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The Half Dome Posterior Lumbar Intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to LS-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document describes the regulatory approval of a medical device, the HALF DOME Posterior Lumbar Interbody System, and focuses on its substantial equivalence to previously approved predicate devices. It does not present a study proving the device meets specific performance acceptance criteria for an AI or diagnostic algorithm.

The document explicitly states: "No clinical studies were performed" for this specific submission (K172947). Instead, the substantial equivalence claim is based on non-clinical tests (mechanical and material properties) demonstrating similarity to predicate devices.

Therefore, I cannot provide the information requested in your prompt as it pertains to a study evaluating an AI or diagnostic algorithm's performance. The prompt's requirements (e.g., sample size, expert consensus, MRMC study, ground truth) are not applicable to this type of medical device submission.

The "acceptance criteria" discussed in this document are primarily related to:

• Mechanical and material performance: Ensuring the device is structurally sound and made of appropriate biocompatible materials.
• Intended Use: The device performs its designed function within the specified patient population and anatomical locations.
• Substantial Equivalence: The new device is as safe and effective as a legally marketed predicate device.

If you had provided a document describing a study for an AI/diagnostic algorithm, I would have extracted the requested information. However, based on the provided text, this is a traditional medical device (implant) approval lacking the type of performance study you are asking about.

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