(30 days)
The PASS LP Spinal System includes a pedicle system 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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, rods and sacralliliac 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, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
The provided document, K100297, describes a Special 510(k) submission for the Medicrea PASS LP Spinal System. This submission is for a product range extension and additional components to an already legally marketed predicate device (K080099).
The acceptance criteria and supporting study described in this document are mechanical performance tests rather than clinical or AI/software performance studies. The core of this submission focuses on demonstrating substantial equivalence to existing predicate devices by ensuring the mechanical integrity of the new components.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Soundness | Performance "as mechanically sound as other devices commercially available" | "the tests performed on the additional components (according to ASTM F1717 or ASTM F1798) or the finite element analysis, indicate that the products are as mechanically sound as other devices commercially available." |
Explanation: The acceptance criterion is a comparative one: the modified components must exhibit mechanical properties equivalent to or better than those of already marketed, similar devices. The reported performance confirms that this criterion was met through standardized testing or finite element analysis.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of components or samples used for the mechanical tests. It refers to "tests performed on the additional components," implying that the specifically added components were tested.
- Data Provenance: The tests are conducted according to recognized ASTM standards (F1717 or F1798), which are standard industry practices for mechanical testing of spinal implant devices. The document does not specify the country of origin of the data beyond the submitter being in France. The data would be prospective in the sense that the tests were performed on the new components to demonstrate their properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable in the context of this device submission. The "ground truth" for mechanical performance of spinal implants is established by adherence to recognized industry standards (ASTM testing) and engineering principles, not by expert clinical consensus on a test set as would be the case for an AI/software device. The regulatory body (FDA) reviews the test results against these standards.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements (e.g., load to failure, fatigue life) against predetermined specifications within ASTM standards, not subjective assessments requiring adjudication by multiple readers.
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 impact of a device (often an AI-powered one) on human reader performance in diagnostic tasks, which is not the nature of this spinal implant submission.
6. If a Standalone Performance Study Was Done
Yes, in a sense. The mechanical performance tests on the "additional components" can be considered a standalone performance study. These tests were conducted on the device components themselves to evaluate their intrinsic mechanical properties, independent of human interaction. The results demonstrated their mechanical soundness.
7. The Type of Ground Truth Used
The "ground truth" for this submission is mechanical performance standards (ASTM F1717 or ASTM F1798). These standards define the expected mechanical behavior (e.g., strength, fatigue resistance) that spinal implant components must meet to be considered safe and effective. The test results are compared directly against these established engineering benchmarks.
8. The Sample Size for the Training Set
Not applicable. The device is a mechanical spinal implant, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.