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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 (T3-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 macs " HMA Anterior Spinal Stabilization 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, lordosis, whether . neuromuscular or related to deficient posterior elements)
• . Tumors (neoplastic disease)
• Pseudarthrosis
• Failed previous fusion surgery ●

The MACS 1 HMA Anterior Spinal Stabilization System includes implantable metallic plates, rods, clamps, locking nuts and screws. The components are used in various combinations to form a construct for use during anterior spinal fusion surgery. The MACS" modular anterior construct system (K002824), which was cleared on May 8, 2001, consists of the twin screws, where as the MAC™ HMA Anterior Spinal Stabilization System consists of the HMA Polyaxial and Monoaxial Screws. Both of these systems are considered a part of each other. The stabilization plates, connection rods, fixation nut, locking screw, bone graft clamp and screw have been cleared under the MACS" modular anterior construct system (K002824).

Here's an analysis of the provided text regarding the acceptance criteria and study for the MACS™ HMA Anterior Spinal Stabilization System:

This device is an anterior spinal stabilization system, a physical implant. The evaluation process for such devices differs significantly from software-based medical devices (like AI algorithms for image analysis) where performance metrics like sensitivity, specificity, and AUC are common. For implantable mechanical devices, the "acceptance criteria" and "study" revolve around mechanical integrity and biocompatibility, often demonstrated through laboratory testing and comparison to predicate devices, rather than clinical trials with human subjects focused on diagnostic accuracy.

Therefore, many of the requested points are not applicable to this type of device and the information provided in the 510(k) summary.

Acceptance Criteria and Study for MACS™ HMA Anterior Spinal Stabilization System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "samples of constructs made of titanium" for fatigue testing. It does not specify the exact number of samples used.
• Data Provenance: The testing was laboratory-based mechanical testing, not human clinical data. Thus, "country of origin of the data" and "retrospective or prospective" do not apply in the typical sense. The testing was prospective in the sense that it was performed specifically for this submission.

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

• This question is not applicable as the "test set" involves mechanical components (spinal implants) and not diagnostic data requiring expert interpretation. The "ground truth" for mechanical testing is established by engineering standards and measurements, not by human experts.

4. Adjudication Method for the Test Set

• This question is not applicable. Mechanical testing does not involve adjudication by experts in the way clinical diagnostic studies do. The results are objective measurements from laboratory equipment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable. This is a physical medical device (implant), not an AI diagnostic algorithm. Therefore, no MRMC study, AI assistance, or human reader improvement metrics are relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. This is a physical medical device (implant), not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on engineering standards and direct physical measurements (e.g., of load cycles for fatigue, stiffness, and strength) in a laboratory setting, as per applicable ASTM and ISO standards (e.g., ASTM F-1717-96 for the predicate device).

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission.

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

• This question is not applicable. There is no "training set" or corresponding "ground truth" in the context of mechanical device testing for a 510(k) submission.

Summary of the Study:
The study performed was a laboratory-based mechanical fatigue test on "worst case" configurations of the MACS™ HMA Anterior Spinal Stabilization System constructs made of titanium. The purpose was to demonstrate the mechanical integrity and fatigue life of the device. The specific results of this testing are referenced as being available in Section IV and Appendix I of the full submission, but not summarized numerically in the provided text. The device's conformance to applicable ASTM and ISO standards is also stated, implying that its mechanical properties (stiffness, strength, fatigue life) meet recognized industry benchmarks that were likely used as performance acceptance criteria. The claim of "substantial equivalence" to predicate devices (like the K-Centrum Anterior Spinal Fixation System, which also underwent ASTM F-1717-96 testing) further supports that similar mechanical performance criteria and testing methodologies were applied.

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