(102 days)
The DePuy Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The DePuy Synthes Titanium 2.4 mm Universal Locking Plates (12. 13 and 20 hole) are indicated for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum and promote fusion.
Contraindication: The DePuy Synthes Titanium 2.4 mm Universal Locking Plates are contraindicated for use in acute cardiac patients.
The DePuy Synthes MatrixRIB Fixation System is indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation, where:
DePuy Synthes MatrixRIB pre-contoured plates are indicated for the fixation, stabilization and reconstruction of:
- · Rib fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
- · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
DePuy Synthes MatrixRIB straight plates are indicated for the fixation, stabilization and reconstruction of:
- · Rib and sternum fractures, fusions, osteotomies, and/or resections, including spanning gaps and/or defects
- · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
DePuy Synthes MatrixRIB sternal plates, 2.8mm thickness, are indicated for the fixation, stabilization and reconstruction of:
- · Sternum fractures, fusions, and/or osteotomies
- · Pectus Excavatum, Pectus Carinatum, and other chest wall deformities
The DePuy Synthes MatrixRIB intramedullary splints and the universal plate are indicated for the fixation and stabilization of ribs.
Contraindications:
The MatrixRIB Fixation System is contraindicated for:
- · The fixation of the sternum in acute cardiac patients, due to the potential delay if emergent re-entry is required
- · Screw attachment or fixation to the clavicle or spine
- · Use in patients with latent or active infection, with sepsis, or who are unwilling or incapable of following postoperative care instructions.
The DePuy Synthes Sternal Fixation System consists of machined titanium plates, a quickrelease pin and 3.0 mm locking screws. The plates utilize screw fixation to create the construct.
The proposed additions to the MatrixRlB Fixation System include sternal plates (straight plates, I-plates and T-plates) for fixation and reconstruction of the chest wall manufactured from commercially pure titanium (CP Ti Grade 4).
The previously cleared devices in the MatrixRlB Fixation System (K133616 and K081623) include locking plates, locking screws, and intramedullary splints for the fixation and stabilization of the chest wall for use in patients with normal or osteoporotic bone quality. These implants are available in multiple sizes and are manufactured from titanium alloy (Ti-6A-7Nb).
The MatrixRIB Self-Drilling Screws (K190409) are available as locking screws, for permanent fixation, and non-locking screws, for temporary fixation only. The screws are provided in a range of lengths - locking screws: 13 lengths from 8mm to 20mm, with 1mm increments - and non-locking screws: 2 lengths from 10mm to 12 mm, with 2 mm increments. The major diameter of the bone thread is 2.7 mm, and all of the screws are manufactured from Titanium Alloy (Ti-6Al-7Nb).
The provided text describes the acceptance criteria and performance testing for two medical devices: the DePuy Synthes Sternal Fixation System - MR Conditional and the DePuy Synthes MatrixRIB Fixation System - MR Conditional. Both submissions aim to add MR Conditional information to existing device labeling, without changing the intended use or technological characteristics of the devices themselves.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the standard tests performed to demonstrate MR Conditional safety. The reported device performance is that the devices meet these standards.
| Acceptance Criteria (Standard Test) | Reported Device Performance |
|---|---|
| Magnetically Induced Displacement Force (ASTM F2052-14) | Devices meet the requirements for magnetically induced displacement force, indicating safe movement in the MR environment under specified conditions. |
| Magnetically Induced Torque (ASTM F2213-06) | Devices meet the requirements for magnetically induced torque, indicating safe rotational forces in the MR environment under specified conditions. |
| Radio Frequency (RF) Heating (ASTM F2182-11a) | Devices meet the requirements for RF heating. The DUKE model was used to place devices in a clinically relevant anatomic position, and the results will be used for labeling of RF heating, implying the heating generated is within safe limits for MR Conditional use. |
| Magnetic Resonance (MR) Image Artifacts (ASTM F2119-07) | Devices meet the requirements for image artifacts, indicating that the artifacts generated in the MR environment are acceptable and permit diagnostic imaging. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The provided text only mentions "non-clinical testing" and does not specify a sample size for a "test set" in the context of patient data. The tests are for the device itself (e.g., individual plates, screws) to assess its physical and magnetic properties. Therefore, the "sample size" would refer to the number of device components tested, which is not provided.
The data provenance is from non-clinical testing, meaning it's laboratory-based testing of the physical device components, not human patient data. There is no information regarding country of origin or whether it's retrospective or prospective, as these are typically applicable to clinical studies.
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. The ground truth for these tests is defined by the standards themselves (ASTM F2052-14, F2213-06, F2182-11a, F2119-07). The performance of the device against these standards is measured by engineers or technicians, not by medical experts establishing a clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. The testing described is objective, quantifiable physical testing against established international standards. There is no subjective interpretation or adjudication by multiple evaluators.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is non-clinical performance testing of the device's compatibility with an MR environment, not an evaluation of human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This submission is for physical medical devices (sternal and MatrixRIB fixation systems), not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is based on established independent engineering and safety standards (ASTM standards) for evaluating medical devices in Magnetic Resonance (MR) environments. These standards define the acceptable limits for magnetic displacement, torque, RF heating, and image artifacts.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is non-clinical physical testing of a medical device, not a machine learning model.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set. The "ground truth" for the device's MR compatibility is established by adherence to recognized ASTM standards.
§ 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.