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When used without cement, the CD HORIZON Fenestrated Screws (with or without SEXTANT® or LONGITUDE® instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with KYPHON HV-R™ Fenestrated Screw Bone Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON™ Fenestrated Screws augmented with KYPHON HV-R™ Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON™ LEGACY™ and CD HORIZON™ SOLERA™ implants contained in the CD HORIZON™ Spinal System. The CD HORIZON™ Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON™ Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These implants may also serve as traditional pedicle screws when used without bone cement. These screws are provided non-sterile.

This document is a 510(k) premarket notification for a medical device called the "CD HORIZON™ Fenestrated Screw Set." It describes the device's indications for use, its comparison to predicate devices, and provides a summary of the reasons for its substantial equivalence determination.

Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way one would describe a performance study for an AI/algorithm-driven device. The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for medical devices in the United States.

Therefore, many of the requested points regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be answered from the provided text because the 510(k) submission for this mechanical medical device (spinal screws) does not typically involve such studies as would be performed for a diagnostic or AI-powered device.

Here's a breakdown of what can be inferred from the document regarding "acceptance criteria" in the context of this device, even though it's not a direct answer to the prompt's implied AI/algorithm context:

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

The "acceptance criteria" for this mechanical device are typically based on demonstrating equivalent mechanical and material properties to a legally marketed predicate device. The document does not provide a table with specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) because it's not an AI or diagnostic device.

Instead, the "performance data" mentioned is:

• "Non-Clinical mechanical testing of the subject fenestrated screws demonstrating substantial equivalence to the traditional pedicle screws found in the predicate CD HORIZON® Spinal System was previously provided in K152604."

This implies the "acceptance criteria" were related to achieving mechanical performance (e.g., strength, fatigue life, torsional stability) that was demonstrably comparable to the predicate devices. The reported device performance is that these tests showed "substantial equivalence."

2. Sample used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

These questions are not applicable to the type of device and regulatory submission presented. This is a spinal implant, not an AI or diagnostic tool. The "testing" involved non-clinical mechanical testing, not a clinical study with human readers or ground truth established by experts in a diagnostic sense.

8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are not applicable as there is no "training set" or "ground truth" in the context of an AI/algorithm for this mechanical device.

Summary based on the document's content:

• Device Type: CD HORIZON™ Fenestrated Screw Set, a mechanical spinal implant.
• Regulatory Pathway: 510(k) Premarket Notification based on "substantial equivalence."
• Nature of "Acceptance Criteria" / Performance Demonstrations: Focused on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices in terms of mechanical properties and material characteristics.
• Study Proving Device Meets Criteria: While the document states "Non-Clinical mechanical testing... was previously provided in K152604," it does not detail the specifics of that testing or its sample size within this document. The "proof" is the demonstration of substantial equivalence through this mechanical testing.
• Applicability of AI/Algorithm-Specific Questions: Not applicable to this type of medical device submission.

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