(97 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 titanium alloy (Ti-6Al-4V) conforming to ASTM F136. 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 a 510(k) submission for the Life Spine PLATEAU® Spacer System Titanium. This is an intervertebral body fusion device, and the submission primarily focuses on demonstrating its substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria for a new, unproven technology.
Therefore, many of the requested categories related to acceptance criteria and performance studies (like sample size for test sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for training) are not applicable to this type of submission.
Here's a breakdown based on the information provided:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated for performance, but implied for substantial equivalence) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | |
| - Indications for Use (Match predicate) | - Equivalent indications to predicate devices. |
| - Design (Comparable to predicate) | - Comparable design to predicate devices. |
| - Function (Comparable to predicate) | - Comparable function to predicate devices. |
| - Materials used (Comparable to predicate) | - Titanium alloy (Ti-6Al-4V) conforming to ASTM F136, similar to material in predicate devices. |
| - No new worst-case performance | - Engineering analysis presented to demonstrate no new worst-case performance. |
Details specifically requested about a "study":
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission relied on engineering analysis and comparison to predicate devices, not a clinical performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth was established by experts for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process as described 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 is a physical intervertebral body fusion 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 is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For this type of device, "ground truth" generally refers to the established safety and effectiveness of the predicate devices. The "truth" for this submission is that its design, materials, and intended use are similar enough to already cleared devices.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an algorithm was used.
Summary of the "study" for this device:
The "study" presented for the PLATEAU® Spacer System Titanium was an engineering analysis to demonstrate that the addition of titanium components "does not present a new worst case in performance and is substantially equivalent to the predicate systems." This means the company performed tests and analyses (e.g., mechanical, biocompatibility, design comparisons) to show that the titanium version behaves safely and effectively like the existing, cleared versions of their device and other predicate devices, without introducing new risks or performance issues. The FDA's determination of "substantial equivalence" is the "acceptance criteria" being met here.
§ 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.