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The Verticor K-Wire System is intended for use in fixation of bone fractures, fusion of joints or bone reconstruction, for osteotomies in the presence of adequate immobilization and as guide pins for insertion of other implants.

K-wires are sharpened or blunt, smooth stainless steel pins. They come in different sizes and are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction. To ensure the multi-use of these devices, many different models are available. Threaded K-wires are available for situations where backing out of the pin is undesirable.

The provided text describes a 510(k) Summary for the Verticor K-Wire System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed acceptance criteria and a study to prove that a device meets those criteria in the same way one would for a novel device or software.

In the context of a 510(k), "acceptance criteria" are implied by the features and characteristics that need to be demonstrated as substantially equivalent to the predicate device. The "study that proves the device meets the acceptance criteria" is the substantial equivalence comparison and non-clinical testing rather than a traditional clinical study with defined performance metrics for the novel device.

Here's an analysis based on the provided text, structured to answer your questions as best as possible within the constraints of a 510(k) summary for a K-wire system:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for K-wires in a 510(k) filing primarily revolves around demonstrating that the new device is as safe and effective as its predicate. This is achieved by showing comparable design, materials, function, and intended use. The table below outlines the key comparative features and notes on the Verticor K-Wire System's performance in relation to these accepted characteristics.

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

• Sample Size: Not applicable in the traditional sense of a clinical or performance study with a test set. This 510(k) relies on a comparison to predicate devices, supported by non-clinical verification of material and dimensional specifications.
• Data Provenance: Not applicable for a comparative equivalence submission of this nature. The "data" are the specifications and characteristics of the predicate devices already legally marketed in the U.S. and the specifications of the new device.

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

Not applicable. Ground truth, in this context, would be the established safety and effectiveness of the predicate devices, which is accepted by their prior 510(k) clearances. No new "ground truth" was established by experts for the Verticor K-Wire System for the purpose of this submission beyond the regulatory review process itself.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a K-wire, which is a physical surgical instrument, not an AI or imaging diagnostic tool that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices (KMedic External Fixation Devices K030336 and SMT Schilling Kirschner/Guide Wires K100736), as accepted by their prior FDA clearances. The Verticor K-Wire System aims to demonstrate substantial equivalence to this pre-existing "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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The VENUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

• degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• spondylolisthesis,
• trauma (i.e. fractures or dislocations),
• tumors,
• deformity (defined as kyphosis, lordosis, or scoliosis),
• pseudarthrosis,
• failed previous fusion,
• spinal stenosis.

WARNING: The VENUS Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The VENUS Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with selftapping and self-drilling bone screws using an anterior approach. Plates are available in a variety of lengths, addressing multiple levels of fixation. Bone screws are available for fixed angle or variable angle implantation in a variety of lengths and diameters. Each screw head forms an autogenic lock to the plate upon insertion, requiring no additional locking mechanism.

Materials:
The plates and screws are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136. The screw retainer clip is fabricated from medical grand nitanol SE 508.

The request asked for information about the acceptance criteria and the study that proves the device meets the acceptance criteria, but the provided text describes a 510(k) summary for a medical device (VENUS Anterior Cervical Plate) and does not include information about an AI/ML device or its performance studies. Therefore, I cannot generate the requested information based on the input provided.

This document describes a medical device called the VENUS Anterior Cervical Plate, which is a traditional, physical implant. It is not an AI/ML device, and thus, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML performance (e.g., sensitivity, specificity, F1 score, MRMC studies, training/test sets, ground truth establishment) are not applicable to this submission.

The "Non-clinical Test Summary" states that "Tests performed according to ASTM F2077 indicate that the VENUS Anterior Cervical Plate meets required mechanical strengths." This refers to mechanical testing standards for implants, not AI/ML performance.

The "Clinical Test Summary" explicitly states, "No clinical studies were performed."

Therefore, I cannot fulfill the request to provide information about the acceptance criteria and study proving the device meets them in the context of AI/ML device performance for the given text.

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The Samson Corpectomy System is a vertebral body replacement system indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The Samson Corpectomy System is intended for use with supplemental fixation and is to be used with autograft and/or allograft.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Verticor, LTD regarding the Samson Corpectomy System. This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document discusses:

• The FDA's review of the 510(k) submission.
• A determination of "substantial equivalence" to a predicate device.
• Regulatory requirements for the device (e.g., registration, labeling, manufacturing practices).
• Contact information for various FDA offices.
• The indications for use for the Samson Corpectomy System.

There is no mention of specific performance metrics, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as would be required to answer the questions posed.

Therefore, I cannot provide the requested information based on the given input.

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