(60 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, screws and end caps are supplied sterile by gamma radiation while the 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 noninvasively 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.
This document is a 510(k) summary for the Precice® Bone Transport System. It refers to a medical device that recently underwent design modifications and is seeking clearance from the FDA. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove a device meets acceptance criteria.
Therefore, the information required to directly answer your request (acceptance criteria, device performance, sample sizes for test/training, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth specifics) is not available in this document.
Here's why and what information is present:
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Acceptance Criteria and Reported Device Performance: This document does not list specific acceptance criteria (e.g., target sensitivity, specificity, or accuracy) for a new algorithm or a device relying on complex performance metrics. Instead, it demonstrates the Precice® Bone Transport System's performance in terms of mechanical testing against relevant ASTM standards.
- Mechanical Performance Data (from the table provided):
- Static Compression Bending Strength: Tested against ASTM F1264.
- Dynamic Compression Bending Strength: Tested against ASTM F1264.
- Torsion: Tested against ASTM F1264.
- Torque Resistance: Tested against ASTM F543.
- Axial Pullout: Tested against ASTM F543.
- Retention Force Testing: N/A (Standard not specified)
- Distraction Force: N/A (Standard not specified)
- Reported Performance: The document states, "The results demonstrate that the subject Precice® Bone Transport System is substantially equivalent to the predicate." However, it does not provide numerical performance data for these tests. It simply confirms the equivalence.
- Mechanical Performance Data (from the table provided):
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Sample sizes used for the test set and the data provenance: Not applicable. This document describes mechanical testing, not a clinical study involving a test set of patient data.
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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. Ground truth as typically defined for AI/diagnostic devices (e.g., by experts interpreting images) is not relevant to this mechanical device submission.
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Adjudication method: Not applicable.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a physical intramedullary fixation rod, not an AI or diagnostic tool that would involve human readers.
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Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an algorithm.
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Type of ground truth used: Not applicable in the context of expert consensus or pathology. The "ground truth" for the mechanical testing would be defined by the specifications and tolerances within the cited ASTM standards.
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Sample size for the training set: Not applicable. This refers to machine learning, which is not described here.
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How the ground truth for the training set was established: Not applicable.
In summary, this FDA submission focuses on showing that a modified physical device is as safe and effective as its predecessor through mechanical testing, rather than presenting a performance study for an AI or diagnostic software product.
§ 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.