(77 days)
The Hoffmann ® II Hybrid Frame System is intended to provide stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Osteotomy
- . Arthrodesis
- Correction of deformity .
- Revision procedure where other treatments or devices have been unsuccessful .
- Bone reconstruction procedures .
- Fusions and replantations of the foot .
- Charcot foot reconstruction and Lisfranc dislocations .
The new Foot Ring components are additions to the Hoffmann ® II Hybrid Frame System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax " External Fixation System and in conjunction with commercially available Fixation Pins such as the Apex® Pins and/or Kirschner Wires.
The Hoffmann® II Foot Ring is an external fixation frame component for stabilizing fractures and performing reconstruction procedures, specifically for the foot. Its acceptance was based on demonstrating substantial equivalence to predicate devices through similarities in intended use, materials, and design, and by conducting specific testing.
Here's an analysis of the provided information regarding acceptance criteria and the supporting "study":
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the predicate equivalence. The acceptance criteria essentially revolve around demonstrating that the Hoffmann® II Foot Ring is as safe and effective as existing legally marketed predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| Intended Use Equivalence: | "Similarities in intended use" to predicate devices. The Hoffmann® II Foot Ring's intended use perfectly aligns with the Hoffmann® II Hybrid Frame System for stabilization of open/unstable fractures and reconstruction, including specific foot procedures. |
| Materials Equivalence: | "Similarities in materials" to predicate devices. (Specific materials are not detailed in the summary but implicit in equivalence claim.) |
| Design Equivalence: | "Similarities in design" to predicate devices. (Specific design features are not detailed, but the Foot Ring is described as an "addition" to existing systems, implying compatibility and similar design principles.) |
| Performance Equivalence (Safety & Effectiveness): | "Testing has been conducted on the Hoffmann® II Foot Ring components demonstrating substantial equivalence to the predicate devices." (No specific quantitative performance metrics or test results are provided in this summary.) |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Testing has been conducted on the Hoffmann® II Foot Ring components demonstrating substantial equivalence to the predicate devices."
- Sample Size for Test Set: Not explicitly stated. The summary does not provide any details on the number of devices or components tested.
- Data Provenance: Not explicitly stated. The summary does not mention the country of origin of the data, nor whether it was retrospective or prospective. It is highly likely to be prospective mechanical testing conducted by the manufacturer to demonstrate substantial equivalence, rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the device's acceptance is based on demonstrating substantial equivalence through engineering/mechanical testing, not through a clinical study requiring expert-established ground truth for a test set. There were no human 'experts' establishing ground truth in terms of clinical diagnosis or outcomes for this type of submission.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (an external fixation component), not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical device; there is no "algorithm" or standalone AI performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is typically established through engineering and mechanical testing standards to ensure strength, durability, biocompatibility, and functional compatibility with existing systems. It's about meeting predefined performance specifications that demonstrate safety and effectiveness for its intended mechanical function, rather than clinical diagnostic accuracy against pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. The Hoffmann® II Foot Ring is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.