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510(k) Data Aggregation
(218 days)
APTUS**®** Coronoid 2.0
ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
The subject device APTUS Coronoid 2.0 plates have an anatomical design and are provided for the left and right ulna. The plates have a uniform thickness of 1.6 mm. The subject device plates are compatible with 2.0 mm diameter screws, and are used with TriLock locking screws and cortical (nonlocking) screws. The compatible screws have cortical threads, are presently marketed as part of the APTUS System, and were cleared under K051567 and K090053. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).
The provided text describes the 510(k) premarket notification for the Medartis AG APTUS® Coronoid 2.0 device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics in the typical sense of a clinical trial or AI device validation.
Instead, the "acceptance criteria" here are focused on demonstrating mechanical performance of the device itself (a bone plate and screw system) and showing it is equivalent to or better than predicate devices. The "study" is a series of non-clinical mechanical tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (referenced from K142906) | Substantially equivalent (all subject device final finished components are manufactured in the same facilities using identical materials and manufacturing processes as for the reference predicate cleared in K142906). Material is Unalloyed titanium ASTM F67. |
| Dimensional Analysis | Subject device plates have a uniform thickness of 1.6 mm. Overall dimensions (approximate) are 28 mm x 34 mm (before bending). These dimensions are within a similar range of physical dimensions appropriate to the coronoid anatomy compared to the predicate (20-21 mm x 31-35 mm). |
| Single Cycle Bending (according to ASTM F382) | Performance of the subject device constructs was superior to that of the primary predicate device constructs. |
| Bending Fatigue Testing (according to ASTM F382) | Performance of the subject device constructs was superior to that of the primary predicate device constructs. |
| Dynamic Compression Testing in a Simulated Coronoid Fracture Model | Performance of the subject device constructs was superior to that of the primary predicate device constructs. |
| Equivalence in Intended Use | ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna. This is deemed to have the same intended use as the primary predicate which provides fixation for fractures, fusions, or osteotomies for various bones including the ulna. |
| Equivalence in Technological Characteristics (Material, Design) | Subject device uses Unalloyed titanium ASTM F67, anodized blue. Designs are anatomical for left/right ulna. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes (e.g., number of plates or constructs) used for the mechanical tests. It refers to these as non-clinical testing data.
- Sample Size (Test Set): Not specified in the provided text. The tests involve "subject device constructs" and "predicate device constructs," suggesting multiple samples were tested for each.
- Data Provenance: Non-clinical testing results. No geographical location or retrospective/prospective nature is mentioned for these lab tests, which is typical for mechanical performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical mechanical performance study for a physical implant, not a study evaluating human interpretation or an AI algorithm that requires expert ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical mechanical performance study.
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 a non-clinical mechanical performance study for a physical implant. It does not involve human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a non-clinical mechanical performance study for a physical implant. It does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" here is established by the specified mechanical testing standards (ASTM F382) and a simulated coronoid fracture model. The performance is objectively measured against these predefined physical and mechanical properties.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical mechanical performance study for a physical implant. There is no concept of a "training set" as there is no algorithm being trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
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