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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

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

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction, including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula.

The Newdeal TIBIAXYS Plates are fixed with the SURFIX ALPHA Locking System 3.5mm diameter screws and Lock screws. Anterior Plates for ankle Arthrodesis have to be fixed with the TIBIAXYS cortical 4mm diameter screws.

The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. All plates and screws are manufactured from titanium alloy and are provided either sterile or non-sterile.

The provided 510(k) summary for the Newdeal TIBIAXYS System describes a medical device, a bone plate fixation system, and does not involve AI/ML components typically associated with the requested criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth, and expert evaluation is not applicable.

However, I can extract the information related to the device's performance based on the general mechanical testing described.

Non-AI/ML Device Acceptance Criteria and Study Details:

The summary states that the device was tested for its mechanical properties to ensure compatibility with its intended uses and compared to predicate devices. The acceptance criteria are implicitly that the device's mechanical properties are compatible with its intended uses and substantially equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size (number of mechanical tests or units tested) or the provenance (e.g., country of origin, retrospective/prospective) for the mechanical testing performed. This information is typically detailed in the full test reports, not usually summarized in this section of a 510(k) submission.

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

Not applicable. This device is a mechanical implant, and its performance is evaluated through engineering tests, not human expert interpretation of data or images. "Ground truth" in this context refers to engineering specifications and performance standards.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements and do not require expert adjudication in the way clinical diagnostic interpretations would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with AI assistance. The Newdeal TIBIAXYS System is a surgical implant.

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

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

7. The Type of Ground Truth Used

The ground truth or performance standard for this device is based on engineering specifications and established mechanical performance criteria for bone fixation plates, along with comparison to the performance of legally marketed predicate devices. This includes properties like strength, fatigue resistance, and biocompatibility (though the summary only explicitly mentions "mechanical properties").

8. The Sample Size for the Training Set

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

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

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

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