(172 days)
When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.
This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.
This submission proposes a new spinal fixation system. The proposed Gibralt Spinal System is a top-loading spinal fixation system that comprises various sizes of polyaxial screws, rods, hooks, and various connectors to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical, and/or upper thoracic spine. The Gibralt Spinal System components are manufactured from titanium alloy per ASTM F136. The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.
The Gibralt Spinal System includes a complete instrumentation system to assist the surgeon in the implantation of each component according to a traditional open surgical procedure.
The provided documentation describes the Exactech® Gibralt™ Spinal System, a medical device, and its 510(k) summary (K110197) for FDA clearance. The clearance is based on demonstrating substantial equivalence to legally marketed predicate devices.
This document does NOT describe an AI/ML powered device, nor does it detail a study involving human readers or AI algorithms as described in your request. The device is a spinal fixation system, and the "study" referred to is a series of mechanical tests and engineering analyses performed to demonstrate its physical performance and substantial equivalence to existing devices.
Therefore, many of the specific details requested regarding acceptance criteria, device performance in an AI context, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this submission.
However, I can extract the information relevant to the device's performance demonstration as presented in the 510(k) summary.
Description of Acceptance Criteria and Performance (Non-AI Device)
The Exactech® Gibralt™ Spinal System is a spinal fixation system. Its "acceptance criteria" and "performance" are demonstrated through biomechanical testing and engineering analysis to show it is substantially equivalent to predicate devices. The core acceptance criterion is that the new system must withstand clinically relevant biomechanical loads, similar to the predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstration Goal) | Reported Device Performance (as demonstrated by) |
|---|---|
| Withstand clinically relevant biomechanical loads. | Mechanical testing and engineering analysis demonstrated that the proposed Gibralt Spinal System withstands clinically relevant biomechanical loads and that its mechanical performance is substantially equivalent to the cited predicate devices. |
| Equivalent intended use/indications for use. | The Gibralt Spinal System was shown to have equivalent indications for use and intended uses as the sited predicates for promoting fusion of the cervical and thoracic spine (C3-T3) for conditions like DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors. |
| Composed of biocompatible materials conforming to industry standards. | The Gibralt Spinal System is composed of titanium alloy per ASTM F136, a biocompatible material, similar to the predicates. |
| Similar design features. | The Gibralt Spinal System was found to have similar design features to the predicates. |
| Dimensionally comparable to predicates. | The Gibralt Spinal System was found to be dimensionally comparable to the predicates. |
| Provided non-sterile for single use, and steam sterilizable by hospital. | The Gibralt Spinal System, like the predicates, is provided clean and non-sterile for single use only, and must be steam sterilized by the hospital prior to use using the same method as predicates. |
| No shelf-life expiration dating for the device itself. | Neither the Gibralt Spinal System nor cited predicates have shelf life expiration dating. |
| Satisfies specific ASTM standards for mechanical testing. | The device successfully underwent: |
- Rod-to-rod connector Flexural Grip and Torsion Grip testing in accordance with ASTM F1798.
- Static Compression Bending, Static Torsion, and Dynamic Compression bending testing in accordance with ASTM F1717.
- A biomechanical assessment comparing its mechanical performance to predicate devices. The results of these tests demonstrated substantial equivalence. |
Regarding the specific questions posed for AI/ML devices:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A (Not Applicable). This is a mechanical device. The "test set" consisted of physical prototypes or materials that underwent mechanical testing. The provenance relates to the manufacturing and testing procedures, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A (Not Applicable). Ground truth was established through adherence to recognized international biomechanical testing standards (ASTM F1798, ASTM F1717) and engineering analysis, not by human experts interpreting clinical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A (Not Applicable). Adjudication methods are for human interpretation of data; this device underwent physical mechanical testing.
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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:
- N/A (Not Applicable). No AI or human reader study was conducted for this spinal fixation device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A (Not Applicable). No algorithm was involved.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this mechanical device is defined by biomechanical engineering principles and established ASTM standards for spinal implant testing. The goal was to demonstrate that the device performs mechanically at least as well as, or comparably to, the predicate devices.
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The sample size for the training set:
- N/A (Not Applicable). This device did not involve machine learning or a "training set."
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How the ground truth for the training set was established:
- N/A (Not Applicable). No training set or ground truth in the context of ML was established.
§ 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.