(122 days)
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the Presidio Surgical Viking Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis), (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).
The Presidio Surgical Viking Lumbar Polyaxial Screw System is a polyaxial pedicle screw system with straight or precontoured crosslink to provide optimal supporting structure for the spinal bodies. The pedicle screw system is a surgically implantable device which is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine. This premarket notification is to add a new crosslink design to the pedicle screw system that was previously cleared.
This document is a 510(k) premarket notification for a medical device, specifically a "Viking Lumbar Polyaxial Screw System." It seeks to demonstrate substantial equivalence to previously cleared devices. The document explicitly states that this premarket notification is to add a new crosslink design to the pedicle screw system that was previously cleared. This means the device in question is a surgical implant for spinal stabilization, not an AI/Software as a Medical Device (SaMD).
Therefore, the requested information regarding "acceptance criteria" related to device performance in diagnosis or treatment, "study that proves the device meets the acceptance criteria" in terms of AI performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this type of device and submission.
The "performance testing" described in the document is mechanical testing to demonstrate the structural integrity of the spinal implant.
Here's the relevant information that can be extracted from the provided text, adapted to the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Mechanical Testing) | Reported Device Performance |
|---|---|
| Mechanical strength adequate for intended use (presumably defined by ASTM F1717 standards) | "confirmatory mechanical testing to demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use." |
2. Sample size used for the test set and the data provenance
- Test Set (for mechanical testing): Not explicitly stated in the provided text. It refers to "confirmatory mechanical testing," which implies testing a certain number of devices or components.
- Data Provenance: Not applicable in the context of human data. The testing is described as mechanical testing of the physical implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a mechanical device, not an AI/SaMD requiring expert ground truth for diagnostic or prognostic performance. The "ground truth" for mechanical testing would be defined by engineering specifications and standards (e.g., ASTM F1717).
4. Adjudication method for the test set
- Not Applicable. Mechanical testing results are typically evaluated against predefined engineering specifications, not through human adjudication.
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 is a mechanical spinal implant, not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical spinal implant.
7. The type of ground truth used
- Mechanical Integrity/Performance Standards: The "ground truth" for this device's performance would be compliance with mechanical testing standards (e.g., ASTM F1717 dynamic compression bending) and engineering specifications to ensure structural adequacy for its intended surgical use.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this mechanical device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this mechanical device.
In summary: The provided document describes a mechanical spinal implant attempting to gain market clearance through the 510(k) pathway by demonstrating substantial equivalence to predicate devices. The "performance testing" involved is physical, mechanical testing of the device's components (specifically a new crosslink design) against established engineering standards like ASTM F1717. The concepts of AI performance metrics, test/training sets of patient data, expert readers, and ground truth in the context of AI/SaMD are not relevant to this submission.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.