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This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the MACST Modular Anterior Construct System is indicated for patients with:

• Degenerative disk disease defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
• Spondylolisthesis ●
• Spondylolysis .
• Fracture .
• Spinal stenosis .
• Deformities (i.e., scoliosis, kyphosis, whether neuromuscular or related . to deficient posterior elements)
• Tumors (neoplastic disease) .
• Pseudarthrosis .
• Revision of previous surgery .

The MACST Polyaxial Screw and Thoracic Line is an extension of the existing MACSTL implant system, cleared through 510(k) K002824 on May 8, 2001. The extension consists of a larger Polyaxial screw, as well as, a shorter Polyaxial screw for the Thoracic spine. The MACST Polyaxial screw with the larger diameter (10mm) is also designed to work as a rescue screw in poor bone quality.

The provided text is a 510(k) summary for a medical device called the MACST Modular Anterior Construct System, a spinal stabilization system. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical or performance studies with acceptance criteria for a new device.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document.

However, I can extract the available information and indicate where data is not provided or not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not applicable. No specific test set for performance evaluation is described as this is a substantial equivalence submission relying on prior device data and standard compliance.
• Data Provenance: Not applicable. No clinical or comparative performance data from human or lab studies of the new device is presented. The submission focuses on design equivalence and material compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

• Not applicable. No adjudication method for a test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not done, as this is a spinal implant, not an imaging or diagnostic device typically requiring reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device (spinal implant), not a software algorithm.

7. The Type of Ground Truth Used

• Not applicable. The submission does not describe a study involving "ground truth" as would be relevant for diagnostic or AI-based devices. The "truth" here is the device's adherence to design specifications and material properties, which are generally demonstrated through bench testing or material certifications, not clinical "ground truth" derived from patient outcomes or expert consensus for diagnosis.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, this is a physical medical device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, the "study" demonstrating the device meets acceptance criteria is a declaration of substantial equivalence to predicate devices and conformance to applicable ASTM and ISO standards.

The key points are:

• Reliance on Predicate Devices: The MACST Polyaxial Screw and Thoracic Line is presented as an extension of the existing MACST implant system (K002824) and is deemed substantially equivalent to it and other predicate devices (K011556, K990959, K002371). This implies that if the predicate devices meet performance and safety criteria, the new device with similar design and materials also meets them.
• Standards Conformance: The document states, "The new MACST System conforms to applicable ASTM and ISO standards." This indicates that the device has undergone testing (or its materials/design are known to comply) with recognized industry standards related to spinal implants, likely covering aspects like mechanical strength, fatigue, material biocompatibility, and sterilization. However, specific results from these tests are not included in this summary document. These standards themselves define the acceptance criteria for various physical and mechanical properties.

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