(251 days)
The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:
- Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
- Fusions of the joints and bone (hand, foot, long-bone)
- Correction of bone or soft tissue deformities
- Correction of segmental or non-segmental bone, soft tissue defects or bone loss
- Neutralization of fractures stabilized with limited internal fixation
- Adult and Pediatric subgroups except newborns
The Revolution External Plating System is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components, this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
The provided document is a 510(k) summary for the Revolution External Plating System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies against predefined acceptance criteria in the same way a drug or novel high-risk device might.
Therefore, the document does not contain the kind of information requested regarding acceptance criteria related to device performance metrics for a study proving the device meets those criteria. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: This document reports on "Performance Testing" but does not explicitly state acceptance criteria or detailed performance results in table format.
- Sample size and data provenance for a test set: Not applicable, as this is a mechanical device undergoing performance testing, not a study involving patient data.
- Number and qualifications of experts for ground truth: Not applicable for mechanical performance testing.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a mechanical implant, not an AI or imaging diagnostic device.
- Standalone performance: While the device's mechanical performance is tested "standalone," the nature of the information isn't a human-in-the-loop setting.
- Type of ground truth used: Not applicable. Performance testing for mechanical devices involves measuring physical properties against engineering standards.
- Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How ground truth for the training set was established: Not applicable.
What the document does provide regarding performance testing:
The document states:
"Performance testing (ASTM F1541, and torque to failure testing) was completed to support the modifications to the system and demonstrate its substantial equivalence to the predicate device."
This indicates that:
- Type of testing: Mechanical performance testing.
- Specific tests: ASTM F1541 (Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implants) and "torque to failure testing."
- Purpose: To demonstrate that the modified device's performance is equivalent to that of the predicate device (K181630) and a reference device (K152171), ensuring that "the differences in geometry versus the predicate do not raise different questions of safety and effectiveness."
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through mechanical performance tests against recognized standards and comparison to a predicate device, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for an AI or diagnostic device.
§ 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.