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The Sorin C5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the C5 System.

The C5 System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified, through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The Sorin C5 System modification consists of the addition of the mast pumps and the Electrical Venous Occluder (EVO) to the Sorin C5 System. The function of the modified Sorin C5 System is identical to that of the parent C5 system. Masts pumps expand the number of pumps available to the perfusionist. The Electrical Venous Occluder allows the perfusionist to respond more quickly to detections of air in the extracorporeal circuit. This Special 510(k) was submitted for the addition of optional components and accessories that are provided to assist the perfusionist in their conduct of cardiopulmonary bypass. The mast pumps allow for additional pumping for such activities as left ventricular venting, cardiotomy suction, and administration of cardioplegia solution. The EVO replaces a maximum of two manual tubing clamps and interfaces perfusionist-selected roller pumps to clamp the venous line when a pump alarm condition occurs.

This 510(k) summary (K103762) for the Sorin C5 System is a Special 510(k) submission for modifications to an existing device rather than a new device with a comprehensive clinical or standalone performance study. Therefore, much of the requested information regarding acceptance criteria and detailed study designs for AI-powered devices is not directly applicable or available in this document.

The submission focuses on demonstrating substantial equivalence to a predicate device (Stöckert S5 System and the parent Sorin C5 System) for the modifications introduced, which are the addition of mast pumps and an Electrical Venous Occluder (EVO).

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the modified device in the way one would expect for an AI/algorithm-driven device. The "performance" assessment here is focused on demonstrating that the added components function as intended and do not negatively impact the overall system's safety and effectiveness compared to the predicate.

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

The document does not provide details on specific "test set" sample sizes in the context of clinical data or AI model evaluation. The testing described is verification and validation (V&V) testing of hardware and integrated system functionality, not a clinical study with patient data.

• Sample Size: Not applicable in the context of a "test set" for performance evaluation via clinical data. The V&V testing would involve a sufficient number of tests to confirm functionality and safety, but these are typically engineering tests, not patient data samples.
• Data Provenance: Not applicable. No patient data or clinical data is mentioned as being used for performance evaluation of the modifications.

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. "Ground truth" in the context of expert consensus on diagnostic or prognostic outcomes is not relevant here as this is a hardware modification submission, not an AI or diagnostics device. The "ground truth" for the V&V testing would be engineering specifications and functional requirements.

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

Not applicable. This is not a study requiring adjudication of expert opinions on clinical cases.

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. No MRMC study was conducted, as this device is a hardware modification to a heart-lung machine, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a console with added components, not a standalone algorithm. The EVO component has an automated function (clamping the venous line upon pump alarm), but its performance is verified through engineering tests, not an "algorithm only" study in the sense of AI.

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

The "ground truth" for this submission refers to:

• Engineering Specifications: Functional requirements for the mast pumps and EVO.
• Safety Standards: Compliance with IEC 60601-1 and IEC 60601-1-2.
• Predicate Device Performance: The established safety and effectiveness of the existing Sorin C5 System and the predicate Stöckert S5 System.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set mentioned.

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The Stöckert Gas Blenders (2L, 5L, and 10L) are intended to enable qualified personnel to set monitor and control gas flows of medical grade gases (air/02/CO2) during cardiopulmonary bypass. The Stockert Gas Blenders are used as components of or optional accessories to the Stöckert S5 System (or any compatible Sorin system using the S5 firmware versions of 3.0 or greater) for periods of six hours or less.

The Stöckert Gas Blender Base Unit is 200 mm wide, 185 mm high, and 270 mm deep and it weighs 2.5 kg. It can be used either from a suitable horizontal surface such as a table or cart or it can be mounted on one of the masts (using the mast holder). It is attached to HLM console with the supplied 24V/CAN connector. This connection provides both power and communication between the Stöckert Gas Blender and the System Display Panel of the HLM. The Stöckert Gas Blenders are designed to provide a maximum mixed gas flow rate of 2L/min, 5L/min or 10 L/min depending on the model used to allow the perfusionist to purge the oxygenator with gas during the priming process. The front panel is the user interface and includes the on/off key, displays and controls. The rear panel houses the three inlet gas connections, the gas mix outlet, and the 24V/CAN connector. Gas line connectors are fast release connectors, consisting of a male connector (installed on the tubing) and a coupler socket (on the housing of the Gas Blender). Both sets (male and female) of connectors are labeled with the respective gas for which they are intended to be used. The Stöckert Gas Blenders enable the qualified perfusionists who are managing the cardiopulmonary bypass circuit using a Stöckert S5 or Sorin C5 System to precisely set, monitor and control the gas flows required for the oxygenation of the patient's blood during extracorporeal circulation. The supply sources for air, O2 and CO2 are connected to the rear inlets of the Stöckert Gas Blender and the gas mixture outlet is connected to the oxygenator (not supplied). The Stöckert Gas Blenders are optional accessories to and designed to be operated with the Stöckert S5 System/Sorin C5 System. They cannot be operated independently from the heart lung machine console. The values for total gas flow (air + O2), FiO2 and CO2 can be adjusted independently without affecting the remaining two values. Gas flow is displayed at both the Stöckert Gas Blender base unit and the remote display module situated in the Stöckert S5 System/Sorin C5 System "control desk" or "System Panel." Set values and actual values are continuously monitored and any discrepancy between them causes both optical and acoustic alarms. If desired, the perfusionist may set alarm limits at the remote display module to monitor the blood flow/gas flow ratio for the arterial pump.

The provided text describes the Stöckert Gas Blender and its FDA 510(k) submission. However, it does not include detailed information about acceptance criteria or a study that specifically proves the device meets those criteria in the format requested.

The document is a 510(k) summary for a medical device (Stöckert Gas Blender). For this type of submission, substantial equivalence to a predicate device is the key, not necessarily a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria in the way a new drug or a novel AI diagnostic might.

Based only on the provided text, here's what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

This information is not provided in the document. The document states that "Design verification and validation testing presented in the 510(k) included electrical/safety testing (IEC60601-1), EMI/EMC testing (IEC60601-1-2), and Functional Acceptance testing, and design validation testing (internal and external)." However, it does not list the specific acceptance criteria for these tests (e.g., accuracy of gas flow, precision of mixture) or the numerical performance results of the device against those criteria.

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

This information is not provided. The document mentions general "testing" but no specific test sets or their characteristics.

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

This information is not applicable/not provided. This device is a gas blender for heart-lung machines, not an AI diagnostic that requires expert interpretation for ground truth. Its performance would be validated through engineering and functional testing.

4. Adjudication method for the test set:

This information is not applicable/not provided. (See point 3).

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

No. The document explicitly states: "No formal clinical testing was provided as the basis for substantial equivalence or is required." Therefore, no MRMC study was conducted or reported here.

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

This concept is not applicable to this device. The Stöckert Gas Blender is a physical medical device that blends gases, not an algorithm. Its "standalone performance" would be its functional performance, which is generally verified through engineering tests, but specific details are not provided in this summary.

7. The type of ground truth used:

This information is not explicitly stated or applicable in the traditional sense of clinical ground truth (e.g., pathology). For a physical device like a gas blender, "ground truth" would be established by reference standards, calibrated measurement equipment, and compliance with engineering specifications. The document mentions "prospectively defined design and performance specifications," which would form this basis.

8. The sample size for the training set:

This information is not applicable/not provided. As this is a physical device and not an AI/machine learning algorithm, there is no "training set."

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

This information is not applicable/not provided (see point 8).

In summary:

The provided document is a 510(k) summary for a medical device focused on demonstrating substantial equivalence to a predicate device. It confirms that engineering, safety, and functional testing were performed but does not delve into the specific acceptance criteria or the detailed results of those tests, nor does it involve clinical studies or AI-related performance metrics.

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The Sorin C5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the System.

The Sorin C5 System is a modification of the modular S5 System that comprises basic components and optional components. Optional components/accessories that have been cleared by the FDA for use as part of the S5 System are also compatible with the C5 · System.

The provided text is a 510(k) summary for the Sorin C5 System, a heart-lung machine. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might for diagnostic software.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study, with a test set, ground truth, experts, and statistical analysis, typically applies to diagnostic or prognostic devices, not mechanical medical devices like a heart-lung machine.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document states:

• "Testing of the Sorin CS System has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs."

It does not provide a specific table of acceptance criteria or detailed performance metrics. The submission focuses on substantial equivalence to an existing predicate device (Stöckert S5 System), rather than establishing new performance benchmarks for a novel device. The performance testing is described as fulfilling "prospectively defined performance criteria," but these specific criteria and their fulfillment details are not included in the provided summary.

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

Not applicable/Not provided. The type of testing described (performance testing for a heart-lung machine) is likely mechanical and electrical functional testing, not a study involving patient data or test sets in the context of diagnostic algorithms.

3. Number of Experts, Qualifications, and Adjudication Method for the Test Set

Not applicable/Not provided. This type of information is relevant for studies involving human interpretation or consensus, such as AI for image analysis.

4. Adjudication Method for the Test Set

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a mechanical cardiopulmonary bypass system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a console with integrated roller pumps for cardiopulmonary bypass; it is not an algorithm that performs a task independently.

7. Type of Ground Truth Used

Not applicable/Not provided. The "ground truth" for a mechanical device like this would be its functional specifications and safety standards, rather than expert labels or pathology results.

8. Sample Size for the Training Set

Not applicable/Not provided. This concept applies to machine learning algorithms, not a heart-lung machine.

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

Not applicable/Not provided.

Summary of Relevant Information from the Provided Text:

• Acceptance Criteria Statement: "Testing of the Sorin CS System has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs." (Specific criteria and performance values are not detailed in this summary).
• Study Type: The submission focuses on establishing "substantial equivalence" of the Sorin C5 System to its predicate device, the Stöckert S5 System, based on "intended use, indication for use, operational characteristics, fundamental technological characteristics and performance specifications." This implied that the device met similar performance as the predicate, which was already cleared.
• Device Type: The Sorin C5 System is a Heart Lung Machine Console and integrated roller pumps, a mechanical medical device, not a diagnostic or AI-driven system. Therefore, many of the requested study elements are not applicable to this type of device submission.

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