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The Gish ATR2900 Series Reservoirs with GBS™ Coating are indicated for use:

1. During cardiopulmonary bypass surgery to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit.
2. During general surgery procedures other than cardiopulmonary bypass, for collection and filtration of suctioned blood. During these procedures, the reservoir must be used in conjunction with appropriate cell-washing techniques.
3. Once intraoperative use is completed, for the collection and autotransfusion of the same patients post operative blood using components available separately in the SVP400 or SVP450 STAT-VAC Conversion Pack, ATR200 or ATR250 Supplemental Drainage Set, ATR500 Wound drainage Postoperative Pack or ATR600 Supplemental Wound Drainage Line Set.
4. With or without a water seal when used for postoperative autotransfusion, depending on user preference and application. The SVP400, SVP450 and STAT-VAC provide a water seal for use with ATR2900. The attending physician is solely responsible for the decision to use or not to use a water seal..

The Gish CAP35 Series Reservoirs with GBS™ Coating with integral water seal/water manometer are indicated for use during cardiopulmonary bypass surgery to filter/defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The CAP35 Series Reservoirs are indicated for the collection and autotransfusion of the same patients postoperative shed blood, using components available separately in the CAP400 or CAP450 Postoperative Conversion Pack and ATR200 or ATR250 Supplemental Drainage Set.

The Gish CAP400/450 Pack is indicated for use exclusively with the Gish CAP Series Products: The Gish CAP400/450 Pack provides components used to convert the Gish CAP systems from intraoperative to post operative use.

The ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating are r no ATTLES and defoam suctioned blood and remove particulate matter greater than 160 um (ATR2900 and CAP35) or 20 µm (ATR2900DF and CAP35DF). The integral water seal/water manometer chambers of the ATR2900 and CAP35 series accommodate pleural drainage applications. The CAP series also includes a accommodate plearar arainage application. One stage is for cardiotomy blood and CAPVRF version with a 2 Stage filter of end of the other stage which is for venous return blood (which is significantly cleaner).

The ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating may be The ATR2900 Reservers and the United accessory Postoperative Conversion Packs.

Each device consists of a blood reservoir and a defoamer/filter cartridge. The blood Each device bonolote of a bicarbonate housing with sealed lid. The lid includes inlet reservoir container is a poryeding of the defoamer/filter compartments. Additional luer and "quick prime" inlets allow direct addition to the reservoir. The lid also includes over quick prime "inicto allow all out an out and es. The defoamer/filter cartridge pressunzation and oxooo nasuanent for filtration of cardiotomy blood as it enters the reservoir.

The provided 510(k) submission for the Gish ATR2900 Series and CAP35 Series Reservoirs with GBS™ Coating describes the device and claims substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or detailed study results in a format that lends itself to a table of acceptance criteria and reported device performance.

Instead, the submission states:

• "The Gish ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating have been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."
• "A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safeguards have been incorporated in the design of Gish ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating."
• "The conclusion drawn from these tests is that Gish ATR2900 Reservoirs and the CAP35 Reservoirs with GBS™ Coating are equivalent in safety and efficacy to its predicated devices."
• Under "9. Comparison:", it states "Differences -- None." in relation to the predicate devices.

This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing a detailed breakdown of acceptance criteria and performance against those criteria as might be seen for novel devices or those undergoing PMA approval. The "tests" mentioned are likely internal verification and validation activities to ensure the new device performs comparably to the predicate without explicit new quantitative clinical studies for performance metrics relative to a specific disease detection/classification task.

Therefore, I cannot populate the requested table and sections with specific values and details because the provided text does not contain that information. The submission indicates that these devices are substantially equivalent to existing ones and have undergone internal performance testing to meet their functional requirements, but it does not specify quantitative acceptance criteria or detailed results of these tests, nor does it describe studies involving human readers, training data, or ground truth establishment in the context of AI/diagnostic device evaluation.

Based on the provided document, the following information is not available:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission claims substantial equivalence to predicate devices and states that the device "meets all of its functional requirements and performance specifications", but no specific quantitative criteria or results are listed.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This type of information is typically for diagnostic devices or AI algorithms where expert consensus is needed for ground truth.
4. Adjudication method for the test set: Not applicable/provided.
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 a medical reservoir, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable/provided in the context of device performance claims. The "ground truth" for this type of device would likely be engineering specifications and established performance characteristics of the predicate devices.
8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

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