(88 days)
The Atoll OCT Spinal System is indicated to promote fusion of the occipito-cervico-thoracic regions of the spine (Occiput - T3). The intended indications are as follows:
- Degenerative Disc Disease (as identified by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Spinal Stenosis
- Fracture/Dislocation
- Tumors
- Pseudoarthrosis
- Atlanto/axial fracture with instability
- Occipitocervical dislocation
- Revision of previous cervical and upper thoracic spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the polyaxial and standard screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. Screws are not intended for use in the cervical spine.
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 (C1-T3) spine.
The Atoll OCT Spinal System can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.
The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, occipital plates and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient physiology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F136 and ISO 5832-3. To achieve the best results. unless otherwise specifically described in another Theken Spine document, do not use the Atoll OCT Spinal System components in conjunction with components from any other manufacturer. The purpose of this submission is the addition of an occipital plate.
This document is a 510(k) Summary for a medical device called the "Atoll™ OCT Spinal System." It is a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices.
Based on the provided text, a detailed study proving the device meets specific acceptance criteria is NOT present. The document primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
Therefore, many of the requested details cannot be extracted directly from this specific 510(k) summary. I can, however, extrapolate some information based on the nature of a 510(k) submission for spinal implants.
Here's an attempt to answer as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is typically found in detailed design validation and verification reports, which are summarized in a 510(k) but not fully reproduced in the public summary. For spinal implants, acceptance criteria would generally be related to:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Strength/Fatigue Life | (Not explicitly stated in this summary. Would refer to compliance with relevant ASTM/ISO standards for spinal implants, e.g., ASTM F1717 for static and fatigue testing of spinal implant constructs, ASTM F2077 for intervertebral body fusion device testing. Performance would demonstrate the device meets or exceeds the strength of predicate devices or specified load-bearing capacities without failure for a specified number of cycles.) |
| Biocompatibility | (Not explicitly stated in this summary. Would refer to compliance with ISO 10993 standards and material testing. Performance would confirm the Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 is biocompatible for long-term implantation.) |
| Material Composition | Meets specifications of Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3. |
| Design Dimensions/Tolerances | (Not explicitly stated. Would conform to engineering drawings and specifications to ensure proper fit and function.) |
| Sterility | (Not explicitly stated. Would be validated per ISO 11137 or other relevant standards for sterilization processes.) |
| Packaging Integrity | (Not explicitly stated. Would be validated to maintain sterility and device integrity until use.) |
| Substantial Equivalence (Overall - Key Criterion for 510(k)) | Equivalent in intended use, design, and physical characteristics to predicate devices: Atoll Cervico-Thoracic System (K070638), Mountaineer OCT Spinal System (K080828), OC Fusion System (K053418). This is the primary "performance" metric for a 510(k) submission. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal implants, sample sizes are often determined by statistical power requirements to detect differences between designs or to demonstrate compliance with standards. It typically involves multiple samples for each component and construct configuration.
- Data Provenance: Not specified. For mechanical testing, this data would generally be generated in a laboratory setting (in-vitro testing), potentially conducted by the manufacturer or an independent testing facility. It is not typically human clinical data (prospective or retrospective) for a 510(k) of this device type, unless a device has novel features requiring clinical data, which is not indicated here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable as the "ground truth" concept, in the way it's usually applied to AI or diagnostic devices (e.g., expert consensus on images), does not apply to the mechanical testing required for spinal implants in a 510(k). The "ground truth" for these devices is derived from engineering and scientific principles, validated testing methodologies, and compliance with recognized standards.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically for clinical outcome assessment or image interpretation, not for mechanical device testing. Results from mechanical testing are typically objective measurements against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the performance of diagnostic imaging devices or AI algorithms interpreted by human readers. This document is for a spinal implant, which does not involve human readers interpreting data in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm-only) study was not done. This is not an AI or algorithm-based device.
7. The Type of Ground Truth Used:
As explained in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly applicable here. For a spinal implant, the "ground truth" for performance is based on:
- Engineering Specifications: Conformance to design blueprints and material specifications.
- Standardized Mechanical Testing: Results from tests conducted according to recognized ASTM/ISO standards (e.g., for static compression, torsion, fatigue). These standards define the "truth" of what constitutes acceptable mechanical performance.
- Biocompatibility Testing: Results from tests conforming to ISO 10993.
- Comparison to Predicate Devices: Demonstrating that the new device performs at least as well as, or is equivalent to, legally marketed predicate devices, as evaluated through these objective tests.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device, so there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.