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The Confluent Surgical MicroMyst Applicator and Air Pump is indicated for use in the simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site.

The MicroMyst Applicator and Air Pump will be configured using the following components:
Applicator with flexible tip
Air line with filter
Air Pump

The provided text is a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump. This document focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria for a novel AI/software medical device.

Therefore, many of the requested categories for AI/software medical device studies either do not apply or cannot be extracted from this document.

Here's an attempt to address the points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present specific, quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics in the way a study for an AI/software medical device would.

Instead, the "acceptance criteria" for this device's regulatory clearance is demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially that the device performs functionally similarly and safely to the predicates.

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

• Sample Size for Test Set: Not applicable/not specified. The document refers to "biocompatibility data and results of bench testing" but does not provide details on the sample size of these tests. This is not a study involving a "test set" of patient data for an algorithm.
• Data Provenance: Not applicable/not specified. Given it's bench testing and biocompatibility, concepts like "country of origin" or "retrospective/prospective" data sets for patient data do not apply.

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

Not applicable. This device is a physical medical device, not an AI/software device requiring expert-established ground truth from images or other patient data. The "ground truth" here is the physical and biological properties of the device and its function as demonstrated through engineering tests and biocompatibility assessments.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of expert review and adjudication for an AI algorithm.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This type of study is relevant for evaluating human performance with and without an AI-assisted device, which is not the subject of this 510(k).

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

Not applicable. This is a physical applicator and air pump, not an algorithm.

7. The type of ground truth used

The "ground truth" used for this device's clearance would be based on:

• Engineering specifications and performance metrics during bench testing.
• Results from biocompatibility testing (e.g., cytotoxicity, sensitization, irritation studies).
• Chemical and material characterization.
• Comparison to the established safety and performance profiles of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. This is not an AI/software device that requires a training set or ground truth for algorithmic training.

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The HemaMyst Surgical Applicator System is indicated for the simultaneous application of the two separate components of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.

The HemaMyst Surgical Applicator System is a sterile, single-use device consisting of a Head that attaches by Luer connectors to currently available dual syringe spray noals and is coupled to an air regulator base unit by means of a sterile filtered air applicators, and is obablicator System allows simultaneous delivery, by spraying, of the two components of fibrin sealant to the treatment site.

The provided text describes a 510(k) summary for the HemaMyst Surgical Applicator System. However, it does not contain information about acceptance criteria, device performance, a specific study proving acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

• Device Description: A sterile, single-use device for simultaneous delivery of two components of fibrin sealant.
• Changes from Predicate: The key change is the indication for application of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant.
• Functionality Testing: States that functionality testing shows the device is "function[al] with 3, 50 and 11, 2017 [sic] and and Spray of HEMASEEL APR or Tisseel VH fibrin sealant." This is a very brief and incomplete statement regarding testing and doesn't provide detailed performance metrics or acceptance criteria.
• Intended Use/Indications for Use: Simultaneous application of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
• Substantial Equivalence: The FDA's letter confirming substantial equivalence to predicate devices (K994023 and K981089).

Therefore, based solely on the provided text, I cannot complete the requested tables and information.

Here's an attempt to fill in what can be inferred or directly stated, and to explicitly highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The phrase "function[al] with 3, 50 and 11, 2017" is unclear. It might refer to three specific tests, or some other parameters, but it's not a clear sample size.
• Data Provenance (country of origin, retrospective/prospective): Not specified.

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

• This device is mechanical. The concept of "ground truth" and "experts" as in diagnostic AI studies typically doesn't apply to this kind of functionality testing in the same way. The assessment would likely be based on engineering specifications and direct measurement, not expert consensus on an image or medical condition.
• Number of experts: Not applicable/Not specified.
• Qualifications of experts: Not applicable/Not specified.

4. Adjudication method for the test set

• Not applicable/Not specified, as this refers to a diagnostic assessment process. For a mechanical device, performance is typically measured against specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is a mechanical device, not a diagnostic algorithm involving human readers.

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

• Yes, implicitly. The "Functionality testing" refers to the device's performance. Since it's a mechanical applicator for fibrin sealant, its performance would inherently be evaluated in a standalone manner, separate from a human operator's skill, to ensure it delivers the sealant correctly. However, a specific study detailed as "standalone performance" is not described.

7. The type of ground truth used

• The "ground truth" for a mechanical device's functionality would be its adherence to engineering specifications and proper delivery of the fibrin sealant. The text does not detail these specifications or measurement methods.

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.

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