Search Results

Pressure Display Box: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.
DLP® Disposable Pressure Display Set: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

Not Found

The provided document is a 510(k) summary for a medical device called the "Pressure Display Box" and "DLP® Disposable Pressure Display Set." This submission DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The document explicitly states:

• "No modifications have been made to the Devices as a result of this change. This submission is a result of a change to the labeling. The devices operating principle and technological characteristics are remaining the same."
• "The modifications to the Pressure Display Box and the DLP® Disposable Pressure Display Set described in this submission result in a substantially equivalent device because the fundamental scientific technology and the intended use are unchanged since the proposed labeling change."

This indicates that the submission is for a labeling change to an already cleared device (K852232) and not for a new device or significant modification that would require new performance studies to demonstrate safety and effectiveness. Therefore, the requested information regarding acceptance criteria and performance studies is not present in the provided text.

Ask a specific question about this device

The Stöckert Centrifugal Pump Console (SCPC System) is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through 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 SCPC System provides electrical power and sets specific operational parameters for the Stöckert Centrifugal Pump Control Panel and Drive Unit described in K011838. The SCPC System also monitors the following parameters of the cardiopulmonary bypass circuit:

• . Pressure
• Temperature .
• Level monitoring/bubble detection .
• Elapsed time .

The SCPC System provides procedural flexibility for use of the Stöckert Centrifugal Pump, allowing the pump to be used as a component of other legally marketed heartlung machine consoles.

The provided document, K020571 for the Stöckert Centrifugal Pump Console, describes performance testing but does not explicitly detail acceptance criteria in a quantitative table or the specific results against such criteria for the device itself. Instead, it broadly states that testing was performed to confirm that the proposed SCPC System performed as designed and met user requirements.

The document outlines the types of testing performed rather than specific performance metrics against pre-defined acceptance thresholds.

Re-interpreting for Acceptance Criteria and Study Information:

Given the nature of the device (a cardiopulmonary bypass system console) and the information provided, the "acceptance criteria" can be inferred to be compliance with relevant standards and successful functionality as per design specifications and user requirements. The "study" refers to the performance testing conducted.

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

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

• Sample Size: Not explicitly stated. The document refers to "testing" performed, which generally implies a test set of devices or scenarios, but no specific numbers are given for units tested or duration of tests beyond the "typical durations of six hours or less" for use.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location (Munich, Germany) and the regulatory submission to the FDA (USA), the testing was likely conducted in a controlled environment, potentially in Germany, for submission to US regulatory bodies. The nature of the device suggests in-vitro testing.

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 and hence not provided in the document. This device is a medical instrument console, not an AI/diagnostic software. "Ground truth" in the context of expert consensus or pathology is typically relevant for diagnostic devices or AI algorithms. The "ground truth" for this device would be its adherence to engineering specifications and regulatory standards, evaluated by engineers and regulatory compliance experts.

4. Adjudication method for the test set:

• Not applicable as this is not a diagnostic device involving human interpretation requiring adjudication. Performance was assessed against engineering and regulatory 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:

• Not applicable. This device is a physical medical instrument (a pump console), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is a hardware console with integrated software, not a standalone algorithm. Its performance is assessed as an integrated system.

7. The type of ground truth used:

• The "ground truth" for this device is its adherence to:
  • Engineering specifications and design requirements: The device was tested to confirm it "performed as designed."
  • User requirements: Confirmed it "met user requirements."
  • Regulatory standards: Demonstrated "conformance with the appropriate standards" for electrical safety and EMC.
  • Compatibility: Demonstrated successful interaction with other specified heart-lung machine consoles.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for such devices involves design, prototyping, and testing phases to ensure functionality, not data-driven model training.

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

• Not applicable for the same reasons as point 8.

Ask a specific question about this device

The Quest Myocardial Protection System, consisting of the MPS Console and the MPS Delivery Set used together, is intended for use by perfusionist and physicians to deliver whole blood (from any arterial source) and / or cardiopleqia solutions to the heart during open heart surgery on either an arrested or beating heart

The MPS is designed to deliver whole blood or cardioplegia solution. The MPS pumping subsystem coordinates the pumping and mixing of the blood and additives to deliver the desired composition of cardioplegia solution. The pumping subsystem consist of an electro-mechanical pumping device acting on a variety of disposable cassettes to deliver fluid. A set of four pump pistons, each driven by a stepper motor, displace the contents of the mechanically restrained fluid filled cassettes. Pressure sensors located on the end of each piston diagnose the adequacy of the pumping and filling process. The main blood pump consist of two motor driven pistons and a symmetrically designed pump cassette with two chambers. Each chamber is designed to alternately fill and pump blood. A set of valves operate on channels formed within the cassette to control the flow of fluids into and out of the chamber. As one chamber is filled, the other chamber is delivering solutions. This overlapping and alternating operation of the pumping system provides an essentially constant fluid output

Here's a breakdown of the acceptance criteria and study information for the Quest Myocardial Protection System Perfusion Assisted Direct Coronary Artery Bypass (PADCAB) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text states: "The function test data to support the safety and efficacy of the device has not changed from the predicate device submission. Please refer to paragraph 3 of pages 15 – 16 of TAB 20 of Volume 4 of original submission (#K953838). A copy has been enclosed for your convenience."

Since the detailed K953838 submission is not fully provided, we cannot determine the exact sample sizes for each specific functional test. The data provenance is not explicitly stated as country of origin, nor is it specified as retrospective or prospective, however, functional testing usually implies lab-based, prospective testing conducted by the manufacturer.

For K994274, the provided text directly lists functional testing results, but does not explicitly state sample sizes for these tests.

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

This information is not provided in the given text. The studies described are primarily functional and engineering tests, not clinical studies involving expert interpretation of data or images to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given text. As the studies are functional and engineering tests, an adjudication method like 2+1 or 3+1 typically used for clinical assessments or image interpretation algorithms is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC comparative effectiveness study was not done. The provided document is for a medical device (Cardioplegia Delivery System), not an AI algorithm for diagnostic interpretation that would involve human readers. The document focuses on the functional performance and safety of the device itself, often in comparison to predicate devices, but not on human performance with or without AI assistance.

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

This question is not applicable as the device is a physical medical system (Cardioplegia Delivery System), not an algorithm.

7. The Type of Ground Truth Used

For the functional tests, the "ground truth" is established by engineering specifications, recognized industry standards (e.g., ISO, AAMI, ANSI/HIMA, ASTM), and direct measurement against those specifications. For example:

• "No leaks at 15 psi" implies the ground truth for leakage is verified by applying 15 psi and observing.
• "Detects 100uL size air bubbles" implies the ground truth for air detection is based on the known size of simulated air bubbles.
• "Accuracy of 95% of the flow rates" implies that the true flow rate (ground truth) is measured independently.

8. The Sample Size for the Training Set

This information is not provided in the given text. This device is a hardware system, not an AI algorithm that typically has a "training set." The development of such a device involves design, prototyping, and iterative functional testing, but not machine learning training sets in the conventional sense.

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

This question is not applicable as the device is not an AI algorithm with a training set. The "ground truth" for the device's design and performance during its development would be based on engineering principles, clinical needs, and established medical device standards.

Ask a specific question about this device

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.

Ask a specific question about this device