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The Vitage!™ Surgical Hemostat Spray Set is intended for use in the application (by spraying) of the two components of Vitage]™ Surgical Hemostat onto wound surfaces.

The Vitagel Spray Set consists of a Spray Applicator and Filtered Tubing. The Spray Applicator is connected directly to the joiner of the dual syringe system supplied with the Vitagel preparation and application kit and is connected to a medical grade propellant gas control device via the Filtered Tubing. The Vitagel Spray Set aerosolizes the Vitagel for application to a suitable treatment site as described in the Vitagel instructions for use.

The provided text describes the Vitagel™ Surgical Hemostat Spray Set, a device intended for applying Vitagel™ Surgical Hemostat onto wound surfaces. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the detailed information typically found in studies designed to prove a device meets acceptance criteria for specific performance metrics (like accuracy, sensitivity, specificity, etc., which are common in AI/diagnostic device submissions).

Based on the provided text, here's what can be extracted and what is not available for your requested table and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific numerical acceptance criteria for performance benchmarks (e.g., spray pattern consistency, droplet size, flow rate, hemostatic efficacy improvements with the spray set vs. other application methods).
• Quantitative reported device performance metrics against those specific criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for either bench or animal testing.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Bench testing" and "Animal testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This device is a medical accessory for applying another hemostat, not a diagnostic or AI device that requires expert-established ground truth on a test set. The performance data is derived from bench and animal studies to demonstrate comparable application.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. See point 3.

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:

• Not Applicable. This device is not an AI-assisted diagnostic tool.

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

• Not Applicable. See point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the animal testing, the "ground truth" would likely be the observed hemostatic results achieved by applying Vitagel™ using the spray set, compared to results obtained when Vitagel™ was applied using "previously approved methods." The nature of this measurement (e.g., time to hemostasis, blood loss, subjective assessment) is not detailed.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device that uses a training set.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

Summary of the Study:

The provided text describes a 510(k) premarket notification for the Vitagel™ Surgical Hemostat Spray Set. The study conducted to support this notification was aimed at demonstrating substantial equivalence to predicate devices, not at establishing novel efficacy or specific performance metrics against clinical endpoints.

The performance data included:

• Bench Testing: Demonstrated "comparable" performance of the Vitagel Spray Set to predicate devices (Micromedics FibriJet Aerosol Applicator and Baxter Tissomat and Spray Set) for applying two non-homogenous fluids by spraying. Details on the specific parameters tested and quantitative results are not provided.
• Animal Testing: Confirmed that applying Vitagel™ using the Vitagel™ Spray Set achieved "results comparable" to those obtained when Vitagel™ was applied using "previously approved methods." Again, specific details on the animal models, the endpoints measured (e.g., hemostasis time, blood loss), and quantitative comparisons are not included in this summary.

This type of submission focuses on demonstrating that the new device does not raise new questions of safety or effectiveness compared to legally marketed devices, rather than providing in-depth clinical trial data with predefined acceptance criteria and performance.

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