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Extension Sets are intended to be used with a vascular access device for direction, intermittent infusion, continuous infusion or aspiration. The Extension Sets may be used with power injector procedures to a maximum pressure of 200 kPa (2 bar).

The subject device, Extension sets are single use, sterile, non-pyrogenic, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. The device is to connect the infusion device through the luer lock connector to add length and provide clamping capacities, or added to an intravascular catheter hub as a conduit for flow to and from the catheter. It is available in various lengths and tube dimensions, and may be comprised of various generic components such as connectors, clamps, flow regulators, filters, check valves and needleless injection ports. It can be used for gravity infusion and pressure infusion with pressure up to a maximum of 200 kPa (2 bar).

The provided text is a 510(k) Summary for a medical device called "Extension Set." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and biocompatibility assessments, rather than presenting a performance study with acceptance criteria in the context of an AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance with AI) are not applicable to this document.

However, I can extract information related to the device's performance based on the non-clinical tests performed to ensure its safety and effectiveness.

Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests)

The document lists numerous non-clinical tests performed to demonstrate that the device meets its design input requirements and applicable standards. The "reported device performance" in this context refers to the affirmation that the device met the requirements of these tests. Specific quantitative acceptance criteria are generally not explicitly stated in this summary but are implied by adherence to the referenced standards and guidance documents (e.g., ISO, ASTM, FDA guidance).

Here's the relevant information based on your numbered questions, with explanations for why some information is not present:

1. A table of acceptance criteria and the reported device performance: See the table above. The acceptance criteria are implicitly defined by the referenced international standards (e.g., ISO 8536 series, ISO 80369-7, ASTM F838-20) and FDA guidance documents, which specify performance requirements (e.g., maximum leakage, tensile strength thresholds, bacterial retention rates). The "reported device performance" is a blanket statement that the device met the requirements of these standards for all tests performed.

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

   • Sample Size for Test Set: Not explicitly stated in the summary document. For medical device bench testing, sample sizes are typically determined by statistical methods for quality control or standard requirements, but these details are not provided here.
   • Data Provenance: The tests were conducted by MEDCAPTAIN LIFE SCIENCE CO., LTD. which is based in Shenzhen, Guangdong, China. The document does not specify if external labs were used or the specific origin of materials if different. Tests are non-clinical (bench tests).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This device is a physical medical device (Extension Set), not an AI diagnostic tool. Ground truth for its performance is established through adherence to engineering specifications and performance standards via bench testing, not through expert consensus on medical images or diagnoses.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (often of images) where there can be disagreement, typically in AI/diagnostic studies. Bench testing of a physical device is a direct measurement against defined specifications, not subject to subjective adjudication.

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

   • Not applicable. MRMC studies are specific to evaluating diagnostic systems, especially those involving AI and human readers. This document concerns a physical "Extension Set" device.

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

   • Not applicable. There is no algorithm or AI component in this medical device.

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

   • The "ground truth" for the device's performance is established by the specifications defined in international standards (e.g., ISO, ASTM) and FDA guidance documents. These standards dictate acceptable ranges for physical, chemical, and biological properties (e.g., acceptable leakage rate, minimum tensile strength, non-cytotoxicity). The device's performance is measured directly against these pre-defined, objective criteria.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable, as there is no training set.

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B. Braun Extension Sets are intended for direct injection, intermittent infusion, continuous infusion or aspiration.

B. Braun Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braun Extension Sets may be used for any patient population.

B. Braun Extension Sets are single use, disposable, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. In clinical practice, extension sets are connected to primary IV 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. An extension set attached to a catheter hub allows the clinician to perform syringe aspirations and injections away from the patient's catheter site.

Extension Sets are widely used in the clinical setting, are available in various lengths and dimensions, and may be comprised of various generic components that are broadly used throughout the industry. Various components such as stopcocks, clamps, injection sites, connectors, manifolds, filters and needleless connectors, previously cleared in 510(k)s, may be included on an Extension Set. B. Braun Extension Sets offer a range of lengths and a variety of tubing dimensions (ie: microbore, standard bore) that provide flexibility in a variety of clinical settings. B. Braun Extension Sets are configured to ensure the intended use of the device is met.

B. Braun's optional stabilization component is a non-removable component that slides on the tubing and may be firmly positioned on the patient connector, secured at the discretion of the clinician at time of use. The optional stabilization component provides additional stabilization to intravascular catheters while firmly positioned on the patient connector of the Extension Set. The optional stabilization component supports the patient connector of the extension set, reducing its contact with the skin. The geometrical design of the stabilization component supports the patient connector maintaining the catheter insertion angle, minimizing the catheter movement in the vessel and the potential for catheter kinking at the insertion site.

Select B. Braun Extension Sets that may be used with a power injector at a maximum pressure of 400 psi and a maximum flow rate of 15mL/second.

B. Braun Extension Sets may be used for any patient population.

Extension Sets comprised of a female luer adapter, extension tubing, slide clamp, stabilization component and a male luer adapter with cap are included in this premarket notification. The following Extension Set configurations are subject of this submission.

• Smallbore Extension Set with stabilization component, Spin-Lock connector, removable slide clamp
• Standard Bore Extension Set with stabilization component, Spin-Lock connector, slide clamp
• Extension Set with stabilization component, Spin-Lock connector, slide clamp

This is a 510(k) premarket notification for an Extension Set by B. Braun Medical Inc. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and biocompatibility testing. It is not a study proving device meeting acceptance criteria in the sense of an effectiveness or clinical trial, but rather a submission for regulatory clearance based on performance standards.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, ground truth for test/training set, training set size) are not applicable as this document details a regulatory submission for a medical device rather than a clinical study of AI performance.

However, I can extract information related to acceptance criteria and performance testing for the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All test results met their acceptance criteria" for the performance tests conducted. However, the specific quantitative acceptance criteria for each test are not explicitly detailed in this summary. The summary lists the types of tests performed.

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 performance and biocompatibility tests. The data provenance is B. Braun's internal testing facilities (implicit, as they performed the tests for their device). These are retrospective tests performed on manufactured devices for regulatory submission.

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

Not applicable. This is not a study involving expert assessment of a test set for ground truth. The "ground truth" here is compliance with established performance standards and biocompatibility requirements.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions.

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

Not applicable. This device is not an AI algorithm, and no MRMC study was performed or mentioned.

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

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by compliance with recognized international ISO standards for medical devices and performance criteria derived from these standards. For biocompatibility, the ground truth is established by meeting the requirements of the ISO 10993 series.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set.

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

Not applicable. This is not an AI or machine learning device requiring a training set.

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Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.

The Hospira Extension Sets with Secure Lock are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, stopcock and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Externsion sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hospira Extension Sets, formatted to answer your specific questions.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a clinical effectiveness study of a new AI-powered medical device. Therefore, many of your questions regarding AI-specific studies, such as effect size of human readers with AI, training set details, and specific expert qualifications for ground truth in AI, are not applicable to this document. This device is a physical medical device (intravascular administration set), not an AI/software device.

Acceptance Criteria and Device Performance for Hospira Extension Sets

This document describes a 510(k) submission for Hospira Extension Sets, a physical medical device. The "acceptance criteria" here refer to performance standards and substantial equivalence claims, not diagnostic performance of an AI model.

The study presented focuses on demonstrating that the revised Hospira Extension Sets (with modifications to the Secure Lock Male Luer) perform comparably to previously cleared predicate devices and meet relevant performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in this summary. The summary refers to "performance testing" and "new performance data" under various ISO standards, which would imply defined sample sizes for physical testing, but these specifics are not provided in the publicly available 510(k) summary.
• Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a manufacturing change to an existing device, it's highly likely this "new performance data" would come from laboratory testing conducted by or for Hospira. There is no indication of retrospective or prospective clinical data in the traditional sense for this type of device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This device is a physical, non-diagnostic medical device. The "ground truth" here is adherence to engineering standards and functional performance, not human expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies (e.g., radiology reads). This document describes the testing of a physical medical device against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is not applicable to this physical medical device. This type of study is specifically designed for assessing the diagnostic performance of software or imaging systems, often with and without AI assistance to human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No. This question applies to AI algorithms. The Hospira Extension Set is a physical medical device with no AI component. The performance discussed is the standalone performance of the physical device according to engineering and functional standards.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on adherence to international engineering standards (ISO 594-1, ISO 594-2, ISO 8536-4, ISO 8536-10) and the functional claims outlined in the product labeling. This is determined through physical and mechanical testing, not by expert consensus on clinical findings or pathological outcomes.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no AI component, there is no training set or ground truth established for it.

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Non-Power Injectable:

Extension Sets with an attached BD Q-Syte™ Luer Access Split Septum are intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

Power Injectable:

The Power Injectable Extension Set with an attached BD Q-Syte™ Luer Access Split Septum is intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

The Power Injectable Extension Set is also indicated for use with intravascular catheters indicated for power injection of contrast media. The Power Injectable Extension Set is suitable for use with power injectors set to a maximum pressure of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made.

The Extension Sets with BD Q-Syte™ Luer Access Split Septum consist of a length(s) of flexible non-DEHP PVC clear tubing with a non-removable slide clamp. The devices include an ISO male Luer lock connection with a protection cap on the distal end an ISO female Luer lock connection on the proximal end(s) with a removable BD Q-Syte device or end cap. The Extension Sets with BD Q-Syte™ Luer Access Split Septum are provided in lengths from 5 in (127 mm) to 21 in (533 mm) with tubing diameters ranging from 0.035 in ID (0.89 mm) x 0.094 in OD (2.40 mm) to 0.110 in ID (2.80 mm) x .161 in OD (4.10 mm). Select Extension Sets include injection sites with a permanently attached BD Q-Syte device. The BD Q-Syte device is a needleless access device provided to aid in reducing the risk of accidental needlestick injuries. The Extension Sets with BD Q-Syte™ Luer Access Split Septum do not contain natural rubber latex.

The Power Injectable Extension Set with BD Q-Syte™ Luer Access Split Septum is suitable for use with power iniectors set to a maximum of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made. This device has a label attached to the tubing stating "Power Injectable Max 325 PSI".

The provided document is a 510(k) Premarket Notification for "Extension Sets with BD Q-Syte™ Luer Access Split Septum." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a new study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Specifically:

• It does not present a table of acceptance criteria and reported device performance.
• It does not describe a study involving a test set, its sample size, or data provenance.
• It does not mention experts establishing ground truth, adjudication methods, or MRMC studies.
• It explicitly states that "Performance testing was conducted for the predicate devices" and that the "results of the predicate testing indicate that the subject Extension Sets... are substantially equivalent." This means new performance data for this specific device against new acceptance criteria is not presented.
• It does not detail the sample size or ground truth establishment for a training set, as it relies on predicate device data for performance.

The document's primary purpose is to justify substantial equivalence based on the similarity of the new device to existing predicate devices, implying that the performance criteria for those predicate devices are met by extension.

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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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The Extension Set is intended for the conduction of fluids or medications.

The extension set is used to extend the length of another fluid or medication delivery device to provide continued fluid flow.

The Extension Set is a device used to supplement Epimed's current line of regional anesthesia catheters. The Extension Set consists of flexible plastic tubing, a male luer lock fitting on one end and a female luer lock fitting on the other end. Extension sets will be provided as a sterile, single use, disposable devices. The Extension Set will be available in a variety of lengths ranging from 12" to 60".

The provided document describes a 510(k) premarket notification for an "Extension Set" device and does not contain the information requested in the prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert ground truth establishment, or specific study types like MRMC or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical and technical characteristics.

Here's an analysis of what is provided and what is missing based on your prompt:

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

• Response: Not provided. The document mentions "bench testing performed on the Extension Set to compare performance characteristics to the predicate device(s) confirmed that the performance of the Epimed Extension Set is similar to that of the predicate device(s)." It lists the tested characteristics as "Fitting Bond Strength, Tubing Tensile Strength, Quantitative Flow, Qualitative Flow and Priming Volume." However, specific acceptance criteria values or detailed performance results (e.g., actual bond strength values, flow rates, etc.) are not included in the summary.

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

• Response: Not provided. The document states "bench testing" was performed but does not mention the sample size, type of study (retrospective/prospective), or 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):

• Response: Not applicable. This type of information is relevant for AI/software devices where human expert consensus is used to establish ground truth for classification tasks. The device described is a physical medical device (extension set), and its performance is evaluated through bench testing against physical and technical characteristics, not through expert-reviewed data.

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

• Response: Not applicable. See point 3.

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:

• Response: Not applicable. The device is a physical extension set, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

• Response: Not applicable. See point 5.

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

• Response: For this physical device, the "ground truth" or reference standard for evaluation would be the specified physical and technical requirements or performance characteristics of the predicate devices. The document implies that the Epimed device met these unspecified performance characteristics of the predicate devices.

8. The sample size for the training set:

• Response: Not applicable. There is no training set mentioned, as this is a physical device submission, not an AI/machine learning device.

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

• Response: Not applicable. See point 8.

In summary, the provided document is a 510(k) summary for a physical medical device (an extension set) that demonstrates substantial equivalence through bench testing to predicate devices. It does not contain the detailed study design, acceptance criteria, sample sizes, or ground truth establishment methods typically found in submissions for AI/software devices.

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The CODAN US Extension Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Extension Set Light-Safe BC565." This document outlines the regulatory approval of the device and confirms its substantial equivalence to a legally marketed predicate device.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

The document is purely a regulatory clearance and does not detail the technical performance or validation studies of the device. Therefore, I cannot generate the requested table and information based on the provided text.

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The Extension Set with 0.2u filter and anti-siphon valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps.

The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.

The purpose of this submission is to offer an alternate 0.2u filter, as a matter of customer preference, for use with the SIMS Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2u Filter and Anti-Siphon Valve. The 0.2u filter is similar to the filter on the Abbott Laboratories' Filter Set with 0.22u Filter. An integral anti-siphon valve is included and is designed to protect against unregulated gravity infusion that may result from an improperly attached reservoir.

The provided text is a 510(k) summary for a medical device (Extension Set with 0.2µ Filter and Anti-Siphon Valve and CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve). However, it describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document states that the purpose of the submission is to offer an alternate 0.2µ filter, similar to one on an existing Abbott Laboratories' product. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for certain medical devices, rather than presenting a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested table and detailed study information based on the given text. The provided document is a regulatory submission for premarket notification, not a performance study report.

No information is available in the provided text for the following requests:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps.

The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump.

The purpose of this submission is to offer an alternative, as a matter of customer preference, to the current commercially available SIMS Deltec Extension Sets. The Extension Sets have been modified to include microbore tubing for use in microinfusions and a new compatible female luer on two of the sets. A 0.2 micron filter has been included on two of the sets and is an air eliminating filter similar to the filter on the Baxter Extension Set. An anti-siphon valve is included on one of the sets and is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.

The described device is an "Extension Set with Microbore Tubing" and variants. This 510(k) summary does not contain information typically found in an acceptance criteria table or a detailed study report for AI/ML-based medical devices. The submission concerns a standard medical device (tubing) and focuses on functional and biocompatibility testing rather than performance metrics related to AI or a "test set" in the context of an algorithm.

Therefore, I cannot provide the requested information for an AI/ML device. However, I can extract the relevant information about the functional testing performed for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not detail specific quantitative acceptance criteria or a performance table in the way one would for an AI/ML device. Instead, it states that "Functional testing performed on the sets to establish their operating parameters" and "The results of the testing indicated that the Extension Sets with Microbore Tubing function according to specification." No numerical results or specific pass/fail thresholds are provided in the summary.

2. Sample Size for the Test Set and Data Provenance

This information is not applicable. The submission refers to "functional testing" and "biocompatibility testing" of physical medical devices, not a 'test set' of data for an algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because data collection for AI/ML algorithms is not relevant here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. Ground truth, in the context of an AI/ML algorithm, involves expert labels or pathological findings. For this device, "ground truth" would be the engineering specifications and performance standards against which the functional tests were conducted. The experts would be the engineers and technicians performing the functional and biocompatibility tests, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among experts when establishing ground truth for AI/ML training or test sets. This concept does not apply to functional and biocompatibility testing of a physical medical device.

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

No. An MRMC comparative effectiveness study is used to assess the impact of AI assistance on human reader performance. This device is not an AI/ML algorithm, so such a study was not performed or necessary.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical medical device (extension set), not an algorithm. Therefore, a standalone performance study for an algorithm was not done.

7. Type of Ground Truth Used

The "ground truth" for this device would be defined by engineering specifications and performance standards. The functional testing verified whether the device performed "according to specification." Biocompatibility testing verified that "the materials used in the sets are biocompatible."

8. Sample Size for the Training Set

This information is not applicable. Training sets are used for machine learning algorithms. The design and testing of this medical device did not involve machine learning, so there is no concept of a "training set" in this context.

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

This information is not applicable, as there was no training set for an algorithm.

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