(75 days)
The Picasso II MIS Spinal System is intended to provide immobilization 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 II MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso II 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); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the Picasso II 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, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
The Picasso II MIS Spinal System is comprised of percutaneous cannulated poly axial screws, a set screw and rods designed to allow for minimally invasive surgery. The screw diameters are 5.5mm, 6.5mm and 7.5mm. The screw length ranges from 30mm in 5mm increments.
The Picasso II system will utilize Ø6.0mm MIS rods. Straight and curved rods are provided with the subiect system. Straight rods are available in 35mm-600mm lengths, and curved rods are available in 35mm-150mm lengths.
The implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. The device specific instrumentation intended for patient contact is manufactured from stainless steel materials that conform to ASTM F899.
The provided document is a 510(k) premarket notification for a medical device (Picasso II MIS Spinal System), not a study evaluating an AI device. This type of notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically associated with AI device evaluation.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI device is not applicable to this document.
However, I can extract information related to the device and the non-clinical testing performed to support its substantial equivalence.
Here's a breakdown of what can and cannot be provided from the given text:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document implies acceptance criteria by stating that the modified housing dimensions "do not create a worst case construct as compared to the predicate" and that "mechanical test results submitted in support of the predicate systems are considered applicable to the subject system." This suggests that the device must perform at least as well as, or not worse than, the predicate devices in specific mechanical tests. The specific numerical acceptance criteria (e.g., maximum deflection, ultimate load) are not explicitly stated in this document.
- Reported Device Performance: The document states, "Results of the engineering analysis provided in support of this premarket notification demonstrate that the modified housing dimensions for the proposed system do not create a worst case construct as compared to the predicate." It also indicates that non-clinical tests were conducted "to confirm the results of the engineering analysis." However, actual performance values (e.g., specific forces, deflections) are not reported. The conclusion is a qualitative statement of equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performance (mechanical properties) is not worse than predicate device. | Modified housing dimensions do not create a worst-case construct compared to the predicate. |
2. Sample sized used for the test set and the data provenance:
- This information is not applicable as this is not an AI device study requiring a "test set" in that context. The testing involved mechanical evaluations of the physical device. The sample size for the mechanical tests is not specified. Data provenance is also not applicable in the context of data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. This document describes the mechanical testing of a physical medical device, not an AI algorithm requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. This refers to expert adjudication in AI studies, which is not relevant here.
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:
- This is not applicable. This type of study is for evaluating observer performance with AI in diagnostic or other decision-making tasks, which is not the subject of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This document does not concern an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This is not applicable. For mechanical testing of a physical device, the "ground truth" would be the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1798-13). There is no "ground truth" in the clinical AI sense.
8. The sample size for the training set:
- This is not applicable. This document does not describe an AI device or a training set.
9. How the ground truth for the training set was established:
- This is not applicable. This document does not describe an AI device or a training set.
Summary of Relevant Information from the Document:
- Device: Picasso II MIS Spinal System (spinal pedicle fixation system)
- Purpose of Study/Submission: To demonstrate substantial equivalence to predicate devices (Picasso MIS Spinal System and Raphael System) to obtain clearance for market.
- Testing Performed: Non-clinical mechanical tests were conducted in accordance with ASTM F1798-13.
- Static axial grip
- Static torsional grip
- Static cantilever bending
- Static tulip head disassociation (nominal and extreme angle)
- Conclusion: The subject device is substantially equivalent to the predicate devices, with no impact on device performance due to minor differences. The modified housing dimensions do not create a worst-case construct compared to the predicate.
§ 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.