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The Idys® ALIF ZP 3DTi devices (Anterior Lumbar Interbody Fusion) are intended for use in patients with degenerative disc disease (DDD) at one (1) or (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain in discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The Idys® ALIF ZP 3DTi cages should be used with the integrated fixation screws provided.

The Idys® ALIF ZP 3DTi cages are intended to be used with autograft.

The Idys® ALIF ZP 3DTi consists of interbody fusion devices intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the lumbar spine.

The Idys® ALIF ZP 3DTi cages, which have various widths and heights, are designed for use as lumbar intervertebral body fusion devices. The device shape restores the intervertebral height and lordosis. The device contains two slots to receive the autologous bone graft to promote the fusion process between the endplates. The device has to be used with autograft.

The Idys® ALIF ZP 3DTi cage is manufactured from medical grade Ti-6Al-4V ELI Titanium alloy compliant with ASTM F3001 and ASTM F136 and is used with autograft. The screws are made from Ti-6Al-4V ELI per ASTM F136 and are anodized in different colors, according to their length. Idys® ALIF ZP 3DTi cages are positioned using a set of surgical instruments common for anterior lumbar approach. It is essential to insert implants with instrumentation specifically designed for this purpose. The cages are provided sterile and are for single use only.

The provided text is related to a 510(k) premarket notification for a medical device called "Idys® ALIF ZP 3DTi", an intervertebral body fusion device. The document describes the device, its intended use, and states that it has been determined to be substantially equivalent to previously cleared predicate devices.

However, the information required to fully answer the request, particularly regarding acceptance criteria and a study proving a device meets these criteria for an AI/algorithm-based medical device, is not present in the provided text.

The text focuses on hardware modifications (material change from PEEK to Titanium alloy), biocompatibility, and mechanical testing of an implantable device, comparing it to existing predicate devices based on structural and functional equivalence, not on performance metrics of an AI or algorithm.

Therefore, I cannot extract the following information from the provided document:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample size used for a test set and data provenance related to an AI/algorithm study.
• Number of experts and their qualifications used to establish ground truth for an AI/algorithm test set.
• Adjudication method for an AI/algorithm test set.
• Results or even the conduct of a multi-reader multi-case (MRMC) comparative effectiveness study for an AI/algorithm.
• Results or even the conduct of a standalone (algorithm only) performance study.
• The type of ground truth used for an AI/algorithm (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set of an AI/algorithm.
• How ground truth for the training set of an AI/algorithm was established.

The document discusses "Performance Data" but this refers specifically to:

• Biocompatibility: "The modified device has been demonstrated to be biocompatible in accordance with ISO 10993-1 Part 1."
• Mechanical Testing: "Bench mechanical testing according to ASTM F2077 and ASTM F2267 were used to support the decision of substantial equivalence... Specifically, CLARIANCE performed static and dynamic axial compression testing, static and dynamic compression shear testing, subsidence testing, expulsion testing, static torsion testing (titanium particles), all of which demonstrated the substantial equivalence of the system to legally marketed devices."

These are engineering and material science tests, not performance studies of an AI or algorithmic medical device.

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