(105 days)
The APTUS® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.
The APTUS® 2.0 Radial Head System consists of small titanium fixation plates, conventional screws and locking screws. The system is intended to be used for internal fixation of small bones.
This is a 510(k) premarket notification for a medical device called the "APTUS® 2.0 Radial Head System." A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel device performance against acceptance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, and performance metrics (like sensitivity, specificity, or reader improvement with AI) is not explicitly present in a standard 510(k) summary for a device like a bone fixation system.
However, I can extract and infer some contextual information based on the provided text, particularly concerning the device's equivalence to predicate devices, which serves as a proxy for "meeting acceptance criteria" in the context of a 510(k).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) for a bone fixation system, the "acceptance criteria" revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices. The performance is assessed by comparing key attributes of the new device to those of the predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate) | Reported Device Performance (APTUS® 2.0 Radial Head System) |
|---|---|
| Same Intended Use | The APTUS® 2.0 Radial Head System has the same intended use as the predicate devices: for use in proximal radial fractures and osteotomies. |
| Same Operating Principle | The APTUS® 2.0 Radial Head System uses the same operating principle as the predicate devices: internal fixation of small bones using plates and screws. |
| Same Basic Design | The APTUS® 2.0 Radial Head System incorporates the same basic design as the predicate devices: small titanium fixation plates, conventional screws, and locking screws. |
| Same Materials | The APTUS® 2.0 Radial Head System incorporates the same materials as the predicate devices: titanium for plates and screws. |
| Similar Packaging and Sterilization | The APTUS® 2.0 Radial Head System has similar packaging and is sterilized using the same materials and processes as the predicate devices. |
| Safety and Efficacy (implied by substantial equivalence) | The FDA's substantial equivalence determination implies that the device is as safe and effective as the predicate devices. The K090053 letter confirms this determination, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission for this type of device. There isn't a "test set" of patients or images used to evaluate its diagnostic or predictive performance in the way described for AI/software devices. The evaluation is primarily based on a comparison of device characteristics.
- Data Provenance: Not applicable. The "data" here refers to the specifications and materials of the device and the predicate device, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" established by experts for a test set in a 510(k) for a bone fixation system. The assessment is a regulatory review comparing the physical and functional aspects of the device to predicates.
4. Adjudication method for the test set:
- Not applicable. No test set requiring adjudication in this context.
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 physical orthopedic implant (plate, screws), not an AI/software device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical orthopedic implant, not an algorithm or software.
7. The type of ground truth used:
- Not applicable in the typical sense of clinical ground truth (e.g., pathology, outcomes). The "ground truth" for a 510(k) in this context is the established safety and effectiveness of the predicate devices to which the new device is compared. The FDA has already determined these predicate devices to be safe and effective.
8. The sample size for the training set:
- Not applicable. No "training set" is used for a bone fixation system in a 510(k) submission.
9. How the ground truth for the training set was established:
- Not applicable. No "training set" or corresponding ground truth establishment in this context.
In summary:
The provided document is a 510(k) summary for a physical medical device (bone fixation system). The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to already approved predicate devices across several key characteristics (intended use, operating principle, design, materials, manufacturing processes). This type of submission relies on comparing the device's specifications and characteristics to those of legally marketed devices, rather than conducting new clinical performance studies that define specific acceptance thresholds for metrics like sensitivity or specificity.
§ 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.