(104 days)
The RibFix Titan Fixation System is indicated for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
The Riverpoint Medical RibFix Titan Fixation System is comprised of titanium bone plates that are secured to bone by a deplovable ultra-high molecular weight polyethylene (UHMWPE) suture anchor with a titanium washer and button. Bone plates are provided in configurations for intrathoracic and extrathoracic use. Intrathoracic bone plates are provided in 60mm and 94mm lengths. Extrathoracic bone plates are provided in 60mm, 94mm, and 120mm lengths.
The provided text does not contain detailed acceptance criteria or results of a study proving the device meets those criteria in a tabular format as requested for all points. The document is a 510(k) summary for the RibFix Titan™ Fixation System, which describes performance testing generally but does not provide specific metrics, acceptance criteria, or detailed study results.
However, based on the limited information available, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document states: "In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RibFix Titan Fixation System performed as intended." However, no specific numerical acceptance criteria or performance metrics are provided in the document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met all acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify sample sizes for mechanical testing or usability validation, nor does it provide information on the data provenance (country of origin, retrospective/prospective).
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. The reported studies are mechanical and usability engineering, not clinical studies requiring expert ground truth for diagnosis/assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study involving human judgment on cases.
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 medical device (fixation system), not an AI/software device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. For the mechanical and usability testing mentioned:
- Mechanical testing: Ground truth would be defined by engineering specifications and physical measurements according to standards like ASTM F382 (for plate components) and ASTM F1717 (for assembled constructs).
- Usability engineering validation: Ground truth would be the defined usability goals and safety requirements, assessed through expert evaluation and simulated use.
8. The sample size for the training set:
Not applicable. This is not a machine learning/AI study involving a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning/AI study.
Summary of available information regarding studies:
The document mentions the following non-clinical performance data studies were conducted:
- Four-point bend testing (static and fatigue) of bone plate components per ASTM F382.
- Cyclic and Ultimate Tensile Strength (UTS) testing of anchor constructs.
- Cyclic fatigue testing of assembled constructs using ASTM F1717 as a guide.
- Usability engineering validation with simulated use in cadaver lab performed per EN62366-1.
- MR Compatibility testing per ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182.
The document states that "In all instances of the testing referenced above, the acceptance criteria were met, and the proposed RibFix Titan Fixation System performed as intended." It also mentions that the testing compared the RibFix Titan Fixation System to the predicate device, especially regarding fixation strength. For usability, it notes that the "usability study and performance testing of the RibFix Titan support the use of the RibFix Titan Fixation System and eIFU."
§ 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.