(229 days)
When used with the Gibralt System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3). The Gibralt Occipital Spine 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, occipital-cervical dislocation, atlanto-axial fracture with instability, failed previous fusion and/or tumors.
The Occipital Bone Screws are limited to occipital fixation only.
The use of polyaxial screws is limited to placement in TI-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.
The Gibralt Occipital Spine System is a new posterior system intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital-cervical-thoracic region of the spine.
The system consists of a variety of sizes of the occipital plates and occipital bone screws, and articulating rod and set screws. All components of the system are manufactured from titanium allov per ASTM F136.
The Gibralt Occipital system should be used in conjunction with the Gibralt Spine System components such as hooks, polyaxial screws and connecting components. The Gibralt Spine System has been cleared by FDA through 510(k) # K 110197 on July 15, 2011.
The Gibralt Occipital Spine System is provided with a complete instrumentation system to assist the surgeon in the implantation of the components according to a traditional open surgical procedure.
The provided text describes a 510(k) premarket notification for the Exactech® Gibralt® Occipital Spine System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance through clinical studies with acceptance criteria in the manner requested.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (like sensitivity, specificity, accuracy, etc.) cannot be extracted from this document, as it is not a clinical study report for AI/CADe devices.
Instead, the document details mechanical testing and engineering analyses performed to demonstrate substantial equivalence to predicate devices. This represents the "study" conducted for this type of medical device submission.
Here's a breakdown of the available information, reframed to address the spirit of your request:
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Equivalence):
The "acceptance criteria" for a 510(k) submission for this type of device are primarily about demonstrating that its mechanical performance is comparable to legally marketed predicate devices, ensuring it can withstand clinically relevant biomechanical loads. The "reported device performance" refers to the results of the mechanical tests performed.
| Acceptance Criteria (Demonstrates Substantial Equivalence via Mechanical Properties) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Withstand clinically relevant biomechanical loads comparable to predicate devices. | Mechanical testing (Static Compression Bend, Dynamic Compression Bend, Static Yield Torsion, Dynamic Torsion, Axial Pullout, Static Torque per ASTM F2706 and ASTM F543) and biomechanical assessment demonstrated the proposed device is substantially equivalent to cited predicates in mechanical performance and design features. |
2. Sample Size for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance of an AI/CADe device. For mechanical testing, the "sample size" would refer to the number of device components tested. This specific number is not provided in the summary.
- Data Provenance: The mechanical testing was conducted by or for Exactech®, Inc. The country of origin for the data is implicitly the manufacturing location or testing facility, likely the USA (where Exactech is based). The data is prospective in the sense that these tests were specifically performed for this 510(k) submission to evaluate the new device.
3. Number of Experts and Qualifications to Establish Ground Truth for the Test Set:
Not applicable. For this type of mechanical device, "ground truth" is established through standardized engineering tests and measurements, not through expert consensus on clinical data.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical ground truth establishment, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a submission for a spinal implant system, not an AI/CADe device that assists human readers. Therefore, an MRMC study is not relevant and was not performed.
6. Standalone (Algorithm Only) Performance Study:
No. This is a submission for a physical medical device. "Standalone performance" in the context of AI algorithms does not apply.
7. Type of Ground Truth Used:
The "ground truth" for demonstrating substantial equivalence for this device is based on standardized biomechanical and material testing specifications (e.g., ASTM F2706, ASTM F543) and comparisons to the established mechanical properties and design features of predicate devices. It's not clinical "ground truth" like pathology or outcomes data.
8. Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of a physical medical device's mechanical test data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.