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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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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
• 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 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 purpose of this submission is to add transition rods and rod connectors

This document is a 510(k) summary for a medical device called the Atoll Cervico-Thoracic System. It is a premarket notification to the FDA to demonstrate substantial equivalence to existing legally marketed devices.

It describes a spinal implant system and its intended use, rather than a diagnostic device or AI software. Therefore, the questions related to studies proving acceptance criteria for device performance, ground truth, expert involvement, and AI specific metrics (like MRMC studies) are not applicable in this context. These questions typically apply to diagnostic devices, particularly those involving image analysis or AI algorithms, where performance relies on measurable metrics against a 'ground truth'.

For this device, "acceptance criteria" are related to mechanical and material properties, and "substantially equivalent" claims. The study proving acceptance is typically mechanical testing and material characterization, not clinical studies with patients for diagnostic accuracy.

Here's an attempt to answer the relevant aspects based on the provided text, while explicitly stating where information is not applicable:

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

Note: The acceptance criteria for this type of medical device are typically defined by engineering standards for mechanical strength, biocompatibility, and manufacturing quality, and by demonstrating that the device is "substantially equivalent" to legally marketed predicate devices in terms of intended use, design, and materials.

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 applicable as this is a 510(k) submission for a spinal implant, not a diagnostic device or AI algorithm that would typically involve a "test set" of data for performance evaluation in the way described. The "test" for this device would involve mechanical testing and material characterization, the specifics of which are not detailed in this summary.

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 applicable. "Ground truth" in the context of expert consensus is typically relevant for diagnostic accuracy studies of image-based or clinical data, which is not the nature of this device submission.

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

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not relevant to this device's submission.

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 applicable. MRMC studies are specifically for evaluating diagnostic performance of imaging systems, often with AI assistance. This device is a surgical implant.

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

This information is not applicable. This 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 applicable in the context of data-driven performance evaluation. For this device, the "ground truth" would be related to established engineering standards for material properties and mechanical performance, and the clinical outcomes for the predicate devices that established their safety and effectiveness.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this device submission.

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

This information is not applicable. There is no "training set" in the context of this device submission.

Ask a specific question about this device

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.

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