(39 days)
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 radios, 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 connected to the PASS LP Spinal System rods with the dual diameter rods or dominos. Refer to the PASS LP Spinal System package insert for a list of the PASS LP Spinal System indications of use.
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. See package insert of the system for labeling limitations.
The implants are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications and in cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537 specifications, and also CP Titanium according to ASTM F67 and ISO 5832-2 specifications.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the PASS OCT Spinal System:
The provided document is a 510(k) summary for additional components to the PASS OCT Spinal System. It does not contain information about the acceptance criteria for the device's clinical performance, nor does it detail a study that proves the device meets specific clinical performance acceptance criteria. This document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, materials, and mechanical performance.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The document describes the system components and their intended use, but it does not specify quantitative clinical acceptance criteria (e.g., success rates, complication rates, or functional outcomes) or report on specific clinical performance against such criteria. The document explicitly states: "No clinical data or published literature were used to demonstrate substantial equivalence."
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document states "No clinical data or published literature were used to demonstrate substantial equivalence." Therefore, there was no clinical test set for which a sample size or data provenance would be reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. As no clinical study or test set data was used, no experts were needed to establish ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided. No clinical test set.
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/Not provided. This device is a spinal implant system, not an AI-driven diagnostic or assistive device for human readers. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a spinal implant system, not an algorithm or software-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. As no clinical data was used to demonstrate substantial equivalence, there was no ground truth established for this submission. The "truth" for this submission hinges on demonstrating substantial equivalence to predicate devices through comparison of design, materials, and mechanical testing, rather than clinical outcomes.
8. The sample size for the training set
The document refers to mechanical testing as a "Non-clinical Test Summary." It mentions that "The components of the PASS OCT spinal were mechanically evaluated in static and dynamic compression and static torsion tests following the ASTM F2706-08."
- Training Set Sample Size: The sample size for this non-clinical testing is not specified in the provided text.
- How ground truth for training set was established: The "ground truth" for non-clinical mechanical testing would be the compliance with pre-defined engineering and material standards (e.g., ASTM F2706-08 for mechanical properties, ISO and ASTM standards for material specifications). This is established by engineering and materials science principles and testing procedures.
9. How the ground truth for the training set was established
For the non-clinical tests, the "ground truth" is established by the specified ASTM and ISO standards for mechanical testing and material properties. The device components are tested to confirm they meet the strength, durability, and material composition requirements outlined in these recognized standards, which are considered objective measures of performance for this type of device.
§ 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.