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The Osteonics® ACCP System is intended for anterior intervertebral screw fixation of the cervical spine for the following indications:

• degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• decompression of the spinal cord following total or partial cervical vertebrectomy .
• trauma (fractures) .
• tumors
• pseudarthrosis .
• · failed previous fusions

The Osteonics® ACCP System is an anterior cervical plate that incorporates a one-piece monoblock design, or a two- or three-piece modular design, depending on plate length, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. Optional bone graft screws are also available for insertion through the center screw hole of the modular plate designs. The Osteonics® ACCP is placed logitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. The Osteonics® ACCP is available in lengths ranging from 24mm to 100mm. A slotted locking screw hole on the proximal and distal end of each preassembled plate allows the surgeon to adjust the plate in order to apply compression to a specific area along the cervical spine, thus optimizing the compressive forces which aid in achieving a successful fusion. Locking screws are firmly tightened after the surgeon has adjusted the plate to the desired level of compression. All Osteonics® ACCP System components are manufactured from ASTM F-136-96 titanium alloy.

The provided text indicates that the Osteonics® ACCP System (Anterior Cervical Compression Plating System) was cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device, specifically anterior cervical plates offered by Synthes. This means the primary "acceptance criteria" and the "study that proves the device meets the acceptance criteria" largely revolve around this concept of substantial equivalence rather than a detailed performance study with quantitative metrics for the Osteonics® ACCP System itself.

Here's a breakdown of the requested information based on the provided text, highlighting what is implicitly or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for a 510(k) submission is substantial equivalence to a predicate device.

Note: For 510(k) submissions, the acceptance criteria are not typically expressed as numerical performance targets (e.g., "fusion rate > 90%") for the new device, but rather as demonstrating that the device is as safe and effective as a legally marketed predicate device (which presumably met such standards in its own approval process).

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

The provided document does not describe a clinical performance study with a distinct "test set" and sample size for the Osteonics® ACCP System. The submission relies on a comparison to a predicate device to establish substantial equivalence. Therefore, there is no information on:

• Sample size for a test set
• Country of origin of data
• Retrospective or prospective nature of data

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

Since no clinical "test set" or performance study for the Osteonics® ACCP System is described, there is no information on:

• Number of experts used to establish ground truth
• Qualifications of those experts

4. Adjudication Method for the Test Set

As no clinical "test set" or performance study is described, there is no information on an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. This type of study is more common for diagnostic imaging AI devices, whereas this submission is for a medical implant (anterior cervical plate).

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

Not applicable. The Osteonics® ACCP System is a physical medical implant, not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" essentially comes from the established safety and effectiveness of the predicate device (Synthes anterior cervical plates) and clinical experience with similar devices. The regulatory pathway relies on demonstrating that the new device is sufficiently similar to the predicate that it can be assumed to operate with the same level of safety and effectiveness, leveraging the existing "ground truth" of the predicate. No specific pathology, outcomes data, or expert consensus was directly established for a new clinical trial concerning the Osteonics® ACCP System within this submission.

8. The Sample Size for the Training Set

The provided document does not describe a training set in the context of an algorithm or AI. It describes a physical medical device.

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

Not applicable, as there is no training set mentioned for this physical device.

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