(76 days)
This submission describes a Carbon Fiber Composite Connecting Rod intended to be used with the components of the Hoffmann® II External Fixation System for the stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments.
The rod is designed to provide a connecting element for the clamps in an external fixation frame. It is manufactured from a carbon fiber reinforced epoxy resin.
This document is a 510(k) Summary for a medical device (Hoffmann® II Carbon Connecting Rods) seeking market clearance, not a study report detailing performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in the provided text.
Here's an analysis of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of pass/fail thresholds. The document implies that the "equivalency" of the carbon rods to existing metallic rods (Hoffmann® Stainless Steel, Hoffmann® II Aluminum) and other carbon fiber rods (Synthes Carbon Fiber Rods, Monotube Carbon Tubes) in terms of "materials, design and operational principles" is the primary acceptance criterion for regulatory clearance. For the mechanical tests, the acceptance criteria would implicitly be that the carbon rods perform comparably to or better than the predicate devices for the measured parameters.
- Reported Device Performance:
- Tests Performed: Static bending strength and stiffness, and torsional strength and stiffness.
- Comparison: Hoffmann® II Carbon Rods were compared to Hoffmann® stainless steel rods and/or Hoffmann® II aluminum rods in each test.
- Specific Results: The actual numerical results of these tests (e.g., specific bending strength values, stiffness values for all rods tested) are not provided in this 510(k) summary. The summary only states that testing was performed and that comparisons were made.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. (This would be the number of rods tested for each design).
- Data Provenance: Not specified. (This would typically be internal testing by Howmedica Inc. in the US, but not explicitly stated).
- Retrospective or Prospective: Not applicable as this refers to a retrospective or prospective clinical study, and this document describes mechanical bench testing for device clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a mechanical device, not an diagnostic imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this refers to a clinical study with human interpretation, not mechanical testing.
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-powered 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, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth: For mechanical testing, the "ground truth" is typically the measured physical properties of the materials and designs under standardized test conditions. This is established by engineering standards and measurement equipment, not expert consensus or pathology in the clinical sense. The comparison is made against existing, cleared devices.
8. The sample size for the training set
- Not applicable. This is a mechanical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
In summary:
The provided text is a regulatory summary, which focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and general operational principles, supported by mechanical bench testing. It does not contain the detailed study results, acceptance criteria, or clinical study design elements that would typically be found in a comprehensive performance study report for a diagnostic AI device.
§ 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.