(68 days)
Cases of fracture of the long arm bones are not uncommon and are usually caused by Cases of the surgical re-construction of the humeral is necessary to restore the patients natural alignment of the arm. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections together, until natural healing of the fracture occurs. The separate fractured bone societic when the fracture is healed for full load bearing.
The Omni-Fix, intra-medallary nails were designed to be used for fracture stabilization and fixation of the femur and tibia. Nails are manufactured from Titanium Alloy (Ti-6A1-4V) wrought bar stock material as per ISO 5832 part 3 and ASTM F136-84.
The provided text describes a 510(k) pre-market application for a medical device, the "Omni-Fix, Intra-medullary Nail System." This type of application focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than comprehensive de novo clinical trials or detailed performance studies against specific acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and detailed ground truth establishment is not available in the provided document, as it is not typically required or included in a 510(k) submission focused on substantial equivalence.
However, I can extract information related to the mechanical testing which serves as a form of performance evaluation for the device's safety.
Here's an attempt to answer your questions based on the available information:
-
A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Compliance with ASTM F383-89 mechanical testing protocol (for axial and torsional load and displacement tests). "No failures were seen using the test protocol on the Omni-Fix nails." Absence of failures during mechanical testing. "No failures were seen using the test protocol on the Omni-Fix nails." Substantial equivalence to the predicate device (Biomet, Uniflex nail system). The FDA found the device "substantially equivalent" for the stated indications for use. -
Sample size used for the test set and the data provenance
- Sample Size for Mechanical Testing: "Two different mechanical tests were performed using the smallest size nails." This implies a very limited sample size, likely 2 nails (one for each test type) or a small number of nails of the "smallest size" for each test. The exact number of individual nails tested is not specified beyond "smallest size nails."
- Data Provenance: The mechanical testing was performed at "the University of Teesside (England) Engineering Materials Test Center."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the document. Mechanical testing typically involves engineers and technicians following standardized protocols, not medical experts establishing a "ground truth" in the clinical sense. The "ground truth" for mechanical testing is adherence to the standard and observation of material failure.
-
Adjudication method for the test set
This information is not available in the document. Adjudication methods like 2+1 or 3+1 are typically used for clinical study endpoints involving human interpretation, not for mechanical testing. The results of mechanical tests are usually objective measurements against a standard.
-
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
This type of study was not performed and is not relevant to this device or its 510(k) submission. This device is a surgical implant, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical surgical implant, not an algorithm or AI system.
-
The type of ground truth used
For the mechanical testing, the "ground truth" was compliance with the ASTM F383-89 standard and the absence of mechanical failure under the specified test conditions.
-
The sample size for the training set
This information is not available as the document describes mechanical testing for a physical implant, not a machine learning model. There is no concept of a "training set" in this context.
-
How the ground truth for the training set was established
This information is not available/not applicable for the same reasons as above.
§ 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.