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The Synthes Spine Auterior Thoracolumbar Rod Clamp (ATRC) System consists of a rod, a choice of three clamps, one bone screw and one set screw. It is intended for use in stabilizing

• · bone graft following anterior decompression of hurst fractures.
• · vertebrectorny and vertebral body replacement in turnor patients.
• · anterior fusion following failed posterior lumber surgery.
• · suterior following severe disc degeneration. Degenerative Dise Disease is defined as back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies
• · correction of anterolateral lordone deformities for the spine, lumbar scolliosis and pseudoardirosis of the thoracolitm spine.

This system is intended for anterolaters interventebral hady secew tixation/attachment to the T8 - LS spine.

The Syathes Spine Anterior Thoracolumbar Rod Clamp (All'RC) System consists of a rod, a choice of three clamps, one bone screw and one serew. It is intended for use in stabilizing

• · bone graft following anterior decompression of burst liactures.
• verrebrectorny and vertebral body replacement in turnor patients. f
• · anterior fusion following failed posterior lumbar surgery.
• · anterior fusion following severe disc degenerative Disc. Disease is defined as back pain of a discogenic origin with degeneration of the disc confirmed by hUstory and rulivyruphic studies
• · correction of anterolateral locatic deformities for the spinc, lumber scollosis and peeudearthrosis of the thoracolumbar spine.

This system is meaded for anterolateral littervertebral body screw fixasion/auculuncul to the T8 - LS spinc.

The rod and set screw used in this system are identical to that of the USS. The bone screw is identival to that in the ATLP system.

The rwo ends of two rods, of upprupriate length, are inserted into the two (unthreadod) holes of each clamp and locked into position by the set serews included in the construct is then placed on the anterolateral aspect of the spinal segment to be subilized. The cousunct is anached to the vertebral bodies by four 7.5mm self-tapping unicortical screws.

All implantable ways are manufactured from cither CP timium, which conforms to ASTM Standard F67, or TAN, which conforms to ASTM F1795. The instruments used to attach the spine are made from various grades of Stainless Steel.

This system is provided non-sterile; moist heat sterilization is recommended

The provided text is a 510(k) summary for the SYNTHES Spine Anterior Thoracolumbar Rod Clamp (ATKC) System. It details the device's intended use and claims substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission demonstrating substantial equivalence, not a scientific study report with performance metrics.

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: These are typically quantitative measures (e.g., accuracy, sensitivity, specificity, mechanical strength tolerances) that a device must meet. This document focuses on equivalency to existing devices for safety and effectiveness, not on specific performance criteria derived from a new study.
• Sample Size and Data Provenance for Test Set: No specific test set or study is described to evaluate the ATKC System's performance against defined criteria. The comparison is based on the components and indications being similar to predicate devices.
• Number of Experts and Qualifications: There's no mention of experts establishing ground truth because no specific performance study is detailed.
• Adjudication Method: Not applicable as no ground truth establishment is described.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: This type of study is for evaluating human performance with and without AI assistance. The ATKC system is a mechanical implant, not an AI diagnostic tool, so such a study would not apply.
• Standalone Performance: While the device acts in a "standalone" mechanical capacity, the document doesn't provide quantitative performance data for it in isolation. It rather states that the "implantable components are equivalent in terms of safety and effectiveness" to predicate devices.
• Type of Ground Truth: No ground truth is mentioned because no study directly measuring the ATKC's performance is presented.
• Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a regulatory submission for premarket notification (510(k)) that focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance data for the new device.

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