(254 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, polyaxial screws, transverse connectors, set screws and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Screws, Set Screws, and Connecting components are comprised of Titanium Alloy per ASTM F 136. Rods are comprised of Titanium Alloy per ASTM F 136 or Cobalt Chromium Molybdenum Alloy per ASTM F 1537.
The provided text describes the 510(k) summary for the Pioneer Streamline TL Spinal System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static and fatigue compression bending per ASTM F1717. | Performed. Results demonstrated that the mechanical performance of the Pioneer Streamline TL Spinal System is substantially equivalent to the predicate devices. |
| Static torsion per ASTM F1717. | Performed. Results demonstrated that the mechanical performance of the Pioneer Streamline TL Spinal System is substantially equivalent to the predicate devices. | |
| Crosslink disassociation (per internal protocols). | Performed. Part of "component performance" testing. | |
| Saddle/cap separation (per internal protocols). | Performed. Part of "component performance" testing. | |
| Yoke disassociation from screw head (per internal protocols). | Performed. Part of "component performance" testing. | |
| Technological Characteristics | Polyaxial screw lengths and diameters matching predicate systems. | The Streamline TL Spinal System consists of a range of polyaxial screw lengths and diameters that match that of predicate systems. |
| Rods and connecting components identical to predicate systems. | The rods and connecting components are identical to that of the predicate system. | |
| Intended Use similar to predicate systems. | Intended Use... are similar to that of the predicate systems. | |
| Materials similar to predicate systems. | Materials are also similar to that of the predicate systems. (Screws, Set Screws, and Connecting components: Titanium Alloy per ASTM F 136. Rods: Titanium Alloy per ASTM F 136 or Cobalt Chromium Molybdenum Alloy per ASTM F 1537). | |
| Locking mechanism functionality (though differing in design from one predicate). | The mechanism by which this component locks to the screw head is different (threaded vs. cam lock). Performance tested via mechanical testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of implants, cycles, or tests) used for the mechanical testing. It mentions "mechanical testing was presented to characterize construct and component performance."
- Data Provenance: The testing was conducted "per recognized ASTM F1717 as outlined in FDA's 'Guidance for Industry and Staff: Spinal Systems 510(k)s' issued May 3, 2004," and "additional testing was performed per internal protocols." This indicates the data is from laboratory testing (likely within the United States, given the FDA submission), not from human or animal subjects. It is prospective in the context of the device's design, as the tests were performed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This device is a mechanical implant, not an AI/software device that requires human expert interpretation of data or images. Therefore, the concept of "ground truth established by experts" in the context of medical imaging or clinical diagnosis is not applicable here.
- The ground truth for mechanical performance is established by the validated testing standards (ASTM F1717) and internal protocols, which are objective engineering criteria. The "experts" would be the engineers and technicians performing and interpreting these mechanical tests according to established scientific and engineering principles. Their specific qualifications (e.g., mechanical engineer, materials scientist) are not detailed but are implicit in conducting such tests.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert reviews of ambiguous cases, particularly for AI image analysis or diagnostic studies. This is a mechanical device submission where performance is assessed against objective engineering 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 spinal implant, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are relevant.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on objective engineering measurements and compliance with established international standards (ASTM F1717) and internal mechanical testing protocols. The "truth" is whether the device can withstand specified static and fatigue loads, and whether its components remain integrated under various stresses, performing equivalently to predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that uses a "training set." The design and manufacturing processes are informed by engineering principles, material science, and past experience with similar devices, rather than a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of this device's submission.
§ 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.