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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 ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated. whichever occurs first.

The ulrich Transfer Set (Transfer Set) is a sterile tubing set connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast injection systems. The Transfer Set consists of a spike with protective cap and integrated air filter on one side, 20" (50.8 cm) tubing segment and one female swabable (also referenced as swabbable) valve (Swabsite Swabbable Valve - K002689) with a protective cap on the other side. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.

The provided text describes the ulrich Transfer Set and its successful 510(k) submission for substantial equivalence to a predicate device. This is a medical device, and the acceptance criteria and supporting studies are focused on its safety and performance standards rather than AI/algorithm performance.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test mentioned (e.g., number of transfer sets tested for sterility, biocompatibility, or performance). The studies are "verification results" indicating compliance with standards, implying a sufficient sample size was used as per the standard's requirements.

• Data Provenance: The studies are laboratory-based bench tests and materials testing, conducted by ulrich GmbH & Co. KG or their contracted testing facilities. The country of origin of the data would likely be Germany (where ulrich GmbH & Co. KG is located) or the location of the testing laboratories. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate compliance.

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

This section is not applicable to this device submission. The ulrich Transfer Set is a physical medical device (an intravascular administration set), not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. The "ground truth" here is defined by meeting established engineering, chemical, and biological standards (e.g., a device is sterile if it meets SAL 10⁻⁶; materials are biocompatible if they pass ISO 10993 tests).

4. Adjudication method for the test set

This is not applicable as it pertains to expert consensus on diagnostic or interpretative AI performance. The tests described are objective, quantitative measurements against predefined standards.

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

This is not applicable. The device is an intravascular administration set, not an AI or imaging diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This is not applicable. The device is a physical medical device, not an algorithm or AI.

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

As explained in point 3, the concept of "ground truth" in the AI/diagnostic sense is not directly applicable. The "ground truth" for the ulrich Transfer Set's performance is established by:

• International Standards: Compliance with ISO 11135-1, ISO 11607-1/2, ISO 10993 series, ISO 8536-4, ISO 22413, ISO 594-2.
• National Standards: Compliance with ASTM F756-13, ASTM F619-14, USP 38.
• Predetermined Specifications: The device's own internal design and performance specifications confirmed by testing.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This is not applicable. See point 8.

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The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.

The InfuSite Needleless Access Device is a closed system needleless multi-purpose catheter accessory, permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer systems. The InfuSite Needleless Access Device has a polycarbonate male/female luer housing with a swabable silicone membrane, which opens automatically upon connection with a male luer and closes automatically when the male luer is disconnected. Disinfection must be carried out before and after use. The InfuSite contains no metallic components.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the InfuSite Needleless Access Device:

Important Note: The provided document is a 510(k) summary for a medical device (Needleless Access Device), not a diagnostic algorithm or AI software. Therefore, many of the requested categories like "multi reader multi case (MRMC) comparative effectiveness study," "standalone algorithm performance," "number of experts for ground truth," and "training set details" are not applicable to this type of device submission. The focus of this submission is on demonstrating substantial equivalence to predicate devices through performance testing and biocompatibility, not on diagnostic accuracy of an AI.

Acceptance Criteria and Device Performance

Study Details (Applicable to this device type)

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

   • The document does not explicitly state the sample sizes for the performance testing. This information would typically be detailed in the full 510(k) submission, not the summary.
   • Data Provenance: Not specified. It's likely that the testing was conducted in a laboratory setting by the manufacturer or contracted labs, rather than involving patient data from specific countries. The testing would be prospective in the sense that the device was specifically tested to meet certain criteria.

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

   • Not applicable for this type of device (needleless access device). Ground truth for diagnostic accuracy (which requires experts) is not relevant here. The "truth" for this device's performance would be objective measurements (e.g., fluid flow rates, leak testing, material integrity, microbiological barrier testing) against established engineering and regulatory standards.

3. Adjudication method for the test set:

   • Not applicable. As the "ground truth" is based on objective, measurable performance characteristics rather than expert interpretation, adjudication methods used for diagnostic studies (like 2+1) are not relevant here.

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 a physical medical device, not an AI or diagnostic algorithm that interacts with human readers.

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

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

6. The type of ground truth used:

   • The "ground truth" for this device's performance is based on objective engineering and regulatory standards, including:
     • Biocompatibility test results (e.g., cytotoxicity, sensitization, irritation indices).
     • Physical performance metrics (e.g., flow rates, pressure resistance, leakage, connection integrity, seal integrity after disconnections, microbial barrier performance).
     • Compliance with recognized standards (e.g., ISO, specifically ISO 14971 for risk assessment, and likely other ISO fluid connector standards).
     • Comparison to the performance characteristics of predicate devices.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI model that requires a training set.

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

   • Not applicable. No training set for an AI model.

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To administer IV fluids/medication to a patient's vascular system.

The Victus I.V. Administration and Extension Sets are single use, sterile, non-pyrogenic devices used to administer filtered intravenous solutions and/or nutritional solution to a patient's vascular system via a catheter venous site under gravity-controlled flow. When used, the purpose of the filter is for filtering solution during intravascular administration. The device may include a needle-free valve injection site/connector which eliminates the use of needle to access the set during IV administration and aids in the prevention of needlestick injuries.

This document describes a 510(k) premarket notification for Victus Intravascular (I.V.) Administration Sets and Victus I.V. Extension Sets. The submission details changes and additions to the product line, including substituting a Flow Regulator for a Roller Clamp, replacing PVC tubing, substituting a Needle-Free connector, and adding a filter and check valve to some configurations. The document asserts that these changes do not affect the safety and effectiveness of the devices.

The information provided is primarily focused on the declaration of substantial equivalence to predicate devices and the scope of the device's intended use. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested. The only mention of testing is "The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance," without detailing the tests, criteria, or results.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted based on the provided text, with significant gaps for the unavailable information:

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

Unfortunately, the provided text does not contain a table of acceptance criteria or specific reported device performance metrics beyond the statement "The VICTUS IV Extension Set and IV Administration Set have undergone Mechanical testing to verify performance." No quantitative results or predefined thresholds are mentioned.

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

The document does not specify the sample size used for any mechanical testing or the data provenance.

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 present as this is a mechanical medical device, not an AI or diagnostic imaging device.

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

This information is not applicable and not present. No adjudication method is mentioned for any testing.

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 information is not applicable as this is a mechanical medical device and not an AI-assisted diagnostic device.

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

This information is not applicable as this is a mechanical medical device and does not involve an algorithm.

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

For mechanical devices, "ground truth" typically refers to established engineering standards or regulatory requirements that the device must meet (e.g., flow rate, tensile strength, sterility). The document states that the devices underwent "Mechanical testing to verify performance" and that the "Technological characteristics of the Victus Sets are substantially equivalent to the referenced predicates." This implies that the performance was compared to established standards for similar predicate devices, though the specific 'ground truth' metrics are not detailed.

8. The sample size for the training set

This information is not applicable and not present as this is a mechanical medical device, not an AI or machine learning device.

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

This information is not applicable and not present as this is a mechanical medical device, not an AI or machine learning device.

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