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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 XTRA Autotransfusion System 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 include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and gynecology, Urology

XTRA is an Autotransfusion System designed to recover shed blood during intraoperative and postoperative procedures and for collection of platelet poor plasma (PPP) and platelet rich plasma (PRP) in preoperative procedures. It is a software-controlled device provided with disposable and hardware elements that include the following major components: centrifuge, blood pump, automatic clamps, control and monitoring sensors, and an user interface (display panel and kevboard). The modified device is a software upgraded version (SW 1.0.2.0) of the unmodified device. Besides fixing the software bugs, the main differences introduced with the new SW upgrade consist of: change of the parameters of the Pstd intraoperative factory protocol (when a 225 mL bowl size is used for blood processing); change of the table related to hematocrit measurement. when Heparin is used as anticoagulant; addition of Sorin Group Deutschland GmbH as supplementary manufacturing site for the device. Labeling has been also generally updated.

Here's an analysis of the provided text regarding the XTRA Autotransfusion System, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to the unmodified device and compliance with "safety and effectiveness requirements" through "established performance specifications."

The performance reported is generally qualitative:

• The results of in vitro tests "met established performance specifications."
• The device is "substantially equivalent to the unmodified device in terms of safety and effectiveness."

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

• Sample Size: Not specified. The document only mentions "in vitro testing" without detailing the number of samples or runs.
• Data Provenance: The tests were "in vitro," implying laboratory-based testing. While the submitter is Sorin Group Italia S.r.l., the location of the actual testing is not explicitly stated, although it can be inferred to be internal to the manufacturer. The data is retrospective in the sense that it was conducted on the modified device after its creation to demonstrate its performance.

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

• Number of Experts: Not applicable. The "ground truth" for this device, an autotransfusion system, would typically relate to its mechanical performance, blood processing efficiency, and safety parameters (e.g., cell viability, contaminant removal). These are objective measurements determined through laboratory testing and engineering specifications rather than expert consensus on diagnostic images or clinical assessments.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As mentioned above, the "ground truth" is based on objective in vitro measurements and engineering specifications, not on subjective interpretations requiring adjudication.

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

• MRMC Study: No. This device is an autotransfusion system, a medical device for blood processing, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not performed.

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

• Standalone Performance: Yes, in the sense that the device's performance was evaluated based on its own operational parameters and outputs (e.g., processed blood quality) through "in vitro testing." Since it's an autotransfusion system, its primary function is automated blood processing, not providing diagnostic information that would then be interpreted by a human. The "algorithm" here refers to the software controlling the machine. The "in vitro studies" directly assess the algorithmic and mechanical performance of the device without a human in the diagnostic loop.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device is based on objective laboratory measurements and established performance specifications for autotransfusion systems. These specifications would relate to parameters like:
  • Blood processing efficiency (e.g., red blood cell recovery).
  • Removal of contaminants (e.g., plasma, anticoagulant, cellular debris).
  • Hemolysis levels.
  • System accuracy and consistency.
  • Biocompatibility, as evidenced by cross-referencing to the unmodified device and ISO standards.

8. The Sample Size for the Training Set

• Sample Size: Not applicable/Not specified. This document describes a software upgrade (SW 1.0.2.0) to an existing autotransfusion system. Such systems are traditionally developed and validated through engineering design, rigorous testing, and verification/validation activities against specifications. They are not typically "trained" in the machine learning sense with a "training set" of data to learn patterns. The software upgrade focused on fixing bugs and changing parameters, which would be part of a traditional software development lifecycle, not an AI/machine learning training process.

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

• How Ground Truth Was Established: Not applicable. As explained above, there isn't a "training set" in the context of an AI-driven learning algorithm for this device. The software's "ground truth" or correct behavior is defined by its engineering specifications and the functional requirements of the autotransfusion process. Any "training" would have been in the traditional engineering sense of testing and refining the software against known correct outputs based on physical principles and established medical standards for blood processing.

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The Preassembled Surgical Wash Set is intended for use with specific Autotransfusion machines which are identified on the primary label. It contains the basic components necessary to process blood collected during open heart or other surgical procedures for autotransfusion.

The Preassembled Surgical Wash Set is sterile, non-pyrogenic device designed for blood collection from the operating field or from the extracorporeal circuit, washing, concentrating and reinfusion of the blood products to the patient. The Preassembled Surgical Wash Set is composed of a rotary separation chamber (i.e. bowl) and bags connected with the appropriate the a connectors to fit the intended autotransfusion equipment.

The device may be offered in different configurations based on the specific autotransfusion machine for which it is designed. The basic components and the intended use remain the same.

The device is a modified version of the unmodified device, Preassembled Surgical Wash Set.

The provided document describes a 510(k) submission for a modified "Preassembled Surgical Wash Set." The study conducted is a non-clinical in vitro test comparing the modified device to the unmodified predicate device to demonstrate substantial equivalence, rather than a study defining acceptance criteria for a new AI or diagnostic device based on performance metrics like sensitivity or specificity.

Therefore, many of the requested categories (like number of experts, adjudication methods, MRMC studies, standalone performance for AI, and specific ground truth types) are not applicable to this type of device and study. The information provided focuses on the physical and functional characteristics of a medical device used for blood processing.

Here's an attempt to answer the questions based on the available information, noting when a question is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a table with specific quantitative acceptance criteria or performance metrics directly. Instead, the "acceptance criterion" essentially was that the modified device would perform "in a manner substantially equivalent to the unmodified Preassembled Surgical Wash Set with respect to biocompatibility and the functional parameters." The reported performance is that the "results of these tests met established specifications" and the device "performs in a manner substantially equivalent to the unmodified Preassembled Surgical Wash Set."

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

• Sample Size: The document does not specify a numerical sample size for the in vitro tests. It mentions that "all the tests were performed on sterile wash sets where only the bowl was aged (accelerated aging up to 3 + 1 years)." It also states that "For comparative purpose the modified and unmodified Preassembled Surgical Wash Sets were compared." This implies at least one modified set and one unmodified set were tested for each scenario, but a specific quantity is not given.
• Data Provenance: The study was conducted in-house by the manufacturer ("internal methods developed by the manufacturer"). The country of origin would be Italy (where Sorin Group Italia is located). It is an in vitro study, not a human-data-based study (prospective or retrospective).

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

• Not applicable. This study is a non-clinical, in vitro comparison of a physical medical device. Ground truth, in the context of expert review for diagnostic or AI devices, is not relevant here. The "ground truth" is established by the physical and chemical properties and functional performance of the devices as measured by internal test methods.

4. Adjudication Method for the Test Set

• Not applicable. See explanation for #3.

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

• Not applicable. This study is for a physical medical device (wash set), not an AI or diagnostic tool involving human readers.

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

• Not applicable. This pertains to an AI algorithm; the device being studied is a physical wash set.

7. The Type of Ground Truth Used

• The "ground truth" for this engineering and functional performance study is implicitly the established specifications and performance of the predicate (unmodified) device, against which the modified device was compared. This is based on in vitro measurements and comparisons of physical properties, biocompatibility, and functional operation (blood processing).

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI study; therefore, there is no "training set."

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

• Not applicable. See explanation for #8.

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