(24 days)
The Pioneer LowTop Spinal Rod System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system 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 LowTop Spinal Rod System components are non-cervical spinal fixation devices. Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.
This document describes a medical device, the "LowTop Spinal Rod System," and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, many of the requested categories for AI/ML device evaluation (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment) are not applicable.
However, I can extract the acceptance criteria and the study type used to demonstrate equivalence for this specific device.
Acceptance Criteria and Study for LowTop Spinal Rod System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ASTM Standard Specifications for materials | Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications. |
| Performance demonstrated to be substantially equivalent to previously cleared Pioneer spinal system | Testing per recognized ASTM standards was presented. The LowTop Spinal Rod System implants are substantially equivalent to the components of a previously cleared Pioneer spinal system, with similar materials, performance, and indications for use demonstrated. |
| Similar materials, performance, and indications for use as predicate devices | The device demonstrated similar materials, performance, and indications for use as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. The "test set" in this context refers to the physical components being tested for mechanical properties, not a dataset for an algorithm. The testing would involve a sufficient number of samples to meet ASTM standards for mechanical testing, but a specific "sample size" in terms of clinical cases or data provenance is not relevant here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus or pathology is typically for diagnostic devices or AI/ML. For a spinal rod system, the "ground truth" would be the mechanical properties as defined by engineering standards (e.g., tensile strength, fatigue life), which are determined by laboratory testing, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is a physical device undergoing mechanical testing, adjudication methods like 2+1 or 3+1 (common for expert consensus in medical imaging) are not relevant. Mechanical testing results are objectively measured against established ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is a physical medical device, not an AI-assisted diagnostic or treatment planning system that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used:
- For the performance criteria: Engineering standards (ASTM standards) for material properties and mechanical performance.
- For the substantial equivalence determination: Comparison to the materials, performance, and indications for use of legally marketed predicate devices.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. This is a physical medical device.
§ 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.