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The NuVasive® ACP System is intended for anterior screw fixation of the cervical spine C2-C7 for the following indications: 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, failed previous fusion, spondylolisthesis, and spinal stenosis.

The NuVasive ACP System is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or ISO 5832-3.

The provided document is a 510(k) summary for the NuVasive® ACP System, an anterior cervical plating system. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to previously cleared devices.

1. Table of acceptance criteria and the reported device performance

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

The document does not detail specific sample sizes for the mechanical testing. It refers generally to "testing" and "studies" but doesn't quantify the number of units tested. The data provenance is not explicitly stated as retrospective or prospective, but given it's mechanical testing of a new device for regulatory submission, it would inherently be a prospective testing program. The country of origin of the data is implied to be the US, where the manufacturer is located and the regulatory submission is made.

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

This section is not applicable. The study described is nonclinical mechanical testing, not a clinical study involving human or expert evaluation for ground truth.

4. Adjudication method for the test set

This section is not applicable. Mechanical testing does not involve 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 section is not applicable. The document describes nonclinical mechanical testing, not an MRMC study or AI-assisted interpretation.

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

This section is not applicable. The document describes mechanical testing of a medical implant, not an algorithm or AI.

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

The "ground truth" for this nonclinical study is the performance thresholds defined by the ASTM F1717 standard and the performance of the predicate devices. The device's mechanical properties were tested against these established criteria.

8. The sample size for the training set

This section is not applicable. This is a nonclinical mechanical testing study, not a machine learning study that would have a training set.

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

This section is not applicable. This is a nonclinical mechanical testing study, not a machine learning study.

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The NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Camber Laminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.

The NuVasive® Camber Laminoplasty System consists of plates and screws of various sizes made from titanium alloy (ASTM F136) to provide reinforcement while expanding the spinal canal and preserving the posterior elements. Instruments required to implant the device are also available.

This document describes the FDA 510(k) clearance for the NuVasive® Camber Laminoplasty System. This is a medical device, not an AI/ML imaging device, so the typical acceptance criteria and study designs for AI/ML devices (e.g., MRMC studies, standalone performance, ground truth establishment for AI training/testing data) are not applicable here.

Therefore, the response below will describe the device-specific acceptance criteria and the methods used to prove the device meets these criteria, based on the provided text, while explicitly stating that AI/ML specific criteria were not relevant for this device.

Acceptance Criteria and Study Proving Device Meets Criteria for NuVasive® Camber Laminoplasty System

The NuVasive® Camber Laminoplasty System is a spinal implant device cleared through the FDA's 510(k) pathway. The core acceptance criterion for this pathway is demonstration of substantial equivalence to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. For devices like this, performance is primarily assessed through non-clinical, bench-top mechanical testing rather than AI/ML specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

• Axial Pullout (per ASTM F2193)
• Static 3-Point Bend
• Dynamic 3-Point Bend
  The results demonstrate that the subject Camber Laminoplasty System meets the same criteria as the predicate devices. |

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

• Sample Size: Not specified as "sample size" in the context of human data or imaging data. For mechanical testing, the number of test specimens (e.g., number of plates/screws tested) would typically be defined by the test standard (e.g., ASTM F2193) and internal protocols. The document does not provide the specific number of units tested.
• Data Provenance: The studies were non-clinical, bench-top tests performed by the manufacturer, NuVasive, Incorporated. The provenance is internal engineering lab testing. These tests are not retrospective or prospective in the sense of clinical studies.

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

• This question is not applicable as the device is a mechanical implant, not an AI/ML imaging device. There were no "experts" establishing ground truth in the sense of image interpretation for AI. Device performance was assessed via engineering specifications and mechanical testing standards.

4. Adjudication Method for the Test Set

• This question is not applicable for the same reasons as #3. Performance was measured objectively through mechanical tests (e.g., force, displacement), not through human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable. This describes an AI/ML imaging device study. The NuVasive® Camber Laminoplasty System is a physical medical implant. No MRMC study was conducted.

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

• This question is not applicable. This refers to AI/ML algorithm performance. The device is a mechanical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is defined by established mechanical engineering standards and criteria relevant to spinal implants (e.g., ASTM F2193, and criteria for static and dynamic bend tests). The device had to demonstrate it met these pre-defined engineering criteria, which are derived from the biomechanical requirements for such implants. There was no clinical outcomes data, pathology, or expert consensus used as "ground truth" in the way it's used for AI/ML diagnostic devices.

8. The Sample Size for the Training Set

• This question is not applicable. There was no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There was no "training set."

Summary of Relevant Information from the Document:

• Device Type: Spinal interlaminal fixation orthosis (mechanical implant).
• Regulatory Pathway: 510(k) Premarket Notification.
• Primary Evidence for Clearance: Demonstration of substantial equivalence through comparison of intended use, technological characteristics, and non-clinical performance data (mechanical testing) against legally marketed predicate devices.
• Key Tests Conducted: Axial Pullout (per ASTM F2193), Static 3-Point Bend, Dynamic 3-Point Bend.
• Conclusion: The device was found to be substantially equivalent to the predicate devices, meeting the necessary mechanical performance criteria. No clinical studies were required or conducted.

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