(131 days)
The Acumed Ankle Plating System is intended for fixation of fractures, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.
The Acumed Ankle Plating System consists of plates and accompanying screws implanted in the distal fibula and tibia. The plates are available in a variety of sizes and use a variety of screw sizes to accommodate varying patient anatomies and fracture patterns. All plates are anatomically pre-contoured, and are provided in left and right limb-specific options where applicable. All implants are manufactured from Ti-6Al-4V per ASTM F136 and provided both sterile and non-sterile. The system contains precontoured plates, 2.7, 3.5, and 4.0mm screws, syndesmosis targeting instrumentation, and other typical instrumentation for ankle plating cases.
This document describes a 510(k) premarket notification for the Acumed Ankle Plating System, a metallic bone fixation appliance. The information provided outlines the device, its intended use, and a non-clinical study conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific details required to answer your request about acceptance criteria and study proving device meets acceptance criteria, as those terms are typically used for AI/ML device performance evaluations.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- This is a medical device approval, not an AI/ML device approval. The document pertains to an ankle plating system, which is a physical implant, not a software-based or AI device. Therefore, the concepts of "test set," "ground truth," "expert consensus," "MRMC study," "human improvement with AI assistance," or "standalone algorithm performance" are not applicable in this context.
- The "study" described is non-clinical comparative testing. It's a mechanical test to show physical equivalence, not a clinical trial or performance study against specific diagnostic or treatment criteria.
Therefore, many parts of your request are not relevant to this document.
However, I can extract the closest analogous information based on the provided text, focusing on the non-clinical testing performed to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
For a physical medical device like an ankle plating system, "acceptance criteria" in this context usually refer to meeting established mechanical performance standards. The document mentions compliance with ASTM F382-99.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in static 4-point bend per ASTM F382-99 | Acumed Ankle Plating System was substantially equivalent to the predicate device in static four-point bend. |
| Substantial equivalence to predicate device in bending fatigue per ASTM F382-99 | Acumed Ankle Plating System was substantially equivalent to the predicate device in bending fatigue tests. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated in the document. ASTM F382-99 outlines standards for material mechanical testing, which typically involves a small number of samples per test condition.
- Data provenance: Non-clinical (laboratory testing)
- Country of origin: Not specified, but generally performed in a certified testing lab.
- Retrospective or prospective: N/A for mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is non-clinical mechanical testing, not a study requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" is adherence to mechanical standards.
4. Adjudication method for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for clinical judgment of images or outcomes, which is not applicable here. Mechanical tests yield objective measurements.
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. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used
- Mechanical performance standards: The "ground truth" for this device's non-clinical testing is its ability to meet specified mechanical properties (e.g., strength, fatigue resistance) as defined by established ASTM standards (ASTM F382-99) and to be substantially equivalent to the predicate device's performance under those standards.
8. The sample size for the training set
- N/A. This is not an AI/ML device, and there is no "training set."
9. How the ground truth for the training set was established
- N/A. There is no training set for this type of device.
In summary, the provided text describes the regulatory clearance of a physical medical device (ankle plating system) based on a non-clinical comparative mechanical study. The questions posed in your request are primarily tailored for AI/ML-based diagnostic or assistive devices, which are not relevant to this specific 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.