(285 days)
The Conventus Orthopaedics PHS™ System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.
The Conventus PHS™ is an intramedullary device intended to treat proximal humerus fractures. The PHS™ System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.
The provided text describes a medical device called the Conventus PHS™ System, an intramedullary device for fixing proximal humerus fractures. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic or AI-assisted performance.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical and biocompatibility testing. It outlines the device's physical properties and mechanical performance, not its diagnostic accuracy or the performance of any AI component.
Therefore, I cannot provide details for most of your requested information as it is not present in the provided text.
Here is what I can extract:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or performance metrics related to diagnostic accuracy or AI performance. The pre-clinical tests performed are mechanical and material characterization tests (e.g., static and cyclic axial/bend testing, screw pullout testing, corrosion testing, wear testing, biocompatibility testing, animal testing). The conclusion is simply that "The results demonstrate that the PHS™ System is substantially equivalent to the legally marketed predicate devices," without providing specific numerical acceptance criteria or performance values for these tests.
2. Sample size used for the test set and the data provenance
Not applicable. There is no "test set" in the context of diagnostic or AI performance evaluation described. The "testing" refers to mechanical and material characterization of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a diagnostic test set is described.
4. Adjudication method for the test set
Not applicable. No test set adjudication method is described.
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
No. An MRMC study or any study involving human readers or AI assistance is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. There is no mention of an algorithm or AI performance.
7. The type of ground truth used
Not applicable. No ground truth for diagnostic or AI performance is established. The "ground truth" equivalent for the pre-clinical tests would be established engineering standards and material properties, but these are not for diagnostic performance.
8. The sample size for the training set
Not applicable. No training set for an AI or diagnostic algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI or diagnostic algorithm is mentioned.
§ 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.