(22 days)
The Streamline 71. 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 discase (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), turnor, 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® and rods. This 510(k) is intended to introduce a line extension to the existing Streamline TL Spinal System. The line extension consists of additional diameters for the poly-axial screws.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies:
Based on the provided text, the Streamline TL Spinal System is a Class III medical device requiring premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel technology.
Crucially, the provided text does not describe any specific acceptance criteria or a study designed to prove the device meets such criteria in the way one might expect for a diagnostic AI/ML device.
Instead, the submission focuses on substantial equivalence to existing predicate devices.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance (Not applicable in the AI/ML sense)
Since this document is for a spinal fixation system, there are no "acceptance criteria" for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC). The "performance" of this device is assessed through its material properties, design, and intended use being substantially equivalent to a predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable, as this is not an AI/ML device. | Not applicable, as this is not an AI/ML device. |
| (e.g., Sensitivity > X%) | (e.g., Achieved Y% Sensitivity) |
| (e.g., Specificity > Z%) | (e.g., Achieved W% Specificity) |
Study Information (Focused on Substantial Equivalence, not AI/ML performance)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for a clinical study in the AI/ML context. The submission states: "Engineering analysis was completed for the subject components and demonstrated no pre-clinical performance data was required to demonstrate equivalence of the product." This indicates that physical testing (e.g., mechanical, fatigue) of the new components to demonstrate equivalence was likely performed, rather than a clinical trial with a "test set" of patients or data. No details on the sample size for this engineering analysis are provided, nor is data provenance relevant in this context.
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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. There was no clinical "test set" requiring expert-established ground truth for performance evaluation in the context of an AI/ML device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical "test set" requiring adjudication.
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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, an MRMC comparative effectiveness study was not done. This device is a pedicle screw system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth in the clinical sense (for AI/ML performance) was needed. The "ground truth" for this device's safety and effectiveness relies on its physical properties and design conforming to established standards and demonstrating equivalence to predicate devices, which have already been deemed safe and effective.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI/ML.
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How the ground truth for the training set was established:
- Not applicable. This device does not involve a "training set."
Summary of the Product's Regulatory Pathway Based on the Provided Text:
The Streamline TL Spinal System (specifically the line extension with additional poly-axial screw diameters) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices (the original Pioneer Streamline TL Spinal System and Blackstone Medical's Firebird Spinal Fixation System).
The primary method for demonstrating this equivalence was through engineering analysis, which concluded that "no pre-clinical performance data was required to demonstrate equivalence of the product." This means that the FDA was satisfied that the new components did not raise new questions of safety or effectiveness, and their performance could be inferred from the predicate devices through design and material similarities, likely backed by mechanical testing (though not explicitly detailed as "data" in this summary).
§ 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.