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The Synthes TSLP System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1 - L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Synthes Thoracolumbar Spine Locking Plate (TSLP) System consists of a range of plate sizes and 5.5 mm cancellous screws with a locking head. The plates attach to the anterolateral aspect of the vertebral body of the thoracolumbar spine (levels T1-L5) and provide stabilization to permit the biological process of spinal fusion to occur. All components are manufactured from Titanium alloy.

This document is a 510(k) Premarket Notification for a medical device called the "Synthes Thoracolumbar Spine Locking Plate (TSLP) System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing novel acceptance criteria or conducting studies to prove device performance against such criteria in the way a new drug or novel high-risk device might.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software or AI-driven diagnostic devices. Instead, it describes a mechanical implant's indications for use and its regulatory clearance process based on substantial equivalence.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The Synthes TSLP System is a physical implant (plate and screws) designed for spinal stabilization and fusion. It is not an AI-driven diagnostic or treatment device, nor does it have associated software that would require performance criteria like sensitivity, specificity, or inter-reader agreement.
• Regulatory Pathway: The 510(k) pathway (K020244) is for demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, and intended use, along with non-clinical performance data (e.g., mechanical testing for implants) that would be conducted internally by the manufacturer, rather than clinical trials with external ground truth or human reader studies.
• Absence of Clinical Performance Data: The provided text focuses on the device description, indications for use, and the FDA's clearance letter. There is no mention of clinical studies, performance metrics (like sensitivity, specificity, accuracy), ground truth, expert readers, or sample sizes related to diagnostic performance.

In summary, the provided document does not contain the information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria, as these concepts are typically applied to AI/software-based diagnostic devices and not to mechanical implants being cleared via the 510(k) pathway.

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