(79 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment 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® Spinal 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.
When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The PILOT® Spinal System consists of an assortment of rods, screws, and bodies in various shapes ITIC I THE PILOT® Spinal System side loading bodies are designed to accept either a 5.5mm or 6.35mm diameter rod. The rods are either pre-lordosed or straight.
The proposed modification to the PILOT Spinal System enhances the ease of use of the system by increasing the force transfer efficiency.
The PILOT® Spinal System implant components are made from titanium alloy described by ASTM F 136. Stainless steel and titanium implant components must not be used together in a construct. Do r 150. Sameess steel and notes spinal System components with the components from any other system or manufacturer. The PILOT® Spinal System components should never be reused under any circumstances.
The provided document is a 510(k) summary for the PILOT® Spinal System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a clinical study with real-world data and expert ground truth.
Therefore, many of the requested information points, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI/ML device studies, are not applicable to this document as it describes a physical hardware device validated through mechanical testing, not an AI/ML algorithm.
However, I can extract the relevant information regarding performance data.
1. Table of Acceptance Criteria and Reported Device Performance
This device is not an AI/ML device, so "acceptance criteria" here refers to the standards for mechanical performance.
| Acceptance Criteria (Standard) | Reported Device Performance (Methodology) |
|---|---|
| ASTM F1717 Static Testing | Static test data were presented to demonstrate substantial equivalency. |
| ASTM F1717 Fatigue Testing | Fatigue test data were presented to demonstrate substantial equivalency. |
Note: The document states that the performance data (static and fatigue testing per ASTM F1717) was presented to "demonstrate the substantial equivalency of the PILOT Spinal System" to its predicate devices. Specific numerical results for these tests are not provided in this summary but would have been part of the full 510(k) submission.
2. Sample size used for the test set and the data provenance
This is not applicable as the document describes mechanical testing of a spinal implant system, not an AI/ML algorithm evaluated on a dataset. The "test set" would refer to the physical devices tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, in the context of AI/ML, involves human interpretation or pathology. For mechanical device testing, the "ground truth" is established by the objective physical properties and behavior under defined loads, as measured by testing equipment according to established standards.
4. Adjudication method for the test set
This is not applicable. Adjudication methods are relevant for subjective human assessments in clinical or AI/ML ground truth establishment. Mechanical tests have objective pass/fail criteria based on standards.
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
This is not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used
This is not applicable in the AI/ML sense. For this mechanical device, the "ground truth" for performance is based on established engineering standards and physical measurements (e.g., load-bearing capacity, fatigue life) according to ASTM F1717.
8. The sample size for the training set
This is not applicable, as this device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This is not applicable, as this device does not involve a "training set" or "ground truth" in the context of AI/ML.
§ 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.