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The Hoffmann® 30 Degree Pelvic Double Ball Joint is intended to be used with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX " External Fixation System and in conjunction with Apex Pins. This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation. The indications 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 ●
• Bone reconstruction procedures .

The subject Hoffmann® 30 Degree Pelvic Double Ball Joint is a modification of the Hoffmann® 5 Hole Ball Joint. The modification involves lengthening the clamp, adding an additional ball joint, modifying the pin interface and tilting the pin holding portion of the clamp by 30 degrees.

This document describes a 510(k) premarket notification for the Hoffmann® 30 Degree Pelvic Double Ball Joint, an external fixation frame component. The focus of the submission is on demonstrating its substantial equivalence to a predicate device, the Hoffmann® 5 Hole Ball Joint, rather than proving performance against specific clinical acceptance criteria in a study.

Therefore, many of the requested categories (e.g., sample size, expert ground truth, MRMC study, training set) are not applicable to this type of device submission. The device is a mechanical component, and its "performance" is assessed through engineering testing to ensure it meets the same standards as the predicate device.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a mechanical device, and "test set" in the context of clinical data or imaging algorithms is not relevant here. The testing would be engineering verification and validation, likely using a sample of the manufactured device. The origin of the data would be laboratory-based engineering tests.

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

Not applicable. This is a mechanical device. "Ground truth" in the context of expert consensus on clinical findings is not relevant.

4. Adjudication Method for the Test Set

Not applicable.

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 mechanical medical device, not an AI or imaging diagnostic tool.

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

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device would be its mechanical properties and performance against established engineering standards and comparison to the predicate device. For example, torque resistance, fatigue life, strength, etc., as determined by laboratory testing. Not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning algorithm.

9. How the ground truth for the training set was established
Not applicable.

Summary of the Study (Implied by the 510(k) Summary):

The provided text details a 510(k) submission for a medical device: the Hoffmann® 30 Degree Pelvic Double Ball Joint. The "study" referenced is the testing conducted to demonstrate substantial equivalence to a predicate device, the Hoffmann® 5 Hole Ball Joint.

• Objective: To show that the modified device (Hoffmann® 30 Degree Pelvic Double Ball Joint) is as safe and effective as the legally marketed predicate device (Hoffmann® 5 Hole Ball Joint).
• Methodology (Inferred): This involved comparing the new device to the predicate in terms of:
  • Intended Use: Both are external fixation frame components.
  • Materials: Implied to be similar ("Equivalency of this device is based on similarities in intended use, materials and design...").
  • Design: Acknowledged modification (lengthening clamp, additional ball joint, modified pin interface, 30-degree tilt), but implied that these changes do not alter fundamental safety and effectiveness.
  • Performance: "Testing has been conducted on the Hoffmann® 30 Degree Pelvic Double Ball Joint demonstrating substantial equivalence to the predicate Hoffmann® 5 Hole Ball Joint." This testing would typically involve mechanical tests (e.g., fatigue, strength, torsional stability) to ensure the new design performs at least as well as the predicate under simulated physiological loads.
• Acceptance Criteria (Inferred): The acceptance criteria for the "study" was the demonstration of substantial equivalence to the predicate device. This means the new device met the same performance standards and exhibited similar characteristics to the predicate, even with design modifications. The specific quantifiable criteria (e.g., "must withstand X N-m of torque," or "fatigue life must exceed Y cycles") are not provided in this summary but would be part of the full 510(k) submission's engineering reports.
• Conclusion: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

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