(69 days)
JULIET® Ti 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). The JULIET® Ti LL Lumbar Interbody Device are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Implants with 15-degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least two integrated fixation screws. The JULIET® Ti LL implants must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.
Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebral body spacers, with various sizes and footprints so as to adapt different patient's conditions. The Juliet® Ti LL spinal implants are made of Titanium alloy Ti6A4V ELI conforming to ASTM F136. The Juliet® TilL spinal implants are additively manufactured and porous structures. The Juliet® Ti LL spinal implants are delivered sterilization). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
The purpose of this submission is to add a new height (10mm) for the hyperlordotic spacers (five footprints) with a lordosis of 15° to the previously cleared Juliet® Ti LL range of devices (K190877, K173702).
The design of the connection interface of the plates and the screws are not modified. The solid, lattice and porous structures are the same. No modifications have been made to the indications for use, materials, manufacturing process, sterilization process.
Previously cleared (K190877, K173702) and added Juliet® Ti LL implants conform to Class II special controls established for Sec 888.3080 Intervertebral body fusion device.
Additionally, the Juliet Ti LL package insert has been updated to describe the conditions under which patients an MR environment.
This document describes a 510(k) premarket notification for the "Juliet® Ti LL Lumbar Interbody Device". The acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to previously cleared predicate devices, primarily K190877 and K173702, following a product line extension to include a new height (10mm) for hyperlordotic spacers with a 15° lordosis.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with numerical performance data in the typical sense of a diagnostic AI device. Instead, the "acceptance criteria" are implied by the demonstration that the modified device (new height) is substantially equivalent to predicates, particularly for the mechanical and MR environment performance. The performance is assessed by confirming that existing predicate device testing covers the new device, and by conducting new MR assessments where applicable.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: Does not introduce new worst cases regarding mechanical testing, ensuring safety and effectiveness. | The engineering analysis demonstrated that the Juliet® Ti LL line extension (present submission) does not introduce new worst cases regarding the mechanical testing. Therefore, the tests performed on Juliet® Ti LL predicate devices (K1733702 / K190877) – including static and dynamic axial compression, static and dynamic shear compression, static and dynamic torsion, expulsion, subsidence, and mass loss determination after dynamic testing – are still valid and cover the added cage references. No new mechanical tests were carried out as there is no significant difference between the line extension and predicate devices that would adversely affect use, performance, safety, or effectiveness. |
| MR Safety and Compatibility: Safe for use in an MR environment. | New assessment against updated MR-related standards was performed. Standards used include: Magnetically induced displacement force (ASTM F2052), Magnetically induced torque (ASTM F2213), MR image artifact (ASTM F2119), Radiofrequency (RF) induced heating (ASTM F2182), Standard practice for marking medical devices for safety in the magnetic resonance environment (ASTM F2503), and Testing and labeling medical devices for safety in the magnetic resonance environment (Guidance for Industry and FDA Staff, October 10, 2023). The package insert has been updated to describe the conditions under which patients can be safe within an MR environment. |
| Substantial Equivalence: No new safety or effectiveness concerns compared to predicate devices. | The subject Juliet® Ti LL devices are substantially equivalent to the previously cleared Juliet® Ti LL devices (K190877, K173702) with respect to their intended use, indications for use, device description, technological characteristics, and performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document focuses on mechanical and MR testing of the device itself, rather than human clinical or imaging data (which would typically have a "test set" and "data provenance").
- Mechanical Testing: Performed on physical device samples (the predicate devices). The exact sample size for mechanical tests (e.g., how many devices were tested for compression, shear, etc.) is not specified in the provided text, but it refers to "assemblies (spacer + plate + fixation screws) that passed 5 million cycles."
- MR Testing: Performed on physical device samples. No specific sample size is mentioned, but typical MR testing involves a limited number of device samples.
- Data Provenance: Not applicable in the context of clinical patient data, as this is a device modification submission based on benchmarking against predicates and engineering analysis, not a new clinical study with patient data.
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)
This information is not applicable. The submission relies on engineering analysis and testing against established mechanical and material standards (ASTM, USP), rather than expert assessment of a clinical "test set" for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical "test set" requiring expert adjudication of diagnoses or findings.
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 for an intervertebral body fusion device, not an AI-powered diagnostic device, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is defined by existing performance standards and the mechanical properties of the device materials and design validated through established testing protocols (e.g., ASTM standards for mechanical properties, USP for endotoxin, ASTM/FDA guidance for MR safety). The comparison is against the performance of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is involved for this device submission.
§ 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.