(315 days)
The distractable WAVE PLIF Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Distractable WAVE PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The distractable WAVE PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The distractable WAVE cage is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6' lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs. The distractable WAVE cage is different from the previously cleared WAVE by the ability to distract the implant and restore disc height. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications).
The provided text describes a medical device, the "Distractable WAVE Cage," and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, device performance, results from a study proving it meets acceptance criteria, sample sizes, data provenance, expert-established ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document only describes:
- Device Name: Distractable WAVE Cage
- Submitter and Contact Information
- Trade Name, Common Name, Classification Name, and Product Code
- Predicate Devices
- Device Description: Rectangular, trapezoidal cross-section, neutral and 6° lordosis options, posterior threaded hole, solid tapered end, implanted in pairs, ability to distract and restore disc height.
- Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026)
- Intended Use/Indications for Use: Intervertebral body fusion for skeletally mature patients with DDD of the lumbar spine (L2-S1) at 1 or 2 contiguous levels, with or without up to Grade 1 spondylolisthesis/retrolisthesis. To be used with autogenous bone graft, implanted via open posterior approach, and with supplemental fixation. Patients must have 6+ months of non-operative treatment.
- Comparison to Predicate Devices: Similar indications, material, and design.
- Summary of Nonclinical Tests: States that tests performed according to ASTM F2077/F2267 indicate the device meets required mechanical strengths.
- FDA Clearance Information: Confirmation of substantial equivalence and general controls provisions.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because this information is not present in the provided text. The "study" mentioned is "Nonclinical Tests" that confirm mechanical strength without providing details on specific acceptance criteria or performance metrics.
§ 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.