(26 days)
The Plateau Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The Plateau Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau Spacer System components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.
This 510(k) summary (K121116) describes the PLATEAU®-X Spacer System, an intervertebral body fusion device. The submission is for a line extension to add a Lateral implant offering.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K080411, K071795, K112496) in indications for use, material, and basic design. | An engineering analysis was presented to show that the line extension (Lateral implant) does not impose a new worst-case scenario and is therefore substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a test set of data or participants. The evaluation for substantial equivalence was based on engineering analysis rather than human performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study involving human readers or a test set requiring expert ground truth was conducted.
4. Adjudication method for the test set
Not applicable, as no clinical study involving human readers or a test set was conducted.
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 device is an implantable medical device, not an AI-assisted diagnostic tool.
6. 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 algorithm. The "standalone" performance here refers to the device's mechanical and material properties, which were assessed via engineering analysis.
7. The type of ground truth used
The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices. The study aimed to demonstrate that the new device (line extension) is substantially equivalent to these predicates, meaning it performs similarly and does not introduce new safety or effectiveness concerns. The method used was an engineering analysis comparing the new design to existing predicates.
8. The sample size for the training set
Not applicable, as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/algorithm-based device.
§ 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.