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The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. Specifically, the system is intended for:

• Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
• Arthrodesis and osteotomies with associated soft tissue problems;
• Stabilization of limbs after removal of total joint arthroplasty for infection or other failure:
• Stabilization of non-unions; and
• Intraoperative temporary stabilization tool to assist with indirect reduction.

The XtraFix Small External Fixation System subject of this 510(k) submission includes the following elements: Clamps (Bar/Pin to Bar/Pin, Integrated Multi-Pin); Bars; and Half Pins. The XtraFix Small External Fixation System is designed in such a way that several different types of frames can be assembled. Pins are inserted into bone, and then clamps are assembled to the pins. Bars are assembled to the clamps and a frame is constructed. After reducing the fracture, all clamps are tightened to hold the frame in place.

The provided document describes a 510(k) premarket notification for the Zimmer XtraFix® Small External Fixation System, which is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, studies, and ground truth establishment are not applicable.

The document discusses the substantial equivalence of the XtraFix® Small External Fixation System to previously cleared predicate devices based on technological characteristics and performance data.

Here's the relevant information based on the provided text, adapted for a medical device rather than an AI system:

1. A table of acceptance criteria and the reported device performance

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

The document does not specify a "test set" in the context of an AI/ML system. Instead, it refers to non-clinical performance data obtained through characterization and evaluation.

• Sample Size: Not explicitly stated for specific tests (e.g., how many devices were tested for MRI compatibility or mechanical strength). The evaluation was conducted on the "XtraFix Small External Fixation System," implying various components and configurations were subject to testing.
• Data Provenance: The tests were conducted according to established standards (ASTM F1541-02(2007)) and FDA guidance documents. This indicates laboratory testing and analysis, not data collected from human subjects (prospective or retrospective).

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

Not applicable. This is not an AI/ML device, and ground truth, in this context, is established through standardized engineering tests, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device. Performance is determined by meeting physical and material standards measured by equipment, not by human adjudication of results.

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. The study focused on the physical performance and safety characteristics of the device itself, not on human reader interpretation.

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

This refers to the performance of the device itself in a standalone capacity, as its function is mechanical/structural, not diagnostic or AI-driven. The "performance data (nonclinical)" presented (interconnection strength, system rigidity, MRI compatibility) reflects the intrinsic properties and behavior of the device without human interaction once installed or during the MR environment.

7. The type of ground truth used

The "ground truth" for this device is based on:

• Engineering Standards and Specifications: Adherence to requirements outlined in ASTM F1541-02(2007) for external fixation devices.
• FDA Guidance Documents: Specific guidelines for orthopedic external fixation devices and establishing safety/compatibility of passive implants in MRI environments.
• Measured Physical Properties: Quantified measurements for force, torque, heating, and image artifact extension in MRI, compared against predefined safety thresholds.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that sense.

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

Not applicable. As there is no training set for an AI/ML system, this question is not relevant.

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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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