(267 days)
The Ascension ATLAS® Humeral Fracture Plate system is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:
- Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bone
- Pseudoarthroses in the proximal humerus
- Osteotomies in the proximal humerus
The Ascension® ATLAS® Humeral Plate System will be composed of left and right humeral reconstruction plate implants in four-hole (HFP-0930-004LS, HFP-0930-004RS) and seven-hole (HFP-0930-007LS, HFP-0930-007RS) lengths or sizes. The system will also feature 3.5mm locking, non-locking and lag screws and 2.7mm locking and non-locking screws.
The ATLAS® Humeral Fracture Plate will be a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws will be made from stainless steel (SS 316L).
The provided text describes a 510(k) premarket notification for the "Ascension® ATLAS® Humeral Fracture Plate System," a bone fixation appliance. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in terms of clinical outcomes or advanced AI performance.
Therefore, many of the requested sections related to acceptance criteria for AI/diagnostic devices and detailed clinical study parameters (like sample size, ground truth, expert qualifications, MRMC studies, etc.) are not applicable or extractable from the provided submission.
However, I can extract the information related to the non-clinical testing performed to demonstrate substantial equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Meets test specifications for ASTM F382-99, part A1 | The ATLAS Humeral Fracture Plate meets the test specifications for ASTM F382-99, part A1. |
Note: ASTM F382-99 is a standard specification for metallic bone plates, covering mechanical performance requirements like static bending strength and stiffness. The document does not provide the specific numerical acceptance values within ASTM F382-99, nor the exact numerical performance results of the device, only a statement of compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable/Not provided. The provided document describes non-clinical mechanical testing, not a clinical study involving a test set of patient data.
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/Not provided. This information is relevant for clinical studies, particularly those involving diagnostic devices or AI, which is not the subject of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable/Not provided. This is relevant for clinical studies or studies using human expert review as ground truth.
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
Not Applicable/Not provided. This is relevant for AI-assisted diagnostic devices, which is not the nature of the "Ascension® ATLAS® Humeral Fracture Plate System."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable/Not provided. This is relevant for AI-based algorithms, which is not applicable to a bone fixation plate.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical mechanical testing, the "ground truth" is defined by the specifications and methodology outlined in the ASTM F382-99 standard for metallic bone plates. Compliance with this standard indicates acceptable mechanical performance.
8. The sample size for the training set
Not Applicable/Not provided. This device is a medical implant, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable/Not provided. As above, this device does not utilize AI/machine learning requiring a training set with established ground truth.
§ 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.