(298 days)
The Alta ACDF System is a stand-alone cervical fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Alta ACDF System is to be filled with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material, and is to be used with titanium alloy screws which accompany the implant.
The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenous and/or allogeneic bone graft and the upper and lower surfaces have a series of transverse slots or grooves to improve stability and fixation once the device is inserted. The implants in this system are made of PEEK-OPTIMA®, Tantalum, and Titanium alloy (Ti-6AI-4V ELI). The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy.
The Alta ACDF System is intended for stand-alone use in cervical intervertebral body fusion and must be used with the titanium alloy screws which accompany the implant.
This Traditional 510(k) is being submitted to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the Alta ACDF System.
This document describes the 510(k) premarket notification for the "Alta ACDF System" which is an intervertebral body fusion device. The purpose of this submission is to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the existing Alta ACDF System.
Based on the provided text, there is no acceptance criteria or a study proving the device meets acceptance criteria in the traditional sense of a performance study for a new device or software. This submission is for an expanded indication for an existing device.
Here's why and what information is available:
This is not a submission for a new device requiring performance metrics against acceptance criteria. The "Alta ACDF System" itself was previously cleared (K112388). This 510(k) (K152622) is specifically to expand the indications for use to include allograft as a bone graft material.
Therefore, the submission states:
- "The changes proposed did not require non-clinical testing in order to demonstrate substantial equivalence to the predicate devices."
- "No changes are being made to the existing device as subject of this Premarket Notification, aside from the expanded indications; therefore, no additional testing was required or performed."
Instead of a new performance study with acceptance criteria, the manufacturer relies on demonstrating substantial equivalence to predicate devices and referencing published clinical data to support the safety and effectiveness of using allograft in similar devices.
However, I can extract information related to the rationale for the expanded indications:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied for Allograft Inclusion) | Reported Device Performance/Supportive Evidence |
|---|---|
| Safety and effectiveness of using allograft (cancellous and/or corticocancellous bone graft) in cervical interbody fusion. | "Published retrospective clinical data for cervical interbody fusion devices similar to the subject device was completed to support this Premarket Notification. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion poses no new risks to patients." |
The submission also asserts that expanding the indications to include allograft "does not raise new questions of safety and efficacy" given the similar intended use, indications, technological characteristics, and principles of operation to previously cleared predicate devices (K151064, which includes Solitaire®-C Cervical Spacer System, C-Thru™ Anterior Spinal System, and Breckenridge® Small Intervertebral Body Fusion System). |
2. Sample size used for the test set and the data provenance:
There was no dedicated "test set" for this submission as no new testing was performed on the device. Instead, the submission relies on "Published retrospective clinical data for cervical interbody fusion devices similar to the subject device." The specific sample size, country of origin, or how individual data points were selected from this published literature is not detailed in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new test set or ground truth established by experts for a performance study. Clinical outcomes were drawn from published retrospective data.
4. Adjudication method for the test set:
Not applicable. No new test set requiring adjudication was performed.
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 a spinal implant device, not an AI or imaging device involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a spinal implant device, not an algorithm.
7. The type of ground truth used:
For the expanded indication, the "ground truth" (or supporting evidence) for the safety and effectiveness of allograft in cervical fusion is based on published clinical outcomes from retrospective studies of similar cervical interbody fusion devices.
8. The sample size for the training set:
Not applicable. No training set was used as this involved no new performance study or algorithm training.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.