(347 days)
GPC Variable Angle Locking Two Column Volar Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. The system is indicated for use in adult patients only. All implants are for single use only.
GPC Variable Angle Locking Two Column Volar Distal Radius Plates are machined metal plates designed for fixation of various fracture modes of the distal portion of the Variable Angle Locking Two Column Volar Distal Radius Plates allow fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. The variable angle locking mechanism improves the plate-screw construct stability. GPC Variable Angle Locking Two Column Volar Distal Radius Plates are manufactured using titanium material for surgical implant applications.
Following are the types of the GPC Variable Angle Locking Two Column Volar Distal Radius Plates:
- Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 22 mm, 6 Head Holes (with option of Left and Right Variants)
- Variable Angle Locking Two-Column Volar Distal Radius Plate, Width 25.5 mm, 7 Head Holes (with option of left and right variants)
- Variable Angle Locking Two Column Volar Distal Radius Plate- Narrow, Width 19.5 mm, 6 Head Holes (with option of left and right variants)
Corresponding Screws for fixation:
- Variable Angle Locking Screw 2.4 mm, Star drive Lengths: 6mm to 30mm in 2mm increments
- FixLOCK Self-Tapping Screw 2.4 mm, Star drive Length 6mm to 30mm in 2mm increments
- Self-Tapping Cortex Screw 2.7 mm, Star drive Length: 12mm to 24mm
These implants are supplied non-sterile, the products have to be sterilized prior to use.
The provided document describes a 510(k) premarket notification for the GPC 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plates. This notification aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information provided focuses on the comparison to the predicate device and non-clinical testing against established standards, not on a study proving the device meets specific acceptance criteria in a clinical context with human users or AI.
However, based on the provided text, we can extract details related to the "device performance" as demonstrated through non-clinical testing.
Here's an analysis based on the information provided, framed as if the non-clinical tests are the acceptance criteria for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for the mechanical tests. Instead, it states that the device "Conforms" to the specified ASTM standards, implying successful performance according to the methodology and requirements of those standards.
| Acceptance Criteria (Implied by standard conformance) | Reported Device Performance |
|---|---|
| For Plates (ASTM F382): | |
| Static Four Point Bend Test | Conforms |
| Bending Fatigue Properties | Conforms |
| For Bone Screws (ASTM F543): | |
| Torsional Properties | Conforms |
| Driving Torque | Conforms |
| Pull-out Test | Conforms |
| General Characteristics compared to predicate: | |
| Regulatory Classification | Equivalent (Same Classification and Regulation Number) |
| Indications for use | Equivalent (Similar intended use) |
| Material | Equivalent (Both use material for surgical implant application) |
| Performance Standards | Equivalent (Same performance standards) |
| Sterilization | Equivalent (Same method of sterilization) |
| Dimensional Verification | Equivalent (Similar dimensions, minor differences raise no safety concerns) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the sample size (number of plates or screws) used for each mechanical test.
- Data Provenance: The tests are non-clinical, conducted by the manufacturer, GPC Medical Ltd. The country of origin of the data would be India, where the manufacturer is located. The tests are prospective in the sense that they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided context as the "ground truth" here is established by engineering standards and direct physical measurement of mechanical properties, not by human expert interpretation. There were no human readers or expert consensus involved in determining if the device "conforms" to a bending fatigue test.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies with expert reviewers establishing ground truth, which is not the case here. The "adjudication" for mechanical tests involves comparing measured values against specified thresholds within the ASTM standards.
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 question is not applicable. The device is a physical medical implant (bone plate and screws), not an AI software/algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable, as the device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" is defined by the specifications and methodologies of the applicable ASTM standards (ASTM F382 for plates and ASTM F543 for screws). The device's performance is compared directly against these engineering standards. For the comparison of characteristics, the "ground truth" is the specifications and characteristics of the identified predicate devices.
8. The sample size for the training set
This question is not applicable. This is a medical implant, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable, as the device is not a machine learning model.
§ 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.