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The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffmann 3 MR Conditional. Hoffmann II MR Conditional. Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixations for use of external fixation devices include:

• · bone fracture fixation;
• · osteotomy:
• · arthrodesis:
• · correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and
• · bone reconstruction procedures.

The Medline ReNewal Reprocessed Stryker External Fixation Devices are intended to provide temporary stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments. Additionally, the devices may be used for elective orthopedic interventions such as limb lengthening. Devices in the scope of this document include various rods and clamps/connectors that are assembled external to the operative or injury focus and will not be in direct patient contact.

This document describes the 510(k) premarket notification for Medline ReNewal Reprocessed Stryker External Fixation Devices. It focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table with numerical acceptance criteria and reported device performance values. Instead, it broadly states that "The functional characteristics of the subject device have been evaluated and have been determined to be substantially equivalent to the predicate device based on the following tests."

The functional performance studies mentioned are:

• Simulated Use and Artificial Soiling: Implies testing the device under simulated clinical conditions, including exposure to typical biological contaminants. The acceptance criterion would likely be successful cleaning and restoration of functionality after reprocessing.
• Structural Integrity: This would involve mechanical testing to ensure the reprocessed device maintains its structural strength and integrity. Acceptance criteria would likely be a comparison to the original equipment manufacturer (OEM) specifications or to the predicate device's performance, ensuring no degradation after reprocessing.
• Carbon Rod Stiffness per the 4-point bend test (pre-conditioning): Measures the stiffness of carbon rods before they are subjected to simulated use or conditioning. Acceptance criterion would be that the stiffness matches or is within an acceptable range of the OEM or predicate device specifications.
• Cyclical Axial Compression and Tension Bending Test: Evaluates the fatigue life and mechanical durability of the device under repeated loading. Acceptance criterion would be successful completion of a specified number of cycles without failure, demonstrating performance equivalent to the predicate.
• Carbon Rod Stiffness per the 4-point bend test (post conditioning): Measures the stiffness of carbon rods after they have undergone simulated use or conditioning. The acceptance criterion would be that the stiffness remains within acceptable limits and comparable to the predicate device, indicating no significant material degradation from reprocessing or use.
• Disassembly and Reassembly (pre-and post-sterilization): Assesses the ability of the device to be taken apart and put back together correctly and safely, both before its first use (after reprocessing) and after sterilization. Acceptance would involve visual inspection and functional checks to ensure proper fit, function, and absence of damage.
• Cleaning:
  • Visual Inspection: Ensures no visible residue remains after cleaning. Acceptance criterion is no visible residue.
  • Cleaning Efficacy (residual protein and residual carbohydrate): Quantifies residual organic matter after cleaning. Acceptance criteria would be specific threshold levels for residual protein and carbohydrate, typically very low to ensure patient safety and effective sterilization.

Reported Device Performance: The document generally states that the device performance for these tests has been "determined to be substantially equivalent to the predicate device." Specific numerical results for each test are not provided in this summary.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes used for each of the performance tests.
The data provenance is implied to be laboratory testing conducted by Medline ReNewal, as part of their 510(k) submission. It would be considered prospective for the purpose of demonstrating the safety and effectiveness of their reprocessed devices. The country of origin of the data is not explicitly stated but is likely the USA, where Medline ReNewal is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The type of testing described (mechanical, cleaning efficacy) typically relies on objective measurements against established engineering specifications rather than expert consensus on a "ground truth" in the way a diagnostic AI might. Therefore, the concept of "experts establishing ground truth" in the context of clinical images or conditions is less applicable here. The "ground truth" for the performance tests would be the established specifications of the original device and recognized industry standards for reprocessed medical devices.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the type of performance testing described for a reprocessed external fixation device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers evaluating medical images or patient outcomes, which is not the nature of this submission.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what this reprocessed medical device is.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance evaluation was not done. This concept is relevant for AI algorithms. The device under consideration is a physical medical device (reprocessed external fixation components), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described would be:

• Original Equipment Manufacturer (OEM) Specifications: The performance characteristics (e.g., structural integrity, stiffness) of the new, original Stryker External Fixation Devices.
• Industry Standards: Applicable standards for mechanical testing of external fixation devices and cleaning/sterilization of reprocessed medical devices.
• Objective Measurements: Results of physical, chemical, and mechanical tests conducted on the reprocessed devices.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI models. This document describes a reprocessed physical medical device, not an AI or algorithm. Therefore, there is no training set in the context of AI. The "training" for the reprocessing process itself would involve establishing and validating the reprocessing procedures (cleaning, disinfection, sterilization, functional testing), which were applied to a set number of devices for the performance studies mentioned. The document does not specify the number of devices used to develop or validate the reprocessing protocols.

9. How the Ground Truth for the Training Set Was Established

Since there is no AI training set, this question is not applicable. The "ground truth" for the reprocessing procedures would be validated through rigorous testing against established industry standards and internal quality control measures to ensure that the reprocessed devices meet the same performance and safety standards as the original devices.

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