(26 days)
The VERTEBRON PSS™ Pedicle Screw System is intended for non-cervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The modified VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spine and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks and locking caps. This submission adds Curved Rods and Screw Spacers.
The information primarily concerns the regulatory approval of a medical device, specifically the VERTEBRON PSS Pedicle Screw System, based on substantial equivalence to predicate devices, rather than a study evaluating its performance against pre-defined acceptance criteria using AI or image analysis. Therefore, most of the requested fields are not applicable to the provided text.
Here's a breakdown of the available and unavailable information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The approval is based on substantial equivalence, not performance against specific criteria for a novel AI/image analysis device. | Not specified in the document. The document states that "Testing in accordance with ASTM F1717 was performed and demonstrated that the modified VERTEBRON PSS Pedicle Screw System is substantially equivalent to the currently marketed VERTEBRON PSS Pedicle Screw System". This indicates mechanical testing for substantial equivalence, but not specific performance metrics like accuracy, sensitivity, or specificity that would be set for an AI/image analysis device. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. The document describes a medical device (pedicle screw system), not an AI/image analysis software that would have a test set of data. The testing mentioned (ASTM F1717) refers to mechanical testing of the physical device.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable. This information would be relevant for establishing ground truth for an AI/image analysis device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method:
- Adjudication Method: Not applicable. This is typically used in studies where multiple experts interpret data to establish a ground truth, which is not described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. The document describes a 510(k) submission for a physical medical device (Pedicle Screw System), not an AI/image interpretation device that would involve human readers.
- Effect Size of Human Readers' Improvement with AI: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done: Not applicable. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. For the mechanical testing (ASTM F1717), the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices. This is not the same as ground truth for an AI/image analysis system (e.g., pathology, expert consensus).
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set Establishment: Not applicable.
Summary based on the provided text:
The provided 510(k) summary for the VERTEBRON PSS Pedicle Screw System describes a submission for a physical medical device, not an AI or image analysis software. The device's approval is based on demonstrating substantial equivalence to existing predicate devices (VERTEBRON PSS Pedicle Screw System K071376, K051716, K043152 & K033352) through mechanical testing in accordance with ASTM F1717.
Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" as defined by your request (referring to AI/image analysis performance metrics, ground truth, expert review, sample sizes for training/test sets, etc.) are not applicable to this document. The "study" mentioned is the mechanical testing to show substantial equivalence, not a clinical performance study with human readers or AI algorithms.
§ 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.