(106 days)
The Hoffman II External Fixation System is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
The indications for use of metallic external fixation devices include:
- Bone fracture fixation
- Osteotomy
- Arthrodesis
- Correction of deformity
- Revision procedures where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
The Hoffmann II External Fixation System originally cleared under K952730, K971755, K003211 and K031941 includes clamps, couplings and rods used in conjunction with half pins or transfixing pins of the Hoffmann External Fixation System cleared under K861766 and is intended to be used for the stabilization of fractures of the tibia, femur, liumerus, radius or pelvis.
This special 510(k) submission is intended to provide an alternate stainless steel material (Biodir 108) to manufacture Hoffinann II coupling components: Currently the subject Hoffmann II components are manufactured from stainless steel, Custom 455.
Here's an analysis of the provided text regarding the Hoffmann II External Fixation System Line Extension (K102885).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: The alternate material (Biodur 108) must demonstrate equivalent stability and performance to the existing material (Custom 455) for the Hoffmann II coupling components. | "Analysis and testing of the alternate material used on the Hoffmann II External Fixation demonstrated equivalent stability and performance compared to its predicate device." This was achieved by comparing "different contributions of the subject Hoffmann II.External Fixation components made of Custom 455 with components of Hoffmann II. MRI System made from the proposed Biodur material." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data or human subject testing. The evaluation was based on material analysis and testing of the device components themselves. Therefore:
- Sample size for test set: Not applicable in the context of human subjects or clinical cases. The "test set" would refer to the physical components manufactured from the new and old materials. The exact number of components tested is not provided, but it's implied that enough were tested to draw a conclusion of equivalence.
- Data provenance: Not applicable in the context of country of origin or retrospective/prospective clinical data, as this was a materials-based study. The testing was conducted by Howmedica Osteonics Corp.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this submission was based on engineering and materials science standards and testing protocols, not on expert clinical opinion or interpretation of medical images/outcomes. The "experts" involved would be materials scientists, engineers, and quality assurance personnel responsible for conducting and interpreting the physical and mechanical tests. Their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Not applicable. This was a technical/materials equivalence study, not a clinical study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1. The assessment of "equivalent stability and performance" would be based on predefined engineering metrics and statistical comparisons.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not mentioned and would not be relevant for this type of submission, which focuses on material equivalence for an existing external fixation system. This involves no AI component or human readers interpreting data.
6. Standalone Performance Study
Yes, in a way. The "analysis and testing" of the alternate material against the existing material for the Hoffmann II coupling components can be considered a standalone performance study in the context of the device's functional integrity and material properties. It describes the performance of the device components (without human intervention in its functionality as an AI would) against established benchmarks (the predicate device's material).
7. Type of Ground Truth Used
The ground truth used was engineering and materials performance data obtained from in vitro testing. This includes metrics related to stability, mechanical properties (e.g., strength, stiffness, fatigue resistance), and potentially biocompatibility, ensuring that the new material performs equivalently to the predicate device's material.
8. Sample Size for the Training Set
Not applicable. This submission is for a medical device's material change, not an AI/machine learning algorithm. Therefore, there is no "training set" in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
§ 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.