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The NuVasive Halo II Anterior Lumbar Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The NuVasive Halo II Anterior Lumbar Plate System consists of a series of plates and screws manufactured from Ti-6Al-4V per ASTM F-136 and ISO 5832-3. The plates also include components manufactured from Nitinol alloy SE508 per ASTM F2063.

Here's an analysis of the provided text regarding the NuVasive Halo II Anterior Lumbar Plate System, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "nonclinical testing" but does not specify the number of devices or components tested.
• Data Provenance: The studies are "nonclinical testing," meaning they are laboratory-based tests, not human or animal studies. The data is internal to the manufacturer (NuVasive, Inc.). It is retrospective in the sense that the tests were conducted prior to the 510(k) submission, but it's not clinical data.
• Country of Origin: United States (NuVasive, Inc. is based in San Diego, California).

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

• Number of Experts: Not applicable in the context of this device. The "ground truth" for this type of device (spinal implant) is established through engineering and material standards, and benchmark testing against predicate devices. The "experts" are the engineers and scientists who conducted and interpreted the mechanical and material tests, aligning with established ASTM and ISO standards.
• Qualifications of Experts: Not specified. However, by adhering to ASTM and ISO standards, it's implied that the personnel involved possess the necessary engineering and technical expertise.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. For mechanical performance testing of an implant, there isn't typically an "adjudication" process like there would be for image interpretation. The results are quantitative measurements compared against predefined engineering standards and predicate device performance benchmarks. The determination of whether the device "meets or exceeds" these standards is based on direct measurement and statistical analysis (though the specific statistical methods are not detailed).

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

• Was an MRMC study done? No.
• Effect size of human readers with vs. without AI assistance: Not applicable. This device is a physical spinal implant, not an AI-assisted diagnostic or decision-support system.

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

• Was a standalone study done? Not applicable. This device is a physical spinal implant, not an algorithm. The "standalone" performance here relates to its mechanical integrity and material properties, which were tested in a standalone manner (without a human implanting it into a patient during the test).

7. Type of Ground Truth Used

• Ground Truth: The ground truth for this device is primarily based on:
  • Engineering Standards: Established ASTM (F1717) and ISO (5832-3, F2063) standards for material properties and mechanical performance for spinal implants.
  • Predicate Device Performance: The demonstrated performance of legally marketed, substantially equivalent predicate devices (K072339 and K052546). The Halo II system needed to meet or exceed these established benchmarks.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• How Ground Truth was Established: Not applicable, as there is no training set for this device.

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The NuVasive Anterior Lumbar Plate System is indicated for use via the lateral or anterclateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The NaVasive Anterior Lumbar Plate System consists of a variety of plates and screws. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

This document is a 510(k) summary for a medical device (NuVasive Anterior Lumbar Plate System), and it does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML algorithm.

The document states:

• "Summary of Non-Clinical Tests: Mechanical testing was presented." This indicates that physical, engineering-based tests were performed on the device itself (the plate system), likely to assess its strength, durability, and other physical properties. This is typical for orthopedic implants.
• "Summary of Clinical Tests: (Not Applicable)." This explicitly states that no clinical trials were conducted for this submission. This is common for 510(k) submissions where substantial equivalence to a predicate device is demonstrated, meaning the new device is sufficiently similar to an already approved device that clinical trials are not deemed necessary.

Therefore, since the provided text relates to a physical medical implant and not an AI/ML device, the requested information about acceptance criteria, study design, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/ML algorithm is not present.

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