(128 days)
The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, and or fibula, including osteopenic bone.
The AOS Small Fragment Plating System Lite consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments and non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.
The provided text describes a medical device, the "AOS Small Fragment Plating System Lite," and its clearance process (K181035) by the FDA. However, this document does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. Instead, it details a traditional 510(k) submission for a physical medical device (bone plating system) where substantial equivalence is demonstrated through preclinical testing (mechanical strength, material properties) and comparison to predicate devices, rather than AI performance metrics.
Therefore, I cannot fulfill your request for all the specified information as it pertains to an AI device's acceptance criteria and study.
What can be extracted from the document related to "acceptance criteria" (understood as performance standards for this physical device) and "studies" (preclinical testing):
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Metric) | Reported Device Performance (Method) |
|---|---|
| Bending strength | Substantially equivalent (ASTM F382 Static and dynamic four-point bend testing and Engineering analysis) |
| Bending stiffness | Substantially equivalent (ASTM F382 Static and dynamic four-point bend testing and Engineering analysis) |
| Torsional strength (screws) | Substantially equivalent (Engineering analysis) |
| Bending strength (screws) | Substantially equivalent (Engineering analysis) |
| Axial pullout strength (screws) | Substantially equivalent (Engineering analysis) |
| Material (general) | Titanium (explicitly stated in device description) |
| Biocompatibility | Not explicitly stated as a test, but implied by regulatory clearance and material choice (titanium is biocompatible) |
2. Sample sized used for the test set and the data provenance: Not applicable. This is preclinical physical testing, not a clinical study involving a test set of data. The devices themselves are the "samples" for mechanical testing.
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 a physical device's mechanical properties is established through standardized testing protocols (e.g., ASTM standards) and engineering analysis, not expert medical consensus.
4. Adjudication method for the test set: Not applicable.
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. This is for a physical orthopedic implant, not an AI diagnostic or assistance device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: For the mechanical properties, the "ground truth" is defined by the physical laws and material science principles measured by validated test methods (ASTM standards) and engineering calculations.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning model.
9. How the ground truth for the training set was established: Not applicable.
Summary of Preclinical Testing Mentioned:
- Type of Study: Preclinical mechanical testing and engineering analysis.
- Purpose: To demonstrate substantial equivalence of the AOS Small Fragment Plating System Lite to predicate devices in terms of mechanical performance.
- Methods:
- ASTM F382 Static and dynamic four-point bend testing for plates (bending strength and stiffness).
- Engineering analysis for screws (torsional strength, bending strength, and axial pullout strength).
- Comparison to predicate devices (Synthes One Third Tubular Plate K011335, Small Fragment Dynamic Compression Locking (DCL) System K000684, AOS Small Fragment Plating System K161913).
- Conclusion: The device was found to have substantially equivalent bending strength and bending stiffness for plates, and substantially equivalent performance in torsional strength, bending strength, and axial pullout strength for screws through engineering analysis. This demonstrated that the device "does not raise any different questions of safety or effectiveness" compared to the predicates.
- Clinical Data: "There is no clinical data referenced in this 510(k)."
§ 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.