(76 days)
The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys (Ti-6Al-7N per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:
- Titanium alloy AdvantageRib Bridge with threaded locking posts
- Commercially pure locking caps
When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.
The provided FDA 510(k) summary for the AdvantageRib System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device.
The document discusses a medical device for bone fixation (rib fractures) and its equivalence to a predicate device. It focuses on mechanical testing, material specifications, and sterilization validation for a physical implant, not a software algorithm.
Therefore, I cannot extract the following information from the provided text:
- Table of acceptance criteria and reported device performance related to an AI/ML algorithm.
- Sample size and data provenance for a test set (as no AI/ML test set is mentioned).
- Number and qualifications of experts for ground truth (as no AI/ML ground truth is mentioned).
- Adjudication method (as no AI/ML ground truth is mentioned).
- MRMC comparative effectiveness study or effect size of human improvement with AI (as no AI is discussed).
- Standalone algorithm performance (as no algorithm is discussed).
- Type of ground truth used (as no AI/ML ground truth is mentioned).
- Sample size for the training set (as no AI/ML training set is mentioned).
- How ground truth for the training set was established (as no AI/ML training set is mentioned).
The document describes the non-clinical testing performed for the AdvantageRib System as follows:
Non-Clinical Testing Information Provided:
| Category | Description |
|---|---|
| Study Purpose | To demonstrate that the AdvantageRib System, which is identical in geometry and manufacturing process to the predicate device, with specified material and dimensional changes, is as safe and effective as the identified predicate. This was done by ensuring the introduced changes did not create a new "worst case" scenario concerning mechanical performance and by validating the sterilization process. |
| Acceptance Criteria (Implicit from context) | Mechanical Performance: The device (bridge, locking post, locking cap construct) must demonstrate equivalent or superior dynamic and static performance compared to the predicate device. The changes in material or dimensions must not introduce a new worst-case scenario. (Specific numerical acceptance values are not provided in this summary, but would be detailed in the full test reports). |
Sterilization: The sterilization process must achieve a Sterility Assurance Level (SAL) of $10^{-6}$. (This is a standard acceptance criterion for sterilization validation). |
| Reported Device Performance | Mechanical Performance: "Dynamic and static testing was performed on the bridge, locking post, locking cap construct demonstrating that neither the material or dimensional changes introduced a new worst case." (Specific quantitative results not provided in summary).
Sterilization: "Sterilization validation was performed on the subject device per ISO 14937:2009... to establish SAL of $10^{-6}$." (This confirms the acceptance criterion was met). |
Additional Context from the Document:
- Device Name: AdvantageRib System
- Intended Use: Fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
- Predicate Device: MatrixRIB Endo Thorascopic Rib Plating System (K141241)
- Modifications vs. Predicate: Includes option for different titanium alloys, optional washer, increased lengths of locking posts and locking caps with an internal X-drive feature (vs. external hex), and ability for all implants to be steam sterilized (vs. predicate's gamma radiation for some components).
- Conclusion: "The conclusions drawn from the nonclinical testing demonstrates that the device is as safe and as effective as the identified predicate."
In summary, the provided document is a 510(k) summary for a physical medical implant device, not an AI/ML diagnostic or therapeutic algorithm. Therefore, the specific details requested regarding AI/ML performance, ground truth, and study design are not present. The acceptance criteria and performance discussed relate to the mechanical and sterilization properties of the physical implant.
§ 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.