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The NuVasive® VuePoint® OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VuePoint OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the VuePoint OCT System may be connected to the NuVasive SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline™ System via the rod to rod connectors or transition rods.

The NuVasive VuePoint® OCT System is a occipito-cervico-thoracic posterior fixation system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The NuVasive VuePoint OCT System consists of screws, hooks, offset connectors, set screws, cross connectors, occipital plates and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission is to expand the indications for use of bone screws in the cervical (C1-C7) and thoracic (T1 to T3) spine.

This document (K153336) is a 510(k) premarket notification for a medical device called the NuVasive® VuePoint® OCT System. It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not describe a study that proves the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity, as one would expect for an AI/algorithm-based device. Instead, it focuses on mechanical performance testing and clinical literature review to support the safety and effectiveness of a spinal fixation system and its expanded indications for use.

Therefore, many of the requested details about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable (N/A) to this specific device submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

This submission is for a spinal fixation system, not an AI or algorithm. The acceptance criteria revolve around mechanical performance and substantial equivalence to previously cleared predicate devices, rather than performance metrics of an AI model (e.g., accuracy, sensitivity, specificity).

Study Details (Relevant to this type of device submission)

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not applicable in the context of an AI/algorithm test set. For mechanical testing, the "samples" would be the device components tested. The document states that "no new worst case sizes are being introduced," implying that the sample sizes from the original K093319 submission for mechanical testing were deemed sufficient and are reused. Specific numerical sample sizes for mechanical tests are not provided in this summary.
   • Data Provenance: The mechanical testing data refers to previous 510(k) K093319. The clinical literature review would draw from published studies, which are typically retrospective analyses of patient outcomes or procedures.
   • Retrospective/Prospective: The existing data for mechanical performance (from K093319) would have been generated prospectively during the development and clearance of that device. The clinical literature review is inherently retrospective.

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

   • Not applicable. This submission relies on mechanical testing standards and clinical literature. "Ground truth" in the AI sense is not established for this device as it's not a diagnostic or AI-driven system. Mechanical testing standards and established clinical practice serve as the "ground truth."

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

   • Not applicable. No human-based adjudication of performance on a test set is described, as this is not an AI/diagnostic device.

4. 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 not an AI device, so MRMC studies are not relevant.

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

   • Not applicable. This is a physical spinal fixation device, not an algorithm.

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

   • For mechanical performance: Ground truth is established by engineering standards and benchmarks for spinal implants, likely defined by ISO or ASTM.
   • For clinical justification of expanded indications: Ground truth comes from the existing clinical literature and established medical practice regarding the use of bone screws in the cervical and thoracic spine for the specified conditions.

7. The sample size for the training set:

   • Not applicable. This is not an AI device that requires training data.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an AI model is involved.

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The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and is indicated for: (1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery.

The occipital bone screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.

The NuVasive VuePoint OCT System consists of a variety of shapes and sizes of screws, rods, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

Here's a breakdown of the acceptance criteria and study information for the NuVasive® VuePoint® OCT System based on the provided 510(k) summary:

This device did not involve AI or algorithms; it is a spinal fixation system. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices through biomechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (number of constructs or test specimens) used for each biomechanical test.
• Data Provenance: Not applicable in the context of clinical data. The tests are nonclinical (laboratory-based biomechanical tests) performed to demonstrate mechanical equivalence. Country of origin for data is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. recognized standards. The study is nonclinical (in-vitro testing).

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

• Not applicable. This device is a spinal fixation appliance, and the "ground truth" for its performance is established by standardized biomechanical tests demonstrating its physical and mechanical properties, not by human expert opinion or clinical outcomes in the traditional sense. The "ground truth" is adherence to established engineering standards for strength and durability.

4. Adjudication Method for the Test Set

• Not applicable. There was no human adjudication of "cases" or "ground truth" as this was a nonclinical biomechanical study. The adjudication is against the performance of predicate devices and relevant ASTM standards.

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

• No. This is not an AI-powered device. It is a physical spinal implant system. Therefore, MRMC studies and AI assistance are not relevant.

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

• No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Nonclinical Biomechanical Performance. The "ground truth" for this device's performance is its ability to meet or exceed the biomechanical performance (static and dynamic torsion, compression, interconnection strength) of legally marketed predicate devices, as measured by established ASTM (American Society for Testing and Materials) standards.

8. The Sample Size for the Training Set

• Not applicable. This non-AI device does not have a "training set" in the context of machine learning.

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

• Not applicable. This non-AI device does not have a "training set" or "ground truth" established for training in the context of machine learning.

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