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510(k) Data Aggregation
(58 days)
APTUS**®** Forearm Shaft Plates and APTUS**®** Wrist 2.5 System
APTUS® Forearm Shaft Plates are intended for management of fractures and osteotomies of the radius and ulna shaft.
APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
The subject device includes a total of 10 bone plates for internal fixation of the radius and ulna, and hook plates for fixation of avulsed fragments of the distal radius or ulna. All plates have anatomical designs that are appropriate for either the left or right forearm.
The plates for the shaft of the radius and ulna have similar designs, are provided in designs with 10, 14, 18, or 22 holes, with overall lengths ranging from 80 mm to 160 mm. All plates for the radius and ulna have a maximum width of 10 mm, a maximum thickness of 3.4 mm, and the width and thickness taper at the ends of the plates. The radius shaft plates have a slight curvature to match the anatomy of the radius; the ulna shaft plates are straight.
The subject device hook plates are provided in two designs: a design with two curved hooks and six (6) holes, and a design with four (4) curved hooks and twelve (12) holes. The hook plates have approximate overall dimensions of 8.5 mm width by 17.5 mm length, or 18.5 mm width by 17.5 mm length; both plates are 0.6 mm thick.
The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS® System. The compatible screws are 2.8 mm in diameter (shaft plates) and 1.5 mm in diameter (hook plates) and were previously cleared in K091479, K103332, and K142906. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.
All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.
This is a 510(k) premarket notification for a medical device (bone fixation plates), not an AI/ML-powered device. Therefore, the sections for AI/ML-specific criteria (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable and cannot be extracted from the provided text.
The document discusses acceptance criteria and proof of device performance in the context of demonstrating substantial equivalence to predicate devices, which is common for traditional medical devices under 21 CFR 888.3030.
Here's an analysis based on the available information:
Acceptance Criteria and Study to Prove Device Meets Criteria
The acceptance criteria for this medical device (APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System) are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices, primarily K142906, APTUS® Wrist 2.5 System, and reference devices K000684, K103332, and K151468. The study aims to show that the new device is as safe and effective as these predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Substantial Equivalence Justification) | Reported Device Performance / Justification |
|---|---|
| Intended Use Equivalence | The subject device and predicate/reference devices have the same intended use: internal fixation of bones of the upper extremity. Minor differences in IFUs (e.g., specific language for radius/ulna shaft, additional bones, osteopenic bone) do not impact substantial equivalence as they all express equivalent intended use. |
| Technological Characteristics Equivalence (Design Principles) | The subject device and predicate/reference devices have similar technological characteristics and design principles, including screw holes for locking and non-locking screws. |
| Material Equivalence | The subject device plates, K142906, and K103332 are manufactured from identical unalloyed titanium (ASTM F67). The reference device K000684 uses titanium alloy, but this difference is deemed not to impact safety or effectiveness. |
| Physical Dimensions Equivalence | The subject device, predicate, and reference devices encompass a similar range of physical dimensions (overall width, length, thickness) appropriate for the anatomy. Specific mention of similar designs and dimensions for radius/ulna shaft plates (subject device and K000684) and hook plates (subject device and K142906). |
| Compatibility with Screws/K-Wires | The subject device plates accommodate appropriately sized bone screws (2.8mm for shaft, 1.5mm for hook plates) and 1.6mm K-wires previously cleared as part of the APTUS® System (K091479, K103332, K142906, K092038). |
| Biocompatibility | Biocompatibility referenced from K142906 and K103332; all subject device components are manufactured using identical materials and processes as previously cleared Medartis devices. |
| Sterilization | Sterilization referenced from K142906 and K103332; identical packaging materials and sterilization methods are used. |
| Mechanical Performance | Mechanical testing performed according to ASTM F382. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of this 510(k) summary. This submission relies on engineering analysis and mechanical testing of the device itself and comparison to predicates, not a "test set" of patient data for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for an AI/ML algorithm's test set is not relevant here. The "ground truth" for this submission is demonstrating that the device meets defined engineering specifications and is substantially equivalent to existing, safe, and effective devices.
4. Adjudication method for the test set
Not applicable. There is no AI/ML 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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI/ML algorithm.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Established engineering standards: ASTM F382 for mechanical testing.
- Regulatory compliance: Adherence to 21 CFR 888.3030.
- Comparison to predicate devices: Demonstrating similar intended use, technological characteristics, materials, dimensions, and performance as devices already cleared by the FDA. This implicitly means the predicate devices' safety and efficacy, established through their own clearance processes, serve as a reference.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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