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Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.

The IRIS™ Anterior Cervical Plating System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.

The IRIS™ Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and Nitonol per ASTM F2063. Stainless steel and titanium implant components must not be used together in a construct. LIFE SPINE expressly warrants that these devices are fabricated from the foregoing material specification. No other warranties express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use any of the IRIS™ Anterior Cervical Plate System components with the components from any other system or manufacturer.

The provided document is a 510(k) Pre-market Notification for the IRIS™ Anterior Cervical Plate System, a medical device. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than on proving clinical effectiveness or generating new clinical performance data through studies typically associated with AI/ML algorithms.

Therefore, the information requested in your prompt, which pertains to AI/ML model validation (e.g., sample size for test set/training set, expert ground truth, adjudication methods, MRMC studies, standalone performance), is not present in this document. This filing is for a mechanical implant, not an AI medical device.

Here's why your request cannot be fully answered from this document:

• No AI/ML Component: The IRIS™ Anterior Cervical Plate System is a physical spinal fixation implant. It does not involve any artificial intelligence, machine learning, or software algorithms that would require a test set, training set, or performance metrics like accuracy, sensitivity, or specificity.
• Substantial Equivalence: The approval process for this device relies on demonstrating that it is as safe and effective as a predicate device already on the market. This is primarily done through:
  • Technological Characteristics Comparison: Showing similar design, materials, and intended use to existing devices.
  • Performance Data (Bench Testing): Conducting non-clinical (mechanical) tests to ensure the device meets established engineering standards, like ASTM F1717 for spinal instrumentation.

However, I can extract information related to the acceptance criteria and performance data for this mechanical device as described in the document, which are different from an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

Regarding the other points you requested:

• 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/ML model. The performance data refers to mechanical bench testing, where "samples" are physical units of the device tested in a lab, not data points. Data provenance would be from laboratory testing.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. "Ground truth" in this context is established by engineering standards and validated lab testing protocols, not human clinical experts reviewing images or data for diagnosis.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for human expert review in AI studies, not for mechanical testing.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. An MRMC study involves human readers interpreting cases, relevant for diagnostic AI. This device is an implant, not a diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
• 7. The type of ground truth used: For a mechanical device, "ground truth" is defined by established engineering and material standards (e.g., ASTM F1717, ASTM F136, ASTM F2063) and the results of a predicate device.
• 8. The sample size for the training set: Not applicable. No "training set" for an AI/ML model.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical implant, and the requested performance criteria and study details are specific to the validation of AI/ML algorithms, which are not part of this device.

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