(55 days)
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all of the following indications: degenerative disc disease (DDD) (defined as discogenic back pain 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 Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Streamline MIS Spinal Fixation System is a multiple component pedicle screw system comprised of a variety of components that allow the surgeon to build a spinal implant construct through an open or percutaneous approach. The implant components include rods, polyaxial pedicle screws with extended tabs, crosslinks, and locking set screws. The components are available in various sizes to accommodate differing patient anatomy. The system is attached to the pedicles by means of screws to the posterior, noncervical spine. The spinal construct is completed by connecting the screws with titanium alloy rods. Crosslinks can be used if additional stabilization is necessary.
All implant components of the Streamline MIS Spinal Fixation System are manufactured from the implant grade Ti 6Al/4V ELI Alloy, Grade 23 (ASTM F136).
The Streamline MIS Spinal Fixation System components are used with the Streamline TL System locking set screws and crosslinks, and the Quantum Spinal System Crosslinks.
The Streamline MIS Spinal Fixation System includes instrumentation to provide the surgeon with a minimally invasive approach for posterior spinal surgery. Class I manual instruments are also included.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details as requested:
Device: Streamline MIS Spinal Fixation System (Pedicle Screw System)
This document describes a 510(k) premarket notification for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness through clinical trials with specific acceptance criteria for performance metrics (like sensitivity/specificity for AI). Therefore, the "acceptance criteria" here refer to the standards for demonstrating substantial equivalence, and the "study" refers to the pre-clinical performance testing against those standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use | Subject and predicate systems are overall similar in intended use (posterior, noncervical pedicle fixation, T1-S2, as an adjunct to fusion for various indications). |
| Basic Design: Rod-based having screw anchors | Subject and predicate systems are overall similar in basic design. |
| Materials: Titanium Alloy per ASTM F136 | All implant components manufactured from implant grade Ti 6Al/4V ELI Alloy, Grade 23 (ASTM F136). Subject and predicate systems are overall similar in materials. |
| Sizes: dimensions comparable to predicates | Subject and predicate systems are overall similar in sizes. |
| Performance: ASTM F1717 equivalent results | Evaluated per ASTM F1717 Static Compression Bending and Torsion, and Dynamic Compression Bending Testing. Demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of human subject testing. The "test set" here refers to the physical device components tested in pre-clinical mechanical performance studies. The document does not specify the number of individual components or constructs tested for ASTM F1717.
- Data Provenance: The studies were pre-clinical performance tests conducted to physical samples of the device. The data is thus generated in a lab setting, not from patient data, and is therefore neither retrospective nor prospective. The location of the testing is not explicitly stated but is implied to be performed by or for the manufacturer (Pioneer Surgical Technology, Inc., Marquette, MI, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context refers to the outcome of physical/mechanical tests based on established engineering standards (ASTM F1717), not expert interpretation of medical images or patient outcomes. The evaluation is based on objective measurements from mechanical testing machines.
4. Adjudication Method for the Test Set
Not applicable. This was a pre-clinical mechanical performance study against a standard, not a study requiring adjudication of expert opinions.
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 510(k) submission for a non-AI, mechanical spinal fixation system. No human reader studies, AI assistance, or MRMC studies were conducted or are relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was established by standardized mechanical testing protocols (ASTM F1717). This involves objective physical measurements of the device's strength, stiffness, and durability under compression, bending, and torsion, which are then compared to the performance of predicate devices or established minimum standards.
8. The Sample Size for the Training Set
No "training set" in the context of an AI algorithm is applicable. This is a mechanical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
§ 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.