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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 t degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis .
• Fracture/Dislocation .
• 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 can also be linked to the Theken Coral Spinal System with the use of transitional rods and rod connectors.

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 pathology. The Atoll Cervico-Thoracic System components are manufactured from medical implant grade titanium alloy Ti-6A1-4V (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 purpose of this submission is the addition of a head to head cross connector.

This is a 510(k) summary for a medical device called the Atoll™ Cervico-Thoracic System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's clinical performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a table of acceptance criteria or reported device performance in the sense of clinical effectiveness or accuracy studies. This 510(k) submission is primarily focused on demonstrating substantial equivalence based on similarities in intended use, design, and physical characteristics to previously cleared predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The submission focuses on device characteristics, not clinical study data for a "test set."

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)

This information is not provided. There is no mention of a "test set" or ground truth establishment by experts in the context of clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided for the reason mentioned above.

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

This information is not provided. The device is a spinal fixation system, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided and is not applicable as the device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided, as the submission does not detail a clinical study with "ground truth."

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not a machine learning device.

9. How the ground truth for the training set was established

This information is not provided for the reason mentioned above.

Summary of available information relevant to acceptance criteria (interpreted as basis for clearance):

The "acceptance criteria" in the context of this 510(k) submission are the demonstrations that the device is substantially equivalent to legally marketed predicate devices.

• Acceptance Criteria (for 510(k) clearance): The Atoll™ Cervico-Thoracic System must demonstrate substantial equivalence to predicate devices in terms of:

  • Intended Use
  • Design
  • Physical Characteristics
  • Material Composition

• Study/Evidence that proves the device meets perceived "acceptance criteria":

  The submission asserts that the "Equivalence for the Atoll Cervico-Thoracic System is based on similarities of intended use, design, and physical characteristics when compared to the predicate devices."

  • Intended Use: The provided "Indications for Use" for the Atoll™ Cervico-Thoracic System (C1-T3 fusion for various conditions like DDD, Spondylolisthesis, Spinal Stenosis, Fracture/Dislocation, Tumors, Pseudoarthrosis, Revision surgery) are implicitly considered substantially equivalent to the indications of the predicate devices.
  • Design: The device is described as "consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes." The specific modification in this submission is "the addition of a head to head cross connector." The design is deemed similar to the predicates.
  • Physical Characteristics: Not explicitly detailed in comparative tables, but implied by the device description and comparison to predicates.
  • Material Composition: "Implant Grade Titanium Alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3" which is a common and accepted material for such implants, likely matching or being equivalent to the predicate devices.

  The study itself is the 510(k) submission process, where the sponsor provides documentation and justifications for these similarities to the FDA. The FDA's review and subsequent clearance (as indicated by the letter from MAR 13 2009) signify that the agency accepted the sponsor's demonstration of substantial equivalence. No specific clinical trial, as would be conducted for a novel device or one requiring PMA, is described or referenced.

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