Search Results

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

Device Description

The JULIET®LL 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 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 Titanium Ti 6Al-4V ELI conforming to ASTM F136 and ISO 5832-3.

AI/ML Overview

The provided text describes a medical device, the JULIET® LL Lateral Lumbar Cage, and its FDA 510(k) summary for substantial equivalence. It does not describe acceptance criteria and a study proving device performance in the context of an AI/algorithm-based diagnostic or assistive device.

Therefore, I cannot provide the requested information, particularly items 1-9, as they pertain to the evaluation of an AI-powered device's diagnostic performance, which is not detailed in this document. The document focuses on the mechanical and material performance of an orthopedic implant.

Here's why each point cannot be addressed with the given text:

A table of acceptance criteria and the reported device performance: The document discusses non-clinical tests like "Static axial compression, Static shear compression according to ASTM F2077 and subsidence testing according to ASTM F2267," and states that the device "performs as safely and effectively as its predicate devices." However, it does not provide specific quantitative acceptance criteria or detailed numerical results from these tests in a table format that would be relevant for an AI system's performance.
Sample sized used for the test set and the data provenance: Not applicable. This refers to an AI test set, not mechanical testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to an AI test set's ground truth, not mechanical testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to establishing ground truth for an AI test set.
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 describes an AI study, not an orthopedic implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This describes an AI study.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to clinical outcomes or imaging interpretations for an AI, not mechanical properties of an implant. The document mentions "degenerative disc disease (DDD) ... confirmed by patient history and radiographic studies" for the indications for use, but this is not ground truth for a diagnostic AI's performance evaluation.
The sample size for the training set: Not applicable. This refers to an AI training set.
How the ground truth for the training set was established: Not applicable. This refers to an AI training set.

The document is a 510(k) summary for a physical medical implant, demonstrating substantial equivalence to predicate devices based on mechanical testing and material compatibility, not the performance of an AI or diagnostic algorithm.

Ask a Question

Ask a specific question about this device

K Number

K133557

Device Name

JULIET LL LATERAL LUMBAR CAGE

Manufacturer

SPINEART

Date Cleared

2014-02-03

(76 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K081888,K101720,K071795,K081611,K121760,K103666,K090816

Intended Use

Device Description

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.

AI/ML Overview

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

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.

Ask a Question

Ask a specific question about this device

Page 1 of 1