Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.

The Vanguard Blood Cardioplegia Systems are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs.

They are cardiopulmonary bypass devices allowing cardioplegia fluid delivery; they also regulate cardioplegia fluid temperature and trap air emboli.

Vanguard devices are indicated for use for patients undergoing surgical procedures requiring cardiopulmonary bypass procedures.

These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours.

The Vanguard Blood Cardioplegia Systems are the modified version of the disposables currently marketed in the SORIN BLOOD CARDIOPLEGIA SYSTEM (K934763) and the NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847).

The provided document is an FDA 510(k) approval letter for the VANGUARD Blood Cardioplegia Systems. It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through novel clinical studies.

Therefore, many of the requested sections regarding acceptance criteria, new study design, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not applicable to this type of regulatory submission and are not present in the document.

The document emphasizes a non-clinical performance evaluation to demonstrate equivalence, primarily focusing on material changes and updated technical specifications, without conducting new clinical trials.

Here's an analysis based on the provided text, indicating where information is not present or not applicable:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, there are no explicit "acceptance criteria" defined as performance metrics that the device must meet in a novel clinical trial. Instead, the "acceptance" is based on demonstrating that the modified devices perform equivalently to the existing, cleared predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document explicitly states: "No clinical testing was conducted in support of the Vanguard Blood Cardioplegia Systems..." (Page 7).
• The "test set" for performance evaluation was based on non-clinical verification and validation testing. The specific sample sizes for these tests (e.g., number of devices tested for material compatibility, flow rates, temperature regulation, etc.) are not detailed in this summary document.
• Data provenance is also not specified regarding country of origin or whether it was retrospective/prospective, as it pertains to internal lab testing for device verification.

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

• Not applicable. Since no clinical testing was performed, there was no need for experts (e.g., radiologists) to establish a clinical "ground truth" for a test set. The validation was based on engineering and performance criteria against standards.

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

• Not applicable. As there was no clinical test set requiring expert interpretation or adjudication, no such method was employed.

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 hardware system (cardioplegia set), not an AI/software device. No MRMC study was done, and the concept of "human readers improving with AI assistance" is irrelevant here.

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

• Not applicable. This device is not an algorithm or software. It is a physical medical device.

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

• For the non-clinical performance data, the "ground truth" (or reference) would be engineering specifications, regulatory standards, and the established performance characteristics of the predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

• Not applicable. As there is no training set for this device.

Summary regarding the Study:

The "study" that proves the device meets the (implied) acceptance criteria is a non-clinical verification and validation testing program. This means the manufacturer conducted a series of tests in their labs to ensure the modified device functions as intended, meets design specifications, is biocompatible with the new materials, and performs equivalently to the predicate devices, all in accordance with relevant national and international standards. This type of evidence is common for 510(k) submissions, particularly when changes are made to materials or manufacturing processes of existing device types where substantial equivalence can be demonstrated without new clinical data.

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For XTRA Collection sets:
"The XTRA Autotransufion System (including the XTRA Collection sets) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:

• Cardiovascular
• Orthopedics
• Thoracic
• Transplant surgery
• Emergency (Trauma)
• Neurosurgery
• Obstetrics and Gynecology
• Urology"

For XTRA Sequestration set X:
"The XTRA Autotransufion System (including the XTRA Sequestration set X) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:

• Cardiovascular
• Orthopedics
• Thoracic
• Transplant surgery
• Emergency (Trauma)
• Neurosurgery
• Obstetrics and Gynecology
• Urology"

XTRA Sequestration set X: The XTRA Sequestration set X is a single use sterile device made of plastic materials (mainly PVC) and it should be used in combination with a Bowl set and the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, aimed at autotransfusion. The XTRA Sequestration set consists of a system of tubing lines and bags, the autologous blood is recovered from the patient through routine hemodilution techniques and it's mixing with an anticoagulant in a blood bag, when blood is sufficient to fill the bowl set blood processing starts in order to separate blood into red blood cells (RBC), platelet poor plasma (PPP) and concentrated platelets or platelet rich plasma (PRP). In the bowl, because of centrifuqal force the blood components are separated and the RBC. PPP and PRP are collected into collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Sequestration set is a modified version of the disposable currently marketed in the XTRA autotransfusion system (K101586).

XTRA Collection sets: The XTRA Collection sets are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for intraoperative cell salvage and/or postoperative cell salvage, aimed at autotransfusion. The XTRA Collection sets consist of a blood collection reservoir, an aspiration and anticoagulation line, a vacuum extension line and a system of tubing lines, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment) into a blood collection reservoir and filtered to remove large clots, debris and microaggregate and blood defoaming. From the reservoir, the blood may be immediately used for direct administration to the patient in case of emergency, otherwise, the collected blood is processed with a Bowl set (wash set) and then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Collection sets are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586) and in the XRES/XRES 120um Blood Collection Reservoirs (K131103).

This document describes a 510(k) premarket notification for the XTRA Collection sets and XTRA Sequestration set X, which are autotransfusion apparatus. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel AI/software-driven medical device. Therefore, a significant portion of the requested information regarding AI acceptance criteria and performance studies (e.g., MRMC studies, standalone AI performance, training/test set details, expert involvement in ground truth establishment) is not applicable to this filing as it does not describe an AI medical device.

The provided text indicates that the changes to the device are primarily related to material changes (removal of DEHP from PVC components) and a minor design change in an Aspiration and Anticoagulation line, along with a change in supplier for a drip chamber component. No clinical testing was conducted because the device's indications for use and technical characteristics are considered equivalent to the predicate devices with proven safety and efficacy.

However, I can extract information related to the non-clinical performance data and the basis for the substantial equivalence claim.

Here's the breakdown of the information that can be gleaned from the document, along with explanations for the parts that are not applicable:

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

Since this is not an AI/software device, there isn't a table of AI-specific acceptance criteria like accuracy, sensitivity, specificity, etc. The acceptance criteria are implicitly met by demonstrating substantial equivalence through non-clinical performance testing validated against applicable voluntary standards.

The document states:

• "The XTRA Sequestration set X and XTRA Collection sets comply with all the applicable voluntary standards related to Autotransfusion systems. The devices passed all the testing in accordance with national and international standards."

This implies that the acceptance criteria are adherence to these standards, which encompass various performance aspects such as material compatibility, sterility, pyrogenicity, and mechanical integrity of the components required for safe and effective autotransfusion.

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

This information is not applicable as this is not an AI/software device submission requiring a test set for performance evaluation in the context of machine learning. The "testing" referred to is non-clinical verification and validation (e.g., bench testing, material testing, mechanical testing). No patient data is involved in this type of submission for demonstrating substantial equivalence based on material and minor design changes.

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)

This is not applicable. Ground truth establishment by experts is relevant for AI/software submissions that rely on human-labeled data for training and evaluation. For this device, "ground truth" would relate to the functional specifications and safety/performance standards for autotransfusion apparatus, which are established through engineering design, material science, and regulatory compliance, not expert image/data labeling.

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

This is not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling for AI ground truth or in reader studies. This type of review is not relevant for non-clinical device testing in a 510(k) for material changes.

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

This is not applicable. MRMC studies are used to evaluate the impact of AI assistance on human performance in diagnostic tasks. This device is an autotransfusion apparatus, not a diagnostic AI system, and therefore, no MRMC study was conducted.

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

This is not applicable. Standalone performance is evaluated for AI algorithms. This device does not contain an AI algorithm.

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

As explained previously, "ground truth" in the AI context is not applicable here. The "truth" or "basis" for device performance is demonstrated through:

• Compliance with applicable voluntary standards: This includes national and international standards for autotransfusion systems.
• Non-clinical verification and validation testing: This covers aspects like material properties, functional performance (e.g., blood collection, washing, concentrating), sterility, and pyrogenicity.
• Substantial equivalence to predicate devices: The predicate devices have a proven track record of safety and efficacy.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This is not applicable. As no training set exists, no ground truth needed to be established for it.

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The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.

The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir. The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts: an adapter 1/2" – 3/8"; a spare cap set; a blood sampling set. The device is intended to be used for periods up to six hours. The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.

The provided text is a 510(k) summary for a medical device (Quantum Perfusion Hybrid System) and primarily focuses on proving substantial equivalence to predicate devices through non-clinical testing. It does not contain information about a study proving device performance against specific acceptance criteria for an AI/software-driven device.

Therefore, I cannot provide the requested information, as the document details a traditional medical device submission, not one related to an AI/ML component with associated performance studies (MRMC, standalone algorithm, ground truth establishment, etc.). The document explicitly states: "No clinical data have been included in the current 510(k) submission to support substantial equivalence to legally marketed predicate and reference devices." and "No animal studies have been performed except for mandatory biocompatibility tests...".

The non-clinical testing mentioned is focused on general device performance for a cardiopulmonary bypass blood reservoir, such as pressure drop, mechanical resistance, air handling, and filtration efficiency, verifying it meets established engineering requirements for this type of device, which are inherent to the device's design and function rather than a set of statistical acceptance criteria that would typically be associated with an AI/ML algorithm's performance.

To answer your request, a document detailing an AI/ML device would be needed, specifically discussing its performance study, acceptance criteria, test set details, ground truth, and potentially MRMC study results.

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Model BB811 and Model BB811-NS: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

Model BB841: Oxygenator with Integrated Arterial Filter: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Cardiotomy/Venous Reservoir: The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811), Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text discusses the Affinity Fusion Oxygenator and its acceptance criteria, specifically focusing on the addition of an alternate hollow fiber supplier.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Biocompatibility Testing:

*Note on "Pressure Integrity": Devices conditioned only to factors significant for leaks (per Two Proportion statistical test).

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 explicitly state the sample sizes for the test sets (number of oxygenator units tested) for design verification or biocompatibility. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The nature of the tests (engineering performance and biocompatibility) suggests these were primarily laboratory-based prospective tests.

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):

This information is not applicable to the type of device and testing described. The "ground truth" for a medical device like an oxygenator is established through objective performance measurements and standardized biocompatibility tests, not subjective expert assessment as would be the case for image interpretation or diagnosis.

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

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving subjective human interpretation (e.g., radiology reads) to resolve discrepancies. The tests described here are objective performance and safety tests.

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:

This is not applicable. The device is an oxygenator, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is an oxygenator, not an algorithm.

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

The ground truth for this device is based on:

• Engineering specifications and standards: For performance characteristics like O2 Transfer, CO2 Transfer, Pressure Drop, Burst, Filtration Efficiency, etc. "PASS" implies meeting predefined, objective measurable criteria.
• International standards for biocompatibility (ISO 10993-1:2018): For tests like cytotoxicity, sensitization, genotoxicity, hemocompatibility, etc. "PASS" means meeting the established safety thresholds for these biological endpoints.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set. The "study" described is a series of laboratory-based design verification and biocompatibility tests.

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

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

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The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.

The MVR Venous Reservoir Bag, with or without Cortiva bioactive surface, is a single-use, sterile, nonpyrogenic variable volume device used in conjunction with a membrane oxygenator during cardiopulmonary bypass (CPB) surgery. It is sterilized using ethylene oxide. It is designed to accommodate blood from the patient and suctioned blood from the cardiotomy reservoir. The internal screen of the venous reservoir is designed to assist in tramping air, which may enter the venous reservoir during priming or perfusion on the inlet side of the reservoir. Air trapped in the venous reservoir bag can be removed using the one-way stopcock located at the top of the reservoir.

Blood that comes from the patient flows into the reservoir and is delivered through a pump to the oxygenator and other axillary devices, and back to the patient. The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path.

Products coated with Cortiva bioactive surface include a "CB" prefix in the model number. The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa.

The document provided does not describe a study involving device performance, diagnostic accuracy, or clinical outcomes that would typically include acceptance criteria, sample sizes for test and training sets, expert involvement, or adjudication methods.

Instead, this is a 510(k) premarket notification for a medical device (MVR™ Venous Reservoir Bag) which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "Summary of Testing" section describes biocompatibility testing and a design assessment related to a material change in a component (one-way stopcock) of the device.

Therefore, many of the requested categories (e.g., specific acceptance criteria for performance, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for performance, training set sample size/ground truth establishment) are not applicable to the information presented in this document.

However, I can provide the available information related to the biocompatibility testing and design assessment.

1. Table of Acceptance Criteria and Reported Device Performance (for Biocompatibility and Design Assessment):

Given the nature of the document, the "performance" here refers to meeting biocompatibility standards and
the assessment that functional performance is unaffected.

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

• Biocompatibility Testing: The document does not specify exact sample sizes for each biological endpoint test. It references compliance with ISO 10993 and USA FDA Guidance Document on Use of ISO 10993-1 standards, which typically outline specific sample size requirements for each test.
  • Data Provenance: The tests for the device component were either conducted by Medtronic (or a contracted lab) or referenced from a supplier certificate. The reference device data ("Step™ Auto Suture™ Dilator and Cannula") was applied, suggesting internal company data or previous submissions. The supplier certificate indicates tests were conducted "in accordance with 'Good Laboratory Practice'". This appears to be prospective testing for regulatory submission. Country of origin for data is not specified beyond being part of a US FDA submission process.
• Design Assessment: No specific sample size is discussed as it was a qualitative assessment.

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

• Not Applicable in this context. The biocompatibility tests are laboratory-based, with "passing" results determined by established scientific/regulatory standards rather than expert consensus on a ground truth. For the design assessment, no specific number or qualification of experts is mentioned; it's a statement of internal engineering/design conclusion.

4. Adjudication method for the test set:

• Not Applicable. As mentioned above, the results are determined by objective laboratory test outcomes against established Pass/Fail criteria, not by human adjudication of observations or interpretations.

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 device (venous reservoir bag) and does not involve AI, human readers, or diagnostic interpretation.

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

• Not Applicable. This is a physical medical device, not an algorithm or software.

7. The type of ground truth used:

• For Biocompatibility: The "ground truth" is defined by the objective pass/fail criteria of the specified ISO 10993 and USP Class VI biological endpoint tests (e.g., no significant cytotoxicity, no sensitization, no systemic toxicity, etc.).
• For Design Assessment: The "ground truth" is the engineering assessment that the material change has no impact on the functionality or performance of the final product.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The biocompatibility tests are evaluative, not for training.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The BMR1900 PHISIO Closed Venous Reservoir Bag is intended to be used in cardiopulmonary bypass procedures for periods of up to six hours.

The BMR1900 PHISIO Closed Venous Reservoir Bag (hereinafter BMR1900) is a softshell, flexible, polyvinylchloride bag designed for use in cardiopulmonary bypass surgery for periods up to six hours. It is supplied sterile with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. As for the unmodified device, the BMR1900 PHISIO. is composed of the following elements: - · A collapsible bag that serves as an in-line closed venous reservoir to contain blood volume. - · An integral 105 micron polyester filter screen which is mainly intended to facilitate the removal of large air bubbles from the blood. - A dual four-wav stopcock assembly used to manually purge the air captured by the filter screen or to administrate drugs or other solutions as needed during the cardiopulmonary bypass procedure. - A 1/2" venous blood inlet port and a 3/8" blood outlet port. - Connectors integral to the blood inlet port that are used to measure temperature and saturation/hematocrit of the incoming blood using external monitoring equipment, as needed. The BMR1900 PHISIO is designed with a 1900 mL maximum operating volume and a minimum operating volume equals to 300 mL and can be used at any flow rate up to 6 liter per minute. The venous blood inlet/outlet ports and the dual four-way stopcock assembly are opposite located with respect to the horizontal axis: the formers are placed in the bottom of the device while the latter at the top of the bag. Considering the vertical axis, both modified and unmodified devices present the blood inlet port with the integral cardiotomy inlet placed on one side of the bag while the blood outlet port is located on the opposite side of the bag. Blood enters the bag through the inlet port and passes through a polyester filter screen before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood. The BMR1900 PHISIO will be available with two configurations that differ only for the orientation of the venous blood inlet. The BMR1900 PHISIO. has the connector of the venous blood inlet right oriented (figure 1) while the BMR1900 L PHISIO. has the connector of the venous blood inlet left oriented (figure 2) The modified device is modified version of the currently marketed BMR1900 PH.I.S.I.O product

The provided text describes a 510(k) premarket notification for the BMR 1900 PHISIO Closed Venous Reservoir Bag, a medical device. This is a submission for a modified medical device, which is compared to its unmodified predicate device. The document focuses on demonstrating substantial equivalence rather than a device's initial performance study against clinical endpoints.

Therefore, the specific information requested in the prompt, such as acceptance criteria based on clinical outcomes, human reader improvement with AI, or detailed ground truth establishment for novel algorithms, is not applicable in this context. The study outlined here is a non-clinical performance study to show that the modified device is as safe and effective as the original, legally marketed device.

Here's the information that can be extracted and how it relates to the prompt's questions:

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

Since this is a substantial equivalence submission for a modified device, the "acceptance criteria" are effectively that the modified device performs equivalently to the unmodified predicate device across several non-clinical tests. The document states that the modified device "successfully met all acceptance criteria."

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

The document does not specify the sample size for each non-clinical test. The tests were performed on "sterile aged devices" equivalent to "at least 3 years" of aging. The provenance is not explicitly stated beyond the applicant being Sorin Group Italia S.R.L. and the tests being "in vitro testing." This implies laboratory-based tests rather than human patient data, and thus is more akin to prospective testing of manufactured devices.

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. This is a non-clinical engineering and materials performance study, not a study involving human expert interpretation or ground truth establishment in a clinical sense.

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

Not applicable. This is a non-clinical engineering and materials performance study, not a study requiring adjudication of expert opinions.

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 non-clinical performance study for a physical medical device (a blood reservoir bag) and does not involve AI or human readers.

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

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

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

The "ground truth" in this context would be the established performance characteristics and safety profile of the unmodified BMR1900 PHISIO predicate device. The tests performed on the modified device aim to demonstrate that it functions identically to this established benchmark.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable. There is no training set. The "ground truth" for the non-clinical comparisons is the performance of the previously cleared predicate device, which would have been established through its own initial premarket submission and subsequent clinical use.

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The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The provided text is a 510(k) Summary for the Medtronic Affinity Fusion Oxygenator System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information about a specific study proving the device meets acceptance criteria is not explicitly provided in this type of regulatory submission.

However, I can extract the relevant information that is available and clarify what is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics relevant to an "AI system" or "medical device performance" in the general sense, as typically sought in such a request. Instead, it refers to "predetermined requirements" and "improved bond performance" for specific components.

The "performance" referred to in this document primarily relates to the device meeting its intended function as an oxygenator and arterial filter during cardiopulmonary bypass. The summary states that "Operation and performance qualification... were completed" and that "the manufacturing process consistently produces product that meets predetermined requirements."

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

The document does not specify a "test set" in the context of an AI/algorithm evaluation. For the physical device modifications, it mentions "random sampling and statistical modeling" for the TMA seal, but no specific sample sizes or data provenance (country, retrospective/prospective) are provided for these manufacturing/design evaluations.

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

This information is not applicable to the provided document. The submission pertains to modifications of a physical medical device (oxygenator) and its manufacturing process, not to an AI/algorithm that requires expert-established ground truth from a dataset.

4. Adjudication Method

This information is not applicable to the provided document, as it does not describe an AI/algorithm evaluation requiring adjudication of ground truth.

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

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve AI assistance to human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable to the provided document. The submission is for a physical medical device and does not involve an AI algorithm.

7. Type of Ground Truth Used

This information is not applicable in the context of an AI/algorithm. For the physical device, the "ground truth" or verification is based on engineering specifications, performance testing (pressure integrity, burst, torque, insertion depth), and biocompatibility standards (ISO 10993).

8. Sample Size for the Training Set

This information is not applicable to the provided document, as it does not describe an AI/algorithm that would require a training set.

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

This information is not applicable to the provided document, as it does not describe an AI/algorithm.

Summary of what the document does provide:

The document describes a 510(k) premarket notification for the Affinity Fusion Oxygenator System, which involves modifications to a legally marketed predicate device (K203111). The core of the submission is to demonstrate substantial equivalence to this predicate device.

The study presented is not a classic "clinical trial" or "AI validation study" but rather a series of engineering and qualification tests to ensure that the modifications (specifically, changes to the Temperature Monitoring Adapter (TMA) insert component material and insertion depth, and different bioactive surfaces) do not alter the fundamental performance, safety, or efficacy of the device.

Key points from the document regarding "proof" and "acceptance":

• Proof of Meeting Acceptance Criteria: The proof is based on "Operation and performance qualification (OQ/PQ)" and "Design Characterization" activities. These activities evaluate various physical properties and manufacturing consistency.
• Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device's performance (e.g., pressure integrity, burst, torque, insertion depth, biocompatibility) meets internal predetermined requirements and does not introduce new hazards compared to the predicate device. For example, the TMA bond evaluation "indicated improved bond performance relative to the current material," suggesting a performance target was met or exceeded. Biocompatibility was accepted based on the new material already being used in another cleared device and conforming to ISO 10993.
• Study Design: The study is a non-clinical engineering and bench testing evaluation rather than a clinical trial or AI performance study. It's focused on validating the impact of specific component changes.
• Conclusion: The manufacturer concluded, and the FDA agreed by clearing the device, that these modifications maintain substantial equivalence to the predicate device, meaning it is as safe and effective as a device already on the market.

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The MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.

The MiniGuard Arterial Safety Valve ensures unidirectional flow in a blood filled line by means of a duckbill check valve located in the valve housing. If the line becomes pressurized, the check valve would automatically close and prevent flow in the reverse direction. A directional arrow as shown in Figure 12.1 below is printed on the valve to provide the user with a visual indication of blood flow. The MiniGuard Arterial Safety Valve consists of a an inlet and outlet housing made from Terlux 2802 HD ABS and a duckbill made from GLP-38L6 Off White Silicone rubber. The MiniGuard is sold with a cap made from PVC, 6811G-05. The cap is removed before use and has no patient contact. No colorants or adhesives are used on the valve.

The provided text describes the MiniGuard™ Arterial Safety Valve, outlining its intended use, technological characteristics, and performance data to support its substantial equivalence to a predicate device (RetroGuard Arterial Safety Valve, K922356). However, the document does NOT contain explicit acceptance criteria defined by specific numerical thresholds for each test, nor a detailed study that directly "proves" the device meets these criteria in the typical sense of a clinical trial or a statistically powered performance study against pre-defined metrics.

Instead, the document states: "Results of the performance testing demonstrates that the device meets all established specifications necessary for consistent performance." This implies that internal specifications were met, but these specifications are not explicitly detailed for each test.

Therefore, the following information is extracted or inferred based on the provided text. Many fields cannot be directly answered due to the nature of the available document, which is a 510(k) summary focused on substantial equivalence rather than a full study report with detailed acceptance criteria and performance data.

Acceptance Criteria and Reported Device Performance

Note: The document only states that the device "meets all established specifications necessary for consistent performance." It does not provide the specific numerical values for these specifications (e.g., "Opening pressure

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The Intersept filtered cardiotomy reservoir with Cortive surface is indicated for use in the cardiopulmonary bypass circuit during surgery for:

• an air/fluid separation chamber
• a temporary storage reservoir for priming solution and blood
• the filtration of particulates from bank blood and the storage and filtration of blood recovered from the field by suction
• the addition of medications or other fluids.

The Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is a single-use, device with a sterile, nonpyrogenic fluid path. The maximum capacity of each reservoir is 2,600 mL. The maximum recommended flow rate is 2 liters per minute (LPM). Each reservoir has eight luer or 0.6 cm (0.25 in) ID access ports; four suction access ports, two pre-defoamer and two post-defoamer access ports. One of the post-defoamer access ports is intended for use as a vent. Each Intersept Filtered Cardiotomy Reservoir contains an open cell polyurethane defoamer with a 20-micron microaggregate filter covered with a polyester sleeve.

The provided document is a 510(k) premarket notification for a medical device, the "Intersept™ Filtered Cardiotomy Reservoir with Cortiva™ BioActive Surface." It details the device's indications for use, comparison to predicate devices, and a summary of testing conducted to demonstrate substantial equivalence.

However, this document does not contain the kind of detailed information typically found in acceptance criteria or a study write-up designed to prove a device meets those criteria, especially in the context of an AI-powered diagnostic device performing a specific task (like identifying lesions in medical images).

Here's why and what information is missing:

• Device Type: This submission is for a physical medical device (a cardiopulmonary bypass blood reservoir), not an AI algorithm. Therefore, the "acceptance criteria" and "study" described in the prompt, which are strongly geared towards AI performance metrics (sensitivity, specificity, AUROC, reader studies, ground truth establishment), don't directly apply in the same way.
• Performance Metrics: The "reported device performance" in this document refers to physical and biological performance (bioactivity, leaching, coverage, biocompatibility, filtration efficiency, blood trauma), not diagnostic accuracy.
• Clinical Study Design: There is no description of a clinical study involving human subjects or experts assessing diagnostic performance as would be relevant for an AI algorithm. The testing described is laboratory-based and focused on material properties and basic device function.

Based on the provided document, here's what can be extracted and what remains unanswered regarding the prompt's specific requests (assuming the prompt's structure is still applied, despite the mismatch in device type):

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

Interpretation/Note: These are not "acceptance criteria" in the sense of diagnostic performance thresholds for an AI, but rather verification/validation checks for physical and biological device properties. The "Pass" indicates the device met Medtronic's internal criteria for these tests.

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

• Sample Size for Test Set: Not specified in the provided document. The document lists "tests" but doesn't detail the number of units or samples used for each test.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for a physical device's lab testing. The tests are laboratory-based and not derived from clinical patient data from a specific country or study type.

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

• This question is not applicable as the device is not an AI diagnostic algorithm, and "ground truth" in the context of medical image interpretation by experts is not relevant to this submission. The tests performed are laboratory-based physical and biological assays.

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

• Not applicable. There is no adjudication process involving human interpretation or consensus for the validation of this physical device. Verification/validation tests are typically performed according to established protocols.

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 not an AI algorithm, and therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.

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

• Not applicable. The device is a physical medical device, not an algorithm.

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

• Not applicable / Differently Defined: "Ground truth" for this device refers to established scientific/engineering principles, validated analytical methods, and predetermined specifications for physical and biological characteristics (e.g., certain levels of bioactivity, filtration efficiency, or absence of harmful leaching). It's not clinical "ground truth" derived from patient outcomes or expert reads.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a training set. The development of the device would involve engineering design, material selection, and iterative testing, not "training."

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

• Not applicable. As above, no training set or its associated ground truth establishment is relevant to this physical device submission.

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INSPIRE SVR 1200 with Ph.I.S.I.O. coating is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It collects and handles venous blood from cardiotomy reservoir. The INSPIRE SVR 1200 is intended to be used for 6 hours or less.

INSPIRE SVR 1200 with Ph.I.S.I.O. coating is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects and handles venous blood and suction blood from cardiotomy reservoir. The INSPIRE SVR 1200 is intended to be used for 6 hours or less.

The Sorin INSPIRE SVR 1200 (hereinafter referred to as INSPIRE SVR 1200) is a flexible PVC soft shell venous reservoir bag. This reservoir may be attached to the INSPIRE 6F C and INSPIRE 8F C oxygenator systems using a molded fitting connected to the gas exchange module. The blood contacting surfaces of this device are coated with a phosphorylcholine-based (Ph.I.S.I.O.) coating that provides a uniform surface. The device is provided with a 1/2" venous inlet connector and a 3/8" blood outlet connector. The venous inlet has an integral cardiotomy reservoir connector to allow receipt of blood from both venous cannulation and from a cardiotomy reservoir.

The INSPIRE SVR 1200 can be operated at flow rates up to 8 liters per minute (I/min) and has a maximum reservoir volume of 1325 mL.

The INSPIRE SVR 1200 soft shell venous reservoir is similar to the predicate devices as it consists of a soft PVC material and is used to collect blood during cardiopulmonary bypass procedures lasting up to 6 hours. The intended use and principles of operation are consistent with the predicate devices. It differs from the predicate devices in volume and dimensions, length of purge lines, and it includes a mounting backplate.

The device is ethylene oxide sterilized, has a non-pyrogenic fluid path and is for single use only.

The provided text describes the 510(k) premarket notification for a medical device called INSPIRE SVR 1200, a flexible PVC soft shell venous reservoir bag used during cardiopulmonary bypass procedures. The document focuses on demonstrating the substantial equivalence of this new device to previously marketed predicate devices.

However, the information required to answer your specific questions about acceptance criteria, study details, and ground truth establishment (especially for AI/ML device testing) is not present in the provided text. The document describes a traditional medical device submission, where "acceptance criteria" primarily refer to meeting specific performance and safety standards through non-clinical laboratory testing, rather than a study involving a test set, expert readers, or AI/ML performance metrics.

The document lists various non-clinical tests performed on the device (e.g., biocompatibility, blood trauma, flow rate capacity, structural integrity) and states that the device "successfully met all acceptance criteria for each of the following tests." These acceptance criteria are implicitly the performance specifications for these physical and functional tests, designed to show the device's substantial equivalence to predicates.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (in the context of AI/ML performance metrics like sensitivity, specificity, etc.): The document lists types of tests but not specific quantitative acceptance criteria or their corresponding numerical results for each test.
2. Sample size used for the test set and data provenance: The tests are likely bench tests or in-vitro tests on mechanical properties and blood interaction, not a "test set" of patient data in the AI/ML sense.
3. Number of experts used to establish ground truth and qualifications: This is not relevant to the type of testing described (physical and chemical properties of a medical device).
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance: This device is a physical component used in a surgical procedure, not an AI diagnostic or assistance tool.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in this context would be laboratory measurements and established biological safety standards, not case-level diagnostic ground truth.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that undergoes training.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes the regulatory approval process for a physical medical device (a blood reservoir) based on its functional, material, and safety properties, demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information relevant to the testing and validation of an AI/ML-based medical device.

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