(154 days)
The Picasso MIS Spinal System 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 the thoracic, lumbar and sacral spine. And the Picasso MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation.
The Picasso MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the Picasso MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
Picasso MIS Spinal System consists of cannulated polyaxial screw, straight and curved rod, Cross-link and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile.
Acceptance Criteria and Study for Picasso MIS Spinal System
The Picasso MIS Spinal System is a medical device, specifically a pedicle screw spinal system, designed to provide immobilization and stabilization of spinal segments. For such devices, acceptance criteria are typically based on mechanical performance to ensure the device can withstand the physiological loads it will experience in the human body. The provided document details a study demonstrating the device's compliance with these mechanical acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Standard | Reported Device Performance |
|---|---|---|
| Static Compression Bending | ASTM F1717 | Performed as well as the predicate device |
| Tension | ASTM F1717 | Performed as well as the predicate device |
| Dynamic Compression Bending | ASTM F1717 | Performed as well as the predicate device |
Note: The document states "Performed as well as the predicate device." This implies that the Picasso MIS Spinal System met or exceeded the established mechanical performance benchmarks derived from the predicate device under these specific ASTM F1717 tests. The exact numerical values for these benchmarks and the device's performance are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The study described is a mechanical performance study, not a clinical study involving human or biological samples. Therefore, the concept of "sample size used for the test set" typically refers to the number of device constructs tested. The document specifies that the tests were performed "on a worst-case, screw construct." This suggests that at least one, and likely several, of the most challenging configurations of the device (e.g., specific screw diameter, length, and rod dimensions) were subjected to these mechanical tests.
Data Provenance: This is a pre-clinical, in-vitro study, meaning it was conducted in a laboratory setting using physical specimens of the device, not on humans. Therefore, there is no country of origin for clinical data, nor is it retrospective or prospective in the clinical sense. The data is generated directly from mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This being a mechanical performance study, the ground truth is established by the ASTM F1717 standard, which outlines the specific testing methodologies and criteria for pedicle screw systems. The "experts" in this context are the standardization bodies and engineers who developed and validated the ASTM F1717 standard itself. No additional external experts are typically used to establish a subjective "ground truth" for each specific test sample in such a study, as the test parameters are objective and defined by the standard.
4. Adjudication Method for the Test Set
Not applicable for a mechanical performance study. The outcome of each test (e.g., failure load, fatigue life) is a direct, measurable result, not subject to individual interpretation or adjudication by multiple parties in the same way clinical outcomes would be. The raw data from the testing equipment is the primary record.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the clinical performance or diagnostic accuracy of algorithms or imaging devices where human interpretation is involved. The Picasso MIS Spinal System is a physical implant, and its performance is assessed through mechanical testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This term typically refers to the evaluation of AI algorithms. The Picasso MIS Spinal System is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used in this study is objective mechanical performance data as defined by the ASTM F1717 standard. This standard specifies how pedicle screw systems should be tested for static and dynamic strength and provides guidelines for their acceptance. The performance of the Picasso MIS Spinal System was compared against the performance of a predicate device under these standardized test conditions.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is a mechanical engineering study, not an AI or machine learning study.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no corresponding ground truth for it.
§ 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.