(69 days)
The Streamline TL Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (TI-S2), sacral/iliac screw fixation or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), transverse connectors, set screws and other connecting components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Sacral/iliac screws are designed for posterior fixation. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components. The Streamline TL Spinal System may be used with the Streamline TL Crosslink. SpineWorks FixxSure Crosslink or the Quantum® Spinal System X-Link®. The purpose of this submission is to add components to the System. The implant components of the Streamline TL Spinal System are manufactured from the implant grade Titanium Alloy, Grade 23 per ASTM F136. Spinal rods are also available in cobalt chromium alloy per ASTM F1537.
This document is a 510(k) summary for the Streamline TL Spinal System, a spinal fixation device. It describes the device, its intended use, and its equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information provided, focusing on what's missing as the document is a regulatory submission for a physical medical device, not an AI/software device:
Important Note: The provided text is a 510(k) summary for a physical medical device (spinal fixation system), not a software or AI-powered diagnostic device. Therefore, many of the requested categories (like acceptance criteria for performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in the context of this type of submission. The performance assessment here is entirely based on mechanical testing of the physical components.
Analysis for the Streamline TL Spinal System:
Given that this is a 510(k) summary for a physical implantable device (spinal fixation system) and not an AI or software device, the acceptance criteria and study details are focused on mechanical performance and material characteristics, not diagnostic accuracy metrics.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Equivalent or better mechanical test results compared to predicate devices. | "Testing demonstrated that the device is as safe, as effective and performs as well as or better than the predicate device." Specifically, evaluated per ASTM F1717 (Static Compression Bending and Static Torsion, and Dynamic Compression Bending) and ASTM F1798 (interconnection mechanisms and subassemblies). |
| Material Composition | Implant grade Titanium Alloy and Cobalt Chromium Alloy per specified ASTM standards. | "The implant components of the Streamline TL Spinal System are manufactured from the Materials: implant grade Titanium Alloy, Grade 23 per ASTM F136. Spinal rods are also available in cobalt chromium alloy per ASTM F1537." |
| Intended Use | Must align with cleared predicate devices. | Identical or substantially similar intended use as predicate devices. |
| Basic Design | Rod-based having screw anchors, comparable to predicates. | "Basic design: rod-based having screw anchors" |
| Sizes (Dimensions) | Comparable to predicate devices. | "Sizes: dimensions comparable to predicates" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of clinical patient data. For mechanical testing, the "sample size" would refer to the number of physical device units or components tested. This is not specified in the document, but standard ASTM testing protocols dictate the number of samples required for robust mechanical evaluation.
- Data Provenance: Not applicable for clinical patient data as this is mechanical testing. The testing was conducted internally or by a contracted lab to industry standards (ASTM).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. "Ground truth" in this context refers to established engineering standards (ASTM F1717, F1798) and the performance of predicate devices. There are no human "experts" establishing a clinical ground truth for a test set in pre-clinical mechanical testing. The "experts" would be the engineers and technicians performing and analyzing the mechanical tests, adhering to the specified ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This concept is relevant for clinical studies involving human interpretation or data disagreements. Mechanical testing results are objective measurements against defined 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
- No. This is entirely irrelevant for a physical medical device. MRMC studies are used to evaluate diagnostic performance of AI or imaging devices with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is entirely irrelevant for a physical medical device. "Standalone" performance refers to an algorithm's diagnostic accuracy without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical testing is based on established engineering standards (ASTM F1717, ASTM F1798) and the demonstrated performance of the legally marketed predicate devices. The goal is to show equivalence or superiority in mechanical performance.
8. The sample size for the training set
- Not Applicable. There is no "training set" for physical device mechanical testing. This concept applies to machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth established for it.
§ 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.