(90 days)
The PSS 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 and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 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 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.
The PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and ''NON-STERILE".
The provided text describes a medical device, the PSS System, and its substantial equivalence to other legally marketed devices, rather than a study proving performance against acceptance criteria using clinical data and an algorithm. This submission is for a traditional 510(k) premarket notification for a Class II medical device (pedicle screw spinal system), which typically relies on demonstrating substantial equivalence to a predicate device through mechanical testing and comparison of design and materials, not on clinical performance studies comparing accuracy or efficacy.
Therefore, many of the requested fields cannot be filled as they pertain to clinical or AI/algorithm performance studies which are not characteristic of this type of 510(k) submission.
Here's an attempt to answer based on the provided text, highlighting what is not applicable or not provided:
Acceptance Criteria and Study Details for PSS System
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate device performance) | Reported PSS System Performance |
|---|---|
| Mechanical strength and stability (ASTM F1717) | Demonstrates substantial equivalence to predicate devices (Moss Miami Pedicle Fixation System, Optima Spine System, Xia Spinal System) in accordance with ASTM F1717. |
| Biocompatibility (materials) | Components made from medical grade titanium alloy (ASTM F136 or ISO5832-3), consistent with predicate devices. |
| Design and indications for use | Similar design and intended uses for spinal immobilization and stabilization as predicate devices. |
Explanation: For a device like the PSS System, acceptance criteria are generally established based on the performance of legally marketed predicate devices. The "study" here is a mechanical testing comparison against these predicates, not a clinical trial with performance metrics like sensitivity/specificity.
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable/not provided for mechanical testing comparison. The "test set" would typically refer to physical samples of the device components subjected to testing. The document doesn't specify the number of components tested but implies standard mechanical testing.
- Data provenance: Not applicable. This refers to in-vitro mechanical testing conducted by the manufacturer, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This relates to clinical studies and expert consensus for ground truth, which is not relevant for a mechanical testing comparison.
4. Adjudication method for the test set
- Not applicable. This relates to clinical studies and expert review processes, which is not relevant for mechanical testing.
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
- No. This is not a study involving human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or AI product.
7. The type of ground truth used
- Not applicable. For this type of submission, "ground truth" is established through engineering standards (ASTM F1717) and comparison to the known characteristics and performance of predicate devices. There is no clinical or pathological "ground truth" in the context of this 510(k) clearance.
8. The sample size for the training set
- Not applicable. This term is relevant for machine learning algorithms, which is not applicable here.
9. How the ground truth for the training set was established
- Not applicable. This term is relevant for machine learning algorithms, which is not applicable here.
§ 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.