(261 days)
The ORTHO SELECT Bone Plates and Screw System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; and hip arthrodesis.
In pediatric patients, the ORTHO SELECT Bone Plates and Screw System is intended for use on mature bone only. It is not intended for placement across the growth plate.
The ORTHO SELECT Bone Plates and Screw System consists of stainless steel bone plate and bone screw implants intended for internal fixation of pelvic, small and long bone fractures according to the standard of the AO Foundation (AO Principles of Fracture Management). The bone plates and screws are provided non-sterile for steam sterilization by user and single use only.
This document describes a 510(k) summary for the ORTHO SELECT Bone Plates and Screw System. It is a premarket notification, not a study report, so it does not contain the detailed data about an acceptance criteria study for a new AI or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, and performance characteristics.
Therefore, many of the requested categories for an AI or diagnostic device acceptance criteria study cannot be directly extracted from this document. However, I can still provide information based on what is available:
1. A table of acceptance criteria and the reported device performance
This document describes the ORTHO SELECT Bone Plates and Screw System, which is a traditional medical device (implants for fracture fixation), not an AI or diagnostic device. Therefore, the concept of "acceptance criteria" and "reported device performance" typically refers to the device's physical properties, mechanical strength, biocompatibility, and intended function matching those of predicate devices. These are usually established through compliance with recognized standards and testing, but the specific numerical criteria and results are not detailed in this 510(k) summary itself. The summary concludes that the device meets the performance requirements by being substantially equivalent to predicate devices.
| Acceptance Criteria Category (Implied for a Medical Implant) | Reported Device Performance (Summary Conclusion) |
|---|---|
| Mechanical Strength/Performance | "The basic features, design and intended uses... are similar or identical to those of the predicate devices. The minor differences in design and dimensions have no effect on the performance [or] function..." (Conclusion statement) |
| Biocompatibility | Implied through substantial equivalence to predicate devices made of stainless steel. |
| Sterilization Compatibility | "provided non-sterile for steam sterilization by user" (Device Description) - Implies compatibility with standard steam sterilization. |
| Intended Use | Matches the intended use of predicate devices for pelvic, small, and long bone fracture fixation in adult and pediatric patients (on mature bone only). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For traditional medical devices like bone plates and screws, "test set" would typically refer to mechanical testing, material testing, or potentially animal/cadaver studies. The details of such tests (sample sizes, specific protocols, and provenance) are generally found in the full submission, not the summary.
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 to this 510(k) summary. Ground truth and expert consensus are concepts primarily associated with the validation of AI/diagnostic algorithms or clinical trials where human assessment is a benchmark. For a bone plate and screw system, the "truth" is established by engineering principles, material science, and mechanical testing, not expert interpretation of data in the same way an AI model would be evaluated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this 510(k) summary. Adjudication methods are used in studies involving human interpretation (e.g., grading images, evaluating patient outcomes) where disagreements among readers need to be resolved.
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 to this 510(k) summary. MRMC studies and the concept of AI assistance are relevant for diagnostic or AI-powered devices, not for a bone plate and screw system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this 510(k) summary. "Standalone algorithm performance" refers to AI or software-only devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained above ("not applicable" for this type of device and submission, points 3 & 4), the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly relevant here. For a bone plate system, the "ground truth" for its performance would be derived from:
- Mechanical testing standards: e.g., ASTM standards for fatigue life, bending strength, torsional strength.
- Material specifications: Chemical composition, strength, and biocompatibility of stainless steel.
- Clinical history of predicate devices: The long-standing safe and effective use of similar designs and materials.
8. The sample size for the training set
This is not applicable to this 510(k) summary. "Training set" refers to data used to train machine learning models.
9. How the ground truth for the training set was established
This is not applicable to this 510(k) summary. See point 8.
§ 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.