(60 days)
JULIET® 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® 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
The JULIET® PO are rectangle-shaped intervertebral body fusion devices with a central cavity that can be filled with bone graft (autograft) to facilitate fusion. The JULIET®PO is made of PEEK Optima LT-1 conforming to ASTM F2026 with Tantalum markers conforming to ASTM F560.
The provided text is a 510(k) premarket notification for a medical device called JULIET® PO, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than an in-depth study proving performance against specific acceptance criteria for an AI/algorithm-driven device.
Therefore, many of the requested categories for AI/algorithm performance studies cannot be extracted or are not applicable. However, I can extract information related to the device's physical performance testing.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Implied by Conclusion) |
|---|---|
| Static axial compression (according to ASTM F2077) | Performed safely and effectively as predicate devices. |
| Static shear compression (according to ASTM F2077) | Performed safely and effectively as predicate devices. |
| Subsidence testing (according to ASTM F2267) | Performed safely and effectively as predicate devices and is substantially equivalent. |
Explanation of the Table: The document states that the tests were conducted "according to ASTM F2077" and "according to ASTM F2267." This implies that the acceptance criteria are defined by these ASTM standards for intervertebral body fusion devices. The conclusion states that "Results demonstrate that JULIET®PO performs as safely and effectively as its predicate devices" and "Non clinical performance testing demonstrates that JULIET®PO is substantially equivalent to predicate devices." This suggests that the device met the performance requirements outlined in those ASTM standards, relative to the predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for the mechanical testing of the JULIET® PO device itself (e.g., how many devices were tested for each mechanical test). The data provenance is also not specified; it is assumed to be lab-based mechanical testing, not clinical data from patients or a specific country. This is a non-clinical, mechanical test, not a study involving human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a mechanical device, and the "ground truth" for its performance is established through standardized physical tests (ASTM standards), not human expert consensus.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. There is no human adjudication process described for mechanical 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
Not applicable. The JULIET® PO is a physical intervertebral body fusion device, not an AI or algorithm-driven diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The JULIET® PO is a physical intervertebral body fusion device, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on mechanical test results conducted according to established ASTM standards (F2077 and F2267). The performance is then compared to the known performance of predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for a physical medical device.
§ 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.