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JULIET® Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. JULIET® Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage

The JULIET®OL Transforaminal Lumbar cages are rectangle-shaped intervertebral body fusion devices with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. The JULIET®OL system is made of PEEK Optima LT1 conforming to ASTM F2026 with Tantalum markers conforming ASTM F560. The line extension of Juliet® OL device consists in an additional size (height 07 mm) and a lordotic profile in order to better fulfill surgeons' needs and accommodate different patient anatomies and in a design change of the 08 mm height implant with bi-convex profile.

The provided documents describe a traditional 510(k) submission for a medical device, the JULIET® OL Transforaminal Lumbar Cage, which is an intervertebral body fusion device.

Crucially, this type of submission for devices like this typically relies on demonstrating substantial equivalence to a predicate device based on material, design, mechanical properties, and function rather than extensive clinical efficacy studies with specific performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, most of the requested information (like sample sizes for test sets, expert qualifications, HRMR studies, standalone performance, training set details, and specific ground truth methods for clinical endpoints) is not applicable to this type of device and submission. The "study" here refers to non-clinical bench testing.

Here's the breakdown of what can be extracted or inferred from the provided text:

Acceptance Criteria and Device Performance for JULIET® OL Transforaminal Lumbar Cage

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This is a mechanical device, and the "test set" refers to bench testing of the device itself, not clinical data from patients. The document describes "non-clinical tests" (mechanical testing) rather than a clinical 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

• Not Applicable. The "ground truth" for this device's performance is established through engineering and biomechanical standards (ASTM F2077) and comparison to predicate device performance, not by expert interpretation of clinical data in the context of this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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. It's a physical implant for spinal fusion.

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

• Not Applicable. This is not an AI/software algorithm.

7. The type of ground truth used

• Engineering and Biomechanical Standards: The ground truth for this device's safety and effectiveness relies on adherence to established ASTM standards (specifically ASTM F2077 for static axial and shear compression) and the comparative mechanical performance against legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" refers to non-clinical bench testing conducted on the JULIET® OL Transforaminal Lumbar Cage.

• Test Performed: Static axial compression and Static shear compression.
• Standards Adhered To: ASTM F2077.
• Methodology: The device's mechanical performance under these conditions was tested and compared to the performance of several legally marketed predicate devices:
  • JULIET® lumbar cages (K081888 and K101720) manufactured by Spineart
  • Capstone (K121760, K120368) manufactured by Medtronic
  • AVS PL PEEK AVS Plus - UniLIF (K090816) manufactured by Stryker Spine
• Conclusion: The tests demonstrated that the JULIET® OL Transforaminal Lumbar Cage "performs as safely and effectively as its predicate devices." This substantial equivalence in mechanical properties, along with similar intended use, materials, and design, forms the basis for its clearance. No clinical trials or human subject data was presented in this 510(k) summary for establishing efficacy.

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JULIET® OL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. JULIET® Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

JULIET® range of products consists of lumbar Interbody cages available in various models to adapt to anatomical variations and surgical techniques. JULIET® OL cages are dedicated to transforaminal approach and are manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of tantalum conforming to ASTM F0560 are used to visualize the position of the implant in the disc space. JULIET® OL Lumbar Interbody Devices are supplied either sterile or non sterile with a complete set of surgical instruments.

The provided document is a 510(k) summary for the JULIET® OL Lumbar Interbody Device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The "Performance data" section refers to mechanical testing of the intervertebral body fusion device, not an AI algorithm. It states:

• "Mechanical testing includes static axial compression performed according to ASTM F2077-03 and subsidence testing performed according to ASTM F2267-04."
• "Results demonstrate that additional components perform as safely and effectively as their predicate devices."

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets those criteria, as the document does not relate to an AI/ML medical device and thus does not include the type of performance study details requested (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details).

This document is for a traditional medical device (an intervertebral body fusion device) and focuses on mechanical performance and substantial equivalence to a predicate device, rather than the performance of an AI/ML algorithm.

Ask a specific question about this device