(280 days)
The NOVA Minimally Invasive System is intended to provide immobilization 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:
- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
- Spondylolisthesis,
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis,
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor,
- Pseudoarthrosis, and
- Failed previouis fusion
The NOVA Minimally Invasive System consists of cannulated polyaxial screws, straight and pre-bent rods, and set screws. The components are manufactured from titanium alloy per ASTM F136. The screws range in diameter from 5.5 mm to 7.0 mm and in length from 20 mm to 70 mm. The implants are not compatible with components or metal from any other manufacturer's system. The NOVA Minimally Invasive System can be used for both percutaneous and mini-open surgerv.
The provided document (K182416) is a 510(k) summary for the NOVA Minimally Invasive System, a thoracolumbosacral pedicle screw system. It focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical performance testing.
This document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth for a test set or training set for an AI/algorithm. The performance testing described is purely mechanical, comparing the device's physical properties to established standards and a predicate device.
Therefore, for most of your requested information (related to AI performance, human readers, ground truth, sample sizes for test/training sets, and expert qualifications/adjudication), the provided document does not contain the answer.
Here's the information that is available:
1. A table of acceptance criteria and the reported device performance
The document states: "The following tests were performed on the subject components per ASTM F1717: static compression bending, static torsion, and dynamic compression bending. Results of these mechanical tests demonstrate substantially equivalent mechanical performance to predicate devices."
As specific acceptance criteria (e.g., "must withstand X N of force") and exact reported performance values are not detailed in this summary, the table below provides a generalized summary based on the provided text.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Compression Bending (per ASTM F1717) | Substantially equivalent mechanical performance to predicate devices. | Demonstrates substantially equivalent mechanical performance to predicate devices. |
| Static Torsion (per ASTM F1717) | Substantially equivalent mechanical performance to predicate devices. | Demonstrates substantially equivalent mechanical performance to predicate devices. |
| Dynamic Compression Bending (per ASTM F1717) | Substantially equivalent mechanical performance to predicate devices. | Demonstrates substantially equivalent mechanical performance to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The testing was mechanical, not on human subjects or clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a pedicle screw system, and the testing was mechanical. There was no "ground truth" to be established by experts in a clinical context within this submission summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was mechanical testing, not a clinical study requiring 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
No. This is a pedicle screw system, and the submission does not mention any AI component or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device (pedicle screw system), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical testing is typically defined by engineering specifications and material properties, against which the device's performance is measured. It's not a clinical "ground truth."
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/algorithm device submission.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set as this is not an AI/algorithm device 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.