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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 Hoffman II External Fixation System is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The indications for use of metallic external fixation devices include:

• Bone fracture fixation
• Osteotomy
• Arthrodesis
• Correction of deformity
• Revision procedures where other treatments or devices have been unsuccessful
• Bone reconstruction procedures

The Hoffmann II External Fixation System originally cleared under K952730, K971755, K003211 and K031941 includes clamps, couplings and rods used in conjunction with half pins or transfixing pins of the Hoffmann External Fixation System cleared under K861766 and is intended to be used for the stabilization of fractures of the tibia, femur, liumerus, radius or pelvis.

This special 510(k) submission is intended to provide an alternate stainless steel material (Biodir 108) to manufacture Hoffinann II coupling components: Currently the subject Hoffmann II components are manufactured from stainless steel, Custom 455.

Here's an analysis of the provided text regarding the Hoffmann II External Fixation System Line Extension (K102885).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data or human subject testing. The evaluation was based on material analysis and testing of the device components themselves. Therefore:

• Sample size for test set: Not applicable in the context of human subjects or clinical cases. The "test set" would refer to the physical components manufactured from the new and old materials. The exact number of components tested is not provided, but it's implied that enough were tested to draw a conclusion of equivalence.
• Data provenance: Not applicable in the context of country of origin or retrospective/prospective clinical data, as this was a materials-based study. The testing was conducted by Howmedica Osteonics Corp.

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

Not applicable. The ground truth for this submission was based on engineering and materials science standards and testing protocols, not on expert clinical opinion or interpretation of medical images/outcomes. The "experts" involved would be materials scientists, engineers, and quality assurance personnel responsible for conducting and interpreting the physical and mechanical tests. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. This was a technical/materials equivalence study, not a clinical study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1. The assessment of "equivalent stability and performance" would be based on predefined engineering metrics and statistical comparisons.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned and would not be relevant for this type of submission, which focuses on material equivalence for an existing external fixation system. This involves no AI component or human readers interpreting data.

6. Standalone Performance Study

Yes, in a way. The "analysis and testing" of the alternate material against the existing material for the Hoffmann II coupling components can be considered a standalone performance study in the context of the device's functional integrity and material properties. It describes the performance of the device components (without human intervention in its functionality as an AI would) against established benchmarks (the predicate device's material).

7. Type of Ground Truth Used

The ground truth used was engineering and materials performance data obtained from in vitro testing. This includes metrics related to stability, mechanical properties (e.g., strength, stiffness, fatigue resistance), and potentially biocompatibility, ensuring that the new material performs equivalently to the predicate device's material.

8. Sample Size for the Training Set

Not applicable. This submission is for a medical device's material change, not an AI/machine learning algorithm. Therefore, there is no "training set" in the traditional sense.

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

Not applicable, as there is no training set for an AI algorithm.

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