(126 days)
The Precice® System (inclusive of Precice, Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions or bone transport of long bones.
The Precice® Plating System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.
The Precice® Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.
The fourth generation External Remote Controller ERC 4P is a portable hand-held system used to non-invasively distract or retract the Precice System Family implants. The ERC 4P device has a touch screen interface, ergonomic design, a single magnet, and implant detection features that provide feedback to the user on the status of the coupling of the implant with the ERC 4P. It can be operated either cordlessly through a rechargeable battery or with a power cord. When the ERC 4P magnet begins to rotate, it induces a magnetic field which rotates an internal magnet attached to a lead screw in the implanted nail/plate, which then either distracts or retracts accordingly. The ERC 4P has a touch screen interface, as well as a hard button for the user's modes of interaction.
The provided text is a 510(k) summary for the NuVasive Specialized Orthopedics, Inc. External Remote Controller ERC 4P device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, study design, or performance metrics typically associated with studies proving a device meets specific performance criteria, especially in the context of AI-driven medical devices that involve image analysis or diagnostic support.
The document primarily focuses on regulatory approval, establishing substantial equivalence for an orthopedic device controller based on its engineering characteristics and safety standards (Electrical Safety, EMC, Magnet Safety, Usability, Labeling Readability). It details the type of device (a remote controller for limb lengthening/fixation implants), its function (non-invasively distract or retract implants), and general safety testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance: This information is not present in the document. The document lists "Usability Study" as a test but provides no details on its methodology, acceptance criteria, or results.
- Sample sizes used for the test set and data provenance: No such data is mentioned.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as this device does not involve image analysis or diagnostic ground truth establishment by medical experts in the way an AI diagnostic tool would.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Stand-alone performance: Not relevant in the context of how this device's performance is assessed.
- Type of ground truth used: Not applicable.
- Sample size for training set and how ground truth was established: Not applicable, as this device is not a machine learning/AI model.
In summary, the provided document is a regulatory submission for a medical device that does not involve artificial intelligence, image analysis, or complex diagnostic performance evaluation as per your request's focus. The "performance data" referred to in the document pertains to electrical safety, electromagnetic compatibility, and magnet safety, rather than diagnostic accuracy or human-AI interaction in a diagnostic context.
§ 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.