(84 days)
The Atoll Cervico-Thoracic System is indicated to promote fusion of the cervico-thoracic regions of the spine (C1 – 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
• Deformities or Curvature
• Tumors
• Pseudoarthrosis
• Revision of previous cervical and upper thoracic spine surgery
The use of the screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The 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 Cervico-Thoracic System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, 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 Cervico-Thoracic 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 Atoll Cervico-Thoracic System components in conjunction with components for any other system or manufacturer.
The provided text describes a medical device, the Atoll™ Cervico-Thoracic System, for which a 510(k) premarket notification was submitted. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets acceptance criteria through a traditional clinical study with specific performance metrics.
Therefore, the document does not contain information on acceptance criteria or a study designed to prove the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Here's a breakdown of why and what information is present in relation to your request:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) submission for the Atoll™ Cervico-Thoracic System does not define specific performance acceptance criteria (e.g., a certain accuracy, sensitivity, or specificity value) for the device's function as an aid in spine fusion.
- The demonstration of "performance" for this type of device (spinal fixation system) typically involves showing equivalence in terms of:
- Intended Use: The Atoll system shares similar indications for use (promoting fusion in cervico-thoracic regions for conditions like DDD, spondylolisthesis, etc.) with its predicate devices.
- Design: It consists of screws, hooks, rods, and connectors, similar to the predicate devices.
- Material Composition: It is made from medical implant grade titanium alloy (Ti-6Al-4V), a commonly accepted material for such implants and likely consistent with predicate devices.
- Physical Characteristics: While not explicitly detailed as a table, the submission asserts that its characteristics are "similar" to the predicate devices. This would typically be supported by mechanical testing (e.g., fatigue, static strength) to ensure it meets established standards for spinal implants, but specific results or pass/fail criteria are not included in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. Since this is a 510(k) for a spinal fixation system, there isn't a "test set" in the context of a diagnostic or AI device that would require data provenance or a sample size to calculate statistical performance. The "test" for this device involves comparing its design, materials, and intended use against already approved devices.
3. 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):
- Not Applicable. This information is irrelevant for a 510(k) submission of a spinal fixation device, which does not involve establishing ground truth from expert evaluations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 study type is specific to diagnostic aids or AI-powered devices involving human interpretation of medical images. The Atoll™ Cervico-Thoracic System is a physical implant, not a diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. See point 3. The "ground truth" for a spinal fixation device's safety and effectiveness is primarily established through its physical and mechanical properties, biocompatibility, and clinical history of similar predicate devices, rather than expert consensus on diagnostic images.
8. The sample size for the training set:
- Not Applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary:
The provided document details a 510(k) premarket notification for a spinal implant. The regulatory pathway for such devices focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting novel clinical performance data against specific acceptance criteria. This process typically involves comparing intended use, design, materials, and potentially non-clinical (e.g., mechanical) testing results against those of the predicates. The information requested (acceptance criteria, test/training sets, expert ground truth, MRMC studies) is characteristic of submissions for diagnostic or AI-enabled devices, not for a standalone physical implant like the Atoll™ Cervico-Thoracic System.
§ 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.