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Valeo® Spacer System 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® Spacer System-L and Valeo II™ Interbody Fusion Device System - Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft in patients with degenerative disc disease (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 IIIM Interbody Fusion Device System consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material (autograft or allograft). 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 and Valeo II™ Interbody Fusion Device System is manufactured from Si3N4 ceramic material (silicon nitride), and is provided sterile.

The provided text is related to a 510(k) premarket notification for a medical device (Valeo® Spacer System; Valeo II™ Interbody Fusion Device System) and describes its indications for use, technological characteristics, predicate devices, and a summary of the substantial equivalence determination.

However, the document does not contain the kind of information requested in the prompt, which typically relates to performance studies for AI/machine learning devices. The document explicitly states that a "comprehensive, clinical literature review has been provided to investigate the risks and benefits associated with the use of the Valeo® Spacer System - L and Valeo II™ Interbody Fusion Device System - Lumbar devices in lumbar fusion procedures with allograft." This indicates that the device's acceptance was based on a literature review and comparison to predicate devices, not on a new study with specific acceptance criteria, test sets, ground truth establishment, or expert reviews for its own performance.

Therefore, I cannot provide the requested table or detailed information because it is not present in the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance: No such criteria or performance results are listed for the described device.
2. Sample size used for the test set and data provenance: No test set or related data is mentioned.
3. Number of experts and qualifications for ground truth: Not applicable as no new study was conducted.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable as it's not an AI device.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as it's not an AI/ML device.
9. How ground truth for the training set was established: Not applicable.

The submission is for an interbody fusion device, which is a physical implant, and the FDA's review for this type of device typically focuses on material safety, mechanical performance, design equivalence to predicate devices, and clinical literature supporting its intended use. It is not an AI/ML powered device, so the requested information categories (e.g., test set, training set, ground truth by experts, MRMC studies) are not applicable to this type of device submission.

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The Valeo® Spacer System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. The device must be used with additional anterior or posterior instrumentation to augment stability.

The Valeo® Spacer System -C is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -C is to be used in patients who have had six weeks of non-operative treatment.

The Valeo® Spacer System -AL, -TL, -PL, -XT are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Valeo Spacer System -AL, -TL, -PL, -XT is to be used in patients who have had six months of nonoperative treatment.

The Valeo Spacer System consists of cervical and lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Valeo Spacer System is manufactured from MC2, a ceramic material, and is provided sterile.

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way you've outlined. The document is a 510(k) summary for a medical device (Valeo® Spacer System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against detailed acceptance criteria through a specific study with statistical methods.

Here's a breakdown of why I cannot fulfill your request as precisely as you've asked, followed by what information is available in the text:

• No detailed acceptance criteria and reported device performance table: The text states, "Testing performed on this device indicates that the Valeo Spacer System is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met." This is a high-level statement and does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific mechanical thresholds) or the granular performance metrics from a dedicated study.
• No information on sample size, data provenance, number of experts, adjudication, MRMC studies, or standalone algorithm performance: These concepts are typically associated with performance evaluations of diagnostic or AI-driven devices, which is not the nature of this 510(k) submission for an intervertebral body fusion device. The testing mentioned refers to mechanical and biocompatibility testing against standards like ASTM F2077.
• No details on ground truth used or training set information: Again, these are relevant for machine learning or diagnostic device studies, which are not described in this document.

What information is available from the provided text regarding performance and testing:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria/Standard: Adherence to ASTM F2077 performance standards.
   • Reported Device Performance: "all applicable requirements were met," and the device was "substantially equivalent to predicate devices."

2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The document refers to testing against a standard (ASTM F2077), which would involve a specific number of test articles for mechanical and material testing, but this is not detailed in the summary. Data provenance (e.g., country of origin, retrospective/prospective) is not relevant for this type of device submission as described.

3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable/Not provided. Ground truth establishment by experts is not a component of proving substantial equivalence for this type of mechanical device.

4. Adjudication method for the test set: Not applicable/Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/Not provided. This type of study is for evaluating medical imaging or diagnostic device performance, often involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is relevant for AI/algorithm-based devices.

7. The type of ground truth used: Not applicable/Not provided in the context of diagnostic performance. For an intervertebral body fusion device, "ground truth" might refer to known material properties or biomechanical benchmarks, but this is not specified as "ground truth" in the diagnostic sense.

8. The sample size for the training set: Not applicable/Not provided. This is for AI/machine learning.

9. How the ground truth for the training set was established: Not applicable/Not provided.

In summary, the provided text is a 510(k) premarket notification for an intervertebral body fusion device. Its focus is on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through adherence to established performance standards (ASTM F2077) for mechanical and material properties. It does not describe a clinical study in the way one would for a diagnostic device, nor does it provide the detailed performance metrics, ground truth establishment, or expert involvement that your questions imply for a diagnostic or AI-based product.

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