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The Idys® LLF 3DTi system is intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous level(s) of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.

The Idys® LLF 3DTi system is intended to be used with bone graft composed of cancellous and/or corticocancellous bone and with cleared supplemental fixation to the integrated plate and screws.

The Idys® LLIF 3DTi is designed for use as a lumbar intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy using an additive manufacturing method and is to be used with bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The cage has a shape which restores the intervertebral height and lordosis. The cage contains two (2) slots to receive the bone graft to promote the fusion process between the endplates. The Idys® LLIF 3DTi is a system intended to be used with a plate and two (2) bone screws, bone graft and supplemental fixation that has been authorized for surgical use in the lumbar spine. The Idys® LLF 3DTi components are made of compliant ASTM F136 Titanium alloy.

The provided text is a 510(k) summary for the Idys® LLIF 3DTi device, which is an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness. Therefore, the information requested in the prompt, particularly regarding acceptance criteria from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set details, is largely not applicable or explicitly stated in this document for the present device.

However, based on the provided text, here's what can be extracted and inferred regarding performance and "acceptance criteria" in the context of a 510(k) submission primarily relying on mechanical testing and comparison to predicates:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in a 510(k) context for a mechanical device like this relate to meeting established standards and demonstrating performance comparable to predicate devices. The document references specific ASTM standards for mechanical testing and comparisons to predicate devices' material and design characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific "sample sizes" for a clinical test set in the way one might expect for an AI algorithm study or a traditional clinical trial.

• Mechanical Testing: While mechanical tests were performed (e.g., static and dynamic axial compression, shear, expulsion, torsion), the sample sizes for these engineering tests (e.g., number of devices tested for each mechanical property) are not specified in the 510(k) summary. These are typically simulated or bench tests, not involving human subjects.
• Data Provenance: Not applicable in the context of mechanical testing or a 510(k) premarket notification for this type of device, which does not involve clinical data collected from patients for the current submission. The "provenance" refers to the device's design, manufacturing, and R&D conducted by CLARIANCE, SAS in France.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a medical device approval based primarily on mechanical engineering testing and substantial equivalence to existing devices, not on the interpretation of medical images or patient data by human experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As no human expert interpretation of a "test set" for ground truth was involved, no adjudication method was necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC study is relevant for diagnostic imaging AI devices, where multiple readers interpret cases with and without AI assistance. This document is for an implantable intervertebral body fusion device and does not involve such studies.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. The Idys® LLIF 3DTi is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering Standards: Adherence to recognized ASTM and ISO standards for material properties, sterility, and mechanical performance (e.g., ASTM F2077, ASTM F2267, ISO 11737, ISO 11137).
• Comparison to Predicate Devices: Demonstrating that the new device's technological characteristics, mechanical performance, and safety/effectiveness profile are substantially equivalent to previously cleared devices.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in this 510(k) summary for the Idys® LLIF 3DTi itself; such data might exist for the predicate devices or in post-market surveillance.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a physical medical device.

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