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The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracolumbar spine (T1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in sketally mature patients in the treatment of the following:

• · 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)

• · Pseudoarthrosis
• · Spondylolysis
• · Spondylolisthesis
• · Scoliosis
• · Lordotic deformities of the spine
• · Spinal stenosis
• · Failed previous spine surgery

The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of thoracic, lumbar, and sacral plates and screws. The plates attach to the thoracic, lumbar, and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi).

This document is a 510(k) premarket notification for a medical device called the Z-Span Plate System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the provided text does not contain information about acceptance criteria or a study proving that a software device meets acceptance criteria. Instead, it focuses on the Z-Span Plate System, which is an implantable orthopedic device for spinal fixation. The "Performance Data" section specifically mentions mechanical testing (static and dynamic axial compression bending testing and static torsion testing) according to ASTM F1717, which is relevant for the physical properties of surgical implants, not for the performance of a software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for a software device, its reported performance, sample sizes, ground truth establishment, or expert adjudication. The document pertains to a physical medical implant, not a software device.

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The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:
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)
Pseudoarthrosis
Spondylolysis
Spondylolisthesis
Scoliosis
Lordotic deformities of the spine
Spinal stenosis
Failed previous spine surgery

The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the lumbar and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi)

This is a 510(k) premarket notification for a spinal implant, not a medical device software. Therefore, the request for information on acceptance criteria and study proving device meets criteria is not applicable in the context of AI/ML software.

The document describes the Z-Span Plate System, a physical spinal fixation device.

Here's why the AI/ML specific questions are not relevant:

• No AI/ML Component: The submission focuses on mechanical testing, materials, and design of a physical implant. There is no mention of any software component, AI, or machine learning.
• Performance Data: The performance data presented refers to mechanical testing (static and dynamic axial compression bending testing and static torsion testing) conducted in accordance with ASTM F1717, comparing the device to a predicate device. This is standard for orthopedic implants, not software.
• Ground Truth, Training/Test Sets, Experts: These concepts are specific to evaluating diagnostic or predictive AI/ML algorithms, where the algorithm's output is compared against a "ground truth" established by experts or other definitive methods. They do not apply to the mechanical performance evaluation of a spinal plate.

Therefore, I cannot provide answers to the requested questions as they are designed for AI/ML medical devices, and this document pertains to a physical orthopedic implant.

Ask a specific question about this device

The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).

The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in skeletally mature patients in the treatment of the following:

• 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)
• Pseudoarthrosis
• Spondylolysis
• Spondylolisthesis
• Scoliosis
• Lordotic deformities of the spine
• Spinal stenosis
• Failed previous spine surgery

The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the lumbar and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi)

The provided document describes a 510(k) premarket notification for a medical device called the "Z-Span Plate System." This document is a regulatory approval notice from the FDA, not a research study report with detailed acceptance criteria and performance data in the context of a clinical trial or AI model evaluation.

Therefore, many of the requested sections about acceptance criteria, study design, expert involvement, and ground truth are not applicable or cannot be extracted from this type of document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.

Here's what can be extracted and what cannot:

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

Note: The specific quantitative acceptance criteria (e.g., minimum load, fatigue cycles) and the exact performance values are not provided in this summary. It only states that the device "performs as well as or better than" the predicate device based on ASTM F1717 standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing mentioned is mechanical testing, not a clinical study on human subjects with a "test set" in the sense of patient data.

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)

This information is not applicable/not provided. The "ground truth" here refers to the performance of the device in mechanical tests, which is measured objectively, not adjudicated by experts in the context of clinical outcomes.

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

This information is not applicable/not provided. Adjudication methods are relevant for subjective assessments, typically in clinical trials. Mechanical testing results are objective measurements.

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 information is not applicable. This device is a spinal implant, not an AI diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the mechanical testing is the objective measurement of the device's physical properties and performance against established ASTM F1717 standards, and comparison to the predicate device's performance under those same standards.

8. The sample size for the training set

This information is not applicable/not provided. This is not a machine learning model, so there is no "training set."

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

This information is not applicable/not provided. There is no "training set" for this physical device.

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