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The Gish Soft Venous Reservoir with HA Coating is indicated for use collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six (6.0) hours.

The Gish Soft Venous Reservoirs with HA Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one ½" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks. The components of this system which have contact with the fluid path are sterile and non-pyrogenic. All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. The Gish the Soft Venous Reservoirs with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

Here's a breakdown of the acceptance criteria and study information for the Gish Soft Venous Reservoir (SVR) with HA Coating, based on the provided 510(k) summary:

The provided document is a 510(k) summary for a medical device (Gish Soft Venous Reservoir with HA Coating). These types of submissions primarily demonstrate substantial equivalence to a legally marketed predicate device rather than presenting detailed "acceptance criteria" and "study results" in the way one might expect for a novel AI/software product or a clinical trial. Instead, the "acceptance criteria" are implied by the performance of the predicate devices and the "study" is a series of engineering and performance tests to ensure the new device functions similarly and safely.

Therefore, I will interpret your request within the context of a 510(k) submission for a physical medical device.

Acceptance Criteria and Reported Device Performance

• Capable of collecting systemic venous and cardiotomy return blood.
• Designed to operate at flow rates of 1.0 to 8.0 liters per minute.
• Designed to operate for periods up to 6.0 hours.
• Prevents venous air from entering the extracorporeal circuit.
• Reduces blood stagnation.
• Collapses if emptied (safety mechanism). | Device is indicated for collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures.
  Designed to operate at flow rates of 1.0 to 8.0 liters per minute.
  Designed to operate for periods up to 6.0 hours.
  Intended to prevent venous air from entering the extracorporeal circuit.
  Design reduces blood stagnation.
  Will collapse if emptied; a built-in safety mechanism that minimizes accidental air delivery to the oxygenator. |
  | Material Biocompatibility:
• All materials contacting fluid path must be biocompatible. | All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. |
  | Sterility & Non-pyrogenicity:
• Components in fluid path must be sterile and non-pyrogenic. | The components of this system which have contact with the fluid path are sterile and non-pyrogenic. |
  | Safety and Effectiveness:
• Equivalent in safety and effectiveness to predicate devices. | The device has been subjected to extensive safety, performance, and validations.
  Concluded to have the same intended use and similar technological characteristics as predicate devices, thus equivalent in safety and effectiveness. |

Study Information

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

   • The document does not specify a sample size for a "test set" in the context of clinical data or patient outcomes. The "test set" here refers to the actual physical devices (Gish SVR with HA Coating) that underwent "various performance tests" and "validations". The number of devices tested is not explicitly stated.
   • Data Provenance: The testing was conducted by Gish Biomedical, Inc. This is internal company testing, likely done in a laboratory or simulated environment, rather than involving human clinical data from a specific country or being retrospective/prospective in a clinical study sense.

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

   • This concept is not applicable in this 510(k) submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI algorithms where interpretation is involved. For a physical blood reservoir, engineering specifications and established test methodologies serve as the "ground truth" or benchmarks. Product specifications and performance standards are typically set by internal R&D, engineering, and regulatory teams, often informed by industry standards and regulatory guidance.

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

   • Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials or studies to resolve discrepancies in expert interpretation, particularly in diagnostic contexts. For physical device performance testing, results are typically objective measurements against predefined specifications; there is no "adjudication" between expert opinions on the performance data itself.

4. 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:

   • No. This is a physical medical device (blood reservoir) and not an AI or imaging diagnostic device. Therefore, an MRMC study is completely irrelevant and was not performed.

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

   • Not applicable. This is a physical blood reservoir, not an algorithm.

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

   • The "ground truth," while not referred to as such, is based on engineering specifications, performance standards, and comparison to the predicate devices' established safety and effectiveness. The device's ability to meet its functional requirements (flow rates, volume, air prevention, etc.) and demonstrate biocompatibility and sterility are the "truths" being validated.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set."

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

   • Not applicable for the same reason as above.

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The Gish Soft Venous Reservoirs with GBS™ Coating are indicated to collect systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to six (6.0) liters per minute for periods up to six (6.0) hours.

The Gish Soft Venous Reservoirs with GBS™ Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one 12" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks.

The components of this system which have contact with the fluid path are sterile and nonpyrogenic.

All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating.

The Gish the Soft Venous Reservoirs with GBS™ Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

The provided text describes a submission for a medical device, the "Gish Soft Venous Reservoirs SVR with GBS™ Coating," claiming substantial equivalence to a predicate device. However, it does not include specific acceptance criteria, detailed study designs, or reported device performance metrics in a way that allows for the creation of the requested table or the detailed answers to all the questions. The submission focuses on describing the device, its indications for use, and a claim of equivalence based on general "safety, performance, and validations prior to release."

Here's an attempt to answer the questions based only on the provided text, highlighting what information is missing:

1. A table of acceptance criteria and the 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)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. (The document mentions "extensive safety, performance, and validations prior to release," but provides no details on where or how these were conducted, or whether they were retrospective or prospective).

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/Not specified. This device is a physical medical device (blood reservoir), not an AI/diagnostic software. The concept of "ground truth" as typically applied to diagnostic studies or AI algorithms does not directly apply here in the same way. The evaluation would be based on engineering specifications, biocompatibility tests, and functional performance, not expert-adjudicated diagnostic labels.

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

• Not applicable/Not specified. (See explanation for question 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 a blood reservoir, not an AI or diagnostic tool that would involve human readers or an MRMC study.

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

• Not applicable. This device is a physical blood reservoir, not an algorithm.

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

• Not applicable/Not specified. For a physical device like this, "ground truth" would relate to meeting engineering specifications, biocompatibility standards (e.g., ISO 10993), and functional performance parameters (e.g., flow rates, air removal efficiency, blood damage). The document states "extensive safety, performance, and validations" were done but does not detail the nature of these tests or how their "ground truth" (i.e., acceptable performance) was established beyond stating they meet "functional requirements and performance specifications."

8. The sample size for the training set

• Not applicable. This device is a physical blood reservoir, not a machine learning model.

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

• Not applicable. This device is a physical blood reservoir, not a machine learning model.

Summary of Findings:

The provided 510(k) summary is for a physical medical device (a blood reservoir) and focuses on demonstrating substantial equivalence to a predicate device. It references general "safety, performance, and validations" but does not provide the detailed scientific study data, specific acceptance criteria, or performance metrics that would be necessary to answer most of the questions, particularly those related to diagnostic performance or AI algorithms. The questions posed seem to be more tailored for a submission involving AI software or diagnostic tools, rather than a hardware device like the one described.

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