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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). These spinal implants are to be used with autogenous bone graft. JULIET® Ti LL Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebral body spacers, implanted via a lateral approach, with various sizes and footprints so as to adapt different patient's conditions. The Juliet® Ti LL spinal implants are made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. The Juliet® Ti LL spinal implants are additively manufactured and present both solid and porous structures. the The subject implants Juliet® Ti LL will extend the previously cleared Juliet® Ti (PO, OL & TL) range of implants (K153621) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM) and will join the previously cleared Juliet® LL range of implants (K161888; K141135) which presents similar design features and addresses the same surgical approach and utilize the same instrumentation designed purposely. The Juliet® Ti LL spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).

This is a 510(k) premarket notification for a medical device called Juliet® Ti LL, an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting a study proving performance against acceptance criteria for a new AI/CAD device.

Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, MRMC studies, effect size, standalone performance, ground truth establishment) are not applicable to this type of submission. This document describes a medical implant, not an AI software.

Here's the information that can be extracted from the provided text, primarily focusing on the device's characteristics and the testing mentioned for ensuring its safety and effectiveness (as part of establishing substantial equivalence to predicates):

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an implant and not an AI/CAD software, there isn't a direct "acceptance criteria" table in the sense of performance metrics for an algorithm. Instead, the document describes the device and then lists the non-clinical tests performed to demonstrate its safety and effectiveness, primarily by showing it meets established standards comparable to its predicate devices. These standards effectively serve as the "acceptance criteria" for this type of device.

Additional Requested Information:

1. Sample size used for the test set and the data provenance:

   • N/A. This is not an AI/CAD device, so there is no "test set" of patient data in this context. The testing mentioned refers to physical, mechanical, and material testing of the device itself.
   • For the physical device testing, the sample sizes would typically be small, determined by engineering statistical methods for material and mechanical verification (e.g., n=3 or n=5 for specific physical tests), but these are not explicitly stated in this summary.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. No expert ground truth establishment for a patient data test set.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. No adjudication method for a patient data test set.

4. 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:

   • N/A. This is not an AI-assisted device.

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

   • N/A. This is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • N/A. For this device, "ground truth" relates to compliance with established material standards (e.g., ASTM standards for titanium alloy properties) and biomechanical test methods (e.g., ASTM F2077 for intervertebral body fusion device mechanical testing). The ground truth is engineering and materials science-based, not patient-data based in the context of diagnostic accuracy.

7. The sample size for the training set:

   • N/A. No training set as this is not an AI/ML device.

8. How the ground truth for the training set was established:

   • N/A. No training set.

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