(55 days)
The Admiral ACP System is intended for anterior cervical fixation (C2-T1) 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 Admiral ACP System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Admiral plates include locking pins that cover the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the Admiral ACP System implant components are made from titanium alloy per ASTM F136. Associated instruments are available to facilitate the implantation of the device.
This document is an FDA 510(k) clearance letter for a medical device called the "Admiral ACP System." It primarily focuses on the regulatory aspects of the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
Key takeaway: This document explicitly states that the device demonstrated equivalent performance to the predicate system through mechanical testing and refers to ASTM F1717. It does NOT describe a study involving "human readers" or "AI assistance," nor does it present acceptance criteria related to diagnostic accuracy from image analysis.
Therefore, I cannot provide the information requested in terms of acceptance criteria and study details for an AI/human reader performance study because this document does not contain that information. The "study" referenced is a non-clinical mechanical test, not a clinical or diagnostic imaging study.
Here's an explanation based on the provided text, addressing why most of your requested points cannot be answered:
The provided document (K212139) is an FDA 510(k) clearance for the Admiral ACP System, which is a spinal intervertebral body fixation orthosis (a type of surgical implant for spinal fusion).
The "study that proves the device meets the acceptance criteria" in this context refers to mechanical (non-clinical) testing to demonstrate the structural integrity and performance of the implant, not an AI or diagnostic imaging study involving human readers or ground truth derived from image interpretation.
The document states:
- "The Admiral ACP System demonstrated equivalent performance to the predicate system through mechanical testing in static axial compression bending and torsion, and dynamic axial compression bending per ASTM F1717."
Given this, most of your specific questions are not applicable to the type of device and study described in this document.
However, I can extract what is relevant from the provided text:
Acceptance Criteria and Device Performance (Based on Mechanical Testing)
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | Demonstrated equivalent performance to the predicate system in: |
| - Static axial compression bending | |
| - Torsion | |
| - Dynamic axial compression bending | |
| Material Composition | Implants made from titanium alloy per ASTM F136. |
| Substantial Equivalence | Found substantially equivalent to cited legally marketed predicate devices primarily K202064 and K173521 (both also from SeaSpine Orthopedics). |
Information Not Available (as the document describes mechanical testing, not an AI/human reader study)
The following information cannot be extracted from the provided 510(k) clearance letter because it pertains to a mechanical medical device, not a diagnostic imaging AI and/or human reader study:
- Sample size used for the test set and data provenance: Not applicable. This refers to physical test specimens for mechanical properties, not clinical image datasets.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for mechanical testing would involve engineering specifications and direct measurement, not expert image interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is typically the established engineering standards (e.g., ASTM F1717) and the measured physical properties of the device compared to those standards and the predicate device.
- The sample size for the training set: Not applicable. This is for mechanical testing, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.