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When used as a posterior pedicle screw fixation system, the SYNTHES Universal Sacral System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion.

When used as a posterior, non-pedicle screw fixation system, the SYNTHES Universal Sacral System is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann's disease); degenerative disk disease (back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), and fractures of the posterior thoracolumbar spine (levels T8-S2).

The overall levels of fixation for the Universal Sacral System as a whole are T8-S2. The levels of pedicle screw fixation are L3-S2.

The SYNTHES (U.S.A.) Universal Sacral System allows a screw to be connected to the rod through a wide array of screw/rod angles. It consists of a sacral screw assembly with a sacral collar a nut, and a rod. The assembly consists of a sacral screw, a rod/screw connector, and a locking ring. This system is to be used with the SYNTHES (U.S.A.) Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System.

The SYNTHES (U.S.A.) Universal Sacral System is manufactured from titanium alloy, which conforms to ASTM Standard F1295-92, and 316L stainless steel which conforms to ASTM Standard F138-86.

The Synthes Universal Sacral System is provided non-sterile; moist heat sterilization is recommended.

This document describes a medical device, the SYNTHES (U.S.A.) Universal Sacral System, and its substantial equivalence to other existing spinal fixation systems. It is not a study that presents acceptance criteria or device performance data in the typical sense of a clinical or analytical performance study for an AI/ML powered device.

Therefore, I cannot extract the information required by your prompts (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, etc.) because this type of information is not present in the provided text.

The document discusses:

• Device Name: SYNTHES (U.S.A.) Universal Sacral System
• Intended Use: For severe spondylolisthesis (Grades 3 and 4) of L5-S1, and as a non-pedicle screw system for scoliotic, lordotic, or kyphotic deformities, degenerative disk disease, and fractures of the posterior thoracolumbar spine (T8-S2). Pedicle screw fixation levels are L3-S2.
• Device Description: Allows a screw to connect to a rod through wide angles. Consists of a sacral screw assembly, sacral collar, nut, and rod. To be used with the SYNTHES (U.S.A.) Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System.
• Materials: Titanium alloy (ASTM F1295-92) and 316L stainless steel (ASTM F138-86).
• Comparison Devices: Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System Side Opening Screw and Transverse Bar, and the Sofamor Danek Texas Scottish Rite Hospital (TSRH) Pedicle Spinal Screw System Variable Angle Screw, and the Titanium TSRH Spinal System (Screws) Variable Angle Screw.
• Substantial Equivalence Claim: The SYNTHES (U.S.A) Universal Sacral System is substantially equivalent to the aforementioned comparison devices based on similar intended use, component dimensions, sizes, and materials.
• Sterilization: Provided non-sterile; moist heat sterilization is recommended.

There is no mention of an "acceptance criteria" table with reported device performance metrics in the context of an AI/ML algorithm's output. The "study" mentioned here is the comparison done for 510(k) clearance, asserting equivalence to predicate devices rather than proving performance against specific acceptance criteria using a test set, ground truth, or expert review as you've outlined. This document predates the widespread use of AI/ML in medical devices by decades (dated 1997).

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