(151 days)
ARIX Humerus System is indicated for fractures, fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.
The ARIX Humerus System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Humerus System is consists of plates and screws. The ARIX Humerus System is made of Pure Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium- 6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which h are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws vary essentially through different lengths and diameters. It also includes various manual surgical instruments, as drill bits, driver shafts and depth gauge. It also includes various manual surgical instruments, such as hand body, driver, drill bits, depth gauge, drill sleeve, forceps, drill guide block, sleeve handle and drill guide. The ARIX Humerus System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery.
This document is a 510(k) premarket notification for the ARIX Humerus System, a medical device for bone fixation. It does not describe a study involving device performance in terms of diagnostic accuracy or effects on human readers. Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/human reader performance.
The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and mechanical performance (bench testing), rather than clinical performance (e.g., diagnostic accuracy, reader improvement).
Here's why I cannot provide the specific details requested:
- Type of Device: The ARIX Humerus System is a metallic bone fixation appliance (plates and screws). It is a surgical implant, not a diagnostic imaging device or an AI-powered image analysis tool.
- Study Purpose: The studies mentioned (bench tests per ASTM F382 and F543) are mechanical performance tests designed to ensure the device's strength and fatigue resistance are equivalent to existing devices, not to evaluate diagnostic accuracy or how it impacts human interpretation of medical images.
- "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" are related to mechanical and material properties (e.g., bending strength, fatigue life, biocompatibility) rather than diagnostic metrics like sensitivity, specificity, or AUC.
- Lack of AI/Reader Involvement: There is no mention of AI integration, human readers interpreting images, or any comparative effectiveness study involving human performance with and without AI assistance.
However, I can extract the information that is present in the document related to general device performance and regulatory requirements:
1. A table of acceptance criteria and the reported device performance (based on mechanical testing mentioned):
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Plate bending strength (ASTM F382) | No adverse difference from predicate device. | "The results of this testing indicate that the ARIX Humerus System is equivalent to predicate device." |
| Mechanical Performance | Plate bending fatigue (ASTM F382) | No adverse difference from predicate device. | "The results of this testing indicate that the ARIX Humerus System is equivalent to predicate device." |
| Material Properties | ASTM F67 (Unalloyed Titanium) | Compliance with standard. | Meets ASTM F67. |
| Material Properties | ASTM F136 (Titanium Alloy) | Compliance with standard. | Meets ASTM F136. |
| Sterilization | ISO 17665-1:2006 | Achievement of SAL of 10-6. | Sterilization method validated per ISO 17665-1:2006. |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for mechanical testing. These tests are typically performed on a limited number of physical samples (e.g., plates and screws) to demonstrate compliance with standards.
- Data provenance is not specified beyond being "bench tests." These are laboratory tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This device does not involve expert interpretation or ground truth establishment in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretation.
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 MRMC study was done. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical tests, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices or relevant ASTM standards.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning algorithms requiring training sets.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document describes a 510(k) submission for a surgical implant, not an AI-powered diagnostic device. Therefore, questions related to AI performance, human reader studies, and diagnostic accuracy are not relevant to this document.
§ 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.