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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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The hemoconcentrators are intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient physiological hematocrit. The choice of hemoconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

DHF and SH Hemoconcentrators are single-use, non-toxic and nonpyrogenic fluid path devices; they are supplied sterile and individually packaged. The devices are made of plastic materials and are recommended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit: The choice of hemoconcentrator depends on the protocol being used and required filtration rate. The device can be used up to 6 hours.

The DHF and SH hemoconcentrators are the modified version of the disposables currently marketed in the Dideco DHF hemoconcentrators (K021732) and the SH 14 hemoconcentrators (K081313).

The provided FDA 510(k) clearance letter for the DHF and SH Hemoconcentrators does not describe a study that proves the device meets specific acceptance criteria in the manner of an AI/ML algorithm or diagnostic device.

Instead, this document details a change to an existing, cleared medical device (hemoconcentrators used in cardiopulmonary bypass circuits). The core of the 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices, not to establish performance against new, quantitative clinical acceptance criteria as one would find for a novel diagnostic or AI-powered system.

The "study" described here is a non-clinical performance evaluation focused on demonstrating that a material change (from Santoprene to Silicone for O-rings) does not introduce new questions of safety or effectiveness.

Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device clearance.

Here's an analysis based on the provided document, highlighting what is (and isn't) present:

Analysis of Acceptance Criteria and Device Performance for DHF and SH Hemoconcentrators

The information provided describes a 510(k) clearance for hemoconcentrators, which are physical medical devices, not an AI/ML or diagnostic software. The "acceptance criteria" and "study" are therefore framed around demonstrating substantial equivalence to existing predicate devices, particularly after a material change to a component, rather than performance metrics for a diagnostic algorithm.

This document explicitly states: "No clinical testing was conducted in support of the DHF and SH hemoconcentrators, as the indications for use and technical characteristics are unchanged with respect to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."

The "study" instead focuses on non-clinical performance data to ensure that the device still complies with applicable standards and performs as expected after the specified design change.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission, acceptance criteria are generally met through compliance with recognized standards and demonstrating that the device's fundamental characteristics and performance are maintained despite the change. The document does not list specific quantitative performance criteria in a table format, but rather states compliance.

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

• Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" because this was non-clinical performance testing (e.g., bench testing of prototypes or manufacturing samples), not a clinical study on patient data.
• Data Provenance: The testing was conducted by Sorin Group Italia S.R.L. and is "non-clinical," implying laboratory or bench testing. The country of origin would be Italy (where Sorin Group Italia S.R.L. is located). It is not retrospective or prospective in the sense of a clinical trial; it is product performance verification.

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

Not Applicable. This is a physical device, and the testing involved demonstrating compliance with engineering and safety standards, not establishing a "ground truth" for diagnostic purposes by human experts.

4. Adjudication Method for the Test Set

Not Applicable. There was no human adjudication process involved in assessing diagnostic performance. The evaluation was based on engineering and performance testing.

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

No, an MRMC study was NOT done. This type of study is relevant for diagnostic devices (especially imaging-based AI) to assess how human readers perform with and without AI assistance. This device is a hemoconcentrator, not an imaging or diagnostic AI system.

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

Not Applicable. This is not an algorithm. Performance was assessed for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, recognized national and international standards (e.g., for dialyzers), and performance parameters (e.g., filtration rates, material integrity, biocompatibility, sterility assurance). It is not based on expert consensus, pathology, or outcomes data from patients in the context of a new diagnostic claim. The "ground truth" is that the device, with the new material, still meets the same performance and safety requirements as the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm, 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 AI/ML algorithm or training set, this question is not relevant.

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The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less.

KIDS Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and they can be used up to 6 hours.

The KIDS Arterial Filters are the modified version of the disposables currently marketed in the D130 PH.I.S.I.O. Dideco Kids Neonatal Arterial Filter (K063255) and the D131 PH.I.S.I.O. Dideco Kids Infant Arterial Filter (K072308).

The provided text is a 510(k) premarket notification for a medical device called "KIDS Arterial Filters." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, expert review processes, or any form of AI/ML performance study.

The document explicitly states:

• "No clinical testing was conducted in support of the KIDS Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use." (Page 7, Section VIII. Clinical Performance Data)
• The performance data is described as "Non-Clinical Performance Data" and states: "Sorin Group Italia S.r.l. has conducted extensive verification and validation testing of the KIDS Arterial Filters... The KIDS Arterial Filters comply with all the applicable voluntary standards related to Arterial Filters. The devices passed all the testing in accordance with national and international standards." (Page 7, Section VII. Non-Clinical Performance Data)

Therefore, based on the provided text, I cannot answer the questions related to the acceptance criteria and the study proving the device meets these criteria in the context of AI/ML device performance or clinical study results.

The device is a physical medical device (an arterial filter), not an AI/ML software device, and its approval is based on substantial equivalence to existing devices through non-clinical testing and adherence to standards, not through clinical performance metrics or AI algorithm validation.

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The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised.

MICRO Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bvpass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and thev can be used up to 6 hours.

The MICRO Arterial Filters are the modified version of the following currently marketed devices:

a) the D734 Micro 40 included in the Dideco Micro 20 & 40 Adult Arterial Filter (K952270) and in the Dideco MICRO 40 Ph.I.S.I.O. Adult Arterial Filter (K040184); b) the D736 Micro 40 included into the Dideco Newborn/Infant Arterial Filters, 20/40 Micron (K961869) and in the D735 MICRO 20, Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen and for D736 MICRO 40, DIdeco D736 Micro 40 Newborn-Infant Arterial Filter with 40 micron screen (K033987);

c) the D733 Micro 40 included in the D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters (K041061) and in the D731 MICRO 27 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Arterial Filters (K112525).

This document is a 510(k) summary for the MICRO Arterial Filters, detailing their substantial equivalence to previously cleared predicate devices. It focuses on the device's technical characteristics and non-clinical performance data, rather than providing specific acceptance criteria and study results in the context of an AI/human reader performance study.

Therefore, most of the requested information regarding acceptance criteria, study design for AI evaluation, sample sizes, expert ground truth establishment, MRMC studies, and training set details for an AI-powered device cannot be extracted from this document because it describes a hardware medical device (a filter), not an AI/software as a medical device (SaMD).

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

Information that CAN be extracted:

• Device Name: MICRO Arterial Filters
• Regulation Number/Name: 21 CFR 870.4260, Cardiopulmonary Bypass Arterial Line Blood Filter
• Regulatory Class: Class II
• Product Code: DTM
• Applicant: SORIN GROUP ITALIA S.R.L.
• Indications for Use: "The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised."
• Device Description: Single-use, non-toxic, non-pyrogenic fluid path devices, sterile and individually packaged, made of plastic (mainly PVC) and a silicon filtering net. Used for up to 6 hours. Modified versions of existing devices, with changes to tubing material (removal of DEHP) and silicon formulation of the valve's diaphragm. Ethylene oxide sterilized.
• Predicate Devices: Multiple predicate devices listed by 510(k) number and trade name (e.g., K952270 DIDECO ADULT ARTERIAL FILTERS).
• Type of Study (General): Non-clinical performance data (verification and validation testing) was conducted to demonstrate substantial equivalence.
• Clinical Performance Data: "No clinical testing was conducted in support of the MICRO Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."
• Ground Truth Type (for this device's testing): Implied to be based on adherence to applicable voluntary standards and "proven safety and efficacy" of predicate devices through non-clinical testing.

Information that CANNOT be extracted (as this is not an AI/SaMD submission):

• A table of acceptance criteria and the reported device performance (in the context of AI metrics like sensitivity, specificity, AUC): Not applicable for this hardware device. Acceptance criteria would relate to physical performance (e.g., filtration efficiency, pressure drop, biocompatibility), which are not explicitly detailed here beyond a general statement of compliance.
• Sample sizes used for the test set and the data provenance: Not applicable. Testing was likely bench testing, not a clinical study on human data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a filter device is based on engineering specifications and material science, not expert image interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While "ground truth" exists for the filter's performance, it's not in the AI/clinical interpretation sense. It's about meeting engineering and biocompatibility standards.
• The sample size for the training set: Not applicable (no AI model).
• How the ground truth for the training set was established: Not applicable (no AI model).

To summarize, this document describes the FDA clearance of a medical device (an arterial filter) based on "substantial equivalence" to existing hardware devices, primarily through non-clinical performance testing (bench-top testing, material compatibility, etc.). It does not involve any AI/machine learning components or associated studies on human or expert annotated 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 XTRA Autotransfusion System (including the XTRA bowl set) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative 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

The XTRA Autotransfusion System (with XTRA Bowl 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 preoperative sequestration, intraoperative cell salvage, and/or postoperative cell salvage, aimed at autotransfusion.

The XTRA Autotransfusion System (with XTRA Bowl Sets) consist of a disposable bowl pre-connected with a system of tubing lines and bags, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment), then the blood is pumped with a roller pump (provided into the equipment) into the bowl separation chamber and centrifuged. Because of centrifugal force the blood components are separated and the RBC, PPP and PRP are 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 Autotransfusion System (with XTRA Bowl Sets) are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586).

This document describes the XTRA Autotransfusion System, a medical device for blood processing in surgical settings. However, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria, particularly for an AI-enabled device.

The provided text is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive de novo clinical trials with specific acceptance criteria as might be seen for novel AI/ML devices.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Metrics: The document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) for the device's performance. It primarily focuses on the technical characteristics and intended use being equivalent to a predicate device.
• No "Study" in the traditional sense for AI/ML: The document states, "No clinical testing was conducted in support of the XTRA Autotransfusion System (with XTRA Bowl Sets), as the indications for use and technical characteristics are equivalent to those of the predicate device, which has been on the market for several years with proven safety and efficacy of use." This explicitly states that no clinical study was performed to demonstrate performance against acceptance criteria.
• Device Type: The device is an "Autotransfusion apparatus," which is a physical medical device (bowl sets, tubing, bags) for processing blood. It is not an AI/ML-enabled device. Therefore, questions about training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this type of device.

In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving an AI-enabled device meets those criteria. The document is a regulatory submission for a non-AI medical device demonstrating substantial equivalence.

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The Aortic root cannulae are intended for use in adult and pediatric patients to cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery for periods of up to six hours.

The R501-R502 Aortic Root Cannula (hereinafter referred to as R501-R502 cannulae) are aortic root cannulae intended to be used to cannulate the aortic root, to vent and to deliver cardioplegic solution during heat bypass operations.

The device is available in two styles: with a vent line (R502) and without a vent line (R501). Both models consist of a flexible Polyvinylchloride (PVC) tubing body, a PVC flanged tip and luer connector. The introducer is made of stainless steel with a PVC obturator. The vent line model have an additional feature constituted by a vent line provided as integral part of the device. This attribute makes it possible to vent and also introduce cardioplegic solutions using the same device. These cannulae are available in a range of sizes as per table below:

The R501-R502 cannulae are a modified version of the currently marketed R501-R502 Aortic Root cannulae (K200612).

The provided text is a 510(k) premarket notification summary for a medical device, the R501-R502 aortic root cannulae. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets a specific set of acceptance criteria through a clinical study or a multi-reader, multi-case (MRMC) study.

Therefore, many of the requested details, such as acceptance criteria, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this type of regulatory submission. The primary method of demonstrating safety and effectiveness in this document is comparison to a predicate device via non-clinical performance data and a statement of substantial equivalence.

Here's an explanation based on the provided text:

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

This document does not contain a table of explicit acceptance criteria with corresponding device performance results in the way one would expect from a clinical trial or a formal validation study for a novel device. Instead, the performance is demonstrated through a comparison to a predicate device and adherence to applicable voluntary standards.

The non-clinical performance data section states: "The device passed all the testing in accordance with national and international standards." This implies that the acceptance criteria for these tests were meeting the requirements of the standards, but the specific numerical criteria and results are not detailed.

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

• Test Set Sample Size: Not applicable. The submission relies on non-clinical performance data (testing) and a comparison to a predicate device. There is no "test set" in the context of clinical data or AI model evaluation.
• Data Provenance: Not applicable. As there are no clinical studies or AI evaluations described, there is no "data provenance" in terms of subject demographics or study design. The non-clinical testing was conducted by Sorin Group Italia s.r.l.

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

Not applicable. No ground truth was established by experts for a test set in the context of this submission, as it focuses on substantial equivalence through non-clinical testing and comparison to a predicate.

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

Not applicable. No test set requiring expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. This is explicitly stated in the document under "Clinical Performance Data": "No clinical testing was conducted in support of the R501-R502 Cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate device, which has been on the market for several years with proven safety and efficacy of use."

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

Not applicable. This device is a physical medical device (cannula), not an AI algorithm. Therefore, no standalone algorithm performance was assessed.

7. The type of ground truth used:

Not applicable. As no clinical studies or AI performance evaluations are described, the concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) does not apply here. The submission relies on the established safety and efficacy of the predicate device and the results of non-clinical engineering and materials testing.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI models.

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 D100 devices are indicated for use for neonatal patients undergoing surgical procedures requiring cardiopulmonary bypass. The oxygenator is intended to be used for six hours or less.

The D101 devices are indicated for use for infant patients undergoing surgical procedures requiring cardiopulmonary bypass The oxygenator is intended to be used for six hours or less

The D100 KIDS and D101 KIDS oxygenators (hereinafter identified as KIDS) consist of an oxygenator with an integrated heat exchanger and hard-shell cardiotomy venous reservoir.
The KIDS consist of the following main components
• a heat exchanger consisting of a grooved and pleated stainless steel that is placed into a polycarbonate housing with integrated Hansen connectors and is sealed with resin potting at both ends. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
• an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood.
• a hard shell cardiotomy/venous reservoir attached to the top of the oxygenator by means of a molded fitting joint. It is a single chamber reservoir comprised of a rigid polycarbonate housing with an internal hollow support. The filtering system surrounds the internal hollow support and work as a cardiotomy section in the upper part and as a venous reservoir in the bottom part. It collects and filter blood coming from suckers and from the venous return.

The provided document is a 510(k) premarket notification for D100 KIDS and D101 KIDS cardiopulmonary bypass oxygenators. It's a regulatory submission and not a research paper detailing an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria and study details for AI/ML performance (such as sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices by evaluating the impact of modified materials through non-clinical in vitro testing.

Here's the relevant information that can be extracted:

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

The document states that "The modified device successfully met all acceptance criteria." However, it does not provide a specific table or list of quantitative acceptance criteria and corresponding performance metrics. It only lists the types of tests performed:

The document also notes that these tests were conducted on "sterile aged devices; accelerated aging for a period of time equivalent to at least 3 years as per device labeling."

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

• Sample size: Not specified. The document only mentions "in vitro testing" without detailing the number of devices or test repetitions.
• Data provenance: In vitro testing; likely performed in Italy (country of the applicant, Sorin Group Italia S.R.L.). The document does not specify if the data is retrospective or prospective, as it's not a clinical study on patient data.

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

• This is not applicable. The device is an oxygenator, and the testing involves physical and mechanical performance metrics (pull strength, pressure resistance, flow rates), not a subjective assessment like expert reads of medical images. Ground truth would be established by validated measurement equipment and protocols, not by human experts in this context.

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

• This is not applicable. As it's in vitro physical testing, there's no need for adjudication among human readers/experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not applicable. The device is a medical device (cardiopulmonary bypass oxygenator), not an AI/ML software. No MRMC study was performed.

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

• No. This is not applicable. The device is a physical medical device, not an AI/ML algorithm.

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

• The "ground truth" for this type of in vitro testing would be established by physical measurements using calibrated instruments, adhering to engineering and performance specifications. For example, a "pull test" would have a specified force threshold, and the device either meets or fails that. There is no biological or clinical "ground truth" in the sense of a diagnosis or outcome.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" as this is not an AI/ML device.

In summary: This document is a regulatory submission for a physical medical device (oxygenator) demonstrating substantial equivalence based on in vitro performance testing of material modifications. It does not involve AI/ML technology or clinical studies with patient data, and therefore, most of the questions relating to AI/ML device performance evaluation are not relevant to this document.

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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 EOS PMP hollow fiber oxygenator is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 LPM. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The device is intended to be used for 6 hours or less.

The EOS PMP Hollow Fiber Oxygenator (hereinafter identified as EOS PMP) consist of an oxygenator with an integrated heat exchanger.

The EOS PMP consist of the following main components

• a heat exchanger consisting of a grooved and pleated stainless steel that is placed into a polycarbonate housing with integrated Hansen connectors and is sealed with resin potting at both ends. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surqery.
• . an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood..

The modified device is a modified version of the currently marketed EOS product.

Here's a breakdown of the acceptance criteria and study information for the EOS PMP device, based on the provided text:

Device: EOS PMP Hollow Fiber Oxygenator

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes performance testing related to the modification of the EOS PMP device (addition of an epoxy phenolic primer coating to the heat exchanger). The acceptance criteria are implicitly that the modified device performs comparably to the unmodified predicate device and meets established standards.

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

• Test Set Sample Size: Not explicitly stated. The text mentions "in vitro testing was performed" and "This performance testing was conducted on sterile aged devices." It does not provide a specific number of units tested.
• Data Provenance: The studies were retrospective in the sense that they evaluated a modified version of an existing device (EOS PMP) against its unmodified predicate. The testing itself (heat exchanger performance, mechanical integrity, flaking/leaching) appears to be laboratory-based and controlled, thus prospective in execution within that controlled environment. The country of origin of the data is not specified beyond "Sorin Group Italia S.R.L." which suggests it was likely performed in Italy or by a contracted lab.

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 evaluation was based on non-clinical (in vitro) performance data against established standards and a predicate device, rather than on expert interpretation of patient data.

4. Adjudication Method for the Test Set

• This question is not applicable as the evaluation did not involve human interpretation or adjudication of results in the traditional sense; it was based on meeting pre-defined physical and chemical performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is a medical device (oxygenator), not an AI diagnostic tool. The document states: "No clinical testing was conducted in support of the EOS PMP, as the indications for use are equivalent to those of the predicate, which have been on the market for many years."

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

• No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The ground truth used was based on established industry standards and regulatory guidance (ISO 10993-1, FDA Guidance for Cardiopulmonary Bypass Oxygenators, ISO 7199), and the performance of the legally marketed predicate device (Unmodified EOS PMP). The goal was to prove "substantial equivalence" of the modified device to the predicate for specific performance characteristics.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the AI/ML context.

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

• This question is not applicable for the same reason as #8.

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