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The ATEC Posterior Navigated Disc Prep Instruments are indicated to facilitate discectomy, bony resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ATEC Posterior Navigated Disc Prep Instruments are surgical instruments that are designed to be compatible with the Medtronic® StealthStation™ Surgical Navigation System. The navigated disc preparation instruments are intended to facilitate discectomy, and bony resection. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable and are offered non-sterile to be cleaned and steam sterilized by the end user.

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) summary for the "ATEC Posterior Navigated Disc Prep Instruments."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the exact sample size used for the test set in the performance testing. It generally states that "Dimensional analysis of the instruments compared to Medtronic instruments" and "Testing to confirm performance and safety of the subject instruments when used with Medtronic StealthStation System" were conducted.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of performance testing for medical devices, it would generally be prospective testing conducted in a controlled environment to verify design specifications and system compatibility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For device performance testing, "ground truth" might refer to engineering specifications, established performance benchmarks for predicate devices, or validated measurement techniques. The document does not detail how these "truths" were established or if specific experts were involved in defining them.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication method" typically refers to how discrepancies in human reader interpretations are resolved, which is relevant for studies involving human assessment (e.g., diagnostic image interpretation). This document describes performance testing of surgical instruments and their compatibility with a navigation system, not human interpretation of medical data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is a set of navigated surgical instruments intended to facilitate discectomy, bony resection, and implant selection, not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the typical sense of an algorithm. The device is a set of physical surgical instruments designed to be used with a navigation system. The "performance" being evaluated is the physical and functional interaction of the instruments with the navigation system, not an algorithm's standalone diagnostic capability. The closest analogy might be the performance of the navigation system itself (which the instruments are compatible with), but the document focuses on the instruments' performance and safety when used with that system.

7. The Type of Ground Truth Used

For dimensional analysis, the ground truth would be engineering specifications and drawings for the instruments. For performance and safety with the navigation system, the ground truth would involve defined functional and safety criteria based on the intended use and established performance of the Medtronic StealthStation System. This might include measurements of accuracy, precision, and successful navigation outcomes in a simulated or controlled environment. It is not expert consensus, pathology, or outcomes data in the usual clinical trial sense.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The development and testing of these surgical instruments do not involve a "training set" in the context of machine learning or AI models. Performance testing of physical medical devices relies on engineering principles and validation against specifications, not data-driven training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set." The performance of the instruments is validated against established specifications and functional requirements as described in point 7.

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The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

The Invictus Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

The purpose of this submission is to add new fenestrated screws to the Invictus Spinal Fixation System. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device (specifically an AI-powered device) meets acceptance criteria.

The document is an FDA 510(k) clearance letter for the Invictus Spinal Fixation System, which is a medical device described as a "thoracolumbosacral pedicle screw system." This is a purely mechanical implant used for spinal fixation, not a digital health or AI-powered device.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or ground truth establishment for a study proving an AI device meets acceptance criteria. The document simply doesn't contain that type of information.

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