Search Results

The Peekplus® Interbody Fusion Device ("Peekplus Device") is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Peekplus® devices are to be used with autogenous bone graft material and supplemental fixation.

The Peekplus® Interbody Fusion Device is manufactured for Vallum Corporation by Binder Biomedical. Inc. and is identical to the Intervertebral Body Fusion Device cleared in K093015. The Peekplus® is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Peekplus® also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Peekplus® is provided non-sterile.

This document is a 510(k) premarket notification for the "Peekplus® Interbody Fusion Device." The device is being cleared based on substantial equivalence to a predicate device, not on new performance studies. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria is not present in this document in the typical sense of a de novo performance study.

Here's a breakdown based on the provided text:

Summary of Device Acceptance:

The Peekplus® Interbody Fusion Device demonstrates substantial equivalence to the legally marketed predicate device (Binder Biomedical Inc. Intervertebral Body Fusion Device, K093015) by having:

• Identical intended use and indications for use.
• Identical technological characteristics and principles of operation.
• Identical materials and manufacturer (Binder Biomedical Inc. manufactures for Vallum Corporation).
• Same specifications, drawings, and labeling.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence determination based on an already cleared predicate device, there are no new performance criteria or reported performance results in the traditional sense that would come from a dedicated clinical or non-clinical study for the Peekplus® device itself. Instead, the "acceptance criteria" are demonstrating equivalence to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No separate test set for the Peekplus® device's performance was used in this submission beyond the finite element analysis (FEA) to confirm no new worst-case was created due to a minor manufacturing change. The core of the submission relies on the established performance and safety of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No experts were used in this submission to establish ground truth for a new test set, as the device's clearance is based on substantial equivalence to an existing device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical or performance test set requiring adjudication was performed for this submission.

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 not an AI/software device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical interbody fusion device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the Peekplus® device, in the context of this submission, is effectively the established safety and effectiveness of the legally marketed predicate device (Binder Biomedical Inc. Intervertebral Body Fusion Device, K093015). The submission argues that the Peekplus® device is so similar that its "truth" aligns with the predicate's.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical medical device submission for substantial equivalence.

9. How the ground truth for the training set was established:

Not applicable. There is no "training set" for this type of submission.

Ask a specific question about this device