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The Nu Vasive® VuePoint® II OCT System is intended to provide immobilization 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 II 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 II OCT System may be connected to the Nu Vasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline™ System via the rod to rod connectors or transition rods.

The NuVasive VuePoint II OCT System consists of screws, hooks, rods, 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 includes indications for the use of bone screws in the cervical (C1-C7) and thoracic (T1 to T3) spine.

The information provided does not describe a study that uses AI or machine learning, nor does it include many of the requested details such as specific acceptance criteria or performance metrics for such a device. The device described is the NuVasive® VuePoint® II OCT System, which is a spinal fixation system intended for immobilization and stabilization of spinal segments. The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing.

Here's an attempt to answer the questions based on the provided text, acknowledging where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on substantial equivalence based on material composition, design, labeling, and function, rather than specific numerical acceptance criteria for performance against a defined metric (which would typically be found for an AI/ML device's accuracy, sensitivity, specificity, etc.). The performance described is primarily non-clinical mechanical testing.

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

This information is not applicable in the context of this 510(k) summary for a physical medical device. The "test set" here refers to the actual physical devices (implants and instruments) that were subjected to non-clinical mechanical testing. The document does not specify the number of devices tested for each mechanical test. Data provenance in this context would refer to the testing facility and methodology, which aligns with ASTM standards rather than patient data. The document does reference a "review of published literature" to support the use of bone screws in the cervical and upper thoracic spine, but this is not a "test set" for the device's performance.

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

This information is not applicable. For a physical device like a spinal fixation system, ground truth is established through engineering and material science standards (e.g., ASTM standards) and direct measurement of mechanical properties, not through expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" refers to mechanical testing of the physical device, not a diagnostic or interpretative task requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The NuVasive® VuePoint® II OCT System is a physical spinal fixation device, not a diagnostic or AI-assisted system that would involve human readers interpreting images.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This device is not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through physical measurements and adherence to recognized mechanical testing standards (e.g., ASTM F2706, ASTM F1717, ASTM F1798). The results of these tests demonstrate that the device met specified engineering benchmarks for strength, stability, and integrity, which are considered "ground truth" for its mechanical properties.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set."

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

Not applicable.

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When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:

• Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
• Spondylolisthesis
• Spinal Stenosis
• Trauma (i.e. Fracture or Dislocation)
• Atlanto/axial fracture with instability
• Revision of previous cervical spine surgery
• Tumors
  Occipital Plates / Occipital Bone Screws / Hooks:
  The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
  The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
  Hooks and rods:
  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.
  Polyaxial screws/Connectors:
  The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
  The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.

The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured from titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications and in PEEK OPTIMA LT1 conforming to ASTM E2026 specifications.

The PASS OCT Spinal System is a spinal fixation device. No AI/ML components are mentioned in the provided text. The device's substantial equivalence to predicate devices was determined through non-clinical testing.

Here's the information based on the provided text, focusing on the mechanical performance of the device rather than AI/ML related criteria:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of AI/ML. The performance data presented is for non-clinical (mechanical) tests. The sample sizes for these mechanical tests are not explicitly stated. Data provenance is not applicable in the context of device mechanical testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by mechanical testing standards, not expert clinical interpretation.
3. Adjudication method for the test set: Not applicable. Mechanical testing is typically evaluated against defined scientific standards and acceptable ranges, not human adjudication.
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: Not applicable. This device is a physical spinal fixation system, not an AI/ML diagnostic or assistive tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal fixation system and does not contain an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by mechanical testing standards (e.g., ASTM F2706-08) and FDA guidance for spinal systems, which define acceptable physical properties and performance under various loading conditions.
7. The sample size for the training set: Not applicable. This device is a physical spinal fixation system; there is no training set as would be used for an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.

Conclusion from non-clinical data: MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to several predicate devices (SUMMIT System, Mountaineer OCT Spinal System, Vertex Reconstruction System, and PASS 2 Spinal System) in terms of intended use, materials, design, mechanical safety, and performance. The device is considered safe and effective.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Blackstone™ Posterior Cervical System is indicated for:
a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
b) spondylolisthesis
c) spinal stenosis
d) fracture/dislocation
e) atlantoaxial fracture with instability
f) occipito-cervical dislocation
g) revision of previous cervical spine surgery
h) tumors

The occipital bone screws are limited to occipital fixation only.

The use of the multi-axial 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 Songer Cable System to be used with the Blackstone™ Posterior Cervical System allows for wire/cable attachment to the posterior cervical spine.

The Blackstone™ Posterior Cervical System is a titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The Blackstone™ Posterior Cervical System consists of an assortment of rods, set-screws, cross connectors, multi-axial screws, plates, bone screws and Songer Cables.

This document is a 510(k) Premarket Notification for the Blackstone™ Posterior Cervical System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a diagnostic or AI-driven aid.

Therefore, many of the requested categories (e.g., acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

The primary "study" presented here is a comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of the information that is available or can be inferred, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

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 submission is for a medical device (spinal implant) and relies on substantial equivalence to a predicate device, not on a clinical "test set" of patients or data in the context of a diagnostic or AI study. The "test" is a comparison of design, materials, and intended use against an already cleared device.

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. No "ground truth" establishment by external experts for a test set is described in this type of submission for a spinal implant. The FDA itself (specifically, the Division of General, Restorative and Neurological Devices) reviews the submission and determines substantial equivalence based on the provided documentation, which details the device's characteristics and comparison to the predicate.

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

• Not Applicable. No adjudication method for a test set is described. The determination of substantial equivalence is made by the FDA reviewer(s) based on the submitted materials.

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 is a mechanical device (spinal implant), not a diagnostic tool or AI-assisted system. MRMC studies are irrelevant here.

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

• Not Applicable. This is a mechanical device, not an algorithm.

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

• Not Applicable. For this type of submission, the "ground truth" for demonstrating safety and effectiveness is largely established by the predicate device's prior FDA clearance and its demonstrated history of safe and effective use. The new device then needs to demonstrate that it is sufficiently similar in design, materials, intended use, and performance characteristics to the predicate.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, not an AI or diagnostic system that requires a "training set."

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

• Not Applicable. See point 8.

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