(86 days)
The PASS 2 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
When used as a pedicle screw system, the PASS 2 Spinal System is intended 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 2 components consist of pedicle screws, sacral plates, 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.
This 510(k) premarket notification for the PASS 2 Spinal System is for a Class II medical device, specifically a posterior pedicle screw system and sacral plate. The submission describes modifications and an extension of the product range. The "acceptance criteria" here refers to the performance standards the device must meet to be considered substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| Mechanical soundness according to ASTM F1717 | "The tests performed on the additional components according to ASTM F1717... indicate that the products are as mechanically sound as other devices commercially available." |
| Mechanical soundness according to ASTM F1798 | "The tests performed on the additional components according to... ASTM F1798, indicate that the products are as mechanically sound as other devices commercially available." |
2. Sample Size Used for the Test Set and Data Provenance
This is a submission for a spinal implant system (hardware), not a diagnostic or AI-driven device that would involve a "test set" of patient data in the typical sense. The testing is mechanical engineering testing of the components. Therefore, the concept of sample size for a test set of data and its provenance is not applicable here. The "sample" would refer to the physical components tested for mechanical strength. The document does not specify the number of components tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" for a mechanical device is established by standardized material and mechanical testing procedures, not by human expert assessment of clinical data.
4. Adjudication Method for the Test Set
This is not applicable as the testing is mechanical and follows defined ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) with and without AI assistance. This submission concerns mechanical performance of a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for this device is based on mechanical testing standards, specifically ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) and ASTM F1798 (Standard Guide for Evaluating the Static and Fatigue Performance of Posterior Spinal Systems). The "ground truth" is that the device components perform within acceptable mechanical limits defined by these standards.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical mechanical implant, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
This is not applicable. The ground truth for mechanical testing is established by the specified ASTM standards and laboratory protocols, not by a "training set."
§ 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.