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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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The Renovis T 710 Large External Fixation System is indicated for the following:

• Stabilization/fixation of:
  • o Long bone fractures in tibia and femur
  • o Fractures of pelvis and ankle
  • Peri-articular and intra-articular fractures of knee and ankle o
• . Joint arthrodesis
• Non-unions and mal-unions .
• Osteotomies

The Renovis T 710 Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins and clamp components are made from materials conforming to ASTM F136 and ASTM F138.

This 510(k) summary describes a traditional medical device (external fixation system), not an AI/ML powered device. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like accuracy, sensitivity, specificity, and MRMC studies) are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as devices already legally marketed. The "proof" for this comes from comparing the new device's intended use, design principles, materials, and overall dimensions to those of predicate devices, along with engineering analysis.

Here's how the provided information relates to your request, interpreted for a traditional medical device:

1. A table of acceptance criteria and the reported device performance:
   This document does not present acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity) for the device's function, nor does it report such performance.
   Instead, the "acceptance criteria" implicitly revolve around demonstrating that the new device is substantially equivalent to existing predicate devices. The "reported device performance" in this context refers to the characteristics of the device itself (materials, design, intended use) that are compared to those of the predicate devices.

   Characteristic	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Renovis T 710)
   Intended Use	Must be the same as or very similar to predicate devices.	- Stabilization/fixation of long bone fractures (tibia, femur), pelvis, ankle fractures, peri-articular and intra-articular fractures (knee, ankle)

• Joint arthrodesis
• Non-unions and mal-unions
• Osteotomies
  (Stated to be the "same intended use" as predicates) |
  | Design Principles | Must be the same as or very similar to predicate devices. | - Modular system for broad range of frame construction options
• Consists of bone pins, connecting rods, clamps, posts, accessories
• Creates rigid construct (frame) to stabilize instabilities
• Implantable bone pins (titanium alloy or stainless steel, distally or centrally threaded)
  (Stated to incorporate "the same basic design" and "same operating principle" as predicates) |
  | Materials | Must use the same or very similar materials as predicate devices, conforming to relevant standards (e.g., ASTM F136, ASTM F138). | - Connecting rods: unidirectional carbon fiber reinforced epoxy
• Pins and clamp components: materials conforming to ASTM F136 and ASTM F138
• Implantable bone pins: titanium alloy or stainless steel
  (Stated to incorporate "the same or very similar materials" as predicates) |
  | Overall Dimensions | Must have similar overall dimensions or variations that do not raise new safety/efficacy concerns compared to predicate devices. | Not explicitly detailed but implied by the statement: "The intended use, design principles, materials and overall dimensions of the subject and predicate devices are substantially the same." Differences in technological characteristics "do not raise new issues of safety or efficacy." |
  | Sterilization & Packaging | Must use similar or same sterilization and packaging methods as predicate devices. | - Similar packaging
• Sterilized using the same materials and processes
  (Stated in comparison to predicates) |
  | Safety & Efficacy Differences | Any differences in technological characteristics must not raise new issues of safety or efficacy. | "Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy."
  "Data are provided to demonstrate substantial equivalence including detailed engineering analysis of the subject and predicate designs." (This is the "study" proving it meets the implicit criterion). |

2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this type of medical device submission. The evaluation is based on engineering analysis and comparison to predicate devices, not on data analysis for a diagnostic or predictive algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. The "ground truth" equivalent would be established medical knowledge and regulatory standards for mechanical devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set where adjudication is needed.

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 a traditional mechanical medical device, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device with no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for this submission is established through:

   • Regulatory Precedent: The existence of legally marketed predicate devices with known safety and effectiveness.
   • Engineering Principles: Sound biomechanical and material science principles ensuring the device functions as intended.
   • Standardized Testing: Implicitly, the components meet industry standards (e.g., ASTM F136, ASTM F138).
   • Clinical Experience: The long-standing use and understanding of external fixation systems in orthopedic surgery.

8. The sample size for the training set: Not applicable. There is no training set for a mechanical device.

9. How the ground truth for the training set was established: Not applicable. No training set for a mechanical device.

Study Proving Device Meets Acceptance Criteria (Substantial Equivalence Documentation):

The document states: "Data are provided to demonstrate substantial equivalence including detailed engineering analysis of the subject and predicate designs."

This "detailed engineering analysis" serves as the "study" proving the device meets the implicit acceptance criteria for substantial equivalence. It would involve:

• Material Characterization: Testing of the carbon fiber, titanium alloy, and stainless steel to ensure they meet the specified ASTM standards and have properties comparable to predicate devices.
• Mechanical Testing:
  • Static Loading Tests: Evaluating the strength and stiffness of individual components (pins, rods, clamps) and the assembled frame under various loads (e.g., compression, tension, bending, torsion) to simulate physiological forces.
  • Fatigue Testing: Assessing the durability of components and the frame under cyclical loading to simulate long-term use and ensure they do not fail prematurely.
  • Pin Pull-out Strength: Measuring the force required to dislodge pins from bone surrogates, ensuring adequate fixation.
  • Clamp Slippage Resistance: Verifying that clamps maintain their position on rods under load.
• Dimensional Conformance: Measuring components to ensure they meet design specifications and are compatible with surgical techniques and existing predicate systems where relevant.
• Biocompatibility Testing: (Though not explicitly mentioned for this specific device in the summary, it's a standard requirement for all implantable components unless predicate materials have established biocompatibility).
• Sterilization Validation: Ensuring the chosen sterilization method is effective and doesn't degrade materials.

The results of these engineering analyses would be compared directly to the known characteristics and performance of the specified predicate devices (Howmedica Hoffmann Fixation Pin System, Apex Fixation Pins, Hoffmann II External Fixation System, Synthes Adjustable Large Fixator System, and TransFx External Fixation System) to demonstrate that the Renovis T 710 "does not raise new issues of safety or efficacy."

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The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body.

The FEP and Stylo external fixation systems, are modular systems with the components of: joints, bars, clamps or screws. Such components, with various assemblies, form a device indicated for reconstruction and corrections of bone segments of the human body. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316LVM, ISO 5831-1/9.

The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) premarket notification summary and a clearance letter for the "FEP and Stylo" external fixation systems. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, design, and materials, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot extract the requested information from the given text.

To address your request, the document would need to include sections detailing:

• Specific performance objectives for the device (e.g., strength, durability, biocompatibility).
• Test methods used to evaluate these objectives.
• Results of such tests compared against predefined acceptance criteria.
• Details about any clinical or technical studies conducted (sample sizes, ground truth establishment, expert qualifications, etc.).

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