(59 days)
The Proficient® Posterior Cervical Spine System is intended to immobilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies and degenerative disease of the facets with instability. The Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.
The modified Proficient® Posterior Cervical Spine System consists of a selection of non-sterile, single-use polyaxial screws, locking screws, rods, and connectors manufactured from titanium per ASTM F136 and ASTM F67 and cobalt-chrome alloys per ASTM F1537 and ASTM F1058. The rods, screws, and connectors are attached to the cervicothoracic spine of skeletally mature patients to stabilize the spine during fusion of vertebral bodies.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Proficient® Posterior Cervical Spine System." This document primarily focuses on establishing substantial equivalence to a predicate device based on material composition, design, and mechanical performance testing.
Crucially, this document does NOT describe the acceptance criteria or a study that proves the device meets the acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device.
The questions you've asked (about sample size, expert ground truth, MRMC studies, standalone performance, etc.) are highly relevant to the validation of AI/ML-driven medical devices, especially for image analysis or diagnostic support. However, this FDA submission pertains to a physical orthopedic implant, specifically a spinal fixation system. Its "performance data" refers to mechanical testing (e.g., dynamic axial compression bend testing, dynamic torsional testing, and axial grip testing) to ensure the physical device can withstand anticipated forces in the human body, not to the performance of an algorithm or diagnostic accuracy.
Therefore, I cannot extract the information requested from the provided text as it does not contain the type of study design and performance metrics relevant to an AI/ML medical device.
To answer your request, if this were an AI/ML medical device submission, the provided information would be insufficient. Based on the document, here's what can be inferred:
- Type of Device: Physical spinal implant (Proficient® Posterior Cervical Spine System).
- Purpose of Submission: To gain clearance for the addition of new components and a modification to instrumentation for an already cleared device.
- Key Clearance Mechanism: Substantial Equivalence to a predicate device (K172594 - Proficient® Posterior Cervical Spine System by Spine Wave, Inc.).
- Performance Data Mentioned: Dynamic axial compression bend testing, dynamic torsional testing, and axial grip testing. These are mechanical tests for the implant's structural integrity.
Therefore, a direct answer to your specific questions, as if this were an AI/ML device, cannot be provided from this document.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.