(115 days)
Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Valeo™ System-L and Valeo™ II Interbody Fusion Device System - Lumbar are indicated for use with autograft bone graft in patients with DDD at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo™ Spacer System-L and Valeo™ II Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
The Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System devices consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material per the indications stated above. The subject device is offered in various geometries to accommodate different surgical approaches and vertebral body dimensions. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical is manufactured from MC2 ceramic material (silicon nitride), and is provided sterile.
The purpose of the subject 510(k) was to expand the indications of the Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical devices to include use with allograft and use at two contiguous levels from C2/C3 to C7/T1.
This is a 510(k) premarket notification for a medical device, the Valeo™ Spacer System and Valeo™ II Interbody Fusion Device System. This type of document is used to demonstrate that the device is substantially equivalent to a legally marketed predicate device, and thus does not typically contain efficacy studies or performance criteria in the way a pharmaceutical approval or a novel medical device approval might.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, ground truth, expert involvement, adjudication, MRMC studies, standalone performance), and training set information is generally not applicable to this type of regulatory submission.
The document primarily focuses on establishing "substantial equivalence" based on indications for use, design, and performance compared to a predicate device, rather than proving the device meets specific quantitative performance criteria through a dedicated study.
Here's what can be extracted based on the document's content, and where information is not present:
1. Table of acceptance criteria and the reported device performance:
- Not Applicable. This document does not present quantitative acceptance criteria or detailed performance metrics from a study designed to prove such criteria. The "performance" mentioned is in the context of demonstrating similarity to a predicate device.
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. No specific test set or study data is presented to evaluate the device against pre-defined performance criteria. The submission relies on a "comprehensive clinical literature review" to assess additional safety concerns for expanded indications, not a direct study of the device.
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. As no specific "test set" with ground truth determination is mentioned, this information is not provided. The review of existing literature would implicitly involve expert knowledge, but not in the structured way of establishing ground truth for a device performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or direct adjudication process for device performance is described.
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 intervertebral body fusion device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical implant, not an algorithm. Standalone performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As no direct study on the device's performance against a ground truth is reported in this 510(k), this information is not available. The submission's argument for substantial equivalence relies on existing knowledge and a literature review.
8. The sample size for the training set:
- Not Applicable. This device does not involve a "training set" in the context of machine learning or algorithm development.
9. How the ground truth for the training set was established:
- Not Applicable. This device does not involve a "training set" or "ground truth" establishment in the context of machine learning.
Summary of what the document DOES state:
- Purpose of current 510(k): To expand the indications for use of the Valeo™ Spacer System-C and Valeo™ II Interbody Fusion Device System -Cervical devices to include use with allograft and use at two contiguous levels (C2/C3 to C7/T1).
- Predicate Device: ANATOMIC PEEK™ Cervical FUSION SYSTEM (K130177).
- Basis for Substantial Equivalence: The Valeo™ system is similar in design and indicated use to the predicate. A "comprehensive clinical literature review" was conducted to assess any additional safety concerns for the expanded indications (use with allograft and at two contiguous levels). The conclusion was that there were no additional risks, and the device was substantially equivalent.
In essence, this document is a regulatory filing demonstrating equivalence, not a detailed clinical study report with performance metrics against predefined acceptance criteria.
§ 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.