(245 days)
The Streamline MIS Cannulated System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.
The Streamline MIS Cannulated System consists of rods, pedicle screws, connectors, and set screws 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. The Streamline MIS Cannulated System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lower thoracic and/or lumbar spine during open or percutaneous spinal procedures. 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, Rods and Connecting components are comprised of Titanium Alloy per ASTM F 136.
The provided text describes a 510(k) summary for the Streamline MIS Cannulated System, a medical device for spinal fixation. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static and fatigue compression bending per ASTM F1717 as outlined in FDA's "Guidance for Industry and Staff: Spinal Systems 510(k)s" issued May 3, 2004. | Testing demonstrated that the mechanical performance of the Pioneer Streamline MIS Cannulated System is substantially equivalent to the predicate devices. |
| Mechanical Performance | Static torsion per ASTM F1717 as outlined in FDA's "Guidance for Industry and Staff: Spinal Systems 510(k)s" issued May 3, 2004. | Testing demonstrated that the mechanical performance of the Pioneer Streamline MIS Cannulated System is substantially equivalent to the predicate devices. |
| Component Performance | Evaluation of crosslink disassociation per internal protocols. | Testing characterized component performance. |
| Component Performance | Evaluation of saddle/cap separation per internal protocols. | Testing characterized component performance. |
| Component Performance | Evaluation of yoke disassociation from screw head per internal protocols. | Testing characterized component performance. |
| Technological Characteristics | Matching polyaxial screw lengths and diameters of predicate systems. | The Streamline MIS Cannulated System consists of a range of polyaxial screw lengths and diameters that match that of predicate systems. |
| Technological Characteristics | Rods and connecting components identical to predicate system. | The rods and connecting components are identical to that of the predicate system. |
| Intended Use | Identical to predicate systems. | Intended Use is identical to that of the predicate systems. |
| Materials | Identical to predicate systems. | Materials are identical to that of the predicate systems. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the mechanical performance testing. It refers to "testing" and "test results" in a general sense. When a 510(k) submission states that engineering tests were run in accordance with a specified ASTM standard, the sample sizes are taken from that standard. However, the exact sample sizes used for each test are not explicitly detailed in this summary.
- Data Provenance: The data is generated from mechanical laboratory testing performed by Pioneer Surgical Technology. The data provenance is internal to the manufacturer. It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the typical sense for patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this type of submission. The "ground truth" for mechanical testing is established by objective measurements against engineering standards (ASTM F1717) and internal protocols, not by expert consensus or interpretations of patient data.
4. Adjudication Method for the Test Set
- This information is not applicable to this type of submission. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving human interpretation or assessments, not for mechanical laboratory testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This submission is for a spinal fixation device, and the evaluation is based on mechanical substantial equivalence, not on the interpretative performance of a diagnostic algorithm or the effectiveness of human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, the concept of algorithm-only performance is not relevant.
7. Type of Ground Truth Used
- The "ground truth" used for this submission is based on established engineering standards (ASTM F1717) for mechanical properties and internal protocols for specific component performance. The performance of the Streamline MIS Cannulated System was compared to the performance of predicate devices against these established benchmarks.
8. Sample Size for the Training Set
- This information is not applicable. There is no "training set" in the context of this 510(k) submission, as it is not an AI/ML algorithm or a diagnostic device that requires training on data. The device's design and manufacturing processes are validated, and its performance is verified through physical testing.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable, as there is no "training set" for this type of medical device 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.