(147 days)
The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is intended for use in the noncervical spine. The GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is used as an adjunct to fusion, using autograft or allograft, in the treatment of the following instabilities and deformities in skeletally mature patients:
- Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of disc confirmed by history & radiographic studies)
- Spondylolisthesis
- Trauma (Fracture or Dislocation)
- Spinal Stenosis
- Scoliosis, Kyphosis and/or lordosis
- Pseudoarthrosis
- Failed Previous Fusion
The system is indicated for use in adult patients only. All implants are for single use only.
The Monoaxial & Polyaxial screw consists of a body, bushing, and ball head screw. Inner Screw, rods and transverse connectors assemblies complete the spinal construct. The body portion of the screw rotates about the ball head on the screw, which provides increased motion over a fixed post or monoaxial screw. An increase in motion facilitates the capture of rods that are not perfectly aligned.
The Screws, Rods &Transverse Connectors are fabricated from Titanium.
The system contains several models based on the size of the device and application site such as fixation/reconstruction spine.
- Single Lock Monoaxial Screw
- Single Lock Polyaxial Screw
- Transverse connector
- Rod
The diameter of these screw varies from 4mm to 7mm with length 25mm to 50mm.
The corresponding connector are small & large in size.
The diameter of Rod is 5.5mm with length 75mm to 150mm
These implants are supplied non-sterile; the products have to be sterilized prior to use.
The document describes a 510(k) premarket notification for the "GPC Brand Posterior, Non cervical Pedicle Screw Spinal System". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and thus does not typically involve extensive clinical studies with specific acceptance criteria as would be found for a novel device requiring a PMA. Instead, the focus is on a comparison to existing devices and adherence to relevant performance standards.
Based on the provided document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for performance metrics. Instead, it relies on demonstrating compliance with recognized industry standards for spinal implants, and equivalence to predicate devices. The "reported device performance" is essentially that the device met these standards and was found equivalent.
| Performance Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Material | ASTM F136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications. | Complied with standard. |
| Mechanical Performance | ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. | Verified compliance to this standard. |
| Indications for Use | Similar to predicate devices (Zodiac Polyaxial Spinal Fixation System (K100685) and Scient'X MX Monoaxial Pedicle Screw System (K042964)) | Similar intended use, deemed equivalent. |
| Material | Same as predicate devices. | Deemed equivalent. |
| Performance Standards | Same as predicate devices. | Deemed equivalent. |
| Sterilization | Same method as predicate devices (device is supplied non-sterile and must be sterilized prior to use). | Deemed equivalent. |
| Dimensional Verification | Same dimensions as predicate devices. | Deemed equivalent. |
2. Sample size used for the test set and the data provenance
The document refers to "non-clinical testing" performed against ASTM standards. It does not specify a "sample size" in terms of human subjects or a clinical test set. Instead, it refers to mechanical testing of the physical implants. The provenance is internal testing by the manufacturer (GPC Medical Limited) to verify compliance with the standards. This is not a clinical study in humans, but rather laboratory testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of submission. There was no clinical "test set" requiring expert ground truth establishment for diagnostic accuracy or clinical outcomes. The "ground truth" for the non-clinical testing was defined by the ASTM standards themselves (e.g., specific loads, displacement limits).
4. Adjudication method for the test set
Not applicable. There was no clinical test set or subjective assessment requiring adjudication.
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 is a spinal implant, not an AI-powered diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a spinal implant, not an algorithm.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" was defined by the specifications of the referenced ASTM standards (ASTM F136 for material, ASTM F1717 for mechanical performance). These standards provide established methodologies and criteria for evaluating spinal implant constructs. For substantial equivalence, the "ground truth" was the characteristics of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device is a physical spinal implant, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there was no training set.
§ 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.