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This anterolateral/anterior system consists of several vertebral screws, locking Inis allectuateraliances system of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This amerolateral verteoral boures of unilization during the development of a solid spinal fusion.

When used as an anterolateral/anterior spine plate and rod system, the MaCs™ 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
• Spillar schools
  Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or related to deficient . posterior elements)
• Tumors (neoplastic disease) .
• Pseudarthrosis .
• Failed previous fusion surgery

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eyetype screw. The device is used to apply force to a series of vertebrae to correct sway back, scoliosis (lateral curvature of the spine), or other conditions.

The provided text describes a 510(k) premarket notification for the "macsTL modular anterior construct system," a spinal intervertebral body fixation orthosis. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way a clinical study with performance metrics would.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the cornerstone of the 510(k) pathway for medical device approval. This means the device is considered safe and effective because it is similar to other devices already on the market.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in a clinical study for software or diagnostic devices. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices, focusing on:

• Intended Use and Indications for Use: The macsTM system must have the same or similar indications as the predicate devices.
• Material Composition: It must be made of the same implant alloy.
• Design and Function: It must have similar form, function, components, instruments, dimensions, geometry, and features.
• Biomechanical Performance: It must demonstrate comparable performance (stiffness, fatigue endurance) to the predicate devices and existing standards.

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

• The document primarily describes biomechanical testing of the device components and constructs, not a clinical "test set" of patient data in the sense of a diagnostic algorithm.
• The sample sizes for these biomechanical tests are not specified in the provided text.
• There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because this submission is based on engineering and material testing, and comparison to existing devices, not a new clinical study with patient data.

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

• This question is not applicable as there is no "test set" in the context of clinical images or patient data requiring expert consensus for ground truth. The evaluation is based on engineering specifications, material standards, and comparison to predicate devices, which would involve engineering and medical device regulatory experts, but not in the way requested for a diagnostic study.

4. Adjudication Method for the Test Set

• Not applicable, as there is no "test set" in the context of clinical images or patient data to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not conducted or described. This type of study is typically performed for diagnostic or AI-assisted devices to assess human-in-the-loop performance. The macsTL system is an implantable surgical device, not a diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone "algorithm only" study was not done. The device is a physical implant, not a software algorithm. The "standalone" performance here refers to the biomechanical integrity and material properties of the device itself, which are evaluated through engineering tests, not an algorithm's performance.

7. Type of Ground Truth Used

• For the biomechanical testing, the "ground truth" (or reference against which performance is measured) is the established performance standards (e.g., ASTM, ISO standards) and the published data/known performance of the predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or clinical trial.

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI/ML algorithm requiring a "training set" of data.

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

• Not applicable, as there is no training set for this type of device.

In summary:

This 510(k) submission for the macsTL modular anterior construct system relies on demonstrating substantial equivalence through:

• Comparison of intended use, indications, materials, and design features to legally marketed predicate devices.
• Biomechanical testing to ensure its material and structural performance (stiffness, fatigue strength) are satisfactory and comparable to those of existing, approved devices and relevant industry standards.
• Compliance with manufacturing quality systems (QSR/CGMP) and material standards (ASTM, ISO).

It is not a submission for a diagnostic device or a device involving AI, and therefore, the questions related to clinical study design, reader performance, and AI-specific metrics are not addressed in this document.

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