(84 days)
The PASS LP Spinal Systems include a pedicle system 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 thoracic, lumbar, and sacral spine:
- Fractures .
- . Dislocation
- . Failed previous fusion (Pseudoarthrosis)
- . Spinal stenosis
- . Degenerative spondylolisthesis with objective evidence of neurological impairment
- . Spinal deformations such as scoliosis or kyphosis.
- . Loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The PASS LP also includes hooks and rods and sacral/iliac screws indicated for degenerative disc disease (ddd) 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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.
The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, illac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of a new component: 'Revision Post and Nut' and Illiac Link for Ø6mm rod
This document describes device modifications to the MEDICREA INTERNATIONAL's PASS LP Spinal System, specifically the addition of a 'Revision Post and Nut' and an 'Iliac link' for a Ø6mm rod. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a novel AI device or a comparative effectiveness study involving human readers. Therefore, many of the requested criteria related to AI performance, expert-established ground truth, and human reader studies are not applicable or cannot be extracted from the provided text.
Here's the breakdown of information based on your request, as much as can be gleaned from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria and "reported device performance" in this context refer to engineering performance tests for mechanical equivalence, not clinical or diagnostic performance. The acceptance criteria are implicitly met by "demonstrated substantially equivalent performance" to the predicate.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static Axial sliding (Revision Post/Nut) | Substantially equivalent performance to the predicate device per ASTM F1798. | Demonstrated substantially equivalent performance to its predicate. |
| Dynamic flexion extension (Revision Post/Nut) | Substantially equivalent performance to the predicate device per ASTM F1798. | Demonstrated substantially equivalent performance to its predicate. |
| Dynamic Compression Bending (Iliac Link) | Substantially equivalent performance to the predicate device per ASTM F1717. | Demonstrated substantially equivalent performance of the Iliac link to its predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. For mechanical testing, this typically refers to the number of test articles (e.g., number of screws, posts, or links) subjected to the tests.
- Data Provenance: The tests were carried out according to ASTM standards (F1798 and F1717), which are international standards for material and product testing. The location where the tests were performed is not specified, but the manufacturer is based in France. The data is retrospective in the sense that it represents laboratory test results, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a mechanical implant, and the "ground truth" for its performance is established through standardized engineering tests (ASTM F1798, F1717) comparing its mechanical properties to a predicate device. It does not involve expert interpretation of images or clinical outcomes that would require a panel of human experts for ground truth establishment.
4. Adjudication method for the test set
- Not Applicable. As this involves mechanical testing for substantial equivalence, there is no "adjudication method" in the sense of reconciling divergent expert opinions. The outcome is determined by adherence to specified test protocols and comparison of results.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of human readers improve with AI vs without AI assistance
- Not Applicable. This submission is for a medical implant (spinal system components), not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware implant, not an algorithm or software device. Standalone algorithmic performance is not relevant.
7. The type of ground truth used
- Mechanical Testing Standards and Predicate Performance: The "ground truth" for demonstrating substantial equivalence is based on the established mechanical performance characteristics of the legally marketed predicate device, as measured and verified through standardized ASTM tests (F1798 and F1717). The new components must perform equivalently to these established benchmarks.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this device or its evaluation. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.