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When used as an Intervertebral Body Fusion device, the Novel ALIF Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.

When used as a Vertebral Body Replacement device, the Novel ALIF Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.

The Novel® ALIF Spinal Spacer System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit individual pathology and anatomical conditions of the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Novel® ALIF Spinal Spacer System:

The provided documents (510(k) summary and FDA clearance letter K090782) are for a medical device implant (spinal spacer system), not an AI/software device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable to this type of submission.

Medical device clearance for implants like the Novel ALIF Spinal Spacer System typically relies on demonstrating substantial equivalence to a predicate device through material science, mechanical testing, and sometimes biocompatibility testing. It does not involve AI performance metrics.

Here's the information extracted from the provided text, with explanations where categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for the Novel® ALIF Spinal Spacer System:
The fundamental acceptance criterion for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device. This is demonstrated by showing equivalence in:

• Indications for Use
• Design
• Material
• Function
• Mechanical Performance

Reported Device Performance:

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

• Not Applicable. This is a medical implant, not an AI/software device that uses "test sets" of data in the common sense for performance evaluation in the way AI models do. The "testing" refers to mechanical tests to compare its properties to a predicate device. The document does not specify sample sizes for these mechanical tests.
• Data Provenance: Not applicable in the context of clinical data for AI; the "data" here would be mechanical test results.

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

• Not Applicable. Ground truth in the context of AI refers to labels or diagnoses provided by experts on a dataset. For a spinal implant, the "truth" is established through engineering and biomechanical principles, material specifications, and regulatory standards, not expert consensus on image interpretation or clinical outcomes of a dataset.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple experts who are labeling data for an AI model. This is not relevant to the clearance of a mechanical spinal implant.

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

• No. An MRMC study is used to assess the effectiveness of an AI system's influence on human reader performance. This device is a physical implant and does not involve human readers interpreting images or data with or without AI assistance.

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

• Not Applicable. There is no "algorithm" in the sense of software or AI for this device. It is a physical implant.

7. The Type of Ground Truth Used

• Engineering/Biomechanical Standards and Predicate Device Performance Data. The "ground truth" for this type of device is the established performance characteristics (e.g., strength, durability, material properties) of its predicate device, as well as adherence to relevant mechanical testing standards (e.g., ASTM standards for spinal implants). The device's performance is then compared against these established benchmarks.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical implant, not an AI/software device that uses "training sets."

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

• Not Applicable. There is no training set in the context of this device.

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