(125 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, cross links, 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 or 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 510(k) premarket notification for a medical device called the "PSS System," a pedicle screw spinal system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria in the manner typically seen for AI/ML devices. Therefore, much of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, and MRMC studies) is not applicable to this submission.
Here's a breakdown based on the provided text, highlighting where information is not relevant or available for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance in accordance with ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" | Device demonstrates substantial equivalence to the Spinal USA PSS System (K071438) when tested in accordance with ASTM F1717. (Implies the device met the performance standards set by the predicate device and the standard.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a "test set" in the context of an AI/ML device. The "test set" here refers to the physical samples of the PSS System tested according to ASTM F1717. The number of physical units tested is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical data. This is a mechanical testing study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a mechanical device, and "ground truth" as it pertains to expert consensus on clinical data is not relevant. The "ground truth" for mechanical testing is defined by the performance standards outlined in ASTM F1717.
4. Adjudication method for the test set
- Not Applicable. Mechanical testing does not involve adjudication by experts in the same way clinical image interpretation or diagnosis does.
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 a mechanical spinal fixation system, not an AI/ML device. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a mechanical device. Standalone algorithm performance is not relevant.
7. The type of ground truth used
- For mechanical devices, the "ground truth" is typically defined by the performance requirements and testing methodologies specified in recognized standards (e.g., ASTM F1717) and successful performance of a legally marketed predicate device. In this case, the PSS system's performance was compared to a previously cleared predicate device (K071438) using ASTM F1717.
8. The sample size for the training set
- Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable.
§ 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.