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Properly used, this system is intended for anterior interbody screw fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

NOTA BENE: This device system is intended for anterior cervical intervertebral body fusions only. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-assembled to the plates), screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from shape memory alloys (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct. Do not use any of the ATLANTIS® Anterior Cervical Plate System components with the components from any other system or manufacturer.

The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications.

The subject plates and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.

This document describes the ATLANTIS® Anterior Cervical Plate System, a spinal intervertebral body fixation orthosis, and its substantial equivalence determination by the FDA based on non-clinical testing. This is a medical device submission, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the regulatory requirements for medical devices and the testing performed to demonstrate substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text:

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

• Compression fatigue
• Static compression
• Static torsion | Mechanical testing was completed in accordance with ASTM F1717 for compression fatigue, static compression, and static torsion. Test results determined the subject devices to be substantially equivalent to the predicate devices. |
  | Biocompatibility: (Implied, as medical device materials need to be biocompatible) | The subject devices are manufactured from ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy, a commonly accepted biocompatible material for surgical implants. Some plates have subcomponents from shape memory alloy (Nitinol-NiTi). |
  | Substantial Equivalence: To legally marketed predicate devices in terms of intended use, overall dimensions, and fundamental scientific technology. | The subject devices were determined to be substantially equivalent to the predicate devices (K021461, K063100, K130640 ATLANTIS® Anterior Cervical Plate System and K141632 ZEVO® Anterior Cervical Plate System) based on non-clinical test results and additional supporting documentation. |

2. Sample size used for the test set and the data provenance

The document does not explicitly state the "sample size" for the mechanical testing in terms of number of devices or components tested. It only mentions that "Mechanical testing, in accordance with ASTM F1717, was also completed." ASTM F1717 outlines standard test methods for spinal implant constructs in a corpectomy model, which would include specific sample sizes based on the test type (e.g., typically at least 6 samples per group for static and fatigue testing).

The data provenance is non-clinical (laboratory testing), not patient data. Therefore, there is no country of origin of the data in the context of human subjects, nor is it retrospective or prospective in that sense. The testing was conducted by or for Medtronic Sofamor Danek USA, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of submission. The "ground truth" for non-clinical mechanical testing is established by adherence to recognized industry standards (ASTM F1717) and engineering principles, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This is not applicable as the study involves non-clinical mechanical testing, not clinical data requiring adjudication.

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 is not applicable. The device is a physical spinal implant, not an AI software/diagnostic tool that would involve interpretation by human readers.

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

This is not applicable. The device is a physical spinal implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical testing is compliance with established engineering standards (ASTM F1717) and equivalence to the mechanical properties of predicate devices.

8. The sample size for the training set

This is not applicable. There is no concept of a "training set" for physical device mechanical testing.

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

This is not applicable.

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The ATLANTIS ® Anterior Cervical plate system is intended for anterior interbody screw fixation from C2 to T1 in the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis, 5) pseudoathrosis. and/or 6) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The ATLANTIS® Anterior Cervical Plate System is intended for the anterior screw fixation from C2 to T1 in the cervical spine. The device is manufactured from titanium alloy. Stainless steel and titanium implant components must not be used together in a construct.

The ATLANTIS® Anterior Cervical Plate System consists of plates of various lengths and screws. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The ATLANTIS® Anterior Cervical Plate System is to be used with cleared cervical supplemental instrumentation.

This document describes a 510(k) submission for the MEDTRONIC Sofamor Danek ATLANTIS® Anterior Cervical Plate System. It is a medical device for spinal fixation. As such, the submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical performance studies or algorithm-based evaluations. Therefore, many of the requested categories related to acceptance criteria, specific study designs (like MRMC or standalone performance studies for algorithms), ground truth establishment for AI/ML, and sample sizes for training/test sets are not applicable or cannot be extracted from this type of regulatory document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission is for a physical medical device (spinal plate system), not an AI/ML-based diagnostic or imaging device requiring a test set of data samples. The "study" mentioned refers to non-clinical testing for equivalence, primarily focused on sterilization and packaging.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth establishment by experts for a test set is described, as this is not an AI/ML or diagnostic performance study.

4. Adjudication method for the test set

• Not Applicable. No test set or related adjudication is described.

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

• No. This is a physical implantable device, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this submission.

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

• No. This is a physical implantable device; it does not involve an algorithm for standalone performance.

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

• Not Applicable. Given that this is a 510(k) for a physical medical device, the concept of "ground truth" in the context of diagnostic accuracy or AI/ML performance is not relevant. The "truth" here is related to the physical and functional characteristics of the device (sterility, mechanical integrity, material composition) and its equivalence to a predicate device.

8. The sample size for the training set

• Not Applicable. There is no training set mentioned, as this is not an AI/ML device.

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

• Not Applicable. There is no training set or related ground truth to establish.

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Properly used, this system is intended for anterior interbody screw/plate fixation from C2 to T1. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only, WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The ATLANTIS® Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion. The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from a superelastic allov (Nitinol-NiT). Stainless steel and titanium implant components must not be used together in a construct.

This document is a 510(k) premarket notification for the ATLANTIS® Anterior Cervical Plate System. It seeks to establish substantial equivalence to previously cleared devices rather than providing a study demonstrating the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted directly from this submission.

However, based on the provided text, here's what can be stated:

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

No explicit acceptance criteria with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy, mechanical failure rates, etc.) and corresponding reported device performance are presented in this 510(k) summary. The document relies on substantial equivalence to predicate devices rather than demonstrating performance against specific, pre-defined acceptance criteria.

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. This is a 510(k) submission, not a clinical study report. The submission references "prior mechanical testing" but does not provide details on sample size, data provenance, or the nature of this testing.

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. The concept of "ground truth" established by experts for a test set is typically relevant for studies validating diagnostic or predictive algorithms, which is not the nature of this submission. This submission concerns a physical medical device (an anterior cervical plate system).

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or assessment, which is not the focus of this 510(k) 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

Not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools. This submission is for a physical orthopedic implant and does not involve AI assistance for human readers.

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

Not applicable. This device is a physical implant and does not have an "algorithm only" or "human-in-the-loop" performance component.

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

Not applicable. The typical "ground truth" as described (e.g., expert consensus, pathology) is not directly applicable to the substantial equivalence of a spinal implant. The basis for substantial equivalence is primarily mechanical testing and comparison to predicate devices, demonstrating similar design, materials, and intended use.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable. As above, this device does not involve a training set that requires ground truth establishment.

Summary based on the provided text:

The ATLANTIS® Anterior Cervical Plate System's acceptance into the market is based on a 510(k) premarket notification which asserts substantial equivalence to existing legally marketed predicate devices. The document explicitly states:

• "Documentation, including a risk analysis and prior mechanical testing, was provided which demonstrated the subject plates to be substantially equivalent to predicate ATLANTIS® Anterior Cervical Plate System plates previously cleared in K970806, K021461 and K063100 and the C-Tek® MaxAn™ Anterior Cervical Plate System cleared in K080646."

This means that the "study" demonstrating the device meets acceptance criteria (in this regulatory context, substantial equivalence to predicate devices) primarily involved:

• Comparison of design and materials: The new ATLANTIS® system components (titanium alloy, Nidtinol) are compared to those of the predicate devices.
• Comparison of indications for use: The indications for the new device are consistent with or encompass those of the predicate devices.
• Mechanical Testing: Although details are not provided, the submission states "prior mechanical testing" was performed to support substantial equivalence. This testing would likely have compared the biomechanical performance (e.g., strength, fatigue resistance) of the new components to the predicate devices, showing performance within acceptable, comparable limits as established for the predicate devices.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the "acceptance" based on the provided information.

Ask a specific question about this device

Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, or scollosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

The ATLANTIS® Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.

The ATLANTIS® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

The ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from a superelastic alloy (Nitinol-NiTi). Stainless steel and titanium implant components must not be used together in a construct.

The provided text describes a medical device, the ATLANTIS® Anterior Cervical Plate System, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to previously marketed devices through mechanical testing. It does not contain information about acceptance criteria and studies related to AI/ML device performance.

Therefore, I cannot answer your specific questions related to acceptance criteria for an AI/ML device, its performance, sample sizes for test/training sets, expert qualifications, or ground truth establishment based on the provided text.

The document is a traditional 510(k) summary for a physical medical implant, not an AI/ML powered diagnostic or prognostic tool. The "study" mentioned is "Mechanical testing was provided demonstrating that the subject ATLANTIS® Translational Plate and subject screws are substantially equivalent to other commercially available anterior cervical fixation systems." This is a engineering/biomechanical study, not one evaluating the performance of an AI/ML algorithm.

Ask a specific question about this device

The ATLANTIS™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

The ATLANTIS™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy as described by ASTM F-136 or ISO 5832-3 and may be supplied either sterile or non-sterile.

The provided documents are a 510(k) premarket notification summary and an FDA clearance letter for the ATLANTIS™ Anterior Cervical Plate System. These documents are for a medical device (spinal implant) and do not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-driven medical device.

The 510(k) summary focuses on:

• Product Description: Materials, components, and general design.
• Intended Use/Indications: For temporary stabilization of the anterior cervical spine during fusion in various conditions.
• Substantial Equivalence: The key claim in a 510(k) submission, where the device is shown to be as safe and effective as a legally marketed predicate device. In this specific case, it states the device was claimed to be substantially equivalent to itself, which is unusual phrasing but generally means a modification or rebranding of an existing device.

The FDA clearance letter confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria and study details for an AI/algorithm-driven device's performance.

The questions in your prompt (sample sizes for test/training, ground truth establishment, MRMC studies, standalone performance, etc.) are specific to the evaluation of AI/ML-based medical devices, which operate very differently from a physical implant like a cervical plate system. The safety and effectiveness of such implants are typically demonstrated through mechanical testing (e.g., fatigue, static strength), biocompatibility testing, and comparison to established designs (predicate devices), rather than through clinical studies involving expert consensus on algorithm output or multi-reader multi-case analyses.

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