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The Idys™ TLIF 3DTi cages are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a posterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The Idys™ TLIF 3DTi cages, which have various widths and heights, are designed for use as a lumbar intervertebral body fusion device. The device has to be used with autograft. The device has a shape which restores the intervertebral height and lordosis. The device contains a slot to receive the autologous bone graft to promote the fusion process between the endblates. The Idvs™ TLIF 3DTi cages are made of compliant ASTM F136 Titanium alloy. The device is manufactured using an additive manufacturing process to result in a porous material with tightly defined structure. It is essential to insert implants with instrumentation specifically designed for this purpose.

The provided text describes CLARIANCE's Idys™ TLIF 3DTi, an intervertebral body fusion device. Here's an analysis of the acceptance criteria and study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it refers to industry standards (ASTM F2077 and ASTM F2267) and states that the device's performance was found to be "substantially equivalent" to legally marketed predicate devices.

Here's a summary based on the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Performance testing was conducted according to ASTM F2077 and ASTM F2267." It does not specify the exact sample size for each test performed (e.g., number of devices tested for axial compression, expulsion, etc.).

• Sample Size: Not explicitly stated as a number (e.g., "n=5" for each test). The ASTM standards themselves would specify minimum sample sizes for such tests.
• Data Provenance: The testing was conducted by CLARIANCE, SAS, located in France. The provenance of the test data is, therefore, from their internal testing. It's a prospective set of tests designed specifically for this regulatory submission.

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 information is not applicable to this type of device and study. The "ground truth" for a mechanical device like an intervertebral fusion cage is established through physical and mechanical testing against predefined standards or comparison to a predicate device's performance, not by expert consensus on clinical findings or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving interpretative tasks (e.g., image reading) where multiple experts assess cases to reach a consensus for ground truth. For mechanical performance testing, the results are objectively measured against established criteria or predicate device performance.

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 information is not applicable. The device is an orthopedic implant (an intervertebral body fusion device), not an imaging analysis or AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical implant, not an algorithm. Standalone performance for an algorithm would assess its accuracy in tasks like disease detection or measurement without human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation is based on:

• Compliance with recognized testing standards: ASTM F2077 (for static and dynamic compression, shear, and torsion) and ASTM F2267 (for subsidence). These standards define the methodologies and acceptable performance envelope.
• Mechanical equivalence to predicate devices: The device's performance was compared directly to that of legally marketed predicate devices, meaning the established mechanical characteristics of those predicates served as the benchmark for "ground truth" in terms of what constitutes safe and effective mechanical performance for this type of implant.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The "training" for such devices typically refers to the iterative design and development process, which doesn't involve a quantifiable "training set" of data in the same way.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8; there is no "training set" in the sense of machine learning for this physical device. The "ground truth" for the design and development process would be established through engineering specifications, material science principles, clinical needs, and regulatory requirements that guide the creation of the device.

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