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The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.

The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".

The provided text describes a 510(k) submission for "Chest Drainage Tubing" and establishes its substantial equivalence to a predicate device. This type of submission relies on demonstrating similarity to an already cleared device, rather than conducting new clinical trials with acceptance criteria based on performance metrics like sensitivity or specificity.

Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth are not applicable in this context. The "acceptance criteria" here are that the new device is "substantially equivalent" to the predicate device in terms of intended use, design, technology/principle of operation, materials, and performance, and that it raises no new issues of safety and effectiveness.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The "study" here is not a typical clinical trial but rather a demonstration of substantial equivalence through comparison to a predicate device.

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

Not applicable. There is no "test set" in the traditional sense of a clinical or analytical performance study with a specific number of samples. The demonstration of equivalence relies on comparing the device's characteristics and performance to those of a predicate device.

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

Not applicable. Ground truth, in the sense of expert consensus on diagnostic accuracy or clinical outcomes, is not established for this type of 510(k) submission. The "truth" is established by showing that the characteristics of the new device are sufficiently similar to a legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as there isn't a test set requiring adjudication of findings.

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 is not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" for this submission is established by the known characteristics, safety, and effectiveness of the predicate device (Gish Biomedical Tubing, K870792). The new device is compared against this established benchmark.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not a machine learning device.

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

Not applicable. There is no training set.

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The Gish CAP VRF45 is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suctioned blood prior to the extracorporeal circuit. The CAP VRF45 is indicated for the collection and autotransfusion of the same patient's postoperative shed blood.

The Gish CAP VRF45 is a disposable device designed to be used in-line with an extracorporeal circuit during cardiopulmonary bypass surgery. The Gish CAP VRF45 Cardiotomy/Venous Reservoir is designed to be used in-line during cardiopulmonary bypass surgery as a storage reservoir for venous return blood and to filter and defoam intrathoracic suction blood. It is also to be used for collection and autotransfusion of postoperative shed blood. The device consists of a two (2) chamber or compartment configuration. The lower chamber is the venous return blood compartment, and the upper chamber is the intrathoracic suction blood compartment (cardiotomy). The device will be offered with or without a 20 - 28 micron filtration layer.

The provided text is a 510(k) Summary for a medical device (Gish CAP VRF45 Cardiotomy/Venous Reservoir). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details about a device's performance against specific acceptance criteria in a study, especially concerning AI/ML aspects, human reader performance, or training/test set details.

Therefore, many of the requested categories are not applicable or not available in the provided document. The submission is not for a software or AI/ML device, but a physical medical device (blood reservoir).

However, I can extract the information that is present according to the spirit of your request, focusing on how the device demonstrates its safety and effectiveness (which is the goal of acceptance criteria in a broader sense for this device type).

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria in a tabular format as one might see for a diagnostic device. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The "performance" is inferred from this equivalence and the testing performed.

• Storage of venous return blood
• Filtering and defoaming intrathoracic suctioned blood
• Collection and autotransfusion of postoperative shed blood |
  | Technological Characteristics (Substantial Equivalence)| Design, construction, materials, and nominal specifications are either identical or substantially equivalent to predicate devices (K890504, K883923, K922799). A detailed comparison chart is referenced (Appendix III, not provided). |
  | Biocompatibility (Safety) | Biocompatibility testing performed on sterilized product. Data supports that the device does not significantly affect safety. |
  | In-vitro Bench Testing (Performance/Safety) | In-vitro bench testing performed on sterilized and accelerated aged product. Data supports that the device does not significantly affect safety and effectiveness. |

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as "test set" in the context of a diagnostic algorithm. For the biocompatibility and in-vitro bench testing, the specific number of units tested is not provided.
• Data Provenance: The testing appears to be conducted by the manufacturer, Gish Biomedical, Inc. The document does not specify a country of origin for data beyond this. The studies are prospective in the sense that they were conducted for this specific submission to demonstrate equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a physical blood reservoir, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in that typical sense. Its function doesn't involve subjective interpretation by experts to determine "truth."

4. Adjudication Method

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a physical medical device, 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 is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic algorithm. For a physical device like this, "ground truth" implicitly refers to established engineering standards, material properties, and biological compatibility requirements that the device's performance in bench and biocompatibility tests is measured against. For example:
* Biocompatibility: Compliance with ISO standards for biological evaluation of medical devices.
* In-vitro bench testing: Meeting pre-defined performance specifications (e.g., filtration efficiency, defoaming effectiveness, structural integrity) which would be considered the "ground truth" for the device's functional attributes.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

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

Not applicable. See point 8.

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