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The Scout Vessel Guard System is indicated as a cover for vessels during anterior vertebral surgery.

The Synthes Scout Tack Fixation is a method of fixation of the Scout Vessel Guard to bone. The single-use Scout Tack implant is made of a titanium alloy (TAN, per ASTM F1295-05, "Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)," January 1, 2005). It has a low profile head. The tack is inserted by light impaction through the Scout Vessel Guard into lumbar vertebral bone. The Scout Tack implant can be used as an alternative to, or a complement to, suturing the Scout Vessel Guard in place.

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 sizes for each test (pullout, dynamic mechanical, dynamic biomechanical, and usability). However, it implies that the tests involved sufficient samples to draw conclusions about equivalence or superiority.

The data provenance is not explicitly stated as "country of origin," but the testing was conducted by Synthes, an American company. The tests are described as "non-clinical," and the phrase "cadaver lab testing" suggests a controlled, pre-clinical environment. The study is retrospective in the sense that it evaluates the device's performance against established predicate devices and methods.

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

The document does not mention the number of experts used or their specific qualifications for establishing ground truth in the non-clinical tests. For usability testing in cadaver labs, it is implied that surgeons or trained professionals evaluated the device, but their number and specific qualifications (e.g., years of experience, specialty) are not provided.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method. The evaluation of test results (e.g., pullout strength measurements, mechanical properties) would typically involve engineering analysis and comparison against pre-defined thresholds or predicate device performance. For usability, it's likely a qualitative assessment by the testing personnel.

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

No, an MRMC comparative effectiveness study was not done. The tests described are non-clinical, mechanical, and biomechanical evaluations, along with cadaver lab usability, not studies involving multiple human readers interpreting cases.

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

Not applicable. This device is a physical medical device (tack fixation) and not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests was based on direct measurements of mechanical properties (e.g., pullout strength, dynamic response) and observations of usability in a cadaver model, compared against the performance of established predicate devices and traditional fixation methods (suturing). There is no "pathology" or "outcomes data" ground truth as this is a pre-clinical evaluation.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning algorithm, so there is no training set in the conventional sense.

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

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

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