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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). 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.

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.

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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). 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 non-operative 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, 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 subject Product Line Extension consists of an extended range of titanium alloy spacers with integrated fixation. Juliet® Ti LL Product Line Extension also introduces a range of hyperlordotic intervertebral spacers of various sizes, heights, footprints and lordosis with the integrated fixation. The Juliet® Ti LL spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The provided text describes a medical device, the JULIET® Ti LL Lumbar Interbody Device, and its 510(k) summary, which includes information regarding its substantial equivalence to predicate devices based on non-clinical testing. However, the document does not contain information about the acceptance criteria and study details as typically defined for AI/ML-based devices (e.g., performance metrics like sensitivity, specificity, or AUC, and aspects like human reader studies, ground truth establishment, or training/test set sample sizes).

The document is for a traditional medical device (an intervertebral body fusion device) and therefore does not include the typical elements of an AI/ML device approval.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's an attempt to answer based on the information available in the text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of performance metrics that would be applicable to an AI/ML device (e.g., sensitivity, specificity, F1-score). Instead, it discusses the device meeting mechanical and material performance standards for traditional orthopedic implants.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable or provided for this type of medical device which undergoes mechanical and material testing, not data-driven performance evaluation. The "test set" here refers to physical samples of the device and its components.

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 is not applicable as the evaluation involves mechanical and material testing against established ASTM standards, not a clinical assessment requiring expert-established ground truth.

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

This is not applicable for mechanical and material testing.

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

This is not applicable as the device is not an AI/ML-based diagnostic or assistive tool.

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

This is not applicable as the device is not an algorithm.

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

The "ground truth" for this device's evaluation is defined by established engineering and material standards (e.g., ASTM F2077, ASTM F2267, USP standards for endotoxin). The device's performance is compared against these objective standards and against the performance of legally marketed predicate devices.

8. The sample size for the training set

This is not applicable as the device is developed through engineering design and manufacturing processes, not machine learning.

9. How the ground truth for the training set was established

This is not applicable as there is no "training set" in the context of an AI/ML device. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory requirements for intervertebral body fusion devices.

Ask a specific question about this device