(30 days)
The Infinity™ OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:
- Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- · Failed previous fusions (e.g. pseudarthrosis).
- · Tumors involving the cervical spine.
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The Infinity™ OCT 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 in whom life expectancy is of insufficient duration to permit achievement of fusion.
The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System and PASS OCT Spinal System package insert for a list of the indications of use.
Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.
The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.
Note: Segmental fixation is recommended for these constructs.
The PASS OCT® Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, 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 PASS OCT® Spinal System is 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. In order to achieve additional levels of fixation, the PASS OCT® Spinal System may be linked to the PASS LP® Spinal System using the dual diameter rods or specific connecting components.
The PASS OCT® Patient Specific Rod is to be implanted either with PASS OCT® Spinal System or with Infinity (1) OCT Spinal System.
The purpose of this submission is to expand the use of previously cleared Infinity™ OCT System with previously cleared PASS OCT® Patient Specific UNiD OCT Rods.
The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.
The Infinity™ OCT System is fabricated from medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.
The PASS OCT® Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations.
The implants are manufactured in titanium alloy Ti-6A1-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, Grade Titanium conforming to ASTM F67 and ISO 5832-2, Cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO 5832-12 and ASTM F1537 and in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications.
The PASS OCT® Patient Specific Rod has been designed and manufactured for one specific patient. The PASS OCT® Patient Specific Rod should be used during surgery for this patient only and should not be reused (single use only).
The provided text describes a 510(k) submission for the Medtronic Infinity™ OCT System and PASS OCT® Spinal System, specifically for an expansion of use involving Patient Specific UNiD OCT Rods. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria for performance in terms of diagnostic accuracy or a similar measure, as would be the case for an AI/ML medical device.
Therefore, the requested information regarding acceptance criteria, study design for proving device performance (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets), is not applicable to this type of regulatory submission (a 510(k) for a spinal implant system).
A 510(k) submission for a traditional medical device like a spinal implant typically relies on:
- Bench Testing: Mechanical and material testing to ensure the device meets predefined mechanical properties and safety standards (e.g., strength, fatigue, corrosion resistance).
- Biocompatibility Testing: To ensure the materials are safe for human implantation.
- Comparison to Predicate Devices: Demonstrating that the new device has similar technological characteristics and performs as safely and effectively as a legally marketed predicate device.
In this specific case, the "performance data" section (VI) states:
- "Rationales were provided confirming that the use of the PASS OCT® System Patient Specific UNiD OCT Rods did not introduce a new worst case when used with the Infinity™ OCT System."
- "However, confirmatory testing (static and dynamic compression bending and static and dynamic torsion per ASTM F1717) performed met the pre-determined acceptance criteria."
This indicates that the "acceptance criteria" here refer to the mechanical performance standards for spinal implants, as defined by industry standards like ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model). The study conducted was a bench test to confirm that the mechanical properties of the combined system (Infinity™ OCT System with Patient Specific UNiD OCT Rods) meet these engineering standards.
Therefore, I cannot extract the information asked for in the prompt (related to AI/ML device performance study) from this document. The document does not describe an AI/ML device or a study involving human readers, expert consensus for imaging interpretation, or similar elements.
If you would like me to discuss the "acceptance criteria" and "study" in the context of a traditional medical device 510(k) submission based on mechanical testing, please let me know.
§ 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.