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The Altus Spine Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

The Altus Spine Cervical Plate System is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Altus Spine Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.

This FDA 510(k) K163061 submission for the Altus Spine Cervical Plate System focuses on mechanical performance testing rather than AI/software performance. Therefore, many of the requested categories related to AI model evaluation (like sample sizes for test sets, ground truth establishment for training sets, expert qualifications, adjudication methods, or MRMC studies) are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the testing was performed in accordance with ASTM F1717. This standard defines the acceptance criteria implicitly through its testing methodologies for static and dynamic mechanical properties. The "reported device performance" is essentially that the device met these criteria and demonstrated substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated. For mechanical testing, this typically refers to the number of devices or constructs tested per configuration (e.g., specific plate length, screw diameter). The ASTM F1717 standard would generally specify minimum sample sizes for such tests.
• Data Provenance: This is a physical device, so "data provenance" in the sense of patient data doesn't apply. The tests are conducted in a laboratory setting on the physical device and its constructs.

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

Not applicable. For mechanical testing of a physical device, "ground truth" is established by the physical laws and engineering principles tested against the ASTM standard. There are no "experts" in the context of clinical interpretation or AI model training involved here.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical settings or when establishing ground truth for AI. This is a physical device tested against objective mechanical standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human readers' diagnostic performance, which is not applicable to an orthopedic implant.

6. Standalone (Algorithm only without human-in-the loop performance) Study

No, a standalone (algorithm only without human-in-the loop performance) study was not done. This is an orthopedic implant, not an algorithm, so this type of study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this medical device is established by the physical and mechanical properties of the materials and design, evaluated against established industry standards (ASTM F1717) for spinal implants. It's an objective measurement of mechanical performance, not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

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

Not applicable. As there is no training set for a physical device, the concept of establishing ground truth for it does not apply.

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The VERTEBRON SSP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The SSP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The modified VERTEBRON SSP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components, The modified VERTEBRON SSP™ Cervical Plate System attaches to the vertebral body by means of self tapping, self drilling or rigid cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a rigid cervical screw.

The acceptance criteria for the VERTEBRON SSP™ Cervical Plate System are based on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing. The study demonstrating this involved performing tests in accordance with ASTM F1717.

Here's the detailed breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size used for the mechanical tests. The "test set" in this context refers to the physical samples of the VERTEBRON SSP™ Cervical Plate System with the added rigid cervical screw that underwent mechanical testing.

• Sample Size: Not specified. Standard practice for such tests involves a sufficient number of samples to ensure statistical validity and representativeness of the device's performance.
• Data Provenance: The data comes from prospective mechanical testing conducted on the modified VERTEBRON SSP™ Cervical Plate System to evaluate its performance against established standards and predicate devices. No specific country of origin for the data generation is mentioned, but it would have been conducted by or for VERTEBRON Inc. in the US, given the submission to the FDA.

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

This information is not applicable as the acceptance criteria and study in question are for a medical device (spinal implant) and pertain to mechanical performance rather than diagnostic accuracy or clinical outcomes requiring expert interpretation of data. The "ground truth" here is the pass/fail criteria defined by the ASTM F1717 standard for mechanical properties.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing according to a defined standard like ASTM F1717 involves objective measurements and predefined pass/fail thresholds. There is no need for expert adjudication in the way it would be applied to clinical image interpretation or diagnostic accuracy studies.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The VERTEBRON SSP™ Cervical Plate System is a physical implant, and its acceptance is based on mechanical performance, not diagnostic effectiveness.

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

This is not applicable. The device is a physical medical implant, not an algorithm or AI system. Its performance is evaluated intrinsically, not as an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this study is defined by the mechanical performance specifications and limits outlined in the ASTM F1717 standard. This standard dictates the testing methodology and acceptance criteria for spinal intervertebral body fixation devices. The device's performance (e.g., strength, fatigue resistance) is measured and compared against the predefined limits within this standard.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this submission. The device is a physical product, not a machine learning model.

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

This is not applicable. As there is no training set for a machine learning model, there is no ground truth established for it. The "ground truth" for the device's mechanical performance is defined by the established and validated ASTM F1717 standard.

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