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The Pioneer Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Pioneer Anterior Cervical Plate System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document is a 510(k) summary for a medical device called the "Pioneer Anterior Cervical Plate System." It does not contain information about acceptance criteria or a study that proves the device meets such criteria in the way you've described for an AI/algorithm-based device.

Here's why and what kind of information is present:

• Device Type: The Pioneer Anterior Cervical Plate System is a physical implant (plates and screws) used for spinal fixation. It is not an AI/algorithm-based device.
• 510(k) Process: The 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria through clinical or analytical studies in the same way an AI/software device would.
• Performance and SE Determination: The document states, "Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence." This means the manufacturer presented data comparing their new device to existing, already-cleared devices, arguing that it performs similarly. This typically involves mechanical testing or design comparisons, not studies with "test sets," "ground truth," or "expert adjudication" in the AI sense.

Therefore, I cannot populate the table or answer the specific questions you've posed because the provided text describes a different type of medical device clearance process for a physical implant, not an AI software.

What is present in the document:

• Device Name: Pioneer Anterior Cervical Plate System
• Intended Use/Indications for Use: Anterior cervical fixation for degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion.
• Predicate Devices: K053053 and K043066 (other Pioneer Anterior Cervical Plate Systems)
• Classification: Spinal Intervertebral Body Fixation Orthosis, Class II (21 CFR 888.3060)

If you have a document describing an AI/algorithm-based medical device, I would be happy to help extract the requested information.

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The Pioneer Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Pioneer Anterior Cervical Plate System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

I am sorry. The provided text is a 510(k) summary for a medical device (Pioneer Anterior Cervical Plate System) and focuses on establishing substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined for performance studies.

The document states: "Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence." This indicates that the approval was based on demonstrating similarity to an already approved device (PACP - K043066), rather than a de novo study with specific performance metrics and acceptance criteria.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is typically found in submissions for novel devices or those with specific performance claims requiring clinical or bench testing beyond demonstrating substantial equivalence to a predicate.

Ask a specific question about this device