(263 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.
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 and VERTEX Reconstruction 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 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 sole purpose for this traditional 510(k) is to seek clearance for the INFINTIY OCT System.
This document is a 510(k) Pre-market Notification for the INFINITY™ OCT System. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical context with performance metrics like accuracy, sensitivity, or specificity.
Therefore, much of the requested information about acceptance criteria for device performance in terms of diagnostic effectiveness or AI model performance, and the details of such a study, cannot be extracted from this document, as it describes a mechanical spinal implant system, not a diagnostic or AI-driven device.
However, I can extract information related to the non-clinical (mechanical) testing performed to demonstrate substantial equivalence.
Here's the information that can be extracted from the provided text, primarily related to the mechanical performance of the INFINITY™ OCT System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Mechanical Testing) | Reported Device Performance |
|---|---|
| Meet requirements of ASTM F1717 for Spinal Implant Constructs in a Vertebrectomy Model (Static Compression Bending, Static Torsion Testing, Dynamic Compression Bending, Dynamic Torsion Testing) | "The mechanical testing verifies that the subject components are substantially equivalent to the predicate spinal system currently on the market and has met all mechanical testing requirements based on the worst case construct testing." |
| Meet requirements of ASTM F2706 for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model (Static Compression Bending, Static Torsion Testing, Dynamic Compression Bending, Dynamic Torsion Testing) | "The mechanical testing verifies that the subject components are substantially equivalent to the predicate spinal system currently on the market and has met all mechanical testing requirements based on the worst case construct testing." |
| Bacterial endotoxin limit of 20 endotoxin units (EU)/device as per ANSI/AAMI ST72 and USP | "Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted." |
2. Sample size used for the test set and the data provenance:
- Mechanical Testing: Not explicitly stated beyond "worst case construct testing." The number of constructs tested or the specific types of components within those constructs are not detailed.
- Non-Pyrogenicity Endotoxin Testing: "utilizing worst case subject implants." The specific number is not provided.
- Data Provenance: The tests were conducted internally by Medtronic, likely in a laboratory setting, to evaluate the mechanical properties and biocompatibility of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the studies described are non-clinical mechanical and biological compatibility tests, not studies requiring expert interpretation of clinical data or imaging.
4. Adjudication method for the test set:
- Not applicable for mechanical and biological compatibility tests. Results are quantitative measurements against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document pertains to a mechanical spinal implant system, not an AI-assisted diagnostic or imaging interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used:
- Mechanical Testing: The "ground truth" is defined by the performance requirements and methodologies outlined in accepted ASTM standards (ASTM F1717 and ASTM F2706) for spinal implant constructs. The device's performance is compared against these engineering specifications and the performance of predicate devices.
- Non-Pyrogenicity Endotoxin Testing: The "ground truth" is the established limit of 20 EU/device for bacterial endotoxins in medical devices, as specified by ANSI/AAMI ST72 and USP .
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.
Summary of what the document does provide regarding "proof":
The document, a 510(k) summary, demonstrates substantial equivalence to existing legally marketed spinal systems. The "study" described is a series of non-clinical, laboratory-based mechanical and biocompatibility tests. These tests were conducted to show that the INFINITY™ OCT System performs comparably to its predicate devices and meets established industry standards for safety and mechanical integrity. The "acceptance criteria" here are compliance with these standards (ASTM and ANSI/AAMI/USP for pyrogenicity).
§ 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.