(91 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-C Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.
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 conforming to ASTM F2026 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 with components from any other system or manufacturer. The Plateau Spacer System components should never be reused under any circumstances.
The provided text describes the "Plateau Spacer System" as an intervertebral body fusion device. The performance data section indicates that the device's substantial equivalency was demonstrated through static and dynamic testing in compression and torsion, in accordance with ASTM F2077. This establishes the acceptance criteria.
However, the document does not contain information on the following points:
- Reported device performance: While it states testing was done, specific performance metrics (e.g., failure loads, displacement limits) are not reported.
- Sample size used for the test set and data provenance: No details are provided regarding the number of samples tested or where the test materials or data originated.
- Number of experts and their qualifications for ground truth: This is not applicable as the "study" is a laboratory-based biomechanical test, not a clinical study involving expert interpretation.
- Adjudication method for the test set: Not applicable for a biomechanical test.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as this is not a study involving human readers or AI.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical device, not an algorithm.
- Type of ground truth used: For a biomechanical test, the "ground truth" would be the engineering specifications and the established parameters of the ASTM F2077 standard.
- Sample size for the training set: Not applicable for a physical device undergoing biomechanical testing. The concept of "training set" is relevant for AI/machine learning models.
- How the ground truth for the training set was established: Not applicable for a physical device.
Here's the information that can be extracted into a table based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Substantial Equivalency) | Reported Device Performance |
|---|---|
| Static and dynamic testing in compression and torsion | Performed in accordance with ASTM F2077 |
| Showed substantial equivalency to predicate devices in: | |
| - Indications for use | |
| - Design | |
| - Function | |
| - Materials used |
Further details not available in the provided text:
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (biomechanical testing).
- Adjudication method for the test set: Not applicable (biomechanical testing).
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
- The type of ground truth used: Engineering specifications and parameters defined by ASTM F2077.
- The sample size for the training set: Not applicable (biomechanical testing).
- How the ground truth for the training set was established: Not applicable (biomechanical testing).
§ 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.