(252 days)
The Quantum-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 Quantum Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw system (T1 - S2), posterior hook (TI-L5) 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 regardless of the intended use: 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 Quantum Spinal System (including MIS) consists of a variety of rods, fixed and polyaxial screws, transverse connectors, and locking caps used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The Quantum Spinal System (including MIS) are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic and/or lumbar spine. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The Quantum Spinal System (including MIS) components are comprised of Titanium Alloy Ti6A14V per ASTM F136. A subcomponent of the locking cap, a spring clip, is comprised of nitinol (NiTi) per ASTM F 2063. All components of the Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated) are comprised of Titanium Alloy Ti6Al4V per ASTM F136 and have a hydroxyapatite (HA) coating.
The purpose of this submission is to include HA coated pedicle screws to the Quantum Spinal System (including MIS).
This document describes the acceptance criteria and the study conducted for the Pioneer Quantum Spinal System (including MIS) HA Coated Pedicle Screws (Non-Cannulated and Cannulated). This is a medical device, and the evaluation for substantial equivalence to a predicate device is based on non-clinical mechanical tests, not an AI/algorithm-based system. Therefore, many standard AI/ML study components (like sample sizes for test/training sets, ground truth by experts, MRMC studies, standalone algorithm performance) are not applicable.
Here's the breakdown based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pedicle Screw Insertion and Removal Torques | Performance comparable to or better than predicate devices, and within acceptable industry standards. | Performed. Results were sufficient to demonstrate substantial equivalence. |
| Static Flexion-Extension Test | Performance comparable to or better than predicate devices, and within acceptable industry standards. | Performed. Results were sufficient to demonstrate substantial equivalence. |
| Dynamic Flexion-Extension of HA Coated and Uncoated Cannulated Screws | Performance comparable to or better than predicate devices, and within acceptable industry standards. | Performed. Results were sufficient to demonstrate substantial equivalence. |
| Compliance with FDA Guidance for HA Coated Implants | Meet "510(k) Information Needed for Hydroxyapatite Coated Implants" requirements. | Existing testing provided and deemed compliant. |
Note: The document implicitly states that the performance met the criteria by concluding "the subject device demonstrates substantial equivalence to the listed predicate devices" based on the performed mechanical tests. Specific numerical acceptance criteria are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Since this is a mechanical device evaluation, the "test set" refers to the physical devices and components subjected to testing, not a dataset of patient information.
- Sample Size for Test Set: Not explicitly stated as a number of devices/components, but the described tests would have involved multiple samples to ensure reproducibility and statistical significance.
- Data Provenance: The tests were conducted by the manufacturer, Pioneer Surgical Technology. The data is based on laboratory mechanical testing (non-clinical) of prototype or production-representative devices. There is no information about country of origin of data or retrospective/prospective in the context of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a mechanical device. "Ground truth" in this context would be physical measurements and engineering analyses, not expert medical opinion on clinical data.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, there's no "adjudication" in the sense of reconciling expert opinions on medical cases. The evaluation is based on objective mechanical testing results against engineering standards and comparison with predicate devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. This is a medical device, not an AI/algorithm. MRMC studies are used for evaluating diagnostic software/algorithms.
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 an algorithm.
7. The Type of Ground Truth Used
- Mechanical Performance Standards and Predicate Device Comparison: The "ground truth" for the device's performance is its ability to withstand specific forces, torques, and cycles as demonstrated by the mechanical tests (Pedicle Screw Insertion and Removal Torques, Static Flexion-Extension Test, Dynamic Flexion-Extension) and its equivalence to the previously cleared predicate devices in terms of material properties and performance. Compliance with FDA guidance for hydroxyapatite-coated implants also serves as a "ground truth" for material safety and performance.
8. The Sample Size for the Training Set
- Not Applicable. This is a medical device, not an AI/algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is a medical device, not an AI/algorithm. Design and manufacturing processes are iteratively developed and tested against engineering specifications, but there isn't a "training set" in the machine learning sense.
§ 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.