(179 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 provided text is a 510(k) summary for the PRECICE® BONE TRANSPORT™ System. It details the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not describe a study involving a comparison of the device's performance against detailed acceptance criteria using metrics such as sensitivity, specificity, or accuracy in a clinical or diagnostic context.
Instead, the document focuses on non-clinical performance verification testing to demonstrate functional substantial equivalence to a predicate device. Therefore, I cannot provide the information requested in the prompt as it pertains to a clinical efficacy study with acceptance criteria and reported device performance in terms of diagnostic or clinical metrics.
Here's a breakdown of why the requested information cannot be fully provided based on the given text:
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A table of acceptance criteria and the reported device performance:
- The document lists various non-clinical tests (Static Compression, Dynamic Compression Bending strength, Torsion, Torque Resistance, Axial Pullout, Biocompatibility, Sterilization, Package Distribution, Distraction Force Testing, Retention Force Testing, Fluid Ingress Testing, Biomechanical Axial Compression Testing).
- It also lists the applicable standards (e.g., ASTM F1264, ASTM F543, ISO 10993, ISO 11137).
- However, it does not provide specific numerical acceptance criteria for each test (e.g., "must withstand X N of force") nor does it report the actual numerical device performance results (e.g., "device withstood Y N of force"). It only states, "The results demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate device." This is a qualitative statement of equivalence, not a quantitative report against specific acceptance criteria.
- Crucially, these are engineering/mechanical/material performance criteria, not clinical diagnostic performance criteria.
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Sample size used for the test set and the data provenance: Not applicable. The tests are non-clinical, likely involving a certain number of device samples rather than patient data. The document does not specify the number of device samples or their "provenance."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no human "ground truth" establishment in these non-clinical engineering tests.
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Adjudication method: Not applicable for non-clinical engineering tests.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study is for evaluating human interpretation of diagnostic data, often with AI assistance. The device in question is an intramedullary fixation rod, not a diagnostic imaging AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
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The type of ground truth used: For the non-clinical tests, the "ground truth" would be established by the physical properties and performance characteristics dictated by the ASTM/ISO standards and internal design specifications. There's no clinical ground truth (like pathology or outcomes data) mentioned.
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The sample size for the training set: Not applicable. There is no AI model or training set described.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA 510(k) clearance document is for a physical medical device (intramedullary fixation rod) and details non-clinical engineering and material performance tests to establish substantial equivalence, not a clinical study involving AI or diagnostic performance metrics.
§ 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.