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The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System

The EasySpray and Spray Set system represents minor design modifications to the TISSOMAT and Spray Set, 510(k) K981089. The purpose of the design modifications is to accommodate a change in the location of the gas on/off function of the system. The original TISSOMAT and Spray Set design includes a foot pedal to turn the gas flow on and off. The EasySpray and Spray Set system moves the control from a foot pedal, to a clip that attaches to the back end of the DUPLOJECT.

The provided 510(k) summary (K050495) for the EasySpray and Spray Set for TISSEEL (Fibrin Sealant) focuses on demonstrating substantial equivalence to a predicate device through minor design modifications. It does not include specific acceptance criteria or performance studies in the way one might expect for a diagnostic or AI-driven device. The submission primarily addresses the change in the gas on/off function's location from a foot pedal to a clip.

Therefore, the requested information elements related to performance studies (like sample size, ground truth, expert opinions, MRMC studies, and training set details) are not applicable or present in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission describes a design modification to a medical device's control mechanism, not a study evaluating performance against a test set of data (e.g., in diagnostics). The demonstration of substantial equivalence relies on the nature of the design change being minor and not affecting fundamental technology or intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no "test set" in the context of data requiring expert ground truth in this submission.

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

Not applicable. There was no "test set" requiring adjudication.

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. This device is not an algorithm; it is a mechanical accessory for applying fibrin sealant.

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

Not applicable. There was no "ground truth" established from clinical data or expert consensus in this submission. The "truth" considered by the FDA in granting substantial equivalence was that the design modifications were minor and did not change the device's fundamental function, safety, or effectiveness compared to its predicate.

8. The sample size for the training set

Not applicable. There was no training set for an algorithm.

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

Not applicable. There was no training set and thus no ground truth established for it.

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