(63 days)
JULIET® LL 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). These spinal implants are to be used with autogenous bone graft. JULIET® LL 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
The JULIETLL Titanium Lateral 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 JULIETLL intervertebral body fusion spacer comes in various sizes and footprints in order to fulfill surgeons' needs and accommodate different patient anatomies.
The JULIETLL system is made of Titanium Ti 6Al-4V ELI conforming to ASTM F136 and ISO 5832-3.
The JULIETLL Titanium Lateral Lumbar cages are supplied with dedicated surgical instruments (reusable - provided non sterile).
This document describes the FDA 510(k) clearance for the JULIET® LL Lateral Lumbar Cage, an intervertebral body fusion device. The acceptance criteria and supporting studies are primarily related to the mechanical performance and biocompatibility of the device, rather than diagnostic accuracy as would be presented for an AI/ML medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|---|---|
| Mechanical Performance | Static axial compression (ASTM F2077) | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to be equivalent to predicate) | Non-clinical (bench testing) |
| Mechanical Performance | Static shear compression (ASTM F2077) | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to be equivalent to predicate) | Non-clinical (bench testing) |
| Mechanical Performance | Subsidence testing (ASTM F2267) | Not explicitly stated (implied to be equivalent to predicate) | Not explicitly stated (implied to be equivalent to predicate) | Non-clinical (bench testing) |
| Biocompatibility | Bacterial Endotoxin Testing (USP ) | Endotoxin limit of 20 EU / device | Not explicitly stated (implied to meet 20 EU/device) | Non-clinical (laboratory testing) |
| Design & Material Equivalence | Similar material (Titanium Ti 6Al-4V ELI conforming to ASTM F136 and ISO 5832-3) | Equivalent to predicate | Meets ASTM F136 and ISO 5832-3 | Design/Material Comparison |
| Intended Use Equivalence | Same indicated use | Equivalent to predicate | Same indications for use | Clinical/Regulatory Comparison |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (spinal implant), not a diagnostic AI/ML system. Therefore, the concepts of "test set" and "data provenance" in the context of clinical images or patient data are not directly applicable.
- Mechanical Testing: For mechanical tests (static axial compression, static shear compression, subsidence testing), the sample size would refer to the number of physical devices tested. This information is not explicitly stated in the provided document. The tests were performed on the predicate device (JULIET®LL Titanium Lateral Lumbar cages, K141135), and a rationale of "verification activity and validation activity" was used to demonstrate equivalence for the modified devices.
- Bacterial Endotoxin Testing: The sample size would refer to the number of devices or material samples tested for endotoxins. This information is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for a physical medical device clearance based on mechanical testing and biocompatibility. Ground truth in this context is established by adherence to engineering standards and material specifications, not by expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device clearance. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation (e.g., by radiologists).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the subject of this 510(k) clearance for a spinal implant.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone study in the context of an AI algorithm was not done. This 510(k) is for a physical medical device. The "standalone" performance here refers to the device's mechanical integrity and biocompatibility, which were evaluated through non-clinical bench testing.
7. The Type of Ground Truth Used
The ground truth for this device clearance is based on:
- Engineering Standards: Adherence to established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for mechanical testing (ASTM F2077, ASTM F2267) and material specification (ASTM F136, ISO 5832-3).
- Biocompatibility Standards: Adherence to USP (United States Pharmacopeia) standard for bacterial endotoxin testing (USP ).
- Predicate Device Equivalence: The primary ground truth for the modified device is its substantial equivalence to the performance and safety of the previously cleared predicate device (JULIET® LL, K141135).
8. The Sample Size for the Training Set
Not applicable. There is no AI model or "training set" in the context of this traditional medical device clearance. The "training" for such devices involves adherence to manufacturing processes and quality control systems.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no "training set," there is no ground truth established in this manner for the submitted device.
§ 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.