclic testing, static four-point bend (ASTM F382)
MRI Safety and Compatibility	Conform to FDA guidance and ASTM standards for MRI environments:	Demonstrated MR Conditional labeling.
	- Magnetically Induced Displacement Force (ASTM F2052)	Met
	- Evaluation of MR Image Artifacts (ASTM F2119)	Met
	- Radio Frequency Induced Heating (ASTM F2182)	Met
	- Magnetically Induced Torque (ASTM F2213)	Met
Pyrogenicity	Meet pyrogen limit specifications.	The Arthrex Patella SuturePlates meet pyrogen limit specifications.
	Testing method: Bacterial Endotoxins Test (BET) utilizing Kinetic Chromogenic Method (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14)
Biocompatibility	Conform to ISO 10993-1:2018 standards for:	All tests conducted (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation, Material Characterization). Implies successful results as no issues were raised.
	- Cytotoxicity	Met (implicitly, no issues noted)
	- Sensitization	Met (implicitly, no issues noted)
	- Irritation	Met (implicitly, no issues noted)
	- Genotoxicity	Met (implicitly, no issues noted)
	- Systemic Toxicity	Met (implicitly, no issues noted)
	- Subchronic/Subacute Toxicity	Met (implicitly, no issues noted)
	- Implantation	Met (implicitly, no issues noted)
	- Material Characterization	Met (implicitly, no issues noted)
Sterilization & Shelf-Life	No additional risks/concerns introduced compared to predicate.	Assessment determined no additional risks or concerns.

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

Sample Size: Not explicitly stated in terms of number of devices or test repetitions for each specific test, other than implying sufficient samples were tested to demonstrate statistical equivalence for biomechanical tests.
Data Provenance: Not applicable as this relates to physical device testing, not patient data. The tests are laboratory-based.

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

Not applicable as this is a physical device submission; ground truth is established through standardized testing procedures and engineering/biological principles, not expert interpretation of data.

4. Adjudication method for the test set:

Not applicable. Performance is determined by meeting pre-defined test standards and demonstrating statistical equivalence to predicate devices, not through expert 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:

Not applicable. This is not an AI/ML device that assists human readers.

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

For Biomechanical Testing: Ground truth is established by mechanical engineering principles, established ASTM standards (e.g., ASTM F382), and comparative performance against the predicate device.
For MRI Safety: Ground truth is established by established ASTM standards (e.g., F2052, F2119, F2182, F2213) and FDA guidance for MRI environments.
For Pyrogenicity: Ground truth is established by biological testing standards (e.g., ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14) that define acceptable pyrogen limits.
For Biocompatibility: Ground truth is established by international standard ISO 10993-1:2018 "Biological evaluation of medical devices".

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical device, not an AI/ML algorithm.

Ask a Question

Ask a specific question about this device

Page 1 of 1