For administration of fluid from a container into the patient vascular system through a vascular access device.

The Polyfusion IV Administration Sets are available in multiple configurations. In more detail:

Polyfusion NFV IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The set may include a vented or non-vented universal spike, drip chamber, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 µm inline filter, slide clamp, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 15 drops/ml and 60 drops/ml. Different lengths are available, from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.

Polyfusion Air Stop IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The inclusion of an air stop filter maintains a constant fluid level in fluid delivery tubing and reduces the possibility of air entering the line when the I.V. bottle/bag is empty. The set may include a vented or non-vented universal spike, drip chamber, air stop filter, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 um inline filter, slide clamps, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 20 drops/ml and 60 drops/ml. Different lengths are available from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.

This document describes the Polyfusion IV Administration Sets, a medical device designed for administering fluids from a container into a patient's vascular system. The information provided outlines the device, its performance testing, and a comparison to a predicate device to establish substantial equivalence for FDA clearance.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily demonstrated through compliance with recognized international and national standards, and internal testing. The document presents a comparison of the subject device (Polyfusion IV Administration Sets) with a predicate device (Baxter Healthcare Corp.'s Intravascular Administration Set, K203609) to show substantial equivalence.

Since this is a 510(k) submission for an IV administration set, the acceptance criteria are not typically expressed as specific performance metrics with explicit pass/fail values in this summary. Instead, they are demonstrated by fulfilling the requirements of the referenced standards and showing comparable safety and effectiveness to the predicate device.

• ISO 8536-4:2019 (Infusion equipment for medical use - Infusion sets for single use, gravity feed) - FDA recognized
• ISO 8536-14:2016 (Infusion equipment for medical use - Infusion sets for single use with pressure infusion apparatus) - Not FDA recognized, but tested
  Comment #4 on Drip Rates: Subject device offers 10, 15, and 60 drops/ml. Predicate has 10 drops/ml. When used at 10 drops/min, both are similar.
  Comment #5 on Priming Volume: Subject device has approx. 25 ml. Predicate has 6.1 to 21.2 ml. Differences noted but do not raise new safety/effectiveness questions. |
  | Connection Integrity (Luer Connectors) | Successful compliance testing with:
• ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications - Connectors for intravascular or hypodermic applications) - FDA recognized |
  | Particulate Matter Reduction (0.2 µm inline filter) | Successful compliance testing with:
• USP Method 1 (Particulate Matter in Injections) - Not FDA recognized, but tested |
  | Packaging & Sterility Integrity (during Shipping & Shelf-life) | Successful compliance testing with:
• ISTA-3A:2018 (Shipping performance test) - FDA recognized
• ASTM F-1886 / F-1886M-16 (Seal integrity of flexible packaging) - FDA recognized
• ASTM F-2096 (Detecting gross leaks in nonporous flexible packaging) - FDA recognized
• ASTM F-1929 (Seal integrity of flexible packaging by dye penetration) - FDA recognized
• EN 868-5:2018 (Sterile barrier systems for medical devices - Sealable pouches and reels) - Not FDA recognized, but tested
• Microbial Ingress testing (to confirm sterility barrier)
• Sterilization and shelf life confirmed by testing per ISO 8536-4:2019, ISO 8536-14:2016, ISO 80369-20:2015, USP 2012, ASTM F-1929, ASTM F-2096, ASTM F-88 / F88M-15, USP 2012, all following accelerated aging (ASTM F 1980-16). |
  | Microbial Ingress Prevention | Microbial Ingress testing performed. |
  | Biocompatibility | Biocompatibility established by testing in accordance with ISO 10993-1:2018 Annex A, considering relevant FDA guidance, including:
• Cytotoxicity (ISO 10993-5:2009) - FDA recognized
• Sensitization (ISO 10993-10:2010) - FDA recognized
• Irritation or intracutaneous reactivity (ISO 10993-10:2010) - FDA recognized
• Acute systemic toxicity (ISO 10993-11:2017) - FDA recognized
• Subacute/subchronic toxicity (ISO 10993-11:2017) - FDA recognized
• Material mediated pyrogenicity (ISO 10993-11:2017) - FDA recognized
• Hemocompatibility (ISO 10993-4:2017) - FDA recognized
  Comment #2 on Material in Contact with Fluid: Non-DEHP PVC, TPE, TPO materials demonstrated not to raise new safety/effectiveness questions through bench tests. |
  | Sterility Assurance Level (SAL) | Achieved SAL of 10^-6 through validated ethylene oxide sterilization process. Ethylene oxide residuals within specified limits. Comment #6 on Sterilization: Equivalent SAL to predicate's radiation sterilization. |
  | Shelf-life | Validated shelf-life of 5 years. Comment #7 on Shelf life: Longer than predicate (2 years) but raises no new safety/effectiveness questions. Testing included accelerated aging per ASTM F 1980-16 and compliance with standards listed under "Packaging & Sterility Integrity." |
  | Human Factors | A human factors study carried out in accordance with ISO 23908:2011, considering relevant FDA guidance. |

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

The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The performance data section broadly states "Non-clinical testing of the Polyfusion IV Administration Sets has included successful compliance testing with the following standards..." and "Biocompatibility of components...has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018...".

Medical device testing for regulatory submission typically involves internal validation data for each standard's requirements, conducted in a controlled lab environment. The provenance of such data would be the testing facility where the tests were carried out, likely located in the manufacturer's region (India, as per the manufacturer's address, with Donawa Lifescience Consulting in Italy handling some regulatory aspects). These are prospective tests conducted specifically for the device's regulatory clearance.

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

This information is not provided in the document. For IV administration sets, "ground truth" typically refers to established and validated performance characteristics derived from testing against recognized standards. There isn't an explicit "expert panel" establishing ground truth in the way it might occur for AI/imaging devices. The "experts" are implicitly the technical personnel, quality assurance teams, and engineers who conduct the tests and ensure compliance with the specified standards.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/imaging devices where multiple human readers interpret data that is often subjective. For a physical medical device like an IV administration set, performance is measured against objective engineering and biocompatibility standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers with and without AI assistance is evaluated across multiple cases. The Polyfusion IV Administration Sets are a physical fluid delivery device and do not involve human readers for diagnostic interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. Standalone algorithm performance studies are conducted for AI-based medical devices. The Polyfusion IV Administration Sets are a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with recognized international and national standards. This includes:

• Engineering Standards: Such as ISO 8536-4 (gravity feed), ISO 80369-7 (Luer connectors), ISTA-3A (packaging integrity), ASTM F-series (packaging integrity), EN 868-5 (packaging).
• Biocompatibility Standards: ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility).
• Sterilization Standards: Validated ethylene oxide sterilization process achieving a SAL of 10^-6, with residuals within limits.
• Pharmacopoeial Standards: USP (particulate matter).
• Human Factors Standards: ISO 23908.

Essentially, the "ground truth" is that the device, when tested against these prescribed methods and benchmarks, performs as expected and is safe and effective for its intended use, comparable to the predicate device.

8. Sample Size for the Training Set

This information is not applicable. "Training set" is a concept specific to machine learning and AI development. This device is a physical medical product. The "training" in this context would refer to the R&D and design iterations by the manufacturer, but not in the sense of a dataset.

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

This information is not applicable. As mentioned above, there is no "training set" in the AI sense for this type of device. The R&D and design process for such a device relies on established engineering principles, materials science, manufacturing processes, and adherence to relevant standards and regulations, rather than a data-driven "ground truth" for training.

In summary: The submission for the Polyfusion IV Administration Sets relies on extensive non-clinical bench testing for compliance with a wide array of recognized national and international standards. The substantial equivalence argument is built upon demonstrating that the subject device meets these standards and that any differences in features or materials compared to the predicate device do not raise new questions of safety or effectiveness.

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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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IV Sets are intravenous administration sets 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. Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. 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.

IV Administration Sets are gravity, single use, disposable, IV sets and extension sets. IV Administration Sets are used to deliver fluids from a container into a patient's vascular system. Extension sets are connected to primary IV administration sets to add length and provide clamping capabilities or added to an intravascular catheter hub as a conduit for flow to and from the catheter and are used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, tubing, luer connections (connector/adaptor), y-connector, and flow regulator.

This is a 510(k) summary for IV Administration Sets by B. Braun Medical Inc. The document discusses the substantial equivalence of their proposed device (K202618) to two predicate devices (K170595 and K153293). It details the non-clinical performance testing conducted.

Here's an analysis of the provided text in response to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific quantitative performance metrics as typically seen in device efficacy studies (e.g., Sensitivity, Specificity, Accuracy for diagnostic devices). Instead, it lists various non-clinical tests performed to demonstrate substantial equivalence to predicate devices and conformity to established standards. The "performance" is reported as a conclusion that the tests were "successfully completed" or that "verification results confirm that the differences in the set components do not raise new or different questions of safety and effectiveness."

Here's a compilation of the tests and the implicit performance:

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

The document does not specify the sample sizes used for the non-clinical tests. Non-clinical studies for devices like IV administration sets typically involve testing a statistically significant number of units to ensure reliability, but the exact numbers are not disclosed in this summary.

The data provenance is from non-clinical performance testing conducted by B. Braun Medical Inc. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission. There is no information regarding the country of origin of the data beyond the manufacturer being B. Braun Medical Inc. (located in Allentown, Pennsylvania, USA).

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

This information is not applicable in the context of this 510(k) summary. The ground truth for the non-clinical performance tests is based on objective measurements against established engineering standards (e.g., ISO, USP) and internal B. Braun procedures, not on expert consensus or interpretation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. The tests described here are physical and mechanical performance tests with objective pass/fail criteria based on 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

There was no MRMC comparative effectiveness study done. This device is an IV administration set, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.

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

There was no standalone (algorithm only) performance study done. As mentioned, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests is derived from established industry standards (ISO, USP) and internal B. Braun procedures, which outline specific test methodologies, parameters, and pass/fail criteria. For instance, for flow rate, the ground truth would be the expected flow rate range defined by the standard under specific conditions. For tensile strength, it would be the minimum force the material must withstand.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, and the evaluation involves non-clinical performance testing, not machine learning or AI that requires a "training set" of data.

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

This is not applicable for the same reasons as point 8.

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The IV Administration Sets are intravenous administration sets 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.

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 which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, stopcock, manifold, tubing, luer connections (connector, adaptor), and filter. IV Administration sets are configured to ensure the intended use of the device is met. The proposed device, IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system.

The provided text describes a 510(k) premarket notification for "IV Administration Sets" by B. Braun Medical Inc. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that the device meets specific acceptance criteria in the manner of an AI/algorithm-based device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of regulatory submission, as it's for a physical medical device (IV administration sets), not an AI/ML algorithm.

However, I can extract information related to acceptance criteria (performance standards) and the "study" (non-clinical performance testing) used to demonstrate adherence to these criteria.

Here's the information formatted as requested, with "N/A" for inapplicable fields:

Acceptance Criteria and Device Performance for IV Administration Sets (K170595)

1. Table of Acceptance Criteria and Reported Device Performance

Details of the "Study" (Non-Clinical Performance Testing)

2. Sample size used for the test set and the data provenance: Not explicitly stated how many individual IV sets were tested for each performance test. The data provenance is from "nonclinical performance testing" performed by B. Braun Medical Inc. (manufacturer), as part of a 510(k) submission to the FDA. This is considered prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth for physical device testing is typically based on objective measurements against established technical standards, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set: N/A. Testing is based on objective measurement against defined pass/fail criteria from international 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: N/A. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI/ML device.

7. The type of ground truth used: The "ground truth" for this device's performance is adherence to the specified international performance standards (e.g., ISO 594-1, ISO 8536-4) and biocompatibility standards (ISO 10993-1). This involves objective measurement of physical and material properties.

8. The sample size for the training set: N/A. This is not an AI/ML device.

9. How the ground truth for the training set was established: N/A. This is not an AI/ML device.

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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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The IV Administration Sets with 200um Blood Filter are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. When the hand pump component is activated, the device is intended to deliver blood, blood products and crystalloid and colloid resuscitative fluids. 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.

The IV Administration Sets with 200um Blood Filter 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, rapidly through the use of a hand pump, or through gravity flow. The sets include tubing, a 60 cm filter with a 200 micron pore size, bag spike, luer connector, roller clamp and slide clamp. The sets may be equipped with a manually activated hand pump, stopcocks, manifolds, and/or luer access devices.

I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification for an IV Administration Set with a blood filter, primarily focused on establishing substantial equivalence to a predicate device.

Here's what is missing that would be needed to fulfill your request:

• Specific acceptance criteria values: While the document mentions utilizing acceptance criteria from ISO 1135-4 for "Blood Filter Surface Area" and "Blood Filter Composition," it does not explicitly state what those acceptance criteria values are.
• Reported device performance values: Similarly, it lists types of performance tests conducted (e.g., "Flow rate under gravity," "Blood Filter Mesh Efficiency Test"), but it does not provide the actual numerical results or performance metrics achieved by the device for these tests.
• Details about the study and its results: The document broadly states that "functional performance testing was completed" and "performance data were provided in support of the substantial equivalence determination," but it does not detail the methodology, sample sizes, data provenance, ground truth establishment, or multi-reader studies for these performance tests.

Without these specific details about the acceptance criteria and the quantitative results of the performance testing, I cannot create the requested table or describe the study in the manner you specified. This document focuses more on what tests were done and why they were done (to prove substantial equivalence) rather than the precise results of those tests.

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The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.

The IV Administration Sets with Ultrablock UV-Resistant Tubing are a single-use, sterile, non-pyrogenic tubing set intended for the administration of light sensitive solutions from a container to a patient's vascular system. The device is composed of UV-Resistant IV tubing and may include one or more of the following: universal chamber assembly, injection site, male luer lock, slide clamp, 0.2 micron air eliminating filter, flow clip assembly, and pump cassette.

This 510(k) pertains to "IV Administration Sets with Ultrablock UV-Resistant Tubing." The provided document is a 510(k) summary and the FDA's clearance letter, which means it describes the device and its intended use, and states that the device is substantially equivalent to predicate devices.

However, the provided text does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

This type of information is typically found in detailed testing reports, design validation documentation, or perhaps summarized within a more extensive 510(k) submission, but it is not present in the excerpt provided.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria from the given text. The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices.

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An intravascular administration set with needle access to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vessel.

IV Extension/Administration Sets with Needle

The provided text pertains to a 510(k) premarket notification for an "IV Extension/Administration Sets with Needle" device (K980994) received by the FDA in 1998. The document is an FDA clearance letter confirming substantial equivalence to a predicate device.

This document does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone performance), or training set information for an AI/algorithm-based device.

The document is a regulatory clearance letter for a physical medical device (IV administration sets), not a software or AI medical device. Therefore, the questions posed in the prompt about AI/algorithm performance and study methodologies are not applicable to the content provided.

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An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.

Not Found

This document is a marketing clearance letter from the FDA for a medical device, specifically "Starluck® IV Extension Sets with Needleless Access Devices." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.

Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is an administrative document related to market approval, focusing on regulatory classification and substantial equivalence, not performance testing details.

Therefore, I cannot provide the requested information based on the provided text.

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