(121 days)
The distal humerus fracture plates and olecranon fracture plates are indicated for adult patients. The distal humerus and olecranon fracture plates are indicated for fixation of fractures of the humerus and ulna.
The Arthrex Elbow Fracture Plating System consists of a series of olecranon and distal humerus plates of varying lengths, thicknesses, and orientations. The proposed plates are contoured and may be available in left and right configurations, ranging from 73 mm to 294.37 mm in length, 1.93 mm to 5.51 mm in thickness, and 10.06 mm to 22 mm in width. Each plate provides locking screw fixation and may include suture holes for soft tissue refixation. The proposed plates are manufactured from stainless steel conforming to ASTM F138 or titanium alloy confirming to ASTM F136 (ISO 5832-3). The plates are sold sterile (Gamma) and non-sterile and are single-use.
The Arthrex Elbow Fracture Plating System is a medical device for fixing fractures of the humerus and ulna in adult patients. The company did not conduct a study with human readers or AI assistance. The study conducted to prove substantial equivalence to a predicate device (K061352: PERI-LOC Periarticular Locked Plating System) was based on engineering and analytical testing, not clinical performance.
Here's a breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static and Dynamic conditions per ASTM F382-17 | "demonstrate that the mechanical performance of the subject device is substantially equivalent to that of the predicate" |
| Packaging & Shelf-Life | Maintain product and sterility throughout shipping and handling; Meet packaging testing criteria per ISO 11607 and applicable standards. | "The proposed packaging configurations met all the packaging testing acceptance criteria in conformance to ISO 11607 and applicable standards." |
| "The shelf-life of the proposed sterile plates is 5-years." | ||
| MRI Safety | MRI force, torque, and image artifact testing per FDA guidance and ASTM standards (F2052, F2119, F2182, F2213) | "MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance... and ASTM standards." (Implied acceptance - labeling for MR Conditional) |
| Biocompatibility/Sterility | Meet pyrogen limit specifications per ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. | "The testing conducted demonstrates that the sterile devices meet pyrogen limit specifications." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The documentation does not specify a "test set" in the context of clinical data for performance evaluation. The "tests" performed were engineering and analytical in nature (e.g., Finite Element Analysis, 4-point bend tests, packaging validation, MRI testing, bacterial endotoxin testing). There is no mention of patient data, clinical imagery, or any data provenance related to human subjects.
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. The ground truth for this submission was established through engineering standards, mechanical testing protocols, and laboratory procedures, not through expert clinical consensus or interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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 comparative effectiveness study was not conducted as this device is a bone plating system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence for this device was based on:
- Established engineering standards (e.g., ASTM F382-17 for mechanical testing, ASTM F2052, F2119, F2182, F2213 for MRI safety).
- Regulatory standards (e.g., ISO 11607 for packaging, ANSI/AAMI ST72, USP , USP , EP 2.6.14 for sterilization/pyrogenicity).
- Comparison to the predicate device's design, materials, and intended use.
8. The sample size for the training set
Not applicable. There was no "training set" as this device is not an AI/machine learning product.
9. How the ground truth for the training set was established
Not applicable.
§ 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.