(57 days)
The PEEK-OPTIMA® ALIF Spacer is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The PEEK-OPTIMA® ALIF Spacer is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
The PEEK-OPTIMA® ALIF Spacer is a contoured device constructed of Polyetheretherketone (PEEK) medical grade, for spinal applications, inserted into the intervertebral body space of the lumbosacral spine for intervertebral body fusion.
This 510(k) summary describes a medical device, the PEEK-OPTIMA® ALIF Spacer, which is an intervertebral body fusion device. The document focuses on establishing substantial equivalence to previously cleared predicate devices through a comparison of device characteristics and mechanical testing.
Crucially, this document does not describe acceptance criteria, performance data, or a study related to the device's diagnostic or predictive capabilities. Since this is an implantable surgical device, its approval is based on its material properties, design, indications for use aligning with established medical practices, and demonstrable substantial equivalence to already approved devices through mechanical testing. The information provided in the prompt is specific to diagnostic or AI-driven medical devices, which is not applicable here.
Therefore, I cannot populate the table or answer the questions as the provided document does not contain information about acceptance criteria, device performance metrics, sample sizes for testing sets, ground truth establishment, expert adjudication, or any form of clinical study comparing reader performance with or without AI assistance.
The document's purpose is to demonstrate that the PEEK-OPTIMA® ALIF Spacer is substantially equivalent to existing, legally marketed predicate devices based on:
- Intended Use: For intervertebral body fusion in the lumbar spine for patients with degenerative disc disease.
- Design: A contoured device for intervertebral body space.
- Materials: Constructed of PEEK (Polyetheretherketone) medical grade.
- Operational Principles: Functions as a spacer to facilitate fusion with autograft and supplemental fixation.
- Mechanical Testing: The document states that "Based upon the mechanical testing, the PEEK ALIF is substantially equivalent for its intended use to other spacers currently on the market." (Specific details of the mechanical testing, including acceptance criteria and results, are not provided in this summary but would have been part of the full 510(k) submission).
In summary, the provided text describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, primarily through material and design characteristics, and mechanical testing, rather than algorithmic performance evaluation.
§ 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.