(192 days)
The PRECICE® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The PRECICE® Bone Transport System includes the PRECICE® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Bone Transport nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The PRECICE® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models. The purpose of this submission is to introduce additional compatible locking screws to the system.
This FDA 510(k) premarket notification (K193016) is for the PRECICE® Bone Transport System. This device is an intramedullary fixation rod used for limb lengthening, fracture fixation, and bone transport.
The document describes performance data for the device, but it does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner of a clinical or AI-driven diagnostic study. Instead, it focuses on nonclinical performance verification testing to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context as this is an evaluation of a physical medical device, not a diagnostic algorithm or AI.
However, I can extract the relevant information regarding the performance data that was provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, the "acceptance criteria" presented here is based on demonstration of substantial equivalence to the predicate device through performance testing. The reported device performance is that the "results demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate."
| Testing Description | Applicable Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Static Compression Bending Strength | ASTM F1264 | Performance comparable to predicate device | Substantially equivalent to predicate |
| Dynamic Compression Bending Strength | ASTM F1264 | Performance comparable to predicate device | Substantially equivalent to predicate |
| Torsion | ASTM F1264 | Performance comparable to predicate device | Substantially equivalent to predicate |
| Torque Resistance | ASTM F543 (for locking screws) | Performance comparable to predicate device/standard requirements | Substantially equivalent to predicate |
| Axial Pullout | ASTM F543 (for locking screws) | Performance comparable to predicate device/standard requirements | Substantially equivalent to predicate |
| Distraction Force | N/A (likely internal test method with reference to predicate) | Performance comparable to predicate device | Substantially equivalent to predicate |
2. Sample size used for the test set and the data provenance
This section is not applicable as the evaluation is based on nonclinical engineering performance testing (e.g., mechanical tests on physical parts), not a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. Ground truth, in the context of this device, would be established by validated engineering methodologies and potentially comparison to the predicate device's established performance.
4. Adjudication method for the test set
This section is not applicable. Mechanical testing results are objective measurements, not subject to expert adjudication.
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 section is not applicable as this is not an AI-driven diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as this is not an AI-driven diagnostic device.
7. The type of ground truth used
The "ground truth" for this device's performance testing is established through industry standards (ASTM F1264, ASTM F543) and inherent performance characteristics of the predicate device. The testing aims to show that the new device's mechanical properties meet relevant standards and are comparable to those of the already cleared predicate device.
8. The sample size for the training set
This section is not applicable as this is not an AI-driven device requiring a training set.
9. How the ground truth for the training set was established
This section is not applicable as this is not an AI-driven device.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.