(36 days)
The Hoffmann® II Pelvic Clamp is an external fixation frame component for use 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. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The subject Hoffmann® II Pelvic Clamp is used with the components in the Hoffmann® External Fixation System, Hoffmann® II External Fixation System and Monotube Triax™ External Fixation System to stabilize fractures of the pelvis using Apex® Pins. The Hoffmann® II Pelvic Clamp is a modification of the Hoffmann® 30 Degree Pelvic Double Ball Joint and is made from stainless steel and aluminum with threaded locking bolts.
The provided text describes a 510(k) summary for the Hoffmann® II Pelvic Clamp, a mechanical device used for external bone fixation. It is not a report about an AI/ML powered medical device. Therefore, much of the requested information (such as AI performance metrics, ground truth establishment for AI, expert adjudication, MRMC studies, and training/test set details) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's acceptance criteria and the study performed to demonstrate substantial equivalence to a predicate device, as this is the basis for its 510(k) clearance.
Here's an interpretation based on the provided text, recognizing the limitations for AI/ML-specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
For mechanical devices like the Hoffmann® II Pelvic Clamp, "acceptance criteria" and "device performance" in the context of a 510(k) typically refer to demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through bench testing to show equivalent mechanical properties and functionality.
| Acceptance Criteria / Performance Indicator | Reported Device Performance |
|---|---|
| Mechanical Performance / Equivalence | "Testing has been conducted on the Hoffmann® II Pelvic Clamp demonstrating substantial equivalence to the predicate 30 Degree Pelvic Double Ball Joint." |
| Material Equivalence | Made from stainless steel and aluminum, similar to other components in the Hoffmann® systems and predicate devices. |
| Design Equivalence | Described as a "modification of the Hoffmann® 30 Degree Pelvic Double Ball Joint," implying similar design principles. |
| Intended Use Equivalence | Intended for "stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments," which is consistent with the predicate device's use within the Hoffmann® External Fixation System. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. For mechanical devices, this would typically involve a certain number of manufactured units subjected to specific mechanical tests (e.g., fatigue, static load). The document only states "Testing has been conducted."
- Data Provenance: Not applicable in the context of data (e.g., country of origin, retrospective/prospective). The "data" here refers to the results of mechanical bench 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, not an AI/ML system requiring expert-established ground truth. The "ground truth" for a mechanical device is its adherence to engineering specifications and performance benchmarks established through standardized tests.
4. Adjudication method for the test set
- Not applicable. This is not an observational or diagnostic AI/ML study.
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 device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this mechanical device, the "ground truth" or standard for comparison is provided by the performance of the predicate device (Hoffmann® 30 Degree Pelvic Double Ball Joint) and relevant engineering standards or internal specifications for mechanical strength, durability, and functionality. The study aimed to demonstrate that the new device met these established benchmarks, thereby proving substantial equivalence.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/ML system.
9. How the ground truth for the training set was established
- Not applicable. This is a mechanical device, not an AI/ML system.
Summary of the Study for Substantial Equivalence:
The study conducted was a bench testing study designed to demonstrate that the Hoffmann® II Pelvic Clamp is substantially equivalent to its predicate device, the Hoffmann® 30 Degree Pelvic Double Ball Joint.
- Objective: To show equivalence in intended use, materials, and design.
- Methodology: "Testing has been conducted on the Hoffmann® II Pelvic Clamp." While specific test types (e.g., static strength, fatigue testing, torsional rigidity) are not detailed, such tests would typically be performed to compare the mechanical properties of the new clamp against the known properties of the predicate device.
- Outcome: The testing demonstrated "substantial equivalence" to the predicate, allowing for FDA clearance. The basis for this equivalence appears to be that the Hoffmann® II Pelvic Clamp is a "modification" of the predicate and utilizes similar materials (stainless steel and aluminum) and is intended for the same clinical application within the same external fixation systems.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.