(73 days)
The Humerus Locking Plating System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
The Humerus Locking Plating System consists of plates designed for various fracture modes of the humerus bone. The system is used with locking screws, smooth locking pegs, threaded locking peg, locking cortical screws and standard cortical screws. The locking screws, threaded pegs and pegs could be supplied cannulated or not. Each device is manufactured from titanium alloy Ti-6A1-V4 ELI (conforms to ASTM F 136-02a and/or ISO 5832-3) or stainless steel (conforms to ASTM F 138 and/or ISO 5832-1). Each device can be supplied color anodized or non-anodized. The Humerus Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.
This looks like a 510k submission for a medical device. These types of submissions typically don't include studies demonstrating device performance against specific acceptance criteria in the way a clinical trial or AI/software validation study would. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, the information requested in your prompt (especially regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/software) is not present in this 510(k) summary.
A 510(k) summary focuses on:
- Device Description: What the device is.
- Intended Use: What the device is meant to do.
- Predicate Device: A legally marketed device with similar characteristics and intended use.
- Technological Comparison: How the new device is similar to (and sometimes different from) the predicate device.
- Performance Data: Often bench testing (mechanical, material, sterilization efficacy) to ensure the device meets established standards or performs comparably to the predicate, but not necessarily clinical performance against specific acceptance criteria with expert ground truth.
If you are looking for details on studies proving device performance against acceptance criteria, that information would be found in a more comprehensive premarket approval (PMA) application or a different type of regulatory submission, or in a separate clinical study report, depending on the device's risk class and novelty.
To directly answer your prompt based only on the provided text, I must state that the requested information is not available in the given document.
However, I can extract the information that is present:
Key Information from the Document:
- Device Name: Humerus Locking Plating System
- Intended Use: For fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
- Predicate Devices:
- Materials: Titanium alloy Ti-6A1-V4 ELI (ASTM F 136-02a and/or ISO 5832-3) or stainless steel (ASTM F 138 and/or ISO 5832-1).
Regarding your specific questions, as they relate to AI/software performance, none of the following can be answered from this document:
- A table of acceptance criteria and the reported device performance: Not provided. This is a mechanical orthopedic implant, not typically evaluated with "performance criteria" in the AI sense for a 510(k). The "performance" would be related to mechanical strength, biocompatibility, and sterilization, which are confirmed through engineering tests, not clinical studies in this context.
- Sample sized used for the test set and the data provenance: Not applicable in the AI/software sense. Bench testing would have its own sample sizes.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for an orthopedic implant refers to its physical and material properties, not diagnostic accuracy by experts.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for an orthopedic implant, not a diagnostic imaging device or AI assistance tool.
- If a standalone performance was done: "Standalone performance" in this context would refer to mechanical testing (fatigue, torsion, bending), not AI algorithm-only performance. Such tests are usually part of the submission to demonstrate compliance with standards, but specific results and acceptance criteria are not detailed in this summary.
- The type of ground truth used: For a mechanical implant, ground truth typically refers to scientific standards (e.g., ASTM/ISO for material properties, mechanical load capabilities).
- The sample size for the training set: Not applicable (no AI/ML component).
- How the ground truth for the training set was established: Not applicable (no AI/ML component).
In summary, the provided document is a 510(k) summary for an orthopedic implant, not an AI/software device. The regulatory pathway is based on substantial equivalence, and the detailed performance study information you're asking for, especially regarding AI-specific validation, is not part of this type of submission summary.
§ 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.