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The Stöckert Air Purge Control (APC) System detects air in the venous line and removes air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit. The Synergy™/ECC.O™ shall only be used in conjunction with the Stöckert S5 (or any compatible system using the S5 firmware versions of 3.0 or greater) and the SCP Plus System.

The Stöckert S5 System is indicated for speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction and administration of cardioplegia solution.

The Stöckert APC System consists of the APC sensor module (Catalog Number: 23-45-22), 3-joint mast holder with fast clamp connectors for two bubble sensors, 420mm (Catalog Number: 23-26-96), bubble sensor for 3/8 inch tubing (Catalog Number: 23-07-50), and ultrasonic gel, bottle, 250 mL (Catalog Number: 96-06-10). All of these components are identical to those used with the Stöckert S5 System (K091008).

The Stöckert APC can be operated automatically and manually using the APC displet of the heart lung machine.

The Stöckert APC bubble trap is placed just before the venous bubble trap of the Synergy™/ECC.OTM. When bubble activity is sensed, the assigned roller pump on the heart lung machine console begins operation to remove a set tubing volume (as determined by tubing size and pump speed (RPM)) or to run for a set time (in seconds) at a perfusionist-selected flow rate. This fluid is pumped into an appropriate blood collection reservoir. The technology of the Stöckert APC is based on the technology of the Stöckert Air Purge Control System (K041558).

The Stöckert APC is used for detecting air in the venous line and removing air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stöckert Air Purge Control (APC) System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" against specific metrics. Instead, it makes a general statement about the device fulfilling "prospectively defined functional acceptance test" criteria.

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

The document does not specify a distinct "test set" in the sense of a dataset for evaluating an algorithm. The testing described is hardware and system validation.

• Sample Size for Test Set: Not applicable as it's not a data-driven algorithmic evaluation. The testing involved the Stöckert APC System itself, integrated with a heart-lung machine.
• Data Provenance: Not applicable. The testing was described as "non-clinical performance testing" and "simulated use/in-use validation testing" of the physical system, likely conducted internally by the manufacturer (Sorin Group Deutschland GmbH).

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

Not applicable. The ground truth for electrical safety, EMC, and functional performance would be established by engineering standards and internal testing protocols, not by expert consensus on a dataset.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human reader interpretation or diagnostic output that requires adjudication.

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

No. This device is a hardware system for detecting and removing air during cardiopulmonary bypass, not an AI or diagnostic imaging device that would involve human readers.

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

Yes, in a way. The "functional acceptance test and simulated use/in-use validation testing" evaluated the Stöckert APC System's performance in detecting air and initiating removal autonomously (which could be considered its "standalone" performance), even though it operates within the larger Stöckert S5 heart-lung machine system. The device's function is automated.

7. The Type of Ground Truth Used

The ground truth used for this type of device would be:

• Engineering Standards: For electrical safety (IEC60601-1) and electromagnetic compatibility (IEC60601-1-2).
• Physical Principles and Design Specifications: For the air detection and removal capabilities. The "prospectively defined functional acceptance test" would have protocols and metrics based on the expected physical behavior of the system (e.g., ability to reliably detect a certain volume of air, ability to remove air within a specified time).

8. The Sample Size for the Training Set

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

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

Not applicable.

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The Capiox® Bubble Trap with X-coating " is a device intended to facilitate air bubble removal from the blood flowing through a cardiopulmonary bypass circuit for up to 6 hours.

The Capiox® Bubble Trap with X-coating is comprised of a single outer housing with no inner housing. This outer housing is cylindrical in shape and has a slight conical-shaped lid assembly affixed to the upper area of the cylinder. The lid assembly has an air vent (purge) port on the top outer surface to facilitate air removal during use. The blood inlet port is positioned along the upper-side_axis_of_the_cylinder_housing_and_allows_for the entry of blood ... The base_of_the housing contains the blood outlet port. The cylinder housing contains a screen filter assembly through which blood will pass through for filtration of air bubbles. After the blood has been filtered, it then exits the assembly via the blood outlet port.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

Acceptance Criteria and Device Performance Study for Capiox® Bubble Trap with X-coating™

The provided document describes the Terumo Capiox® Bubble Trap with X-coating™ and its performance evaluation for substantial equivalence to a predicate device. The core of the performance evaluation is a comparison study.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets. Instead, it demonstrates "functional equivalence" and "substantial equivalence" to a predicate device, the non-coated BT15 Bubble Trap. Therefore, the "acceptance criteria" are implicitly that the new device performs comparably to the predicate device in the listed performance evaluations. The "reported device performance" refers to the demonstration of this equivalence.

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

The document does not explicitly state the numerical sample sizes for each in-vitro performance evaluation. It only mentions that "the following tests were performed."

• Sample Size: Not explicitly stated for the in-vitro tests.

• Data Provenance: The in-vitro performance evaluations were conducted by "Terumo Corporation, in conjunction with Terumo Cardiovascular Systems Corporation," implying an internal, retrospective (for the purpose of this submission, though the tests themselves would have been prospective investigations) study. No country of origin for the direct test data is specified beyond the Terumo entities.

  An in-vivo animal study was conducted by Terumo Cardiovascular Systems and Sierra Biomedical Laboratories in 1999 to evaluate the X-Coating material itself. This study would be considered retrospective for the current submission.

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

This type of information is not provided in the document. The studies described are primarily in-vitro lab tests and material evaluations, not clinical studies requiring expert ground truth for interpretation of patient data.

4. Adjudication Method (for the test set)

This information is not applicable or not provided. The studies are in-vitro performance evaluations demonstrating equivalence to a predicate, not clinical studies requiring adjudication of medical diagnoses.

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

No, an MRMC comparative effectiveness study was not mentioned. The studies described are in-vitro performance evaluations and an in-vivo animal study for material safety, not studies involving human readers or comparative effectiveness in a clinical setting.

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

This question is not applicable as the device is a physical medical device (bubble trap), not an algorithm or software. The "standalone" performance in this context would be the in-vitro functional performance tests, which were indeed conducted without human intervention in the function of the device itself during the test.

7. The Type of Ground Truth Used

For the in-vitro performance evaluations (Air Removal Efficiency, Hemolytic Effect, Pressure Drop, Mechanical Integrity/Leakage, Prime Volume), the "ground truth" is defined by objective, measurable physical and chemical properties and engineering specifications. The performance of the new device is compared directly against the established performance of the predicate device.

For the X-Coating material's safety, the "ground truth" was established by in-vivo animal study outcomes, specifically looking for "adverse conditions."

8. The Sample Size for the Training Set

This information is not applicable or not provided. The Capiox® Bubble Trap with X-coating™ is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for such a device would be its design, manufacturing processes, and material selection based on established engineering principles and prior device knowledge.

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

This information is not applicable as there is no "training set" in the context of AI/ML for this physical device. The "ground truth" for its development and design would have been established through a combination of engineering principles, material science knowledge, regulatory standards, and performance data from previous device generations (like the predicate device).

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The EDAC™ QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.

The EDAC™ QUANTIFIER is a standalone system in which the ultrasonic sensing system consists of a three-channel ultrasonic pulser-receiver unit, a touchpanel computer, ultrasound transducers and clamps for attached the transducers to the circuit. This system is currently being certified according to voluntary medical device safety standards UL 60601-1 . IEC 60601-1-2 and IEC 60601-1-4, covering electrical device safety in medical products and IEC-60601-2-37, covering ultrasonic diagnostic safety. It also employs software and firmware to provide the embedded signal processing needed to detect gas emboli over the range of sizes described.

The EDAC™ QUANTIFIER is an ultrasonic cardiopulmonary bypass bubble detector. The study validates the device's ability to detect gaseous emboli in an extracorporeal bypass circuit.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it describes "performance claims" and then details the testing conducted to validate these claims. Based on the "Technological Characteristics Comparison Summary" and the "Non-clinical Testing" section, the following can be inferred as the performance claims (which act as acceptance criteria) and the reported performance.

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

• Sample Size: Not explicitly stated. The document mentions "extensive non-clinical testing" and refers to a "System Test Plan (Attachment 5.7)" which would contain specific details, but this attachment is not provided.
• Data Provenance: The testing was conducted in a laboratory setting.
  • Country of Origin: Not explicitly stated, but the parent company (Luna Innovations Inc.) is based in Blacksburg, Virginia, USA.
  • Retrospective or Prospective: Prospective, as the tests were performed specifically to validate the device's performance before marketing.

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. The testing appears to be based on engineering and scientific measurements of bubble detection and sizing, rather than human interpretation of data for ground truth.

4. Adjudication method for the test set:

Not applicable. The ground truth appears to be based on controlled experimental conditions and expected physical phenomena of bubble generation and detection, not on expert consensus or adjudication.

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 standalone bubble detector, not an AI-assisted diagnostic tool that human readers would interpret. Its primary function is automated detection, not to improve human reader performance.

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

Yes, a standalone study was performed. The non-clinical testing was conducted to evaluate the EDAC™ QUANTIFIER's performance as a "standalone accessory," focusing on its ultrasonic sensing system and embedded signal processing. The device is designed to detect gas emboli automatically.

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

The ground truth for the non-clinical testing was established through controlled laboratory conditions using:

• Standardized fluid mimics (28% glycerin solution to mimic blood).
• Biological fluids (canine blood).
• Common medical solutions (crystalloid solution used to prime bypass circuits).
• Presumably, controlled introduction of known sizes and quantities of gaseous emboli into these systems, with measurement of the device's ability to accurately detect and quantify them. The "System Test Plan (Attachment 5.7)" would detail the precise methodology for generating and verifying these "ground truth" emboli.

8. The sample size for the training set:

Not applicable. This device is an ultrasonic sensor with embedded signal processing, not a machine learning or AI model that requires a "training set" in the conventional sense. Its "training" would be more akin to software and firmware development and calibration based on known physical principles and experimental validation.

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

Not applicable, as there is no traditional "training set" in the context of machine learning. The device's operational parameters and signal processing algorithms would have been developed and calibrated based on engineering principles and experimental data derived from various types and sizes of bubbles in different fluid environments, but this is not typically referred to as a "training set" for ground truth establishment in this type of device.

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