(272 days)
The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bones and bone fragments in adult and pediatric patients.
The ATLAS™ Plating System is a metallic plate and screw system for treatment and fixation of fractures, fusions and osteotomies of bones in the Foot, Ankle, Hand, and Wrist of children (2-12 years), adolescents (12-21 years), and adults. The screws are available in different diameters from Ø2.7mm to Ø5.5mm, non-locking configurations with lengths ranging from 8mm to 60mm. All screws are manufactured from Titanium alloy (Ti-6Al-4V ELI per ASTM F136-13). The plates are available in different geometries to accommodate different patient and bone anatomies. The plates are manufactured from MoRe® alloy (Molybdenum-47.5Rhenium Alloy per ASTM F3273-17).
The provided text is a 510(k) summary for the ATLAS™ Plating System. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through mechanical testing of the device itself rather than studies involving human or animal subjects or complex algorithms. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic device performance is not present in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantified acceptance criteria (e.g., specific tensile strength values, fatigue limits with minimum requirement numbers) or explicit reported device performance in a table format. Instead, it states that "Mechanical testing for screws (ASTM F543-17)" and "Mechanical testing for plates (ASTM F382-17)" were performed. The conclusion is that "Performance data demonstrate that the ATLAS™ Plating System is substantially equivalent legally marketed predicate devices." This implies that the device met the performance characteristics demonstrated by the predicate devices through these standard tests, which is the basis for substantial equivalence.
If this were an AI/ML device, this section would typically include metrics like Sensitivity, Specificity, AUC, F1-score, accuracy, etc., with associated thresholds.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this type of device submission. The "test set" in this context refers to the physical devices (screws and plates) subjected to mechanical testing, not a dataset of patient information. No patient data provenance is relevant here.
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)
This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (ASTM F543-17 and ASTM F382-17) and the physical properties of the materials and device design, not by expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to mechanical testing.
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
This is not applicable. This is a medical device (plating system) submission, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is implicitly the established performance characteristics dictated by the referenced ASTM standards (ASTM F543-17 for screws and ASTM F382-17 for plates), which define the methods and expected results for mechanical properties. The device's performance is compared against the performance of predicate devices tested under similar standards to establish substantial equivalence.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission of this nature.
9. How the ground truth for the training set was established
This is not applicable.
Summary regarding the provided document:
The provided 510(k) summary for the ATLAS™ Plating System represents a traditional medical device submission focused on mechanical performance and material compatibility. The "study" proving acceptance criteria is a series of mechanical tests conducted according to recognized ASTM standards (ASTM F543-17 and ASTM F382-17). The "acceptance criteria" are not explicitly quantified in the document but are understood to be the successful demonstration of mechanical properties comparable to predicate devices, thus establishing substantial equivalence.
This type of submission does not involve clinical studies with patient data, AI/ML algorithms, or human reader performance evaluations, which are typically found in submissions for diagnostic software or AI-enabled devices.
§ 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.