Lyka® PORT needle free access device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an I.V. Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The device may be used for patient populations including very low birth-weight infants, children, and adults for up to 7 days.

Lyka® PORT is a needle free accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an IV set. It consists of a housing made from Polycarbonate and a Stem made from Silicone Rubber. The materials used in Lyka® PORT meet the requirements of ISO 10993-1 and have a long history of acceptable use with blood, blood-related products. The device will permit access to a catheter without the used in a closed position, it has a flat, smooth surface. When the male connector of a syringe or secondary line is engaged into the device, the silicone stem opens in the middle creating a straight fluid path. When the male connector is removed from the device, its body forces the stem shut and maintains a sealed fluid path. A cap is not required to seal Lyka® PORT or to maintain sterility. The device will be sold as a sterile, single use for up to seven (7) days.

The provided text describes the Lyka® PORT Needle Free Access Device (4170Y) and its substantial equivalence to a predicate device. However, it does not contain the level of detail requested for acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device studies.

The document is a 510(k) summary for a medical device that appears to be a physical product (a needle-free access device), not an Artificial Intelligence/Machine Learning (AI/ML) software device. The acceptance criteria and performance data discussed are typical for a hardware device, focusing on physical properties and biocompatibility, not diagnostic or predictive performance metrics.

Therefore, I cannot fulfill the request to provide information about the acceptance criteria and study proving an AI/ML device meets them. The provided text is not about an AI/ML device.

To directly answer the questions based on the provided text, while acknowledging its irrelevance to AI/ML:

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

   Acceptance Criterion	Reported Device Performance
   Intended Use	Needle-free access to vascular devices for fluid administration/withdrawal. Suitable for very low birth-weight infants, children, and adults for up to 7 days.
   Design and Functionality	Needle-free, swabable, luer-activated, minimizes dead space, ensures sterile access.
   Flow Rate (Subject Device)	Not greater than 600 ml/min.
   Microbial Ingress	Effective barrier for seven days.
   Surface Disinfection	Achieved with 70% isopropyl alcohol in 30 seconds.
   Biocompatibility (ISO 10993-1)	Materials meet ISO 10993-1 requirements.
   Sterilization	Sterilized with ethylene oxide (EO) and packaged in Tyvek pouches.
   Shelf Life	3 years (supported by real-time and accelerated aging studies).
   Priming Volume (Subject Device)	~ 0.1 mL.
   Maximum Pressure (Subject Device)	1550 mmHg (30 psi).
   Valve Mechanism	Silicone valve mechanism with manual flushing (guided by IFU).
   Hemolysis & Biocompatibility (Specific)	Complies with ISO 10993-1 and ASTM F756; non-hemolytic.
   Ethylene Oxide Residuals (ISO 10993-7)	Complies with ISO 10993-7:2008 & AMD1:2019.

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 sample sizes for test sets for any of the performance criteria. Data provenance for testing is not mentioned. The studies appear to be bench testing (non-clinical) rather than clinical studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   This information is not applicable and not provided. The testing described is against engineering specifications and international standards, not against expert human interpretations of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable and not provided.

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. The document explicitly states, "No clinical testing was conducted on this device." This is a physical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. There is no algorithm mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" used for this device's evaluation consists of established engineering specifications, international standards (like ISO 10993-1, ISO 10993-7, ASTM F756), and functional requirements for medical devices of this type (e.g., flow rate, pressure tolerance, microbial ingress prevention).

8. The sample size for the training set:
   Not applicable. There is no AI/ML model, and therefore no training set.

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

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The Blood Administration Sets are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy.

Quest Medical's Q2 Blood Administration Sets are single use, disposable intravenous administration sets used to deliver blood, blood components and IV fluids from a container to a patient's vascular system through the use of a hand pump or through gravity flow. The sets include tubing, bag spike, 200 micron blood filter drip chamber, luer connectors, clamps, hand pump, stopcock and needleless connector.

The provided document is a 510(k) Summary for a medical device called "Q2 Blood Administration Sets." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving the performance of an AI/ML device.

Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document.

This document describes the regulatory approval process for a physical medical device (blood administration sets) and its equivalence to a previously approved device. The "Performance Data" section refers to bench testing (e.g., ISO standards, particulate matter, mechanical hemolysis), biocompatibility testing, and sterility/shelf-life testing for the physical device, not an AI/ML algorithm.

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IV Administration Sets are intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

Quest Medical's Q2 IV Administration Sets are single use, disposable intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components including insertion spike, drip chamber, clamp, check valye, stopcock, tubing, luer connections and needleless connector,

The provided text is a 510(k) Premarket Notification for a medical device (Q2 IV Administration Sets), not a software or AI-based diagnostic device. Therefore, the information requested in points 2 through 9 regarding test sets, ground truth, experts, MRMC studies, and training sets is not applicable to this document. The document describes the substantial equivalence of a physical medical device to a predicate device, focusing on bench and nonclinical performance testing rather than the performance of an algorithm or diagnostic accuracy.

However, I can extract the acceptance criteria and reported device performance from the provided text as it relates to the physical characteristics and functional tests performed on the IV administration sets.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" alongside "reported device performance" in a direct comparison table as one might find for a diagnostic algorithm. Instead, it states that "All necessary bench, nonclinical, and human factors testing was conducted... The subject device met all performance specifications necessary to fulfil its intended use," and "all acceptance criteria were met" for specific tests.

The document lists various nonclinical tests performed to demonstrate safety and effectiveness. For each of these tests, the reported device performance is broadly stated as having met all performance specifications and acceptance criteria. The specific quantitative criteria for each test are not detailed in this summary document, but the conclusion is that the device performed acceptably for its intended use.

The following points are mostly Not Applicable (N/A) because the provided document concerns a physical device (IV administration set) submission, not an AI/software as a medical device (SaMD).

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

N/A. The document refers to "nonclinical testing" and "bench tests" rather than a clinical "test set" in the context of an AI/ML algorithm. The specific number of physical units tested for each nonclinical test is not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not relevant for physical device bench testing as described here.

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

N/A. Ground truth in the context of diagnostic accuracy (e.g., for an AI algorithm) is not relevant for this physical device's performance testing. The "ground truth" for the device here is whether it meets engineering and safety specifications through defined physical and chemical tests.

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

N/A. Adjudication methods are typically used in clinical studies or for establishing ground truth from expert opinions, which does not apply to the bench testing of a physical device.

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

N/A. This is a physical device, not an AI software. No human reader studies were performed.

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

N/A. This is a physical device, not an algorithm.

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

The "ground truth" implicitly used for this device's acceptance is adherence to established engineering standards, material specifications, and performance criteria for IV administration sets, as defined by relevant ISO, USP, and other medical device standards. This is determined through physical, chemical, and biological testing rather than expert consensus on diagnostic images or outcomes data.

8. The sample size for the training set

N/A. This is a physical device, not an AI/ML algorithm that requires a training set.

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

N/A. As above, this is a physical device.

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The Precision Delivery Infusion Sets are intended to administer or aspirate fluids. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

Ouest Medical's Precision Delivery Infusion Sets are single use, disposable, extension sets used to deliver fluids to a patient. The Precision Delivery Sets consist of various configurations, which includes tubing, filter, clamp, needleless connector and luers.

This document is a 510(k) premarket notification for a medical device (infusion sets). It does not describe an AI/ML medical device, therefore, the requested information about acceptance criteria and study proving the device meets the criteria in the context of AI/ML performance is not present.

The document discusses substantial equivalence to a predicate device based on non-clinical performance testing. It explicitly states that clinical testing was not performed to support this 510(k) submission and that no human-in-the-loop, multi-reader multi-case (MRMC) comparative effectiveness study, or standalone algorithm performance study was conducted.

Therefore, I cannot provide the requested information regarding:

1. Table of acceptance criteria and reported device performance (in the context of AI/ML metrics). The acceptance criteria mentioned are related to physical and chemical properties of the infusion set (e.g., priming volume, flow rate, bond strength, filter efficiency, biocompatibility, sterilization) rather than AI/ML performance metrics.
2. Sample size for the test set and data provenance. No such test set for AI/ML performance is described.
3. Number of experts and their qualifications for ground truth. No ground truth establishment related to AI/ML is mentioned.
4. Adjudication method. Not applicable.
5. MRMC comparative effectiveness study and effect size. Stated as "Not applicable. Clinical testing was not performed."
6. Standalone (algorithm only) performance. Not applicable.
7. Type of ground truth used. Not applicable in the AI/ML context.
8. Sample size for the training set. Not applicable.
9. How ground truth for the training set was established. Not applicable.

The document focuses on demonstrating that the "Precision Delivery Infusion Sets" are substantially equivalent to a previously cleared predicate device by comparing their indications for use, design features, materials, and non-clinical performance data.

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The Quest MPS 3 ND Myocardial Protection System, consisting of the Quest MPS 3 ND Console, the Quest MPS 3 Controller, and the Quest MPS 3 ND Disposables (Quest MPS 3 ND Delivery Set and optional Accessories) together is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and/or cardioplegia solutions to the heart during open-heart surgery on either an arrested or beating heart for use up to six hours in duration.

The Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) is a software controlled system designed to aid the perfusionist in cardioplegia delivery to a patient during Cardiopulmonary Bypass Surgery. The Quest MPS 3 ND System combines blood from the heart-lung machine and crystalloid from the IV-bag in a specified ratio and then adds in the drug (arrest or additive agent) for delivery to the patient. The Quest MPS 3 ND System consists of a reusable MPS 3 ND Console, a reusable MPS 3 Controller, and single use MPS 3 ND Disposables.

The Quest MPS 3 ND Console incorporates two Blood/Crystalloid pumps (B/C pumps), pressure and temperature monitors, a sensor interface, an Arrest Agent pump, an Additive pump and ultra-sonic air detection sensors. The Quest MPS 3 ND Console monitors and controls the blood:crystalloid ratio, drug concentration, flow rate, pressure and delivery route of the cardioplegia solution delivered to the patient. The MPS 3 ND Console also monitors the temperature of the cardioplegia solution which is regulated by an external heater cooler device.

The Quest MPS 3 Controller is a touchscreen user interface utilized by the operator to select all parameters, initiate/stop cardioplegia delivery, monitor delivery parameters and view/save relevant case information and data.

The Quest MPS 3 ND Disposables includes single use delivery sets (also known as the "MPS 3 ND Delivery Sets"), delivery set accessories and blood bypass tubing. The MPS 3 ND Delivery Sets and accessories consist of a flexible cassette, a heat exchanger with water line, drug cartridges and relevant tubing and connectors used to complete the cardioplegia circuit for use with the Quest MPS 3 ND Console. The blood bypass tubing is used as a backup in the event the Quest MPS 3 ND Console becomes unusable.

The provided text is a 510(k) premarket notification for a medical device, the Quest MPS 3 ND Myocardial Protection System. It outlines the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

However, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop study. The device in question is a medical protection system for cardiopulmonary bypass surgery, not an AI-powered diagnostic or assistive tool.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of device and its 510(k) submission.

Here's how to address the request based on the provided document:

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

The document broadly mentions "Performance Specifications" and "Software Verification Tests," "MPS 3 ND System Performance Tests," as well as other bench and nonclinical tests. It concludes that "The collective results of the performance testing demonstrate that the Quest MPS 3 ND Myocardial Protection System (MPS 3 ND) meets the established specifications necessary for consistent performance during its intended use."

However, specific numerical acceptance criteria and their corresponding achieved performance values are not detailed or tabulated in this summary document. This level of detail would typically be found in the full test reports submitted to the FDA, not in the public 510(k) summary.

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

• Test Set Sample Size: Not specified in the provided document. The tests performed are primarily bench and nonclinical (e.g., software verification, electrical safety, system performance). These are not tests on a "test set" of patient data in the way an AI algorithm is evaluated.
• Data Provenance: Not applicable in the context of clinical data for AI. The tests are benchtop, simulated use, and engineering verification.

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

• Not applicable. This device is not an AI diagnostic device that requires expert-established ground truth from medical images or patient data. Its performance is evaluated against engineering specifications and safety standards.

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

• Not applicable. This is not a study involving human readers or interpretation of data beyond standard engineering and quality control procedures.

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, a MRMC study was not done. This is not an AI-assisted device. The device's function is to deliver medical solutions during surgery, not to aid human readers in diagnostic interpretation.

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

• Not applicable. This is a hardware and software system for medical fluid delivery, not an AI algorithm evaluated for standalone performance. Its "performance" refers to its ability to accurately pump, heat/cool, and control fluids as designed.

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

• Not applicable in the context of typical AI ground truth. For this device, "ground truth" would equate to established engineering standards, physical laws (e.g., pressure, flow, temperature measurements), and functional requirements for a medical device of its type. For example, a flow rate "ground truth" would be the expected flow rate based on pump settings and calibration, not a medical diagnosis.

8. The sample size for the training set:

• Not applicable. This device is not an AI system trained on a dataset. Its software is deterministic and based on specified operating parameters.

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

• Not applicable. See point 8.

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The Quest Medical MPS 3 Myocardial Protection System, consisting of the MPS 3 Controller, and the MPS 3 Disposables (MPS 3 Delivery Set and optional Accessories) together is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and/or cardioplegia solutions to the heart surgery on either an arrested or beating heart for use up to six hours in duration.

The MPS 3 Myocardial Protection System (MPS 3) is a software controlled system designed to aid the perfusionist in cardioplegia delivery to a patient during Cardiopulmonary Bypass Surgery. The MPS 3 System combines blood from the heartlung machine and crystalloid from the IV-bag in a specified ratio and then adds in the drug (arrest or additive agent) for delivery to the patient. The MPS 3 System consists of a reusable MPS 3 Console, a reusable MPS 3 Controller, and single use MPS 3 Disposables.

The MPS 3 Console incorporates two Blood/Crystalloid pumps (B/C pumps), a temperature- controllable water circulation system, pressure and temperature monitors, a sensor interface, an arrest agent pump, an additive pump and ultra-sonic air detection sensors. The MPS 3 Console monitors and controls the blood:crystalloid ratio, drug concentration, flow rate, pressure, temperature, and delivery route of the cardioplegia solution delivered to the patient.

The MPS 3 Controller is a touchscreen user interface utilized by the operator to select all parameters, initiate/stop cardioplegia delivery, monitor delivery parameters and view/save relevant case information and data.

The MPS 3 Disposables includes single use delivery sets (also known as the "MPS 3 Delivery Sets"), delivery set accessories and blood bypass tubing. The MPS 3 Delivery Sets and accessories consist of a flexible cassette, a heat exchanger, drug cartridges and relevant tubing and connectors used to complete the cardioplegia circuit for use with the MPS 3 Console. The blood bypass tubing is used as a backup in the event the MPS 3 Console becomes unusable.

The provided text describes the 510(k) premarket notification for the Quest Medical, Inc. MPS 3 Myocardial Protection System. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device, as implied by the structure of the requested output (e.g., ground truth, MRMC study, training sets).

The MPS 3 Myocardial Protection System is a hardware system for delivering cardioplegia solutions during heart surgery, and its 510(k) submission is based on demonstrating substantial equivalence to a predicate device (MPS 2 Myocardial Protection System) through non-clinical bench testing. It is not an AI/algorithm-driven diagnostic or assistive device that would typically involve the types of studies outlined in your request (e.g., assessing sensitivity/specificity based on expert consensus, multi-reader multi-case studies, or standalone algorithm performance).

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document explicitly states:

• "Clinical Testing Summary [807.92(b)(2)] Not applicable. Clinical testing was not performed to support this 510(k) submission." This means there was no human clinical trial assessing the device's performance in patients in the manner that would generate the data for the requested metrics (e.g., accuracy against ground truth).
• The performance data sections detail bench and nonclinical tests (e.g., sterilization, shelf-life, biocompatibility, electrical safety, system performance, mechanical hemolysis, human factors/usability, disposables performance), which are standard for hardware medical devices but do not involve the types of acceptance criteria you've outlined for an AI/algorithm.

To directly answer your request based on the provided document:

1. A table of acceptance criteria and the reported device performance:
* N/A. The document does not present quantitative acceptance criteria or reported performance metrics in the format of precision, recall, accuracy, sensitivity, specificity, etc., which are typical for AI/algorithm-driven devices. Instead, it lists various non-clinical tests (e.g., "Sterilization, Shelf-Life, and Packaging Testing", "System Performance Tests", "Mechanical Hemolysis Test," "Leak Test," "Efficiency Test") that would have their own internal acceptance criteria (e.g., sterility must be maintained, pressure must hold, flow rate within tolerance). These specific criteria and their results are not detailed in this summary document. The document simply states "The collective results of the performance testing demonstrate that the MPS 3 Myocardial Protection System (MPS 3) meets the established specifications necessary for consistent performance during its intended use."

2. Sample sized used for the test set and the data provenance:
* N/A. As no clinical or AI-centric performance study was conducted, there are no "test sets" of patient data in the context of an AI/algorithm. The "samples" used would be the physical devices and components subjected to various bench and non-clinical tests (e.g., multiple units for reliability testing, materials for biocompatibility). The document does not specify the number of units/samples for each bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* N/A. Not relevant for this type of device and its non-clinical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* N/A. Not relevant.

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. The device is a hardware system, not an AI assisting human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. The device is a hardware system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* N/A. Not applicable for the bench testing performed. Ground truth for the device's function would be based on engineering specifications and physical measurements (e.g., flow rate accuracy measured against a calibrated standard, pressure measurements).

8. The sample size for the training set:
* N/A. Not applicable as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:
* N/A. Not applicable.

In summary, the provided document details the regulatory submission for a physical medical device (Myocardial Protection System) and relies on demonstrating substantial equivalence through non-clinical performance testing. It does not involve an AI component or the types of clinical/AI performance studies that would generate the specific data points requested in your prompt.

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

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

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

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

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

Acceptance Criteria and Reported Device Performance

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

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The Quest Medical MPS®2 Myocardial Protection System, consisting of the MPS2 console and the MPS Delivery Set together, is intended for use by perfusionists and physicians to deliver whole blood (from any arterial source) and/or cardioplegia solutions to the heart during open heart surgery on either an arrested or beart for use up to six hours in duration.

The MPS 2 console is a single device for myocardial perfusion that incorporates several different functions: heat exchanger, temperature control, pressure control, flow rate control, automatic priming and air detection / removal, and 3 flow modes - normal, cyclic, low volume.

The provided text describes a 510(k) premarket notification for the Quest Medical MPS2 Myocardial Protection System Console, focusing on a labeling modification related to disinfection protocols. The submission asserts substantial equivalence to a predicate device (K041979).

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not explicitly state the sample size used for the disinfection efficacy testing (e.g., number of test articles, number of microbial inoculations). It mentions "bench testing," which implies laboratory-based studies. The provenance information (country of origin, retrospective/prospective) is also not provided.

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 section is not applicable as the study is a benchtop disinfection validation, not a clinical study requiring expert interpretation of patient data. The ground truth for microbial reduction (e.g., 6-Log and 3-Log reduction) is established through standardized microbiological testing methods rather than expert consensus on medical images or clinical outcomes.

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

This section is not applicable for a benchtop disinfection validation study. Adjudication methods are relevant for clinical studies where multiple experts interpret data.

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 section is not applicable. The study described is a benchtop validation of a disinfection protocol for a medical device, not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted.

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

This section is not applicable. The device is a "Myocardial Protection System Console" and the study focuses on validating a disinfection protocol for its water circulation system. There is no mention of an algorithm or AI functionality for standalone performance testing.

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

The ground truth used for the disinfection efficacy testing is microbiological quantification. This involves:

• Inoculation: Introducing a known concentration of target microorganisms (P. aeruginosa and M. chimaera) onto surfaces or into test systems.
• Disinfection: Applying the validated disinfection protocol.
• Recovery and Enumeration: Quantifying the number of surviving microorganisms after disinfection using standard microbiological techniques (e.g., plating and colony counting).
• Log Reduction Calculation: Comparing the initial microbial load to the post-disinfection load to determine the log reduction.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not a machine learning or AI device that requires training data. The study is a validation of a disinfection protocol.

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

This section is not applicable for the same reason as point 8.

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Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. This set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second. Non Pressure Rated: The Q2 Low Pressure Power Injector Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Sterile, single use non-pyrogenic intravenous administration extension set comprised of 7 inch tubing bonded to a male luer on one end and a female luer on the other end with a clamp in between. A swabable, needle-free port is connected to the female luer. This device is not made with the plasticizer Diethylhexylphthalate (DEHP).

The provided text describes information for the Q2® Low Pressure Power Injection Extension Set, which is a medical device, and does not contain information about an AI/ML powered device. Therefore, I cannot extract information pertaining to AI/ML acceptance criteria or studies.

However, I can provide available information regarding the device's performance as described in the document in a table format:

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

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The Q2 and CheckMate Multiport IV Administration Sets and Extension Sets are indicated for use for the following: For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Sterile, single use non-pyrogenic intravenous fluid administration sets which may include a multiport IV manifold, integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. The subject devices for this Premarket Notification are manufactured with tubing and drip chamber materials not made with the plasticizer Diethylhexylphthalate (DEHP).

Acceptance Criteria and Device Performance for Q2 and CheckMate Multiport IV Administration Sets and Extension Sets

This document describes the acceptance criteria and the studies performed to demonstrate that the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets (with non-DEHP tubing and drip chamber) meet these criteria, thereby proving substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific numerical sample sizes used for each of the test sets (e.g., how many units were subjected to high pressure testing, how many for biocompatibility). However, it indicates that testing was performed on "the proposed IV Administration Sets" and "a fully assembled representative IV Administration Set" and "devices manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber."

The data provenance is internal to Quest Medical, Inc. The studies appear to be prospective as they were conducted specifically for this 510(k) submission to demonstrate the performance of the modified device. The country of origin of the data is implicitly the USA, where Quest Medical, Inc. is located.

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

This document describes performance testing for medical devices (IV administration sets), not diagnostic or interpretative studies requiring expert ground truth establishment for a test set. Therefore, this section is not applicable in the context of this submission. The "ground truth" for these tests is defined by established international standards (e.g., ISO 10993) and engineering specifications.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1, none) are typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies in diagnoses or assessments. Given that this is a submission for an IV administration set based on functional and biocompatibility bench testing, an adjudication method for a "test set" in this context is not applicable. The results are quantitative measurements against predetermined specifications or qualitative observations of performance according to established test protocols.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically conducted for diagnostic imaging devices or algorithms where human readers interpret medical cases, and the effectiveness of an AI system, with or without human assistance, is evaluated. This submission pertains to an IV administration set, a non-diagnostic medical device.

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

This question is geared towards AI/algorithmic devices. Given that the device is an IV administration set, there is no algorithm involved, and thus, no standalone (algorithm-only) study was performed. The performance evaluation focuses on the physical and chemical properties of the device components.

7. The Type of Ground Truth Used

For this device, the "ground truth" for evaluating its performance is based on established industry standards, regulatory guidelines, and scientific protocols. Specifically:

• Bench Testing: Performance specifications derived from engineering principles and comparison to predicate devices.
• Sterilization: Compliance with ISO 10993-7:2008 for Ethylene Oxide residuals.
• Shelf Life: Internal validation protocols to confirm stability over time.
• Biocompatibility: Adherence to ISO 10993-1:2009 for material biocompatibility. Specific tests like Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, and Material-mediated Pyrogenicity are part of this standard.
• Pyrogenicity: Compliance with established guidelines for endotoxin levels, measured using the kinetic chromogenic LAL method.

8. The Sample Size for the Training Set

This document does not describe a machine learning algorithm, and therefore, there is no training set in the conventional sense. The "training" or development of the device itself would involve engineering design and prototype testing, but not a dataset for training an algorithm.

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

As there is no training set for an algorithm, this question is not applicable. The development of the device relies on design inputs, engineering specifications, and adherence to quality system regulations, rather than ground truth established from a training dataset.

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