(55 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 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.
| Acceptance Criteria (Implicit from testing) | Reported Device Performance |
|---|---|
| Static and dynamic axial compression (per ASTM F2077) | Demonstrated comparable mechanical properties to predicate device. |
| Static and dynamic shear compression (per ASTM F2077) | Demonstrated comparable mechanical properties to predicate device. |
| Static and dynamic torsion (per ASTM F2077) | Demonstrated comparable mechanical properties to predicate device. |
| Expulsion | Tested (results imply satisfactory, but specific numbers not provided). |
| Subsidence (per ASTM F2267) | Tested (results imply satisfactory, but specific numbers not provided). |
| Mass loss determination after dynamic testing (5 million cycles) | Tested (results imply satisfactory, but specific numbers not provided). |
| Axial push out on fixation screws through the plate | Tested (results imply satisfactory, but specific numbers not provided). |
| Bacterial endotoxin limit of 20 EU/device (USP standard for pyrogenicity) | Compliance based on endotoxin testing. |
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.
§ 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.