(30 days)
The Hoffmann® II Compact™ Baltimore Coupling is intended to be used with the components of the Hoffmann® II Compact™ External Fixation System and in conjunction with the half pins or transfixing pins of the Hoffmann® External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, or other means of internal fixation.
This Special 510(k) submission is intended to address the introduction of a supplemental component to the predicate Hoffmann® II Compact External Fixation System. The subject device, named the Hoffmann® II Compact™ Baltimore Coupling, is a line extension of the Hoffmann® II Compact "Rod to Rod Coupling. The predicate Hoffmann® II Compact™ Rod Coupling is fabricated from stainless steel and aluminum. The subject Hoffmann® II Compact™ Baltimore Clamp is also fabricated from stainless steel and aluminum. The Hoffmann® II Compact™ Baltimore Coupling is a modification of the Hoffmann® II Compact" Rod to Rod Coupling. The modification involves a change to the rod to clamp interface which includes a change in profile, an added lip to provide resistance to rod slippage and chamfered edges to aid in rod insertion. Both the predicate Hoffmann® II Compact™ Rod to Rod Coupling and the subject Hoffmann® II Compact™ Baltimore Coupling will be made available to provide surgeons with a choice of couplings for use with the Hoffman® II Compact™ External Fixation System.
The provided document describes a 510(k) premarket notification for a medical device called the Hoffmann® II Compact™ Baltimore Coupling, which is a line extension to an existing external fixation system. This is a submission demonstrating substantial equivalence to a predicate device, not a study showcasing device performance against specific acceptance criteria in the way a clinical trial or algorithm validation would.
Therefore, many of the requested elements for a study proving device performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) are not applicable to this type of regulatory submission. This document focuses on mechanical testing to demonstrate comparable properties to an existing, cleared device, rather than a clinical study evaluating diagnostic accuracy or a similar performance metric.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate component."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate device (Hoffmann® II Compact™ Rod to Rod Coupling) | Mechanical testing demonstrated comparable mechanical properties. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in this summary document.
- Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." However, the "mechanical testing" implies a laboratory setting, likely conducted by the manufacturer (Howmedica Osteonics Corp in Allendale, NJ, USA).
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 mechanical testing is based on engineered specifications and standardized test methods, not expert consensus (e.g., radiologists interpreting images).
4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert reviews. Mechanical testing results are objective measurements.
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-assisted device, nor is it a diagnostic imaging device subject to MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical coupling component for an external fixation system, not an algorithm.
7. The type of ground truth used
For mechanical testing, the "ground truth" would be established engineering standards, material properties, and benchmark performance of the predicate device under specific test conditions. It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The sample size for the training set
Not applicable. This is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.