(51 days)
Pangea Platform:
The Pangea Platform is indicated for the internal fixation and stabilization of bone fractures, osteotomies, and arthrodesis in normal and osteopenic bone, including:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- Non-unions, malunions, and deformities
- Periprosthetic fractures
The Pangea Platform is also indicated for children (2-12 years) and adolescents (12 - 21 years) for the internal fixation and stabilization of bone fractures of the diaphysis in which growth plates have fused or in which growth plates will not be crossed by implants.
Pangea Femur Plating System:
The Pangea Femur Plating System is indicated for the internal fixation and stabilization of femur bone fractures and osteotomies in normal and osteopenic bone, including:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- Non-unions, malunions, and deformities
- Periprosthetic fractures
Pangea Tibia Plating System:
The Pangea Tibia Plating System is indicated for the internal fixation and stabilization of tibia bone fractures and osteotomies in normal and osteopenic bone, including:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- Non-unions, malunions, and deformities
- Periprosthetic fractures
Pangea Humerus Plating System:
The Pangea Humerus Plating System is indicated for the internal fixation and stabilization of humerus bone fractures and osteotomies in normal and osteopenic bone, including:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- Non-unions, malunions, and deformities
- Periprosthetic fractures
This traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the new devices of the Pangea Platform, Pangea Femur Plating System, Pangea Humerus Plating System, and Pangea Tibia Plating System. This line extension consists of Class II instruments intended to assist in targeting.
The provided text describes a 510(k) premarket notification for the Stryker Pangea Platform and related plating systems. This document outlines the regulatory review and clearance of a medical device based on substantial equivalence to a predicate device, rather than a study demonstrating the device meets acceptance criteria through its own performance evaluation.
Specifically, the text states for "Performance Data":
- Non-Clinical Performance: "The new subject devices... are reusable and provided non-sterile. Comparative assessment to the predicate and reference systems demonstrated substantial equivalence. Testing was performed on the subject devices to verify that the T20 and T15 targeting construct can withstand typical physical loads during its use using functional aging. A biocompatibility safety evaluation was performed per ISO 10993-1 to support the verification of biological safety."
- Clinical Performance: "Clinical data was not needed for the subject devices to demonstrate substantial equivalence to the predicate devices."
The conclusion is that "The subject devices have identical intended use and indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using same materials and processes as the predicate devices. The performance analyses demonstrate that: Any differences do not raise new questions of safety and effectiveness; and The subject devices are at least as safe and effective as the legally marketed predicate devices."
Therefore, the document does not present a study with acceptance criteria and reported device performance in the way typically expected for a new AI/software device or a device requiring new clinical efficacy data. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
Given this, I cannot extract most of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets, as this type of information is not present in the provided 510(k) summary for this particular device submission.
I will, however, attempt to fill in what information can be inferred or directly stated from the text in relation to the non-clinical performance and the basis for clearance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence and Non-Clinical Testing) | Reported Device Performance (Inferred from Substantial Equivalence and Non-Clinical Testing) |
|---|---|
| Material/Design equivalence to predicate devices | Subject devices are identical in intended use, indications for use, operating principle, basic design, labeling, materials, and processes to predicate devices. |
| Mechanical integrity during typical physical loads | The T20 and T15 targeting construct can withstand typical physical loads during use, as verified by functional aging testing. |
| Biocompatibility safety | A biocompatibility safety evaluation performed per ISO 10993-1 supports biological safety. |
| No new questions of safety and effectiveness compared to predicate | Performance analyses demonstrate no new questions of safety and effectiveness caused by any differences. |
| At least as safe and effective as legally marketed predicate devices | Performance analyses demonstrate the subject devices are at least as safe and effective. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in the provided text. The non-clinical testing mentioned "functional aging" but did not specify the number of units or cycles.
- Data Provenance: Not specified. The testing was non-clinical.
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)
- Not applicable as no clinical or human-expert-based ground truth was established for this submission. The evaluation was primarily based on engineering and biocompatibility testing, and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of submission.
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. The device described is a metallic bone fixation appliance and accessories, not an AI or imaging diagnostic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) clearance is primarily based on compliance with established engineering standards (e.g., for mechanical load and biocompatibility) and the demonstrated "substantial equivalence" to legally marketed predicate devices, which are assumed to be safe and effective.
8. The sample size for the training set
- Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI/machine learning device.
§ 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.