(235 days)
The PASSmed which includes the subject components, is a pedicle screw 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 the thoracic, lumbar and spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
As a pedicle screw system PASSmed is indicated 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.
It also includes hooks and a sacral plate 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.
The PASSmed Spinal System consists of pedicle screws, hooks, 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-6AI-4V ELI) that conforms to ASTM F136.
The purpose of this submission is to include the following components to PASSmed Spinal System:
- Ø7.2 mm Sacral screw length 30 mm: extension of the range cleared in -K032094
- Ø6.5 mm Sacral screws in lengths ranging from 30 mm to 60 mm: same . design as sacral screws cleared in K032094
- . Ø6 mm pre bent rods in lengths ranging from 40 mm to 110 mm: same design as rods cleared in K032094 before bending
- . Creation of a commercial reference for the nut of polyaxial pedicle screw cleared in K032094.
- Crosslink systems in lengths ranging from 22 mm to 62 mm; the crosslink is a nuts, plate and clamps assembly, that hooks onto the rods to the assembled PASS Spinal System (K032094) to provide torsional stability to the construct.
The provided text describes a Special 510(k) submission (K070276) for the PASSmed Spinal System, focusing on product range extension and additional components. This submission is for a medical device (spinal fixation system), not an AI or software-based device. Therefore, the typical acceptance criteria and study designs associated with AI performance evaluations (like sensitivity/specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this document.
The "acceptance criteria" for this type of medical device submission are primarily related to mechanical performance and substantial equivalence to a predicate device. The study described is a mechanical performance study.
Here's an analysis based on the provided text, structured to answer the questions as best as possible within the context of a mechanical device:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Mechanical) | Reported Device Performance |
|---|---|
| Components are mechanically sound (e.g., strength, durability). | "Tests performed on the additional components according to ASTM F1717 or ASTM F1798, indicate that the products are as mechanically sound as other PASSmed devices commercially available." |
| Substantial Equivalence to predicate device (K032094). | The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. |
| Conformance to ASTM F136 (for titanium alloy). | All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of components tested. Mechanical testing typically involves a sufficient number of samples to ensure statistical validity, but the specific quantity is not reported in this summary.
- Data Provenance: The tests were performed on "additional components" of the PASSmed Spinal System. The location of the testing is not specified, but the submitter is "MEDICREA® Technologies" based in La Rochelle, France. The tests were likely conducted in a laboratory setting. This is a prospective evaluation of the new components' mechanical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. For mechanical performance studies, "ground truth" is established by adherence to recognized industry standards (like ASTM F1717 or ASTM F1798) and material specifications (ASTM F136). The "ground truth" is the objective mechanical properties as measured against these standards, not expert interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. Mechanical tests are objective and typically do not require adjudication by multiple human experts. The results are quantitative measurements interpreted against established standards.
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
- Not Applicable. This is a mechanical device, not an AI or diagnostic software. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. As this is a mechanical medical device, there is no "algorithm" or standalone software performance to evaluate.
7. The Type of Ground Truth Used
- Standardized Mechanical Test Results / Material Specifications: The "ground truth" relies on the objective measurements obtained from tests conforming to ASTM F1717 or ASTM F1798 for mechanical performance, and adherence to ASTM F136 for material composition.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence. The predicate device (K032094) serves as a baseline for comparison.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not applicable. The performance of the predicate device (K032094) was established through similar mechanical testing and regulatory clearance processes.
§ 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.