Search Results

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), posttraumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.

The ABC Cervical Extension Plate is used to extend the existing anterior stabilization plate (K974706) and Anterior Cervical Screw Spinal Fixation System (K000486).

The ABC E-Plates are exclusively used to extend an existing anterior stabilization plate on the cervical spine, which has been carried out using the ABC system. The E-Plate allows a mono-segmental or bi-segmental extension at the cranial or caudal end of the existing ABC plate.

The provided document is a 510(k) premarket notification for a medical device called the "ABC Caudal and Cranial Extension Plate." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/ML device evaluations. Therefore, a direct response to your request for acceptance criteria and study details (like sample sizes, expert qualifications, etc.) for a performance study proving the device meets those criteria is not present in the document.

The document states:

• "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This explicitly indicates that there are no pre-defined performance standards or acceptance criteria that this device is being tested against in a formal performance study in the way an AI/ML device would be.
• The entire submission hinges on demonstrating "SUBSTANTIAL EQUIVALENCE" to existing, legally marketed predicate devices.

Therefore, many of the requested fields cannot be filled as they pertain to a type of performance study that was not conducted or presented in this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

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

2. Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical data of this nature is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert consensus is mentioned as part of a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No 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: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth is discussed in the context of a performance study.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary based on the document:

This 510(k) submission successfully demonstrated that the ABC Caudal and Cranial Extension Plate is substantially equivalent to legally marketed predicate devices. The basis for this determination is:

• Indications for Use: The device shares the same intended use as the predicate devices, which is for stabilizing the cervical spine due to conditions like degenerative disc disease, trauma, tumors, and failed fusions (C2-T1).
• Technological Characteristics: The ABC Cervical Extension Plate is designed to extend existing anterior stabilization plates from the ABC system, indicating a similar mechanism of action and materials to the existing ABC plates and screws (K974706 and K000486), which were the primary predicate devices.
• Performance Data: The document explicitly states "No performance standards have been promulgated... The new ABC System conforms with those and the Guidance for Spinal System 510(k)." This means a formal performance study with predefined acceptance criteria was not required or conducted as part of this 510(k) in the way a novel device or AI/ML product would need. Instead, the equivalence pathway relies on the safety and effectiveness profile of the predicate devices.

The FDA's decision letter confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

Predicate Devices for Substantial Equivalence:

• Aesculap's existing Anterior Cervical Spine Plates and Screws (K974706)
• Aesculap's Anterior Cervical Screw Spinal Fixation System (K000486)
• Osteonics Anterior Cervical Compression Plating System, Line Extension - Howmedica Osteonics Corp. (K992344)
• Howmedica Osteonics Compression Plating System, Cortical Screws – Howmedica Osteonics Corp. (K993181)

Ask a specific question about this device