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The Stöckert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for cardiopulmonary bypass. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The output protocol provides a complete overview of all relevant data obtained from the heart lung machine as well as from external devices. The serial output data are intended for procedure documentation, and are not intended for making clinical decisions for diagnosis.

The Stöckert Interface Module IDDD is an addition to the Stöckert S3 heart lung machine (K950990) and the SC heart lung system (K982014), which were both previously cleared for marketing. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording data on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The Interface Module IDDD is installed into the Electronics and Power Supply Pack (E/P) of the S3 or the Sensor Module Rack of the SC. A CAN bus system manages the data transfer.

The provided text describes the Stöckert Instrumente Interface Module IDDD, an accessory to cardiopulmonary bypass heart-lung machines. The document focuses on its substantial equivalence to predicate devices and testing performed to ensure its safety and functionality.

Here's an analysis of the acceptance criteria and study information contained in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "sample size" in the conventional sense for a test set of data. Instead, the testing involved:

• Physical Devices: Stöckert S3 System, SC heart-lung system, and an Interface Module IDDD installed in each.
• Operating Conditions: No-load and full-load states for EMI/EMC testing, with pump heads running at 100 RPM.

The data provenance is not specified, but given the manufacturer (Stöckert Instrumente GmbH, Munich, Germany) and the testing descriptions, it can be inferred that the testing was conducted prospectively by the manufacturer. No information regarding country of origin of "data" is provided, as the "data" being evaluated is the device's operational performance, not clinical or diagnostic data.

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

This information is not provided in the document. The testing described is primarily engineering and safety testing, not diagnostic performance evaluation requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used in clinical studies where disagreement among experts needs resolution to establish ground truth for classification or diagnostic tasks. The described tests are objective pass/fail criteria based on device functionality and safety standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. The Interface Module IDDD is an accessory for data output and documentation, not an interpretive or diagnostic AI tool.

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

Yes, in essence, standalone testing was performed. The described electrical safety, functional safety, and EMI/EMC tests evaluate the device's performance independently of human interaction beyond setting up and operating the system for the test. The "algorithm" here refers to the device's internal logic for data transfer and processing. The tests establish that the device operates correctly on its own and does not interfere with the primary heart-lung machine functions.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation is primarily engineering specifications, safety standards (IEC 60601-1), and functional requirements. For example:

• Electrical Safety: Compliance with IEC 60601-1.
• Functional Safety: Correct operation of safety-critical pump functions.
• EMI/EMC: No pump stops, no pump runaway, no sensor alarms, stable displayed values, and correctly functioning IDDD.
• CAN Message Acceptance: Only specified messages are accepted by respective modules.

These are objective, measurable outcomes directly related to the device's design and intended function, rather than subjective interpretations like pathology results or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Interface Module IDDD is a hardware accessory for data transfer, not an AI or machine learning model that requires a "training set" of data.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.

The SC 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 Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.

The provided document, K982014, describes a Special 510(k) for a device modification of the Stöckert Compact System (SC System). A Special 510(k) is used when a modification to a legally marketed device does not alter the fundamental technology or intended use, and therefore the determination of substantial equivalence relies heavily on the equivalence to the predicate device and the validation of the modifications according to design control procedures. This type of submission typically does not involve a traditional "study" in the sense of a clinical trial or performance study with acceptance criteria being met by reported device performance against a ground truth.

Instead, the "acceptance criteria" for a Special 510(k) are typically the demonstration that the modified device remains substantially equivalent to the predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The "study" proving this usually involves design validation and verification activities.

Based on the provided text, here's an analysis against your requested information:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with reported device performance in the manner requested for a new device submission. Instead, the "acceptance criteria" are implied by the nature of a Special 510(k) and the claim of substantial equivalence.

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

The document does not mention a "test set" in the context of a performance study with a specific sample size. The validation performed focused on the modifications to the existing S3 system. There is no information about data provenance like country of origin or retrospective/prospective nature because it's not a performance study on a new clinical dataset.

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

Not applicable. No "test set" or "ground truth" was established by experts in the context of a new performance study. The validation relates to engineering and design control processes.

4. Adjudication method for the test set

Not applicable. There was no test set requiring adjudication in the context of a performance study.

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 heart-lung machine, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a heart-lung machine, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate S3 System, and the demonstration that the modifications to create the SC System do not alter this. This is validated through design, engineering, and quality system procedures, not comparison to a clinical "ground truth" dataset.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and therefore does not have a "training set."

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

Not applicable. As above, this is not an AI/ML device.

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The Stockert S3 Mast Pump is a modular component of the Stockert S3 Perfusion System. The S3 Mast Pump is intended to provide speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of normally six hours or less, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution, when used by a qualified perfusionsist who is experienced in the operation of the S3 System.

The Stockert S3 (cardiopulmonary bypass) Mast Pump Module is intended for use during cardiopulmonary bypass surgery. The S3 Mast Pump Module is a component of the Stockert S3 Perfusion System, and is intended to provide speed controlled pumping of fluid through the cardiopulmonary bypass circuit, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution. The predicate and predecessor device to the S3 Mast Pump Module is the S3 Double Head Pump Module. The S3 Mast Pump has the same double head pump design and intended use as the S3 Double Head Pump Module(K955038). The basic difference between these two double head pumps is that for the Mast Pump, the pump heads are mounted on the mast of an S3 Mast Pump Extension Unit, and the control/operating unit is placed on a swivel plate on the console, whereas for the standard 69 double head pump module, the control unit is mounted directly over the pump theads and the entire module is installed on the S3 Console Base. The Mast Pump configuration enables the perfusionist to position the pump heads in close proximity to the patient, thus reducing the length of tubing required for the extracorporeal blood circuit and the associated priming volume required. This option is useful in clinical situations where it is important to minimize the amount of tubing in the circuit, e.g. infant perfusion.

The provided 510(k) summary for the Stöckert S3 Perfusion System Mast Pump Module does not include acceptance criteria or a study demonstrating device performance against such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (S3 Double Head Pump Module) and outlines the device's description, intended use, and conformity to general safety standards (IEC 601, IEC 62a, and UL 544).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided text.

Here's why the requested information isn't present:

• No Acceptance Criteria: The document does not define specific performance metrics, thresholds, or pass/fail criteria for the device.
• No Performance Study Details: While it mentions "extensive testing results characterizing device performance and software verification and validation," it does not provide any details about these studies, such as:
  • The specific tests performed.
  • The results of those tests.
  • The methodologies used.
  • Any comparison to acceptance criteria.
  • Sample sizes, ground truth establishment, or expert involvement.

In summary, the provided text describes the device and its regulatory status, but lacks the detailed performance study information required to answer your specific questions.

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The Stöckert S3 Cyclic RPM Control Module is an accessory to the S3 Cardiopulmonary Bypass System Console which allows for the cyclicapm control offan;S3:pump.

The Stöckert S3 Cyclic RPM Control Module is an accessory module to the Stöckert S3 (cardiopulmonary bypass) Perfusion System, and is intended to allow the roller pump or double head pump to operate in the pulsed flow mode. The predicate and predecessor device to the S3 Cyclic RPM Control Module is the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456). Similar devices have been used for many years for this same intended purpose. The new S3 Cyclic RPM Control Module is a simple upgrade of the technological aspects of the predicate device, e.g., the software controls and have been updated and the control and display panels have been updated for user convenience in operating the system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stöckert S3 Cyclic RPM Control Module:

Limitations of the Provided Information:

It's important to note that the provided document is a 510(k) summary, which is a high-level overview. It describes the device, its intended use, and states that testing was performed to support substantial equivalence. However, it does not provide detailed acceptance criteria, specific reported performance data, or the methodologies of the studies in the granularity typically requested.

Therefore, many sections of your request will be answered by stating that the information is either not provided or not applicable based on the context of this specific document.

Description of Acceptance Criteria and Study for Stöckert S3 Cyclic RPM Control Module

The Stöckert S3 Cyclic RPM Control Module is an accessory to the Stöckert S3 Perfusion System, designed to enable pulsed flow operation for the roller pump or double head pump during cardiopulmonary bypass. The device is a technological upgrade of a predicate device, the Stöckert-Shiley CAPS PFC 100 S Control unit (K883456).

The provided 510(k) summary indicates that the device underwent testing to demonstrate substantial equivalence to its predicate. The testing conducted included:

• Electrical testing: To ensure compliance with electrical safety standards.
• Functional acceptance testing: To verify that the device performs its intended functions correctly.
• Software verification and validation testing: To ensure the software controls operate as designed and meet specified requirements.

The device also conforms to applicable international standards: IEC 601 and IEC 62a.

1. Table of Acceptance Criteria and the Reported Device Performance

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

This information is not provided in the 510(k) summary. The document states "extensive testing results characterizing device performance" but does not detail the sample sizes for any test sets or the provenance (e.g., country of origin, retrospective/prospective nature) of data. Given that this is a hardware and software control module, the "test set" would typically refer to the number of units tested or specific scenarios run, rather than patient data.

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

This information is not provided and is largely not applicable in the context of this type of device (a control module for a perfusion system). Ground truth, in this case, would be established by engineering specifications and objective measurements, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable for the type of testing described (electrical, functional, software V&V for a control module). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where subjective interpretation is involved.

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

An MRMC study was not done and is not applicable for this device. This device is a control module for a perfusion system, not an AI-assisted diagnostic or clinical decision support system that involves human readers interpreting cases.

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

The device itself (the Cyclic RPM Control Module) is essentially a standalone control algorithm that modulates the pump's RPM. The "standalone" performance testing would be categorized under the "functional acceptance testing" and "software verification and validation testing" mentioned. The document states these tests were performed, but does not provide details on the specific performance metrics or results of these standalone tests.

7. The Type of Ground Truth Used

The ground truth for the testing of this device would be based on:

• Engineering specifications and design requirements: For electrical performance, functional parameters like RPM control accuracy, and software logic.
• Established international standards: IEC 601 and IEC 62a.

It would not involve expert consensus, pathology, or outcomes data in the typical sense for a medical device.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. The Stöckert S3 Cyclic RPM Control Module is described as possessing updated software controls, implying traditional software engineering and validation rather than a machine learning model that requires a "training set."

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

This is not applicable as there is no indication that a "training set" for a machine learning model was used. The software controls would have been developed and validated against engineering specifications and functional requirements.

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The Stockert S3 Cardioplegia Control Module is an accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System, and is intended to control and monitor the use of cardioplegia solutions during the bypass procedure.

The Stockert S3 Cardioplegia Control Module is an accessory module to the Stockert S3 (cardiopulmonary bypass) Perfusion System, and is intended to control and monitor the use of cardioplegia solutions during the bypass procedure. The predicate and predecessor device to the S3 Cardioplegia Control Module is the Stockert CAPS Cardioplegia Control unit. Similar devices have been used for many years for this same intended purpose. The newly modified Cardioplegia Control Module from Stockert (the S3 Cardioplegia Control Module) is a simple upgrade of the technological aspects of the device, e.g., the software controls have been updated and the control and display panels have been updated for user convenience in operating the system.

This K963300 submission for the Stöckert S3 Perfusion System Cardioplegia Control Module does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.

The provided text only includes:

• A 510(k) summary for the device.
• Device description and comparison to predicate products.
• A general statement about "extensive testing results characterizing device performance, including electrical testing, functional testing, and software verification and validation testing."
• Mention of conformance to IEC 601, IEC 62a, and UL 544, and holding the CE mark.

There is no detailed information provided on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any testing.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This submission is from 1997, and the level of detail regarding testing and validation, especially for software-controlled medical devices, was generally less extensive in public summaries compared to what might be expected from more recent submissions or detailed technical documentation.

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