(52 days)
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
| Performance Metric/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | Substantial Equivalence to Predicate Devices | |
| Static axial compression | Performance comparable to predicate devices (K081888, K101720, K121760, K120368, K090816) | JULIET®OL performs as safely and effectively as its predicate devices. |
| Static shear compression | Performance comparable to predicate devices (K081888, K101720, K121760, K120368, K090816) | JULIET®OL performs as safely and effectively as its predicate devices. |
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:
- 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.
§ 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.