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The MONOLYTH C Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir is intended for use in an extracorporeal bypass circuit. The device provides oxygenation and removal of carbon dioxide from venous or suctioned blood. The integral heat exchanger provides blood temperature control, allows for the use of hypothermia, or aids in the maintenance of normothermia during surgery. The integral venous reservoir is intended for use as a storage reservoir for blood. The device is indicated for use with blood flows of 1.0 - 8.0 liters per minute (LPM). The MONOLYTH C 600 and the MONOLYTH C 1200 have been tested for 6 hours of continuous use. Use longer than 6 hours is not advised.

The MONOLYTH C is a high efficiency hollow fiber oxygenator with integral heat exchanger and a softshell venous reservoir. The venous reservoir is available both integrated with the device or as a separate device.

The oxygenator consists of microporous capillary polypropylene fibers wound around a perforated core in a crossed mat configuration. The fiber bundle has a surface area of approximately 2,2 m2. The blood path is around the outside of the fibers, while the gas path is through the lumens of the fibers. An arterial temperature probe is located close to the arterial outlet. The arterial sampling line contains an integrated one-way valve to prevent accidental air injection. The gas outlet is equipped with a capnograph connector for CO2 measurement. The gas outlet cap has a safety anti-occlusion feature to aid in gas venting.

A line between the gas module and the venous reservoir facilitates gravity priming of the system and allows for recirculation. This line is accessed via a high-pressure stopcock located at the lower portion of the membrane. The stopcock provides access to arterial blood throughout the procedure for cardioplegia, perfusion, or blood concentration.

The heat exchanger is on the venous side of the device and is comprised of epoxy-coated pleated stainless steel. The heat exchanger has a surface area of 0.17 m2.

The softshell venous reservoir is attached to a rigid external shell which is mounted on top of the oxygenator module. The softshell venous reservoir is a soft, flexible plastic bag with an integral screen and a rigid backplate. The backplate contains two inlet ports, a recirculation port, and a temperature probe port. The reservoir collects blood coming from venous return and from the cardiotomy reservoir. Blood from venous return and from the cardiotomy reservoirs is collected via separate inlet ports. Blood is then filtered through the screen to deflect air bubbles to the top of the reservoir. Bubbles may be purged through a double purge line with an additional luer port located at the top of the reservoir, which join together into a common line. The common purge line contains a one-way valve which prohibits air from returning into the reservoir. The temperature port, located below the venous inlet port, is designed to receive a YSI series 400 compatible probe.

The venous reservoir has one outlet line located at the bottom center of the bag. A 1/4-inch recirculation line is attached to a port on the back of the reservoir. This line may be connected to the arterial outlet or the recirculation port of the oxygenator to recirculate blood back to the venous reservoir.

Here's an analysis of the provided text regarding the MONOLYTH C Hollow Fiber Membrane Lung with Integrated Softshell Venous Reservoir, focusing on acceptance criteria and the supporting study information.

It's important to note that this 510(k) summary is for a medical device (oxygenator/blood reservoir), not an AI/software device. Therefore, many of the typical AI/ML study questions (like expert readers, adjudication, MRMC studies, training set details) are not applicable. The "acceptance criteria" here refer to the performance specifications and safety requirements for the physical device, not the performance of an algorithm.

Acceptance Criteria and Device Performance

The provided 510(k) summary describes various performance characteristics and integrity tests. However, it does not present a clear table of specific, quantitative acceptance criteria values alongside corresponding reported device performance values. Instead, it outlines categories of tests performed and states that the results "showed that the MONOLYTH C is substantially equivalent to the predicate devices and is acceptable for its intended use."

To construct the requested table, we'll have to infer the types of acceptance criteria based on the tests described, and the reported performance is generally stated as "acceptable" or "substantially equivalent" rather than precise measurements against a specific threshold.

Table of Acceptance Criteria (Inferred from Tests) and Reported Device Performance

Study Details (Applicable to Physical Device Testing)

This section addresses the questions specifically in the context of the physical device testing described in the 510(k) summary.

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

   • Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested for each in vitro study). It states that "representative samples (whole units, subassemblies, and components)" were used for biocompatibility testing, and "aged and unaged MONOLYTH C Hollow Fiber Membrane Lung with Integrated Membrane Lung with Softshell Venoir Reservoir and on CVR Softshell Venous Reservoirs" were tested for performance.
   • Data Provenance: The studies are "in vitro," implying laboratory testing. The company, Sorin Biomedical Inc., is located in Irvine, CA, USA, suggesting the testing was likely conducted in the USA. The tests are prospective in the sense that they are conducted on newly manufactured devices or components to demonstrate performance.

2. 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)

   • N/A. This is a physical medical device submission, not an AI/software device. Ground truth, in the context of clinical or diagnostic accuracy, is not applicable in the same way. The "truth" is established by direct measurement of physical or biological parameters in a controlled laboratory setting against predefined, validated test methods and specifications.

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

   • N/A. Adjudication is not applicable as this is not a diagnostic device requiring human interpretation of results against a consensus. Performance is measured objectively.

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

   • N/A. This is a physical medical device, not an AI/software device. MRMC studies are not relevant.

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

   • N/A. This is a physical medical device, not an AI/software device. Standalone algorithm performance is not applicable.

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

   • Physical/Chemical Measurement against Specifications: The "ground truth" (or reference standard) for this device's performance is established through validated in vitro test methods that measure characteristics like gas exchange, pressure drop, heat exchange, hemolysis, air removal efficiency, and structural integrity against predetermined engineering specifications and industry standards (e.g., for biocompatibility).

7. The sample size for the training set

   • N/A. There is no "training set" in the context of a physical device's performance validation. The devices are manufactured and then tested (acceptance testing) or subjected to larger-scale validation testing.

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

   • N/A. No training set is applicable.

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Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags.

Code 151 Blood Component Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from directly the patient.

The process of PRP/PPP is to be performed in the immediate preoperative period, prior to the surgical procedure and before the establishment of cardiopulmonary bypass. The collected PRP/PPP shall be administered during or after the operation to aid in the normalization of the patient's hemocoagulative state.

The Electronmedics PRP/PP Sequestration Kits are indicated for the same use as the Code 150 and Code 151 Blood Component Collection Sets.

The Blood Components Collection Set consists of a four-way adapter, a bag spike assembly, and two (2) collection bags. The four way adapter is inserted between the wash bowl and waste bag components of a preassembled surgical wash. The collection bags are attached to the free arms of the adapter. Whole blood to be processed may be collected in the immediate preoperative period into a transfer bag, which is then attached to the inlet side of the wash set using the bag spike assembly. In addition, blood may be collected directly from the patient by utilization of a filtered burette assembly intended for the administration of anticoagulation solution during preoperative collection of patient blood for sequestration of PRP/PPP. Alternately, whole blood from the extracorporeal circuit (e.g. cardiotomy reservoir or oxygenator) may be processed during the intraoperative period in the same manner.

The provided text describes a 510(k) premarket notification for the Sorin Biomedical Inc. Dideco Blood Component Collection Sets (Code 150 and Code 151). This notification focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a study report as might be expected for novel devices or performance claims. Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, and study methodologies is not present in this document.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics for the device's clinical efficacy (e.g., PRP purity, platelet recovery). Instead, it focuses on demonstrating substantial equivalence based on physical and functional tests to an existing predicate device (Electromedics Plasma Sequestration Set and AT-1000 Sequestration Set).

The "acceptance criteria" can be inferred as successful completion of these nonclinical tests, indicating the device performs as intended and is safe.

Study Details

The provided document describes nonclinical (in vitro) tests rather than a clinical study.

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

   • Test Set Sample Size: Not explicitly stated for any of the nonclinical tests. The text mentions "All burettes" for volume accuracy and "Each unit" for leak testing, implying the testing of multiple units, but the exact number isn't provided. For biocompatibility, it states "Biocompatibility testing was performed on finished devices," again without a specific number.
   • Data Provenance: The tests were performed "in vitro" by Sorin Biomedical Inc.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these nonclinical tests would be defined by engineering specifications and direct measurements (e.g., known forces for pull tests, precise volumes for accuracy, direct observation of leaks). Experts were not involved in establishing the "ground truth" in the sense of clinical interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. These were objective physical and functional tests, not subjective assessments requiring expert adjudication.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The document describes nonclinical in vitro tests and a comparison of technological characteristics to a predicate device, not a human reader study.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical blood component collection set, not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the nonclinical tests, the ground truth was based on:

   • Engineering specifications and objective measurements: For pull testing (force required to disconnect), volume accuracy (comparison to known volumes), and leak testing (absence of bubbles under pressure).
   • Regulatory standards/guidances: For biocompatibility testing, adherence to "Tripartite Guidances for the category of 'externally communicating devices, blood path direct: with a short term contact duration (5 minutes to 29 days)'."

7. The sample size for the training set: Not applicable. This document does not describe the development or evaluation of an algorithm using a training set.

8. How the ground truth for the training set was established: Not applicable.

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The Dideco Compact-A and Compact-M Autotransfusion Systems are intended to process, shed or collect blood for autologuous transfusion. The Compact-A and Compact-M autotransfusion systems are to be used with disposables for the collection of shed blood and aspirated body fluids, and the separation of erythrocytes from other components of the aspirated blood prior to, during and/or after a surgical procedure. The systems are also recommended to collect platelet-rich plasma (PRP) and/or platelet-poor plasma (PPP) from the patient's whole blood immediately preoperative to a surgical procedure.

The Dideco Compact-A and Compact-M Autotransfusion Systems are composed of the a high-speed lightweight automatic autotransfusion system following equipment: including a rolling cart for the system with an IV pole and a portable vacuum pump module.

Here's an analysis of the provided text regarding the Dideco Compact-A and Compact-M Autotransfusion Systems:

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Electromedics AT-1000), rather than establishing new performance criteria through extensive clinical trials. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, expert involvement, and ground truth for an AI-like device is not present in this document because it is not typically required or relevant for a substantial equivalence claim for this type of medical device.

Key takeaway: This is a traditional medical device submission, not an AI/ML device submission. The study described is for substantial equivalence to a predicate device, not for establishing new performance metrics against a defined acceptance criterion for a novel algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (substantial equivalence to a predicate device), explicit, quantifiable "acceptance criteria" and direct "reported device performance" against those criteria are not presented in a table format as one might find for a novel device or AI/ML algorithm. Instead, the submission states that substantial equivalence was based on a comparison of test results from in-vivo functional tests between the Dideco systems and the predicate Electromedics AT-1000.

The overall "acceptance criteria" is that the Dideco systems are functionally equivalent to the Electromedics AT-1000, as demonstrated by the comparable in-vivo test results and similar technological characteristics.

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

The document states "Summary of In-Vivo Tests" but does not specify the sample size used for these tests. It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that these are in-vivo functional tests for a physical medical device, it is highly likely that they are prospective tests performed on biological samples (likely human or animal blood).

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

This information is not provided in the document. For a substantial equivalence claim of this type of medical device, the ground truth is typically established by laboratory measurements or clinical observations, not necessarily by expert consensus in the way it applies to image interpretation or AI diagnostics. The "ground truth" would be the actual measured values of Hgb, ADP/Collagen, pH, cell counts, and platelet counts, derived from standard analytical methods.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This concept (e.g., 2+1, 3+1) is typically relevant for studies where subjective expert review is required to establish ground truth for a diagnostic output, particularly in AI/ML performance evaluations. For functional comparisons of physical devices like autotransfusion systems, adjudication in this sense is usually not applicable.

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

No, an MRMC comparative effectiveness study was not done. This type of study framework is specific to evaluating diagnostic technologies, especially in fields like radiology where multiple human readers interpret cases and their performance is compared with and without AI assistance. The Dideco Compact-A and Compact-M Autotransfusion Systems are physical devices for processing blood, not diagnostic AI algorithms. Therefore, the concept of human readers improving with AI assistance does not apply.

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

This question is not applicable as the Dideco systems are physical autotransfusion devices, not an AI algorithm. The performance described relates to the machine's ability to process blood and separate components, which is inherently a "standalone" machine process when considering its direct function. However, it's not an "algorithm only" performance claim in the context of AI.

7. The Type of Ground Truth Used

The ground truth used for the in-vivo functional tests (plasma free Hgb, ADP/Collagen, pH, cell and platelet counting) would be based on laboratory analytical measurements against established standards for those biological parameters. These are objective, quantifiable measurements.

8. The Sample Size for the Training Set

The document does not mention a training set. This concept (training set, validation set, test set) is fundamental to machine learning and AI development. Since this submission is for a traditional medical device demonstrating substantial equivalence, there is no AI algorithm being "trained."

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

This question is not applicable as there is no training set mentioned or implied in the submission.

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The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended to allow for the collection and autotransfusion of shed mediastinal blood following cardiopulmonary bypass procedures or other procedures where shed blood is expected.
The VRF40 Venous Reservoir with Integral Cardiotomy Filter is intended for use in CPB circuits and postoperative blood salvage procedure

The VRF40 is a sterile, nonpyrogenic, disposable, hardshell venous reservoir with an integral cardiotomy filter. It contains a polyurethane defoamer sponge and outer gross filter screen,

The provided 510(k) summary for the Sorin Biomedical Inc. VRF40 Venous Reservoir with Integral Cardiotomy Filter (K964908) describes a substantial equivalence determination based on nonclinical (in vitro) testing. There is no mention of clinical studies, human reader performance, or AI systems.

Therefore, the response below reflects the information present in the document, and many of the requested sections (e.g., related to AI, human readers, experts, and training data) are not applicable or cannot be extracted from this type of regulatory submission.

Acceptance Criteria and Device Performance Study

The acceptance criteria for the VRF40 Venous Reservoir with Integral Cardiotomy Filter and the study proving its performance are based on a comparison to a predicate device, the Sorin Hardshell Venous Reservoir (HSVRF). The study primarily involved in vitro physical and functional tests to demonstrate substantial equivalence for the expanded use in chest drainage autotransfusion.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with specific numerical targets. Instead, the acceptance was based on showing "similar performance characteristics" to the predicate device.

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

• Sample Size for Test Set: The document states that "All testing was conducted on nonaged, sterile devices," but it does not specify the number of devices used in the physical and functional tests.
• Data Provenance: The tests were "in vitro" and performed by Sorin Biomedical Inc. No information regarding country of origin of data or retrospective/prospective nature is applicable as it's not a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is not an AI/diagnostic device that requires expert ground truth for its performance evaluation in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a study involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is not an algorithm or AI device.

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was the established performance characteristics of the predicate device (Sorin Hardshell Venous Reservoir), as assessed through specific physical and functional in vitro tests.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model requiring a training set.

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

Not applicable. There is no training set for this device.

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The Dideco Venomidicard and Midicard are hardshell blood collection reservoirs intended for use in CPB circuits and postoperative blood salvage procedures.

The Venomidicard and Midicard are sterile, nonpyrogenic, disposable, hardshell reservoirs that contain an integral cardiotomy filter. Each device contains a polyurethane defoamer sponge and outer gross filter screen.

The provided 510(k) summary for the Sorin Biomedical Inc. Venomidicard/Midicard describes a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they pertain to the evaluation of AI/ML software.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.

Acceptance Criteria and Device Performance for Sorin Biomedical Inc. Venomidicard/Midicard

The acceptance criteria for the Venomidicard and Midicard reservoirs were based on their "substantial equivalence" to a legally marketed predicate device, the Sorin Hardshell Venous Reservoir (HSVRF), for the expanded use of chest drainage autotransfusion. Substantial equivalence was demonstrated through a comparison of technological characteristics and nonclinical test results.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document states that "All testing was conducted on nonaged, sterile devices." It does not specify the number of units tested for each physical and functional test.
• Data Provenance: The tests were "in vitro physical and functional tests," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are generally more applicable to clinical studies.

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

• Not applicable. This device evaluation relies on objective physical and functional measurements, not expert interpretation of data.

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

• Not applicable. This device evaluation relies on objective physical and functional measurements, not 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 is a medical device (a physical reservoir), not an AI/ML algorithm or imaging diagnostic device.

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

• Not applicable. This is a physical medical device.

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

• The "ground truth" for this device's performance was established by comparing its physical and functional test results to those of the predicate device (Sorin Hardshell Venous Reservoir). The predicate device itself was presumably cleared based on its known performance and safety. Biocompatibility was assessed against established Tripartite Guidelines using negative control groups.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires training data.

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

• Not applicable. This is a physical medical device.

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