(76 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). This device is 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 with an intervertebral cage
The JULIET®LL 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 JULIET®LL intervertebral body fusion spacer comes in various sizes and footprints in order to fulfill surgeons' needs and accommodate different patient anatomies. The JULIET®LL system is made of PEEK Optima conforming to ASTM F2026 with spikes made of Titanium 6Al-4V ELI conforming to ASTM F136 and ISO 5832-3 and Tantalum markers conforming ASTM F560.
This submission describes the JULIET® LL Lateral Lumbar Cage, an intervertebral body fusion device. The provided text, a 510(k) summary, focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not present a clinical study involving human participants or analysis of device performance based on clinical outcomes. Therefore, information typically found in clinical studies, such as the use of an AI algorithm, expert ground truth establishment, sample sizes for training/test sets, or MRMC studies, is not applicable or available in this document.
Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not present:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the JULIET® LL device are implicitly defined by its ability to perform "as safely and effectively as its predicate device JULIET®PO" in non-clinical mechanical tests. These tests are standardized methods for evaluating intervertebral body fusion devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Performs safely and effectively in static axial compression. | Results demonstrate that JULIET®LL performs as safely and effectively as its predicate device JULIET®PO. This implies the JULIET®LL device met or exceeded the performance of the predicate in this test, adhering to ASTM F2077. |
| Performs safely and effectively in static shear compression. | Results demonstrate that JULIET®LL performs as safely and effectively as its predicate device JULIET®PO. This implies the JULIET®LL device met or exceeded the performance of the predicate in this test, adhering to ASTM F2077. |
| Performs safely and effectively in subsidence testing. | Results demonstrate that JULIET®LL performs as safely and effectively as its predicate device JULIET®PO. This implies the JULIET®LL device met or exceeded the performance of the predicate in this test, adhering to ASTM F2267. |
| Substantially equivalent in terms of intended use, material, design, mechanical properties, and function to predicate devices. | The conclusion states: "The JULIET® LL is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Non-clinical performance testing demonstrate that JULIET®LL is as safe, as effective, and performs as safely and effectively as its predicate devices." |
Study Information
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Sample size used for the test set and the data provenance:
The studies conducted were non-clinical tests (mechanical testing), not clinical studies involving patient data. Therefore, there is no "test set" in the context of patient data, data provenance, or country of origin. The sample size would refer to the number of devices or constructs tested in the laboratory, but this specific number is not provided in the summary. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Mechanical tests do not involve expert interpretation of data to establish ground truth in the way a clinical study or AI algorithm evaluation would. The "ground truth" for mechanical testing is based on the physical properties and behavior of the device under specific loads according to recognized standards. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used in clinical studies or expert reviews to resolve disagreements in interpretations; this is not relevant for mechanical testing. -
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 a medical device for intervertebral body fusion, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No AI algorithm is involved with this device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For mechanical testing, the "ground truth" is established by adherence to recognized ASTM standards (F2077 for static compression and shear, F2267 for subsidence) and the comparative performance against a legally marketed predicate device. This is a mechanical/engineering ground truth based on established physical testing protocols, rather than a clinical ground truth. -
The sample size for the training set:
Not applicable. There is no AI component, and thus no "training set." -
How the ground truth for the training set was established:
Not applicable, as there is no training set.
§ 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.