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Valeo II Interbody Fusion Devices - Cervical are 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 radios. Valeo II Interbody Fusion Devices-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 using autograft or allogenicbone graft comprised of cancellous and/or corticocancelous bone graft.

Valeo II Interbody Fusion Devices-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 II Interbody Fusion Devices-Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with desenerative disc disease (DD) 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 II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

The Valeo II Interbody Fusion 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 (autograft or allograft comprised of cancellous and/or corticocancelous bone graft).

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 II Interbody Fusion Device is manufactured from Si3N4 ceramic material (silicon nitride), and is:

• provided sterile (gamma sterilization)
• single use

The purpose of the subject 510(k) is to add additional sizes to the Lateral Lumbar Interbody Fusion Device - Valeo II LL.

The provided text describes a 510(k) premarket notification for the Valeo II™ Interbody Fusion Device System. It states that "Performance Testing: Failure Effects Analysis was performed to determine if the new sizes created a new worst case with respect to ASTM F2077 and ASTM F2267. No new worst cases were identified with regard to the ASTM standards requirements. No additional testing required."

This means that no new studies were conducted, and the device's acceptance criteria are based on its substantial equivalence to previously approved predicate devices, specifically the Valeo II™ Interbody Fusion Device (K121892) and the Globus PATRIOT® TransContinental® Llif Spacer (K093242) and Valeo II™ Interbody Fusion Device (K143518). The "No additional testing required" comment implies that the device is relying on testing performed for these predicate devices.

Therefore, the information regarding the acceptance criteria, study that proves the device meets the acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set size is not explicitly detailed for this specific 510(k) submission. The submission primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting new clinical study data for acceptance.

However, based on the provided text, we can infer the following:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No specific sample sizes for a new test set are provided for this 510(k) as no additional clinical or in-vitro testing beyond the Failure Effects Analysis was deemed necessary. The device relies on previous testing of its predicate devices.

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 new test set requiring expert ground truth establishment for clinical or diagnostic performance is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new test set requiring adjudication is mentioned.

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 interbody fusion device, not a diagnostic AI system requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is an interbody fusion device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this medical device's performance would primarily be related to its mechanical integrity and biocompatibility, as established through engineering standards (like ASTM F2077, ASTM F2267) and chemical/biological testing (like Bacterial Endotoxin Testing). Clinical outcomes are inferred from the predicate devices.

8. The sample size for the training set:
Not applicable, as this is a medical device, not an AI/ML algorithm requiring a training set.

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

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