(264 days)
A-CIFT™ SoloFuse™ is intended for stand-alone use for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The A-CIFT™ SoloFuse™ system must be used with the internal bone screws for fixation. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one level from the C2-C3 disc to the C7-T1 disc. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Degenerative Disc Disease is defined as discogenic pain with degeneration of the disc confirmed by a history and radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to the treatment with an intervertebral spacer.
The A-CIFT™ SoloFuse™ consists of a PEEK or PEEK-OPTIMA HA Enhanced spacer with titanium bone screws for intervertebral body fusion. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine. The A-CIFT™ SoloFuse™ PEEK-OPTIMA HA Enhanced implants are provided sterile and irradiated by gamma radiation. The A-CIFT™ SoloFuse™ PEEK implants are provided non-sterile with instructions for sterilization. The lordotic and non-lordotic PEEK or PEEK-OPTIMA HA Enhanced spacers are provided in various sizes. The lag and rigid screws are offered in various diameters and lengths.
This document is a 510(k) premarket notification for a medical device called A-CIFT™ SoloFuse™, an intervertebral body fusion device. The purpose of this submission is to introduce a new material (PEEK-OPTIMA HA Enhanced) for an already cleared device.
Based on the provided text, there is no information about acceptance criteria or a study demonstrating the device meets such criteria in terms of clinical performance or algorithm performance. The document focuses on showing substantial equivalence to a predicate device, primarily through a change in material and a "Failure Effects Analysis" (FEA) instead of mechanical testing.
Here's an analysis of what information is not present related to your request:
- A table of acceptance criteria and the reported device performance: This is not provided. The submission focuses on substantial equivalence based on design changes (material), not a new performance evaluation against specific criteria.
- Sample size used for the test set and the data provenance: Not applicable as no new performance testing study is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document states, "No performance testing is being included as part of this submission."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implantable medical device, not an AI/algorithm-based diagnostic or therapeutic tool.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The submission for the A-CIFT™ SoloFuse™ is a 510(k) premarket notification to introduce a new material (PEEK-OPTIMA HA Enhanced) for an existing device. It relies on the concept of substantial equivalence to previously cleared predicate devices (K151198 and K142026).
The document explicitly states: "No performance testing is being included as part of this submission. Failure Effects Analysis (FEA) was used in lieu of mechanical testing to show substantial equivalence to the previously cleared design."
Therefore, the submission does not include:
- Acceptance criteria for device performance.
- New studies with test sets, training sets, expert ground truth establishment, or MRMC studies.
Instead, the conclusion is based on "overall technology characteristics and mechanical performance data" (which, for this submission, appears to be primarily the FEA and comparison to the predicate) leading to the conclusion that the device is "safe and effective and substantially equivalent to the previously cleared product."
§ 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.