Search Results

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 Aventus Clot Management System is indicated for use with the Aventus Thrombectomy System for autologous blood transfusion.

The Aventus Clot Management System accessory allows for autologous injection of aspirated blood from the Aventus Thrombectomy System embolectomy procedure. The sterile, single-use Aventus Clot Management System is comprised of the following two components:

• Aspiration Syringe
• . Clot Canister
  The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.
  The Clot Canister connects to the Aspiration Syringe via quick disconnect connector at the inlet port on the side of the Canister. The aspirant from the Aventus Thrombectomy System procedure is injected into the Clot Canister. The blood passes through the Clot Canister dual layer nominal 40u/200u polyester screen filter, filling a syringe pre-connected to the female luer lock that is positioned below the filter assembly. The clinician can then return the filtered blood back to the patient via a standard sterile syringe with a required suitable blood transfusion filter (not provided).
  The Clot Canister also has a flush port with a standard 3-way stopcock positioned above the filter assembly where an additional syringe can be attached to inject saline or air to assist in clot visualization without removing the lid.

The provided text describes a 510(k) premarket notification for the Aventus Clot Management System. The document focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria and performance metrics for an AI/ML component.

Therefore, I cannot provide the information requested in the format of acceptance criteria and reported device performance, sample sizes for test and training sets, expert qualifications, or details about MRMC studies. The device is a physical medical device (Autotransfusion apparatus), not an AI/ML-driven device, so many of the requested technical details are not applicable or present in this regulatory document.

However, I can extract the general performance testing categories that were conducted.

The document indicates that Inquis Medical performed comprehensive non-clinical bench testing to demonstrate that the device met all required specifications and performs as intended.

Here's what information I can glean from the provided text regarding performance testing, even without specific acceptance criteria and numerical results:

General Performance Testing Categories

The following categories of performance data were provided in support of the substantial equivalence determination:

• Biocompatibility Testing:

  • Tests Conducted: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity).
  • Guidance: Conducted in accordance with FDA Guidance Document for the Use of International Standard ISO 10993-1.
  • Conclusion: Demonstrated that the materials do not pose a risk of negative interaction with patients.

• Sterilization:

  • Tests Conducted: Sterilization testing and Bacterial Endotoxins Test (BET)/Limulus amebocyte lysate (LAL) testing.
  • Guidance/Standard: ISO 14937:2009 for sterilization, USP and AAMI ST72 for BET.
  • Conclusion: Demonstrated an SAL of 10^-6 and confirmed the system meets established pyrogen limit specifications.

• Distribution, Packaging, and Shelf-Life Testing:

  • Tests Conducted: Distribution testing and accelerated aging.
  • Conclusion: Successfully tested demonstrating integrity of the sterile barrier and preservation of properties through the labeled shelf-life.

• Performance Testing – Bench:

  • Tests Conducted: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Compatibility Testing, Simulated-Use Particulate Testing, Hematocrit Testing, Mechanical Hemolysis Testing, Filtration Efficiency.
  • Conclusion: Design verification testing demonstrated that physical and functional requirements were met.

• Performance Testing – Non-Clinical (Animal Study):

  • Type of Study: GLP animal study (chronic large animal GLP study).
  • Guidance: Complied with GLP regulation (21 CFR Part 58) and FDA Guidance: General Considerations for Animal Studies for Cardiovascular Devices (July 2010), and FDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical devices (March 2023).
  • Conclusion: Demonstrated that the device was able to be used safely to return aspirated blood and met all pre-defined study endpoints.

Note: The document does not contain specific quantitative acceptance criteria or numerical results for any of these tests, nor does it refer to an AI/ML component or associated studies like MRMC or standalone algorithm performance. The focus is on the substantial equivalence of the physical device to a predicate device.

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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 FlowSaver Blood Return System is used with Inari Medical catheters and sheaths for autologous blood transfusion.

The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from Inari Medical catheters and sheaths during embolectomy procedures by dual layer 40 µm/200 µm filtration to minimize intraprocedural blood loss.

The provided text describes the 510(k) summary for the Inari Medical FlowSaver Blood Return System. This document is a premarket notification for a medical device and therefore does not contain information about an AI/ML device that requires traditional acceptance criteria and performance studies for diagnostic accuracy.

The FlowSaver Blood Return System is an autotransfusion apparatus. The submission is for an expansion of indications for an already cleared predicate device (K221483), allowing its use with Inari Medical catheters and sheaths for autologous blood transfusion and with a 30 cc large bore syringe.

Therefore, many of the requested details such as acceptance criteria for diagnostic performance, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for an AI/ML system are not applicable to this type of device and submission.

Instead, the submission focuses on demonstrating that the modified device remains substantially equivalent to its predicate through non-clinical testing.

Here's the information that can be extracted or stated as not applicable based on the provided text:

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

The document does not specify quantitative acceptance criteria in a typical "table" format for diagnostic performance. Instead, it states that "Mechanical hemolysis testing was performed to demonstrate substantial equivalence to the predicate." It also lists various leveraged non-clinical tests without specific, quantitative acceptance criteria numbers in this summary. The implicit acceptance criterion is that the device performs comparably to the predicate and meets safety/performance standards for its intended use.

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

Not applicable for diagnostic accuracy as this is not an AI/ML diagnostic device. The document mentions "Design verification testing was not required to support substantial equivalence for the expanded indications" and lists leveraged tests from previous submissions (K210176 and K221483). These are likely engineering and performance tests on physical devices rather than data from patient studies.

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, as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

Not applicable, as this is not an AI/ML diagnostic device requiring adjudication.

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

Not applicable, as this is not an AI/ML device that assists human readers.

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

Not applicable, as this is a physical medical device (autotransfusion apparatus), not an algorithm.

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

Not applicable, as this is not an AI/ML diagnostic device requiring ground truth for diagnostic accuracy. The "ground truth" for this device would be established engineering and performance specifications and biological compatibility (e.g., hemolysis levels).

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Summary of Device Performance (Based on provided text, not in typical AI/ML format):

The device is deemed to meet acceptance criteria through a demonstration of substantial equivalence to an already cleared predicate device (K221483). This is supported by:

• Identical intended use, principles of operation, fundamental scientific technology, and technological characteristics compared to the predicate device.
• Non-clinical testing leveraging previous submissions (K210176 and K221483):
  • Visual Inspection
  • Dimensional Inspection
  • Engagement & Disengagement Force Testing
  • Flow Rate Testing
  • Media Integrity testing
  • Leakage Testing
  • Vacuum Testing
  • Clot Burden Filtration Validation
  • Simulated Use and Tensile Testing
  • Simulated Use and Torque Testing
  • Burst Testing
  • Particulate Matter Determination
  • Filtration Efficiency
• Specific mechanical hemolysis testing performed for the current submission to demonstrate substantial equivalence to the predicate.
• Sterilization validation in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016 to achieve a sterility assurance level (SAL) of 10-6.

The conclusion states that "The verification testing results demonstrate that the proposed FlowSaver Blood Return System is substantially equivalent to the predicate device." This implies the device performed acceptably across all these tests, meeting the safety and performance standards equivalent to the predicate.

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The FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.

The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from the FlowTriever Retrieval/Aspiration System embolectomy procedure by dual layer 40 µ/200 µ filtration to minimize intraprocedural blood loss.

The provided document is an FDA 510(k) clearance letter for the FlowSaver Blood Return System. It primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device. It briefly mentions "Non-Clinical Testing" and "Clinical Testing" as part of the evidence presented for substantial equivalence.

However, the document does not contain detailed information about acceptance criteria or the specific study design, performance metrics, sample sizes, expert qualifications, or ground truth establishment methods for a new AI/ML-driven device. The request asks for details typically found in the clinical study section of a 510(k) submission or a peer-reviewed publication for an AI/ML medical device.

The "Clinical Testing" section states: "Post-market clinical data from PEERLESS (NCT05111613), FLAME (NCT04795167), and FLASH (NCT03761173) studies demonstrated the FlowSaver's filtration efficiency and safety without use of the second filter in support of substantial equivalence." This refers to clinical studies on the device's performance in a clinical setting, but it does not describe a study to prove the device meets acceptance criteria in the context of an AI/ML algorithm or a new diagnostic tool where performance metrics like sensitivity, specificity, or AUC are typically evaluated. The "acceptance criteria" mentioned in the request, in the context of AI, usually refers to pre-defined thresholds for these performance metrics.

Therefore, many of the requested details cannot be extracted from this document, as it outlines the regulatory approval process for a physical medical device with a labeling change, not a software-as-a-medical-device (SaMD) or AI-enabled diagnostic tool requiring specific AI model validation studies.

Here's a breakdown of what can be extracted and what cannot:

Information Present in the Document:

• 1. A table of acceptance criteria and the reported device performance:
  • The document implies acceptance criteria were met for "Filtration Efficiency" in non-clinical testing.
  • For clinical studies, it states the studies "demonstrated the FlowSaver's filtration efficiency and safety without use of the second filter."
  • However, no specific numerical acceptance criteria (e.g., minimum filtration percentage) or detailed performance results tables are provided.
• 2. Sample sizes used for the test set and the data provenance:
  • The document mentions clinical studies: PEERLESS (NCT05111613), FLAME (NCT04795167), and FLASH (NCT03761173).
  • Sample sizes (NCT numbers are provided, which could be looked up, but not directly stated in the document for the purpose of this submission).
  • Data provenance (country of origin, retrospective/prospective) is not explicitly stated in this document but would be detailed in the full clinical study protocols.
• 7. The type of ground truth used:
  • For filtration efficiency, the ground truth would be the measurement of particles/cellular components filtered out.
  • For safety, it would be adverse event reporting and clinical outcomes.
  • Not explicitly defined as "ground truth" in the AI/ML sense, but rather as measured performance and safety endpoints.

Information NOT Present in the Document (and likely irrelevant for this type of device clearance):

• 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 for expert-labeled ground truth, typically for image or signal interpretation. Not applicable here.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as it's not an AI diagnostic study needing expert adjudication.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This applies to AI-assisted human reading. Not applicable here.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• 8. The sample size for the training set: Not applicable, as no AI model is being "trained" in this context.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance and Study Information (Based on the Provided Text):

The FlowSaver Blood Return System is an autotransfusion apparatus that performs dual-layer 40 µ/200 µ filtration of aspirated blood during embolectomy procedures to minimize intraprocedural blood loss. The current 510(k) submission (K221483) is for a labeling change to remove the secondary filtration procedure, implying that the single-stage filtration by the FlowSaver alone is sufficient.

The acceptance criteria for the device, as evidenced by the studies, are related to its filtration efficiency and safety.

Table of Acceptance Criteria and Reported Device Performance:

Clinical Testing: Post-market clinical data from PEERLESS (NCT05111613), FLAME (NCT04795167), and FLASH (NCT03761173) studies "demonstrated the FlowSaver's filtration efficiency... without use of the second filter." No specific quantitative metrics (e.g., % of particles removed) are provided in this regulatory letter, but the implication is that the performance was acceptable to the FDA. |
| Safety (without secondary filter) | Clinical Testing: Post-market clinical data from PEERLESS (NCT05111613), FLAME (NCT04795167), and FLASH (NCT03761173) studies "demonstrated the FlowSaver's... safety without use of the second filter." This suggests an acceptable safety profile was observed in these studies, supporting the removal of the secondary filtration step from the instructions for use. |
| Functional Performance | Non-Clinical Testing: The document states that various tests were leveraged from the predicate device (K210176) and "demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." These tests include: Visual Inspection, Dimensional Inspection, Engagement & Disengagement Force Testing, Flow Rate Testing, Media Integrity testing, Leakage Testing, Vacuum Testing, Clot Burden Filtration Validation, Simulated Use and Tensile Testing, Simulated Use and Torque Testing, Burst Testing, Hematocrit Testing, Mechanical Hemolysis Testing. Numerical acceptance criteria and detailed performance of these tests are not provided in this summary. |

Study Information:

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

   • Test Set Sample Size: Not explicitly stated as a single "test set" size for the purpose of this submission. The document references post-market clinical data from three studies: PEERLESS (NCT05111613), FLAME (NCT04795167), and FLASH (NCT03761173). The full sample size for these studies would need to be checked in their respective ClinicalTrials.gov entries or publications. The document implies that data from these studies collectively served as the clinical evidence.
   • Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective). These details would be available in the protocols/publications of the mentioned clinical studies. The mention of "post-market clinical data" suggests the data was collected after the initial marketing of the device, likely prospectively as part of ongoing clinical trials.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic device requiring expert labeling of ground truth. The "ground truth" for this device's performance would be objective measurements of filtration efficiency (e.g., particle counts, volume filtered) and clinical outcomes related to safety.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is typically relevant for studies validating AI models against expert interpretation, not for evaluating a physical filtration device.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted reading tool.

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

6. The type of ground truth used:

   • For filtration efficiency: Likely quantitative measurement of filtered components (e.g., blood cell counts, clot burden measurements) before and after filtration, or particle size analysis.
   • For safety: Clinical outcomes data, adverse event reporting, and potentially hematological parameters (e.g., mechanical hemolysis testing mentioned in non-clinical tests).

7. The sample size for the training set: Not applicable. This is not an AI/ML device where a "training set" for an algorithm is used.

8. How the ground truth for the training set was established: Not applicable, for the same reason as above.

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The Haemonetics® Cell Saver® Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, plasma product for reinfusion to the same patient within the recommended time of the American Association of Blood Banks (AABB), 9th Edition.

The subject of this Traditional 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System 7.3 (AQ) software update which allows users the ability to manually control the cell salvage procedure through manual mode, quick transfer and decreased minimum wash volume. The Cell Saver Elite/Elite+ System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite/Elite+ System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

The provided text is a 510(k) Summary for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) software update. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain information about the acceptance criteria and study design for proving the device meets those criteria from an AI/ML perspective.

The changes in this 510(k) are related to a software update (version 7.3 AQ) for an autotransfusion system, specifically adding "manual mode, quick transfer and decreased minimum wash volume" features. This device processes blood (concentrating and washing red blood cells) rather than interpreting medical images or data using AI/ML algorithms.

Therefore, many of the requested items (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, how ground truth for training set was established) are not applicable to this type of device and submission.

The document focuses on:

• Software Verification: To verify the new software revision.
• Functional Testing: To validate washout performance (a physical function of the blood processing).
• Usability Testing: To validate operational needs and usability.

These tests are standard for a medical device software update and functional changes, but they do not involve AI/ML performance evaluation as typically understood in the context of diagnostic or prognostic AI systems that require ground truth, expert readers, and rigorous statistical analysis of AI model performance.

In summary, this document is for a medical device software update, not an AI/ML device. Therefore, it does not provide the information requested about AI/ML acceptance criteria and study paradigms.

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· Evacuate air and/or fluid from the chest cavity or mediastinum.
· Help re-establish lung expansion and restore breathing dynamics.
Chest Drain Auto transfusion (ATS)
To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.

Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems".

A closed thoracic drainage system (chest drain and catheter together) are used to restore the chest to a more normalized condition after surgery, trauma, or spontaneous need for air and/or fluid to be removed. The Auto transfusion (ATS) features of the drains facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

This document describes a 510(k) premarket notification for Atrium Medical Corporation's Auto transfusion (ATS) Chest Drains, specifically the Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, and Express Dry Seal Chest Drain. The filing argues for substantial equivalence to previously cleared predicate devices (K043140 and K043582).

Here's an analysis of the acceptance criteria and study information provided (or absence thereof):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific quantitative performance metrics. This 510(k) submission is focused on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria through new clinical trials.

The performance is implicitly described as being equivalent to the predicate devices and that the device "performs as well as the predicate devices."

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

• Test Set Sample Size: Not applicable. No dedicated "test set" in the context of clinical performance evaluation is mentioned for the modified device. The document states, "There were no clinical studies of the modified device."
• Data Provenance: Not applicable for a new clinical study. The submission relies on the established safety and performance of the predicate devices and extensive non-clinical testing of the modified devices.

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

Not applicable. No ground truth establishment by experts for a new clinical test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is mentioned.

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 an auto transfusion chest drain, which is a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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.

7. The Type of Ground Truth Used

Not applicable in the context of a new clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices (K043140 and K043582), as well as compliance with relevant voluntary standards and successful completion of non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not applicable. The device is not an AI/ML algorithm.

Summary of Acceptance Criteria and "Study" (Non-Clinical) Proving Equivalence:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. The "study" that proves this involves a comprehensive non-clinical assessment, outlined as follows:

Acceptance Criteria (Implied for Substantial Equivalence):

• Same Intended Use: The modified devices must have the same indications for use as the predicate devices.
• Similar Technological Characteristics: The modified devices must operate on the same fundamental scientific technology and have similar features. Any differences in technological characteristics must not raise new questions of safety or effectiveness.
• Similar Materials: The major materials of construction must be the same or demonstrably equivalent in terms of safety and biocompatibility.
• Performance: The modified devices must perform as well as the predicate devices.
• Safety: The risks associated with the intended use must be acceptable and compatible with a high level of protection of health and safety.

"Study" (Non-Clinical Testing) Proving Equivalence:

The document states that Atrium Medical's development process required the completion of the following non-clinical activities:

• Specification Review: Ensuring the designs meet predefined criteria.
• Performance Testing: Verifying the functional aspects of the device.
• Biocompatibility Testing: Evaluating the device's interaction with biological systems (e.g., ISO 10993 series).
• Sterility Testing: Confirming the device is sterile and maintains sterility.
• Stability Testing: Assessing the device's ability to maintain its properties over time (shelf life).
• Design Validation: Ensuring the device meets user needs and intended uses.

These non-clinical tests, along with compliance with voluntary standards (Section 9, though not provided in the excerpt), are the basis for demonstrating that the modified devices are safe and effective and perform as well as the predicate devices, thereby supporting the claim of substantial equivalence. The submission also relies on the low complaint rates and reportable events of the predicate devices over the last 5 years as evidence of acceptable clinical safety and performance.

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The HEMAFUSE™ System is indicated for the collection of whole blood shed during a surgical procedure in which blood can be collected from the surgical field during periods of significant hemorrhage for purpose of reinfusion. It should only be used when performing surgery in remote military and austere military environments, when other sources of blood or autotransfusion are unavailable or thought inadequate for the need. Each Hemafuse System unit is indicated for a period of use no greater than 5 minutes.

Not Found

This document is a 510(k) clearance letter from the FDA for the Hemafuse System. It primarily outlines the regulatory approval for the device and its indications for use. Crucially, it does NOT contain the acceptance criteria or details of a study proving the device meets those criteria, specifically concerning AI/ML performance.

The information requested in your prompt (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.) is typically found in the summary of safety and effectiveness (SSED) or clinical study reports that are part of the 510(k) submission, but this letter itself does not provide that level of detail. It only states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent."

Therefore, based solely on the provided text:

I cannot create the table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 regarding the study specifics. This letter is a regulatory approval document, not a performance study report.

The Hemafuse System, as described, is an autotransfusion apparatus, which is a physical device used to collect and reinfuse blood during surgery. It is not an AI/ML-based device that would typically have the kind of acceptance criteria, ground truth establishment, or human reader enhancement studies you are asking about (e.g., for diagnostic imaging AI).

If you have a document that details the performance study for the Hemafuse System, please provide it, and I would be happy to analyze it according to your requested criteria.

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The FlowSaver Blood Return System is used with Triever Catheters for autologous blood transfusion.

The FlowSaver Blood Return System accessory allows for autologous injection of aspirated blood from the FlowTriever Retrieval/Aspiration System embolectomy procedure. The sterile (EO), single use FlowSaver Blood Return System is comprised of 2 components: • FlowSaver Blood Filter • 60 cc Luer Lock Syringe The FlowSaver Blood Filter has a sideport with a female quick connector for connection to the 60 cc Large Bore Vacuum Syringe (provided with Triever Catheter). Another standard Luer lock 60 cc syringe (provided) is attached to the needleless valve integrated into the FlowSaver's cap. The aspirant from a Triever Catheter embolectomy procedure is injected into the FlowSaver Blood Filter. Blood passes through the FlowSaver's dual layer 40 μ/200 μ polyester screen filter, filling the 60 cc syringe pre-connected to the female Luer Lock that is integrated into the cap of the filter housing. The 60 cc syringe is disconnected and its contents are injected through a suitable transfusion filter (minimum requirement 40 micron filter) prior to immediately reinjecting collected blood through an access sheath or catheter. FlowSaver's threaded cap with filter may be detached allowing rinsing with saline to remove thrombus and permit re-use if another Triever aspiration is performed. The FlowSaver may be used for up to five filtrations.

The provided text is a 510(k) summary for the Inari Medical FlowSaver Blood Return System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against specific acceptance criteria for an AI/device's diagnostic or predictive capabilities. Therefore, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving a device meets these criteria, especially concerning AI performance, MRMC studies, or specific ground truth methodologies.

The document details:

• Device Description: The FlowSaver Blood Return System accessory is used with Triever Catheters for autologous blood transfusion. It consists of a FlowSaver Blood Filter and a 60 cc Luer Lock Syringe. It filters aspirated blood through dual-layer 40 µ/200 µ polyester screens.
• Intended Use: Autologous blood transfusion.
• Comparison to Predicate: The FlowSaver is compared to the CellTrans Postoperative Autotransfusion Set (K024097) and deemed substantially equivalent due to similar intended use and technological characteristics (filtration through 40-micron filters, vacuum aspiration, polyester screens).
• Non-Clinical Testing: A list of verification and validation tests performed to demonstrate compliance with product requirements, including:
  • Visual and Dimensional Inspection
  • Engagement & Disengagement Force Testing
  • Flow Rate Testing
  • Media Integrity testing
  • Leakage Testing
  • Vacuum Testing
  • Clot Burden Filtration Validation
  • Preconditioning/Simulated Use and Tensile/Torque Testing
  • Burst Testing
  • Hematocrit Testing
  • Mechanical Hemolysis Testing
  • Filtration Efficiency
  • Particulate Matter Determination
• Biocompatibility Testing: Conducted according to ISO 10993-1 guidelines, passing various tests such as Elution, Sensitization, Intracutaneous Injection, Systemic Injection, Pyrogen, Hemolysis, UPTT, Complement Activation, and Platelet/Leukocyte Count.
• Clinical Testing: "Clinical testing was not required for the determination of substantial equivalence."

In summary, there is no information in this document about:

• A table of acceptance criteria for diagnostic/predictive performance.
• Reported device performance against specific metrics (e.g., sensitivity, specificity, AUC).
• Sample size for test sets, data provenance related to AI.
• Number of experts, their qualifications, or adjudication methods for ground truth in an AI context.
• MRMC studies or effect sizes of human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used for AI (as this is not an AI device).
• Training set sample size or how its ground truth was established for an AI model.

This document is a regulatory submission for a medical device that performs a mechanical function (blood filtration for autotransfusion), not an AI/ML-driven diagnostic or treatment support system. Therefore, the questions related to AI performance, ground truth, and reader studies are not applicable to the content provided.

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The CATSmart System by Fresenius Kabi is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).

The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intra- and/or postoperative processing of blood lost through surgery or trauma. The CATSmart device operates on the principle of a continuous flow centrifuge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks.

In a typical CATSmart procedure, the shed blood, which is anticoagulated and collected in a sterile reservoir, is processed in a continuous washing process to obtain washed packed red cells for reinfusion to the patient. During this process all plasmatic and nonerythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed. The packed red cells are collected in a reinfusion bag from which they can be reinfused to the patient via a transfusion set when needed.

The system includes disposable sets and accessories previously cleared by FDA in respective 510(k)'s.

This document is a 510(k) summary for the Fresenius Kabi CATSmart device, an autotransfusion system. It is a notification of intent to market a device that the manufacturer believes is substantially equivalent to legally marketed predicate devices.

The document does not contain detailed acceptance criteria for a study showing device performance. Instead, it describes general claims of substantial equivalence based on the device's design, materials, specifications, technological characteristics, and function being unchanged from previously cleared devices, and that manufacturing and sterilization methods at a new site remain the same.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including specific details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, is not available in the provided text.

The document specifically states: "No clinical data was required to support the changes described in this submission." This indicates that a study demonstrating performance against specific criteria was not conducted for this particular submission. The substantial equivalence is based on the device being inherently the same as a previously cleared one.

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