(112 days)
Internal fixation implants are load-sharing devices intended to stabilize and hold an alignment in place until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The PILOT™ Plating System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
The PILOT™ Posterior Lumbar Plating 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (1.e., fracture or dislocation) (4) spinal stenosis, (5) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) (6) tumor, (7) pseudoarthrosis, (8) failed previous fusion.
When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT™ Plating System provides additional support during spinal fusion. The PILOT™ Plating System consists of bone screws, plates, washers, nuts, and collets in various shapes and sizes. The PILOTTM Plating System is manufactured from medical grade titanium and will be sold non-sterile.
This document describes the PILOT™ Posterior Lumbar Plating System, a medical device. The information provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not included in this document.
However, I can extract the available information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biomechanical performance in accordance with ASTM F1717 standards (for substantial equivalence). | Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence. |
| Substantial equivalence in indications for use, design, function, and materials used to a predicate device. | The Life Spine PILOT™ Plating System was shown to be substantially equivalent to a previously cleared device in indications for use, design, function, and materials used. |
2. Sample size used for the test set and the data provenance: Not provided. The document refers to "biomechanical testing" but does not specify the number of samples or the origin of any data (e.g., country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of information is relevant for studies involving human interpretation or clinical outcomes, which are not detailed here. The ground truth for biomechanical testing is typically defined by engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no human adjudication described for the biomechanical 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: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
* For biomechanical testing, the "ground truth" would be the performance criteria and specifications outlined in the ASTM F1717 standard.
* For substantial equivalence, the "ground truth" is the established performance and characteristics of the legally marketed predicate device.
8. The sample size for the training set: Not applicable. This device does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established: Not applicable.
What the document does tell us about the study and acceptance:
The primary "study" mentioned is biomechanical testing in accordance with ASTM F1717. This testing was conducted to demonstrate substantial equivalence to an existing legally marketed predicate device. The acceptance criterion was implicitly that the PILOT™ system performs comparably to the predicate device under the conditions defined by ASTM F1717, and that its indications for use, design, function, and materials are also substantially equivalent.
The FDA's review (K061364) concluded that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This indicates that the submitted evidence (including the biomechanical testing) met the FDA's requirements for demonstrating equivalence.
§ 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.