(204 days)
The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.
The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.
This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Magnetically Induced Displacement Force (ASTM F2052) | The devices were tested and found to be MR conditional. (Specific force values or thresholds are not provided in this summary, but the conclusion states conditional MRI safety was established). |
| Magnetically Induced Torque (ASTM F2213) | The devices were tested and found to be MR conditional. (Specific torque values or thresholds are not provided in this summary, but the conclusion states conditional MRI safety was established). |
| RF-induced Heating (ASTM F2182) | The devices were tested and found to be MR conditional. (Specific temperature increases or thresholds are not provided in this summary, but the conclusion states conditional MRI safety was established). |
| Image Artifact (ASTM F2119) | The devices were tested and found to be MR conditional. (Specific artifact sizes or impacts are not provided in this summary, but the conclusion states conditional MRI safety was established). |
| Overall MR Compatibility (per ASTM F2503 and FDA Guidance) | The completed MR compatibility testing establishes the conditional safety and compatibility of the passive implant devices in the MR environment, and supports the addition of MR Conditional labeling. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
- Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.
4. Adjudication Method for the Test Set
- Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.
8. The Sample Size for the Training Set
- Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
§ 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.