(62 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 (T1-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, pseudoarthosis, and failed previous fusion.
The Streamline TL Spinal System consists of a variety of rods, pedicle screws, connectors, set screws and other connection components used to build a spinal construct. Cross-links available for use with the Streamline TL system include the Quantum X-Link and the SpineWorks FixxSure Crosslink. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Instrumentation is also available to facilitate implant of device components. The purpose of this submission is to include the FixxSure Cross Link to the Streamline TL System. The Cross Link is designed to provide added fixation to the spinal construct and is available in fixed (23-28mm) and variable lengths (28-66mm).
The provided text describes a 510(k) premarket notification for the Streamline TL Spinal System. This is a medical device for spinal fixation, and the submission is focused on adding a new component, the FixxSure Crosslink, to the existing system. The document outlines the device's description, intended use, materials, and performance data used to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functioning as intended | "functioned as intended" |
| Performance substantially equivalent to predicate system | "performed in a manner substantially equivalent to that of the predicate system" |
Note: The document does not explicitly state numerical acceptance criteria (e.g., "must withstand X N of force"). Instead, the acceptance is based on demonstrating that the modified device (Streamline TL with FixxSure Crosslink) performs comparably to the previously accepted predicate device (Streamline TL without the new crosslink, and the predicate FixxSure Crosslink). This is a common approach for 510(k) submissions, where substantial equivalence rather than absolute performance metrics is the primary goal.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "testing was presented to characterize the performance of the Streamline TL construct with the additional FixxSure Crosslink," implying a series of tests, but not the number of units or repetitions used for each test.
- Data Provenance: The study described is a mechanical performance study (ASTM F1717) conducted to characterize the device's performance. It is a prospective study as it involves testing a newly configured device. The country of origin of the data is not specified, but given the sponsor is in Marquette, MI, USA, and the FDA is reviewing it, it's likely the testing was conducted in the USA or by a lab adhering to international standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of study. The ground truth for mechanical performance studies like this is objective, measurable physical properties (e.g., force, displacement, cycles to failure) determined by standardized test methods (ASTM F1717). There is no human interpretation or expert consensus involved in establishing the "ground truth" for the device's mechanical strength.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human adjudication for mechanical testing data. The results are quantitative and directly measured.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of a diagnostic or assistive technology on human reader performance, often in imaging. This submission deals with the mechanical performance of a spinal implant, which does not involve human readers in an interpretive capacity.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, a standalone performance study was done. The performance data presented consists of mechanical testing (ASTM F1717 dynamic compression bending, static compression bending, and static torsion testing) to characterize the performance of the spinal construct. This is a "standalone" assessment of the device's physical properties without human intervention or interpretation for its primary function.
7. The Type of Ground Truth Used
The ground truth used is objective physical measurements obtained through standardized mechanical testing (ASTM F1717). This includes measurements of dynamic compression bending, static compression bending, and static torsion. The "truth" is whether the device withstands certain forces and cycles per defined standards.
8. The Sample Size for the Training Set
This information is not applicable. This submission describes mechanical testing of a medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for mechanical performance testing.
§ 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.