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K Number
K141135
Device Name
JULIET LL
Manufacturer
SPINEART
Date Cleared
2014-12-01

(214 days)

Product Code
MAX
Regulation Number
888.3080
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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:

  1. 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.
  2. Sample sized used for the test set and the data provenance: Not applicable. This refers to an AI test set, not mechanical testing.
  3. 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.
  4. 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.
  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 describes an AI study, not an orthopedic implant.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This describes an AI study.
  7. 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.
  8. The sample size for the training set: Not applicable. This refers to an AI training set.
  9. 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.

§ 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.