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The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion 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 Lateral 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.

The provided text is a 510(k) Premarket Notification for a Medical Device (NuVasive Lateral Plate System). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing for mechanical components. It does not typically involve the kinds of clinical studies or AI algorithm evaluations that would generate acceptance criteria and performance data as requested in the prompt.

Therefore, most of the requested information regarding acceptance criteria for device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set details for AI algorithms is not applicable to this specific document.

The document states:

• "Summary of Clinical Tests (Not Applicable)." This explicitly states no clinical tests were performed.
• "All mechanical testing performed in full compliance with ASTM F1717 was presented." This indicates the primary method of demonstrating performance was through mechanical testing against a standard.

Given this, I cannot provide the requested information from the provided text for most of the points.

Here's what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The device was tested in "full compliance with ASTM F1717". This ASTM standard would define the acceptance criteria for mechanical performance (e.g., fatigue strength, static strength) for spinal implant assemblies. However, the specific values of these criteria and the reported device performance against them are not provided in this summary document. The summary only states that the testing was performed in compliance.
• Reported Device Performance: Not detailed in the provided summary.

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 device underwent mechanical testing, not clinical data collection. Therefore, there is no "test set" in the context of clinical or AI performance evaluation. The term "sample size" would refer to the number of devices tested mechanically, which is not specified.

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. Ground truth, in the context of expert consensus, is relevant for clinical or AI studies. This device underwent mechanical testing.

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

• Not Applicable. No clinical or AI test set requiring adjudication was used.

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 not an AI device, and no clinical comparative effectiveness study was performed.

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

• Not Applicable. This is not an AI device.

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

• Not Applicable. The "ground truth" for mechanical testing is compliance with a specific industry standard (ASTM F1717).

8. The sample size for the training set

• Not Applicable. This is not an AI device, so there is no training set.

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

• Not Applicable. This is not an AI device, so there is no training set or associated ground truth establishment process.

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The NuVasive Lateral Plate System is indicated for use as an adjunct to fusion 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 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 Lateral Plate System consists of a variety of plates, screws, bolts, and lock nut. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

This NuVasive Lateral Plate System submission does not include any information about acceptance criteria or a study to prove the device meets acceptance criteria.

The provided documents consist of a 510(k) summary and the FDA's clearance letter for the NuVasive Lateral Plate System. These documents primarily cover:

• Device identification and classification: Trade name, common name, classification, and product code.
• Predicate devices: Stating that the device is substantially equivalent to previously cleared devices.
• Device description: Overview of components.
• Intended Use: The medical conditions and spinal regions for which the device is indicated.
• Substantial Equivalence: A statement that data was provided to demonstrate substantial equivalence based on indications, design, material, and function.
• Summary of Non-Clinical Tests: Mention of mechanical testing.
• Summary of Clinical Tests: Explicitly states "(Not Applicable)".
• FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text.

The document states "Summary of Clinical Tests (Not Applicable)", which indicates that no clinical study was performed or required for this 510(k) submission. The FDA clearance was based on substantial equivalence to predicate devices, supported by non-clinical (mechanical) testing.

Ask a specific question about this device

The NuVasive Lateral Plate System is indicated for use via the 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 Lateral Plate System consists of a variety of plates, screws, bolts, and locking nuts. Implant components can be rigidly locked to suit the individual pathology and anatomical conditions of the patient.

The provided text describes a 510(k) premarket notification for the NuVasive Lateral Plate System, which is a medical device. This document does not contain information about software with acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document pertains to a physical medical device (spinal implants) and focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing and comparison of indications for use, design, material, and function. There is no mention of an AI/ML device or software in this submission.

Ask a specific question about this device