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The Velano Vascular Blood Collection Adapter is indicated for use as a blood collection system that manually diverts the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.

The Blood Collection Adapter is a sterile, single-use device that removes the initial portion of the blood specimen (potentially contaminated) into a waste or discard tube prior to collecting a subsequent blood sample. The Blood Collection Adapter is comprised of a transfer device, a waste tube, a skirt that holds the waste tube in place, and an adapter inside the transfer device that is used for narrow neck culture tubes and additional blood collection tubes. The device is designed to be attached to a newly placed IV-line, vascular access device, or venipuncture needle set and is not intended for blood specimen collection from preexisting lines or IV site. Place a new peripheral IV catheter prior to drawing blood sample. The device collects approximately 3mL of the initial blood sample into the waste tube. The subsequent blood sample is collected directly into a culture bottle (not provided by Velano Vascular) or into an evacuated tube for additional processing.

Acceptance Criteria and Device Performance Study for Velano Vascular Blood Collection Adapter

The provided FDA 510(k) summary for the Velano Vascular Blood Collection Adapter (K201237) outlines the device's indications for use and the testing performed to demonstrate its substantial equivalence to a predicate device. The core function of the device is to reduce blood culture contamination by diverting the initial potentially contaminated blood specimen.

While the document does not explicitly present a formal "acceptance criteria table" with numerical metrics for clinical efficacy (e.g., specific contamination rate reduction targets), the contamination study serves as the primary evidence for meeting the performance requirement related to its intended use: reducing blood culture contamination.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device and the provided documentation, the acceptance criteria are implicitly derived from the successful outcome of the contamination study, demonstrating the device's ability to prevent the passage of contaminants under simulated conditions.

• Simulated shipping: Passed
• Dimensional measurements: Passed
• Activation force: Passed
• Inlet compatibility: Passed
• Outlet compatibility: Passed
• Simulated use: Passed
• Discard volume: Achieved 3mL discard
• Multiple engagements: Passed |
  | Sterilization | Device achieves and maintains sterility. | - Ethylene Oxide Sterilization: Performed to ISO 11135 and AAMI TIR28, achieving a minimum SAL of 1 x 10-6. |
  | Biocompatibility | Device materials are biocompatible and do not cause adverse biological reactions. | - In vitro cytotoxicity: Passed (ISO 10993-5)
• Skin sensitization: Passed (ISO 10993-10)
• Irritation: Passed (ISO 10993-23) |
  | Efficacy (Contamination Reduction) | Device effectively prevents the passage of various bacterial contaminants from the initial diverted sample to the subsequent collected sample under simulated use conditions. | - Contamination Study: Test samples using the Blood Collection Adapter demonstrated no growth of
  Staphylococcus aureus, Bacillus Cereus, Escherichia coli, Pseudomonas aeruginosa from the collected sample. |

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

• Contamination Study (Test Set):

  • Sample Size: The document states "Test samples" and "all positive control test samples" but does not explicitly provide the numerical sample size (number of devices or tests performed) for this study.
  • Data Provenance: The study was a "simulated use" study, implying it was conducted in a laboratory setting, not on human subjects. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical clinical study sense.

• Functional and Safety Testing (Excluding Contamination Study):

  • Sample Size: The document does not specify the sample size for tests like visual inspection, simulated shipping, dimensional measurements, etc.
  • Data Provenance: These are laboratory-based engineering and quality assurance tests.

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

The provided document does not indicate that expert review was used to establish ground truth for the contamination study or other functional/safety tests. The ground truth for the contamination study was established through laboratory culture results (presence or absence of bacterial growth).

4. Adjudication Method for the Test Set

Not applicable. The contamination study's outcome (bacterial growth or no growth) is an objective laboratory result, not subject to subjective interpretation requiring an adjudication process.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Velano Vascular Blood Collection Adapter is a mechanical blood collection device, not an imaging or diagnostic algorithm.

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

Yes, the contamination study effectively represents a standalone performance evaluation of the device's ability to prevent contamination. The device's efficacy in diverting contaminants was assessed independently in a simulated environment, without direct human influence on the contamination-prevention mechanism during the "collection" phase of the study setup. While human manipulation is required to use the device, the study isolates the device's functional performance regarding contamination prevention.

7. The Type of Ground Truth Used

• Contamination Study: The ground truth was laboratory culture results (positive for growth in controls, negative for growth in test samples). This is a definitive biological outcome.
• Functional and Safety Testing: The ground truth was based on engineering specifications and established test methodologies (e.g., measurements falling within specified ranges, successful activation, absence of visible defects).

8. The Sample Size for the Training Set

Not applicable. The Velano Vascular Blood Collection Adapter is a mechanical device, not an artificial intelligence (AI) or machine learning (ML) algorithm. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The Velano ExT™ Extension Set with needle-free connector is for single use only. Each port of the Velano ExT™ Extension Set may be used for direct injection, intermittent infusion, continuous infusion or aspiration. The pressure rated port of the Velano ExT™ Extension Set may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.

The Velano ExT™ Extension Set is a sterile, single use, non-pyrogenic intravenous administration extension set comprised of an approximate 5" inch tube bonded to a T-connection port on one end and a female luer on the other end with a clamp in between. The T-connection port has a swabable, needle-free port on one side and a locking male luer on the other side. The device contains and integrated stabilizer under the swabable needle-free port. This component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano ExT™ Extension Set is compatible with Velano Vascular PIVOT™ devices.

The provided text is a 510(k) premarket notification for a medical device called the "Velano ExT™ Extension Set". This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on a clinical trial or algorithm performance study as you might find for an AI/ML medical device.

Therefore, the document does not contain the information required to answer questions 1 through 9, as it does not describe an acceptance criteria table, a study proving the device meets these criteria, or details regarding algorithm performance, ground truth establishment, or expert reviews.

The document details the following regarding the device and its testing:

• Device Name: Velano ExT™ Extension Set
• Intended Use: Administration of intravenous fluids, and use with low-pressure power injectors up to 325 psi and a maximum flow rate of 10 mL/second.
• Predicate Device: Velano Vascular Q2® Low Power Injector Extension Set (K182897)
• Functional and Safety Testing Performed: This section lists various tests conducted to verify the device's design meets functional and performance requirements. These tests are physical and mechanical in nature, not related to an algorithm's diagnostic performance.
  • Visual inspection
  • Simulated shipping
  • Priming volume
  • Microbial ingress
  • Particulate
  • Backpressure leak under normal use and power injection
  • Flow rate for normal use and power injection
  • Spin collar height and spin collar angle
  • Simulated use
  • Tubing bond strength
  • Multiple Engagement
  • Continuous Engagement
  • Activation Force
  • Tubing kink resistance
• Standards Applied: The document lists several ISO, USP, ASTM, and AAMI standards related to medical device sterilization, biological evaluation, particulate matter, packaging, and accelerated aging.

In summary, this document is a regulatory submission for a physical medical device (an extension set), not an AI/ML-driven device. Thus, the concepts of acceptance criteria for algorithm performance, test set size, expert adjudication, MRMC studies, standalone algorithm performance, or training set details are not applicable or present in this document.

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The PIVO™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.

The PIVO™ device is a sterile, single use device. It is a needlefree blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge.

This looks like a 510(k) summary for a medical device called PIVO™. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than a study proving performance against acceptance criteria in the context of AI/ML.

Here's why it's not applicable to the requested information and what information it does contain:

• No AI/ML Component: The PIVO™ device is a "blood specimen collection device" (a needle-free blood collection device that attaches to a peripheral IV catheter). There is no mention of any AI or machine learning component in its functionality or development. Therefore, questions related to AI performance, such as sample size for test sets, ground truth establishment, MRMC studies, or standalone algorithm performance, are not relevant.

• Substantial Equivalence, Not De Novo Performance: The document's primary purpose is to justify that the modified PIVO™ device is "substantially equivalent" to an already legally marketed predicate device (K190604). This means the focus is on showing that the changes (alternate colorant material, second contract manufacturer, alternate packaging material) do not raise new questions of safety or effectiveness. It's not about proving inherent performance against new, specific acceptance criteria for a novel device.

• Performance Testing for Equivalence: The "Performance Testing" section lists tests conducted to demonstrate that the modifications do not negatively impact the device's performance compared to the predicate. These are:

  • Leak testing
  • Dimensional testing
  • Joint strength testing
  • Flow rate testing
  • Packaging testing (per ASTM D4169-16, ASTM F1980-16, ISO 11607-1:2019)
  • Biocompatibility testing (per ISO 10993-1)

  The document states: "All testing was performed on sterilized product." And, "The changes made were tested using the same acceptance criteria as the predicate device and demonstrated that there are no new risks and the device is substantially equivalent."

Since it's not an AI/ML device and the submission is for substantial equivalence rather than original performance evaluation, I cannot fill in the requested table and study details related to an AI/ML device. The document does not provide information on:

1. Acceptance Criteria and Reported Device Performance (as typically defined for AI): It states "same acceptance criteria as the predicate device" for the performance tests listed, but doesn't quantify them.
2. Sample sizes for test set and data provenance.
3. Number of experts used to establish ground truth and qualifications.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The PIVO™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.

The PIVO™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV (PIV) catheter system. The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The inner tube is then advanced to collect a blood sample. Once complete, the inner tube is retracted, and the device is removed from the PIV. The device is available in three sizes, 20, 22, and 24 gauge.

The provided text describes a 510(k) premarket notification for the PIVO™ device, a blood specimen collection device. The submission is for a line extension to include a 24G compatible size device, along with some dimensional and material changes to existing 20G and 22G devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly provide a table of acceptance criteria with corresponding performance metrics. However, it lists several performance tests conducted and states that "All testing was performed on sterilized product." The overarching acceptance criterion for the subject device (PIVO™ 24G and modified 20G/22G) is that it "demonstrated that there are no new risks and the device is substantially equivalent" to the predicate devices. It also states that testing used "the same acceptance criteria as the predicate device."

Here's an inferred table based on the provided information:

The subsequent information is either not applicable (N/A), not explicitly stated (NSE), or can be inferred as follows:

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: NSE. The document states that testing was performed, but does not specify the number of devices or samples used for each test.
• Data Provenance: NSE regarding country of origin or whether it was retrospective/prospective. The testing was conducted by the manufacturer, Velano Vascular (based in San Francisco, California, though this doesn't specify test location).

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)

• N/A. This device is a blood collection device, not an AI/diagnostic imaging device requiring expert interpretation of results for ground truth. Performance testing would rely on objective physical and chemical measurements rather than expert consensus on a 'ground truth' image or diagnosis.

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

• N/A. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for the performance testing described for this 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 device is not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

• N/A. This device is not an algorithm or AI.

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

• Physiological standards and engineering specifications. For a blood collection device, "ground truth" would be established by predefined engineering specifications (e.g., specific dimensions, flow rates), established biochemical limits (e.g., for hemolysis), and relevant international standards (e.g., ISO 10993-1 for biocompatibility). The claim of "no new risks" and "substantially equivalent" implies meeting these objective standards relevant to the device's function.

8. The sample size for the training set

• N/A. This device is a physical medical device, not an AI/machine learning model, so there is no "training set."

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

• N/A. As there is no training set for a physical device, this question is not applicable.

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

Non Pressure Rated: The Q2® Extension Set with needleless connector is for single use only. The extension set may be used for direct injection, intermittent infusion, continuous infusion or aspiration.

Sterile, single use non-pyrogenic intravenous administration extension set comprised of 5.75 inch tubing bonded to a male luer on one end and a T-connector on the other end with a clamp in between. The T-connector has a female luer on one side and a swabable, needle-free port on the other side. This device is not made with the plasticizer Diethylhexylphthalate (DEHP). The Velano Vascular Q2® Extension Set is compatible with PIVO™ devices.

This document is a 510(k) Premarket Notification for a medical device (Velano Vascular Q2 Extension Set), which focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria through a rigorous study. Therefore, the information typically required to answer your prompt about AI acceptance criteria and study details (such as sample size for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) for an AI/ML device is not present in this document.

This document describes a traditional medical device (an intravascular administration set) and performs mechanical and functional testing to demonstrate its safety and effectiveness relative to a legally marketed predicate device.

However, I can extract the relevant information regarding the device's functional and safety testing, despite it not being an AI-driven device.

Here's a breakdown of the acceptance criteria and study information provided in the document:

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

The document doesn't explicitly present a table of "acceptance criteria" against "reported performance" in a quantitative manner for each test. Instead, it lists the types of functional and safety tests performed and states that these tests ensured the device design meets its functional and performance requirements. The conclusion explicitly states that "Velano Vascular considers the Velano Vascular Q2® Extension Set device to be substantially equivalent to the predicate device listed above. This conclusion is based upon the intended use, design specifications, patient contacting materials, manufacturing and sterilization processes." This implies that the device met the implicit acceptance criteria for each test to achieve substantial equivalence.

Implicit Acceptance Criteria and Demonstrated Performance (Inferred from the document):

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The PIVO™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.

The PIVO™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with a pusher/slider, proximal flexible tube with female luer, outer housing and clip-to-connect distal end. The clip-to-connect attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes compatible with 20 and 22 gage PIV's, respectively.

The provided document is a 510(k) premarket notification for a medical device called PIVO™, a blood specimen collection device. It details the device's characteristics, indications for use, and a comparison to its predicate device, TIVA™.

However, the document does not contain information related to a study proving the device meets acceptance criteria for an AI-powered medical device, or any acceptance criteria related to AI/algorithm performance. The acceptance criteria mentioned are for a physical medical device, PIVO™, comparing its performance characteristics to a predicate device (TIVA™) after material and component changes.

Therefore, I cannot extract the information required by your prompt regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm.

The document discusses:

• Device Performance Testing:
  • Clamp functional testing
  • Leak testing
  • Dimensional testing
  • Joint strength testing
  • Performance testing
  • Flow rate testing
  • Biocompatibility testing (per ISO 10993-1, -4, -5, -10, -11)
• Summary of Substantial Equivalence: It states that the changes made to PIVO™ (formerly TIVA™) do not raise new questions regarding safety and efficacy, and that PIVO™ is equivalent to the predicate device based on identical indications for use, principles of operation, fundamental scientific technology, and performance specifications. It explicitly states: "The changes made were tested using the same acceptance criteria as the predicate device and provide objective evidence that there are no new risks and the device is substantially equivalent."

Based on the provided text, the device is a physical blood collection device, not an AI or algorithm-driven device. Thus, your request for an AI acceptance criteria table or details about an AI study (sample size, experts, adjudication, MRMC, standalone, ground truth, training set) cannot be fulfilled from this document.

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The TIVA™ device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.

The TIVA™ device is a sterile, single use device. It is a needle- free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with plunger, proximal flexible tube with female luer, and outer barrel with male luer. The male luer attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes compatible with 20 and 22 gauge PIV's, respectively.

The provided document is a 510(k) summary for the TIVA™ blood specimen collection device (K152924). It compares the subject device to a predicate device (K142946). The document does not include information about AI/ML models or clinical studies involving human readers or comparative effectiveness studies of AI vs. human readers. Therefore, I can only address aspects related to the device's functional and safety testing as described.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance testing for both the predicate and subject devices. The "acceptance criteria" are implied by successful completion of these tests, demonstrating the device meets its functional and safety requirements.

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

The document does not specify the exact sample sizes (number of devices tested) for the functional and safety tests. It generally refers to "representative samples of the device." The data provenance is internal testing conducted by Velano Vascular, Inc. (the manufacturer). The testing is retrospective in the sense that it's performed on manufactured devices as part of product verification.

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

This information is not provided. The ground truth for functional and safety testing is typically established by engineering specifications, recognized industry standards (like ISO standards), and internal quality control protocols. The "experts" would be the engineers and technicians performing and validating these tests, ensuring they follow established procedures and standards.

4. Adjudication Method for the Test Set

Not applicable in the context of functional and safety testing of a medical device. The tests have predefined pass/fail criteria based on engineering specifications and industry 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

Not applicable. The TIVATM device is a mechanical blood collection device, not an AI/ML-driven diagnostic or interpretative tool. Therefore, no MRMC study or AI-related comparative effectiveness study was performed.

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

Not applicable, as the device is a mechanical blood collection tool and does not involve any algorithm or AI.

7. The Type of Ground Truth Used

For the functional and safety testing described, the ground truth is based on:

• Engineering Specifications: Defined parameters for device performance (e.g., specific thresholds for leak testing, joint strength).
• Recognized Standards: International standards like ISO 10993 (biocompatibility) and ISO 11137-1 (sterilization).
• User Feedback: The document explicitly states the addition of the clamp was based on "user feedback that a clamp is preferred when using blood control devices with a syringe." This indirectly influences the "ground truth" for a desirable functional feature.

8. The Sample Size for the Training Set

Not applicable, as the device is a mechanical one and does not involve AI/ML requiring a training set.

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

Not applicable, as no training set for AI/ML was used.

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The TIVA™ device is attached to a peripheral IV catheter at the time of IV catheter placement for use as a direct blood draw device into a vacuum tube or a syringe.

The TIVATM device is a sterile, single use device. It is a needle-free blood collection device that attaches to a peripheral IV system (PIV). The device is comprised of an inner tube with plunger, proximal flexible tube with female luer, and outer barrel with male luer. The male luer attaches to the PIV system. The female luer attaches to a blood transfer device or syringe. The device is then advanced to collect a blood sample. Once complete, the device is retracted and removed from the PIV. The device comes in two sizes 20 and 22 gauge.

The provided text is a 510(k) summary for the TIVA™ blood specimen collection device. It describes the device, its intended use, and its substantial equivalence to a predicate device based on functional and performance requirements and a comparison of design specifications.

However, the document does not contain specific acceptance criteria, a detailed study proving performance against those criteria, or information regarding sample sizes for training/test sets, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

The section titled "Functional and Safety Testing" briefly mentions that "representative samples of the device underwent biocompatibility, sterilization, and mechanical testing in accordance with the following industry standards," but it does not provide the results of these tests or specific acceptance criteria for them.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on the study specifics as the input document does not contain this level of detail.

In summary, the document states that functional and safety testing was performed according to industry standards, but it does not report the acceptance criteria or the specific performance results for the TIVA™ device.

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