(30 days)
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (T1 - S2) 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, pseudoarthosis, and failed previous fusion.
The Quantum Spinal System components are non-cervical spinal fixation devices. The Pioneer Quantum Spinal System implants are substantially equivalent to the components of a previously cleared Pioneer spinal system, with similar materials, performance, and indications for use demonstrated. Material: Biocompatible alloys in conformance with ASTM Standard Specifications.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum Spinal System:
This device, the Quantum Spinal System, is a Class III medical device (Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System and Pedicle Screw Spinal System). For Class III devices, especially those going through a 510(k) pathway, clinical studies are not typically the primary means of demonstrating safety and effectiveness but rather substantial equivalence to a predicate device.
Therefore, the information provided focuses on the technical performance testing rather than a clinical study involving human patients and outcomes data in the way one might expect for a digital health or diagnostic AI device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Test Method | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Testing per recognized ASTM standards | "Testing per recognized ASTM standards was presented." (Implies successful completion in line with standards specific to spinal implants for strength, fatigue, material properties, etc.) |
| Material Biocompatibility | Conformance with ASTM Standard Specifications for biocompatible alloys | "Biocompatible alloys in conformance with ASTM Standard Specifications." (Indicates materials meet established safety standards for biological interaction) |
| Intended Use Equivalence | Similar intended use as predicate device (K041167) | The Quantum Spinal System's intended use statement (posterior pedicle screw system, anterolateral fixation system for various spinal conditions) is compared to and determined to be similar to the predicate device. |
| Performance Equivalence | Similar performance as predicate device (K041167) | "The Pioneer Quantum Spinal System implants are substantially equivalent to the components of a previously cleared Pioneer spinal system, with similar materials, performance, and indications for use demonstrated." |
| Material Equivalence | Similar materials as predicate device (K041167) | "The Pioneer Quantum Spinal System implants are substantially equivalent to the components of a previously cleared Pioneer spinal system, with similar materials..." |
Note: The FDA 510(k) summary for this type of device often provides a high-level overview. Detailed numerical acceptance criteria (e.g., specific fatigue cycles or load limits) and their exact results are contained within the full 510(k) submission, which is not fully provided in this extract. The summary confirms that such testing was performed and met the necessary standards for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a spinal implant, not an AI/software device. Therefore, the concept of a "test set" in the context of diagnostic performance or AI model validation does not apply.
- Sample Size: The "testing per recognized ASTM standards" refers to mechanical and material testing of the device components. The sample size would be dictated by the specific ASTM standards for mechanical testing (e.g., number of implants tested for fatigue, static bending, etc.). This information is not explicitly detailed in the provided summary but would be part of the full submission.
- Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to engineering testing conducted by the manufacturer according to regulatory standards. This is not retrospective clinical data or prospective clinical data from human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For a spinal implant device cleared via a 510(k) pathway, "ground truth" is established through:
- Engineering specifications and recognized standards (ASTM): These define acceptable mechanical properties, material composition, and biocompatibility.
- Comparison to a legally marketed predicate device: The safety and effectiveness are largely based on demonstrating equivalence to an already approved device.
- Pre-clinical testing: This may include bench testing, cadaveric testing, and potentially animal studies, but not typically human clinical expert-driven ground truth in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable. See point 3. Adjudication methods (like 2+1, 3+1) are common in clinical trials or diagnostic studies where there's variability or disagreement among human readers or experts, which is not the case for the type of engineering performance data this device relies upon for 510(k) clearance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess the impact of AI on human reader performance. For a spinal implant, the effectiveness is demonstrated through its mechanical stability, biocompatibility, and intended use as a fixation device, and implicitly, the established safety and effectiveness of its predicate device.
6. Standalone (Algorithm Only) Performance
No, standalone performance is not applicable. The Quantum Spinal System is a physical medical device (spinal implant), not a software algorithm or an AI device.
7. Type of Ground Truth Used
The "ground truth" for this device's clearance via the 510(k) pathway is primarily:
- Engineering Standards and Specifications: Meeting the requirements of recognized ASTM standards for mechanical strength, fatigue, and material properties.
- Predicate Device Equivalence: The safety and effectiveness are established by demonstrating that the device is substantially equivalent to a previously cleared legally marketed device (K041167) in terms of materials, performance, and indications for use.
- Biocompatibility Data: Conformance to ASTM standards for biocompatible alloys.
There is no mention of expert consensus from clinical cases, pathology, or specific patient outcomes data being used as "ground truth" for the 510(k) process outlined in this summary.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. The concept of a "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.