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Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly.

Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries.

Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device can be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Deltaven Fast Flash Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use with pressure injectors rated for a maximum of 330 psi when the access ports and stopcocks are removed and a direct connection is made with the proximal luer lock connector.

Deltaven Fast Flash Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.

The devices consist of an over-the-needle, peripheral intravascular catheter made of polyurethane, integrated extension tubing with Luer lock adaptor and slide clamp. The devices are also equipped with a Luer lock final adaptor (single entry version) or a Y Luer lock final adapter (dual entry version).

The provided text describes a 510(k) summary for the Delta Med S.p.A Deltaven Fast Flash Closed I.V. Catheter Systems. This document pertains to a medical device (intravascular catheter) and not an AI/ML-driven device or an imaging device. Therefore, a study proving an AI device meets acceptance criteria, including elements like expert consensus, MRMC studies, or training/test set details, is not applicable to this document.

The document discusses acceptance criteria and the study that proves the device meets them in the context of a physical medical device (intravenous catheter), not an AI/ML system. The "acceptance criteria" here refer to the performance standards, regulatory requirements, and safety benchmarks for this type of medical device.

Here's a breakdown of the acceptance criteria and the study as described in the document, tailored to a medical device:

Acceptance Criteria for Deltaven Fast Flash Closed I.V. Catheter Systems

The acceptance criteria for the Deltaven Fast Flash Closed I.V. Catheter Systems are primarily based on established international and FDA-recognized standards for intravascular catheters, and proving substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance

• Meet specifications for various components (e.g., extension line closure, catheter hub wings, needle sheath). | Functional tests were carried out on all material versions of the new designs. All tests were performed on finished sample devices after a standard ethylene oxide sterilization cycle. The test protocols and acceptance criteria were the same as those used in the predicate submission, indicating the device performed to the established specifications. Specific design changes and their impact were verified. |
  | Material Biocompatibility | - Meet biological safety standards for patient contact.
• Compliance with ISO 10993 series and FDA guidance on biocompatibility.
• Specific tests: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Haemocompatibility (ASTM hemolysis, Complement Activation, Thromboresistance), Genotoxicity (Bacterial Mutagenicity, In Vitro Mouse Lymphoma), Material Mediated Rabbit Pyrogen, EO residuals. | Biocompatibility tests were carried out on new, sterile, complete devices with the new materials, in accordance with ISO 10993-1:2018 and FDA guidance. All listed specific tests were performed: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Haemocompatibility (ASTM hemolysis, Complement Activation Sc5b-9, Thromboresistance), Genotoxicity (Bacterial Mutagenicity Test (Ames Assay), In Vitro Mouse Lymphoma), ISO Material Mediated Rabbit Pyrogen, and EO residuals. The results were deemed acceptable. |
  | Sterility | - Achieve a Sterilization Assurance Level (SAL) of 10-6.
• Compliance with ISO 11135:2014 for ethylene oxide sterilization validation. | The devices are sterilized by ethylene oxide (EO) to an SAL of 10-6. The sterilization process was validated according to ISO 11135:2014, using the half cycle overkill approach. The sterile packaging is unchanged from the predicate device and found acceptable. |
  | Pyrogenicity | - Endotoxin levels within acceptable limits via Limulus Amebocyte Lysate (LAL) test. | Sample devices produced with the new materials were tested for bacterial endotoxins using the LAL test and found to be within limits. |
  | Physical/Mechanical Performance (Bench Tests) | - Compliance with ISO 10555-1:2013 (General requirements for intravascular catheters).
• Compliance with ISO 10555-5:2013 (Over-needle peripheral catheters).
• Compliance with ISO 80369-7:2016 (Small-bore connectors for intravascular/hypodermic applications).
• Compliance with ISO 23908:2011 (Sharps injury protection features).
• Compliance with USP for particulate evaluation (no more than 10 microns and greater).
• Catheter Force at break: Conforms to ISO 10555-1.
• Cannula bonding strength: Conforms to ISO 10555-5.
• Flow rate: Conforms to ISO 10555-1.
• Pressure resistance: 330 psi (for 16-24 gauge). | Bench tests were carried out, and the results demonstrate that the devices meet the applicable technical requirements of the listed FDA-recognized standards. This includes satisfactory performance related to catheter force at break, cannula bonding strength, flow rate, and pressure resistance (330 psi for indicated gauges). Particulate testing per USP was also performed, and the devices met the acceptance criteria. |
  | Material/Shelf-life Stability | - Maintain performance after accelerated aging equivalent to 5 years shelf-life.
• Compliance with ASTM F 1980:2007. | Accelerated aging tests were conducted at 60 ℃ for 19 weeks, which is equivalent to 5 years of real-time shelf-life, in accordance with ASTM F 1980:2007. Functional tests were then performed on these aged samples and found acceptable. |
  | Indications for Use / Intended Use Equivalence | - Maintain the same indications for use as the predicate device (K171530).
• Not raise new or different questions of safety and effectiveness compared to the predicate device. | The Indications for Use statement for the subject device is unchanged from the predicate, K171530. The conclusion states that "The modified device does not raise new or different questions of safety and effectiveness and this conclusion is supported by non-clinical testing," confirming substantial equivalence. |

Study Details (Non-AI Device)

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not explicitly state the specific number of units used for each test (e.g., functional, biocompatibility, sterility) as a "sample size" in the way one would for a clinical trial or AI test set.
   • Instead, for medical devices, testing is performed on representative samples of the device, often according to guidelines within the referenced ISO standards (e.g., ISO 10993 specifies sample preparation, ISO 11135 specifies sample sizes for sterility validation).
   • Data provenance: The testing was performed by Delta Med S.p.A (Italy) through their various testing procedures and subcontractors. The tests are "non-clinical" (bench and lab-based), not from patient data.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • Not applicable as this is a physical medical device, not an AI/ML system requiring expert labeling or ground truth establishment from medical images/data. The "ground truth" is defined by the physical and chemical properties of the device and its performance against engineering and biological standards.

3. Adjudication Method:

   • Not applicable. This concept pertains to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. This type of study is used for diagnostic AI systems where human readers interpret medical images. This document describes a physical medical device.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This device is not an algorithm. The performance evaluation is of the physical catheter and its components.

6. Type of Ground Truth Used:

   • The "ground truth" for this device is based on:
     • Standard Compliance: Adherence to internationally recognized standards (ISO, ASTM, USP) for materials, design, manufacturing, sterility, and performance.
     • Bench Test Results: Direct measurements and observations from laboratory testing (e.g., flow rate, force at break, particulate counts, endotoxin levels).
     • Biocompatibility Assay Results: Laboratory tests on biological interactions.
     • Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (K171530).

7. Sample Size for the Training Set:

   • Not applicable. There is no "training set" as this is not an AI/ML device. The device itself is manufactured. The manufacturing process ensures consistency, and the testing evaluates that consistency and adherence to design specifications.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the reasons mentioned above. The design and manufacturing specifications are based on engineering principles, regulatory requirements, and historical data from similar devices.

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A properly placed ViaValve® Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.

The ViaValve® Safety I.V. Catheter provides access to a vein or artery. The ViaValve® Safety I.V. Catheter incorporates a valve inside the catheter hub which is designed to reduce blood exposure during initial catheter placement. The valve will open and allow flow once the Luer connector is attached and will remain open after initial activation. The needle assembly incorporates a needle guard which locks over the needle as the ViaValve® Safety I.V. Catheter is threaded into the vessel to help reduce the risk of accidental needlesticks.

The provided documentation describes the ViaValve® Safety I.V. Catheter (K160235), which is a peripheral intravenous catheter. This submission is a 510(k) premarket notification, meaning it seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the "acceptance criteria" and "study" described herein are primarily focused on demonstrating this substantial equivalence through a comparison of technological characteristics and non-clinical performance data.

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

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

The document does not explicitly state "acceptance criteria" in a quantitative performance metric format for the device itself (e.g., specific sensitivity/specificity thresholds, or mean values with standard deviations). Instead, the acceptance criteria are implicitly met by demonstrating compliance with various ISO standards and showing that the subject device's performance is equivalent to the predicate device in relevant non-clinical tests. The "reported device performance" is largely framed as "passes" or "complies" with the specified standards.

Implicit Acceptance Criteria and Reported Device Performance

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 relates to a medical device (catheter) and the "study" is a set of non-clinical, bench and biological tests, not a clinical trial with patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country/retrospective/prospective) in the context of clinical data do not directly apply.

• Sample Size for Testing: The specific sample sizes for each bench or biological test (e.g., number of catheters tested for flow rate, or number of units for biocompatibility) are not detailed in this summary. The summary only lists the standards to which the tests were conducted.
• Data Provenance: The data provenance is from non-clinical laboratory testing performed to comply with international (ISO) standards. The location of the testing laboratories or country of origin of the data is not specified.

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 question is not applicable. The device is hardware, and the 'ground truth' for its performance is established through compliance with engineering and biological standards, not through expert consensus on interpretation of medical images or patient outcomes. The testing involves standardized procedures and measurements (e.g., flow rate, material strength, biocompatibility), not expert judgment on diagnostics.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to arbitration processes used when multiple human readers (e.g., radiologists) provide conflicting interpretations of diagnostic data. Since these are non-clinical, objective bench and biological tests, there is no "adjudication method" in this context.

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 question is not applicable. The device is a physical medical instrument (an IV catheter), not an AI algorithm or a diagnostic tool that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This question is not applicable. The device is a physical medical instrument, not a software algorithm.

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

The "ground truth" for the performance of this device is established by:

• Compliance with recognized international standards (ISO): These standards define acceptable performance limits and test methodologies for various aspects of the device (e.g., material safety, physical integrity, functional performance).
• Comparison to a predicate device: The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to an existing, legally marketed device. Thus, the performance of the predicate device, as established by its clearance and adherence to standards, serves as a de facto ground truth for the subject device.

8. The sample size for the training set

This question is not applicable. The device is a physical medical instrument and does not involve AI or machine learning models that require a "training set."

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

This question is not applicable, as there is no training set for this device.

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The proposed device, I.V. Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.

The proposed devices, I.V. Catheters, are sterile, single use devices intended to be inserted in to a patient's vascular system for short term use to withdraw blood samples or administer fluid intravenously.

The I.V. Catheter is a closed system, and further available in two combinations of configurations. All of them are sterilized by Ethylene Oxide to achieve a SAL of 106, and packed in a sterility maintenance package. The shelf life of the product is three years.

This document is a 510(k) summary for an I.V. Catheter (K142797) submitted by Jiangxi Sanxin Medtec Co., Ltd. It declares substantial equivalence (SE) to a predicate device (K083429).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized international and ASTM standards. The reported device performance is that it complies with these standards.

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

The document does not specify the sample size used for each non-clinical test. The data provenance is indicated as "Non clinical tests were conducted to verify that the proposed device met all design specifications" (Page 5), suggesting these were performed by the manufacturer, Jiangxi Sanxin Medtec Co., Ltd. The country of origin for the device itself is China, and the tests were likely conducted there or by affiliated entities. The tests are prospective with respect to the submission, performed specifically to demonstrate compliance.

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

This document describes a 510(k) submission for a medical device (I.V. Catheter). The "tests" here are primarily engineering and biocompatibility evaluations against recognized standards, not diagnostic performance assessments requiring expert ground truth establishment in a clinical sense. Therefore, this information is not applicable and not provided in the document. The standards themselves represent expert consensus on performance requirements.

4. Adjudication method for the test set

Similarly to point 3, adjudication methods like 2+1 or 3+1 are typically for diagnostic studies where there's variability in interpretation or a need to resolve discrepancies. For the non-clinical tests listed (e.g., seal strength, sterilization, biocompatibility), the results are generally objective measurements against predefined criteria in the standards. Therefore, an adjudication method is not applicable and not provided.

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

This document is for an I.V. Catheter, which is a physical medical device, not an AI software or a diagnostic imaging system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable and not mentioned.

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

As this is a physical medical device and not an algorithm, a standalone performance study in the context of an algorithm is not applicable and not discussed in the document. The non-clinical tests represent the standalone performance of the physical device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specifications and limits set forth in the referenced ASTM and ISO international standards. For example, for sterility, the ground truth is "achieve a SAL of 10^-6". For biocompatibility, it's "conforms to the requirement of ISO 10993 series Standards." This is based on established scientific and engineering principles for medical device safety and performance.

8. The sample size for the training set

This document describes non-clinical testing of a physical medical device, not a machine learning algorithm. Therefore, the concept of a "training set" is not applicable and no information is provided.

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

As there is no training set for a machine learning algorithm, this question is not applicable.

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TERUMO® SURFLO® I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.

The TERUMO® SURFLO® I.V. Catheter is a device consisting of a catheter assembly (catheter, caulking pin, and catheter hub) and needle assembly (needle, needle hub, filter cap and filter). The device is an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

Here's an analysis of the acceptance criteria and supporting studies for the TERUMO® SURFLO® I.V. Catheter, based on the provided 510(k) summary:

This device is not an AI device, therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, training set details) are not applicable. The provided document details a traditional medical device submission for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TERUMO® SURFLO® I.V. Catheter are based on conformity to recognized consensus ISO standards and specific internal performance tests. The reported performance indicates that the device Meets Standard or Meets acceptance criteria for all tests.

Biocompatibility Tests:

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

The document does not specify the exact sample sizes (number of units tested) for the performance tests. It states that "Performance testing was conducted to ensure the safety and effectiveness... and demonstrate substantial equivalence to the predicate device."
The data provenance is from the manufacturer, Terumo (Philippines) Corporation, and the tests were performed on the new device, comparing it to the legally marketed predicate device (K891087) manufactured by Terumo Medical Corporation, Elkton, Maryland. These are considered prospective tests performed on the device being submitted for clearance.

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

This information is not applicable as the device is a physical medical instrument (intravascular catheter), not an AI/software device that relies on expert interpretation for ground truth. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set

This information is not applicable because the performance tests involve objective measurements and comparisons against established standards, not subjective interpretations requiring adjudication.

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. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and AI assistance can impact their performance. This is not relevant for an intravascular catheter.

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

No, a standalone performance test in the context of an algorithm's performance was not done. The "standalone" performance here refers to the device's physical and biological characteristics as it would be used, independent of human interaction other than proper insertion and operation.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Established consensus standards: International Organization for Standardization (ISO) standards (e.g., ISO 10555 series, ISO 594 series, ISO 11137 for sterilization, ISO 10993-1 for biocompatibility).
• Predefined acceptance criteria: Internal specifications for physical properties and functionality (e.g., fitting forces, leakage, flashback, needle penetration).
• Demonstrated performance of a legally marketed predicate device: The new device's performance is compared to that of the predicate device (K891087) to establish substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. This submission is for a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

This is not applicable as there is no training set for this type of device.

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The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

The SURFLASH® Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter.
The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin, and catheter hub), needle assembly (needle, needle housing, transparent flash chamber (needle connecting part) with filter, and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, and junction cylinder).
The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

Here's a summary of the acceptance criteria and study information for the SURFLASH® Safety I.V. Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission declares that the device "complies with the acceptance criteria established based on the predicate" and that "No deviations from ISO standards were identified in the testing to standards." However, specific numerical acceptance criteria (e.g., minimum force for needle breaking shutter) are not explicitly stated in the provided text. The table below lists the performance tests conducted and confirms that the device conformed to the relevant standards or internal requirements.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for each performance test. It mentions that "Performance testing was conducted to ensure the safety and effectiveness... verify conformity to the applicable part of ISO standards, and demonstrate substantial equivalence to the predicate device." For the "Simulated Use Study," it refers to "study participants" without specifying their number.
• Data Provenance: The testing was non-clinical performance and biocompatibility testing. The data originates from internal testing conducted by Terumo Corporation's Kofu Factory in Japan, as indicated by the manufacturer's location and the context of the submission. The text implicitly suggests retrospective data collection as these are standardized tests assessing device properties.

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

• This section is not applicable as the studies were non-clinical performance and biocompatibility tests, not studies requiring expert ground truth in a clinical setting (e.g., image interpretation). The "ground truth" for these tests consisted of established ISO standards and internal specifications.
• For the Simulated Use Study, "healthcare workers who use these types of Safety I.V. Catheters" were involved, but their number and specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

• Not applicable. This was non-clinical testing against established standards and internal requirements, not a study requiring adjudication of expert interpretations.

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 submission is for a physical medical device (I.V. catheter) and does not involve AI or human readers for diagnostic interpretation.

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

• Not applicable. This submission is for a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the non-clinical performance tests was rooted in established international standards (ISO standards), FDA guidance documents (e.g., for sharps injury prevention features), and internal specifications derived from the predicate device. For the biocompatibility tests, it was adherence to ISO 10993-1 and FDA G95-1 guidelines.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that would require a training set.

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

• Not applicable. This is not a machine learning or AI device that would require a training set.

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The SURFLASH® Plus Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

The SURFLASH® Plus Safety I.V. Catheter is manually operated and contains a passive safety feature that automatically activates as the needle is withdrawn from the catheter. The devices consist of catheter assembly (catheter, caulking pin and catheter hub containing valve, seal component and plug), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The SURFLASH® Plus Safety I.V. Catheter has a valve and a seal component inside the catheter hub to minimize the possibility of blood leakage at catheter hub after needle removal. The catheter hub is also provided with a plug inside which penetrates the valve to create a fluid path when a connector is inserted in the catheter hub. The fluid path is permanently opened once a secure luer connection is made. The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

The provided text is a 510(k) summary for the Terumo SURFLASH® Plus Safety I.V. Catheter. It outlines the device's description, intended use, non-clinical tests, and substantial equivalence to predicate devices. However, it does not describe an AI/ML-based medical device. Therefore, the information required to answer your questions regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present in the provided document.

To directly answer your request, here's what can be extracted from the document regarding the device (the I.V. catheter) meeting its intended performance, even though it's not an AI/ML device:

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

The document states that "Performance testing was conducted to ensure the safety and effectiveness of the SURFLASH® Plus Safety I.V. Catheter throughout the shelf life, to verify conformity to the applicable part of ISO standards and demonstrate substantial equivalence to the predicate devices." It also lists various performance tests conducted.

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

• Simulated Use Study: "study participants" (number not specified). "Healthcare workers who use these types of safety I.V. catheters."
• Other Performance Tests: Sample sizes are not explicitly stated for the enumerated tests (e.g., burst pressure, tensile strength).
• Data Provenance: The tests were conducted by Terumo Corporation, presumably within their facilities or via third-party labs on their behalf. The country of origin of the data is not specified beyond the manufacturer's location in Japan, with regulatory affairs in the US. The studies are prospective as they are tests performed on the device to demonstrate conformity.

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 and therefore not provided in the document as this is a physical medical device, not an AI/ML-based device requiring expert annotation for ground truth. For the simulated use study, "healthcare workers who use these types of safety I.V. catheters" were participants, but their role was to evaluate usability and safety activation, not to establish a "ground truth" in the AI/ML sense.

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

Not applicable in the context of a physical device's performance testing. The simulated use study reported that "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies a very high level of consistent success, not requiring an adjudication method.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device. The "simulated use study" evaluates the human-device interaction, confirming the safety feature's activation.

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

For the safety function, the "ground truth" is the successful activation of the sharps injury prevention feature and prevention of needle stick injuries during simulated use. This is determined by observation of the device's physical function and user interaction. For other performance tests, the "ground truth" is the established engineering and materials standards (ISO standards and internal standards) for the properties being measured.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device.

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The SURFLASH® Safety I.V. Catheter is inserted into the patient's vascular system for short term use (

The SURFLASH® Safety I.V. Catheter is a device consisting of catheter assembly (catheter, caulking pin and catheter hub), needle assembly (needle, needle housing, transparent flash chamber with filter and needle protector) and a passive needle-shielding mechanism (shutter and needle shaft cover consisting of inner cylinder, outer cylinder, junction cylinder). The devices are an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

A non-clinical performance testing study was conducted to demonstrate the safety and effectiveness of the SURFLASH® Safety I.V. Catheter, its conformity to applicable ISO standards, and substantial equivalence to predicate devices. This study included:

• Compliance to ISO Standards: Tests were performed to confirm conformance with relevant parts of ISO 10555-1, ISO 10555-5, and ISO 23908, as detailed in the table above.
• Testing by Internal Standard: Additional performance tests, not covered directly by the listed ISO standards, were conducted against internal standards.
• Simulated Use Study: This study was conducted in accordance with FDA's Guidance For Industry and Staff, Medical Devices with Sharps Injury Prevention Features (August 9, 2005).

Detailed Information on the Study:

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

• Test Set Sample Size: Not explicitly stated for each individual test. However, the document mentions "study participants" for the simulated use study but does not quantify them. For other physical and material tests, a specific sample size is not provided, but it is implied that a sufficient number were tested to demonstrate compliance with standards.
• Data Provenance: The tests were conducted internally by Terumo Medical Corporation and its Kofu Factory in Japan. The data is retrospective in the sense that it reflects tests completed for the premarket submission.

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):

• Simulated Use Study: Healthcare workers (implied to be experts or trained professionals in I.V. catheter use) were the "participants" in the simulated use study. The number of participants and their specific qualifications (e.g., years of experience) are not explicitly stated, but the intent was to verify proper activation by those who use such devices.
• Physical/Material Tests: These tests rely on standardized methods and equipment, not expert consensus on individual cases. The "ground truth" for these tests is the quantitative measurement against defined ISO or internal standard thresholds.

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

• For the simulated use study, the "adjudication" was based on direct observation of whether "All safety features activated effectively and there were no de-activations after discarding" and if "All participants were able to read and activate the catheter safety feature without further explanation or training." This implies direct observation and evaluation against predefined criteria, not a specific 2+1 or 3+1 expert consensus method.
• For the physical and material tests, adjudication is based on whether the measured performance falls within the specified limits of the ISO standard or internal standard.

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

• No MRMC study mentioning AI was performed or reported. This device is a manual medical device (intravascular catheter with a passive safety feature), not an AI-assisted diagnostic or interpretative system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. This device does not involve an algorithm or AI. It is a physical medical device.

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

• Physical/Material Tests: The ground truth is the objective measurement of physical properties and performance characteristics against established technical standards (ISO) and the manufacturer's internal specifications.
• Simulated Use Study: The ground truth was based on the observable successful activation of the safety feature and the user's ability to follow instructions and operate the device effectively in a simulated environment. This represents a form of performance outcome directly observed.
• Biocompatibility Tests: The ground truth for biocompatibility is whether the materials meet predefined safety criteria as per ISO 10993 and FDA G95-1, assessed through specific biological tests (e.g., cytotoxicity, sensitization, systemic toxicity).

8. The sample size for the training set:

• Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. Performance is based on engineering design, material properties, and physical testing.

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

• Not applicable. See point 8.

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The YOMURA Safety I.V. Catheter is to be inserted into patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

The Yomura Safety I.V. Catheter consists of a catheter connected to a standard conical fitting, and a safety mechanism. Upon activation of the safety mechanism the needle guard covers the entire length of the needle. Therefore, the risks of needle stick injuries can be reduced.
The YOMURA Safety I.V. Catheter consists of an over needle peripheral catheter made of polyurethane material with radiopaque stripes. The stainless steel needle is placed in the catheter to maintain rigidity and to facilitate venipuncture. A safety mechanism constitutes a needle guard is built inside the device. Upon insertion and threading of the catheter, the needle guard extends to full length and locks into place to encapsulate the entire length of the needle. Thus adds in the prevention of accidental needle stick injuries.

The provided text is a 510(k) Pre-market Notification for a medical device, the YOMURA Safety I.V. Catheter. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing novel performance or clinical efficacy through new studies with specific acceptance criteria as you've outlined. Therefore, much of the requested information regarding detailed study design, sample sizes for test and training sets, expert qualifications, and AI-related metrics is not applicable to this document.

The document primarily focuses on bench testing to show that the device meets functional and performance requirements and is safe for its intended use, largely by demonstrating compliance with established international standards and FDA guidance.

Here's a breakdown of the available information based on your request, with an explanation of why certain criteria are not met by this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics in the way one might expect for a clinical study evaluating a diagnostic device. Instead, it refers to compliance with established standards.

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

• Sample Size: The document does not specify the sample size for the bench tests performed. Typically, for compliance with ISO standards, specific numbers of units are tested, but these details are not provided in this summary.
• Data Provenance: The tests were performed by the manufacturer, YOMURA Technologies Inc., based in Linkou District, Taipei, TAIWAN. The tests are "bench tests," meaning they were conducted in a laboratory setting, not on human subjects. They are inherently "retrospective" in the sense that they are conducted on manufactured devices as part of the validation process.

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

• Not Applicable. This device is an I.V. catheter with a safety mechanism, not an AI-driven diagnostic device. "Ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant here. The ground truth for these tests is defined by the technical specifications of the device and the requirements of the standards (e.g., successful activation of safety mechanism, material strength, biocompatibility).

4. Adjudication Method for the Test Set

• Not Applicable. As this involves bench testing against predefined standards, there is no need for expert adjudication in the manner described (e.g., 2+1 review for medical imaging). The results of the physical and material tests are objectively measured against the criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI Assistance

• Not Applicable. This is a physical medical device, not an AI-based diagnostic tool. No human readers or AI assistance are involved in its primary function or the safety tests described.

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

• Not Applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

• The ground truth for the performance and safety tests is based on technical specifications, established international standards (ISO 10993, ISO 10555.1, ISO 10555.5), and specific FDA guidance document requirements. For example:
  • For biocompatibility: Whether the material passes the tests outlined in ISO 10993.
  • For functional performance: Whether the catheter meets the physical and leakage requirements of ISO 10555.
  • For the safety mechanism: Whether the needle guard fully covers the needle and locks as intended, as per FDA guidance.
    Pathology or outcomes data are not used as ground truth for these specific bench tests.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. See point 8.

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The TERUMO® Surshield®-PUR SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (

The TERUMO Surshield-PUR Safety I.V. Catheters are devices consisting of an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term use (

The provided text is a 510(k) Summary for the TERUMO Surshield-PUR Safety I.V. Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment (which are common for AI/ML device submissions) are not present in this K100282 document.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing was conducted in accordance with the consensus standards and design control requirements. All performance testing conducted on the TERUMO Surshield-PUR Safety I.V. Catheter manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate devices."

However, specific numerical acceptance criteria (e.g., minimum flow rate, maximum needle stick rate, specific tensile strength values) and the reported device performance against those criteria are not explicitly listed in the provided summary. The summary focuses on stating that the device met whatever criteria were used to establish substantial equivalence.

Missing:

• Specific numerical acceptance criteria for various performance metrics.
• Quantifiable reported performance data for the device against these criteria.

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

The document does not detail specific "test set" sample sizes, as it doesn't describe a typical diagnostic performance study. It mentions the catheter's types and specifications but not a test set for performance evaluation in the context of diagnostic accuracy.

Missing:

• Sample size for any test set.
• Data provenance (e.g., country of origin, retrospective/prospective).

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

As this is a medical device (intravascular catheter) and not a diagnostic device relying on image interpretation or similar expert-dependent outputs, there's no mention of experts establishing a "ground truth" for a test set. Evaluation would typically involve engineers and biocompatibility specialists, not clinical experts for ground truth in the AI/ML sense.

Missing:

• Number of experts.
• Qualifications of experts.

4. Adjudication Method for the Test Set

Since there's no mention of experts or a "test set" in the context of diagnostic ground truth, there is no adjudication method described.

Missing:

• Adjudication method (e.g., 2+1, 3+1, none).

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

This type of study is relevant for AI-assisted diagnostic tools where human readers interpret cases with and without AI. This is a medical device (catheter) and does not involve human readers interpreting cases.

Missing:

• Information on MRMC study.
• Effect size of human readers improvement with AI.

6. Standalone (Algorithm Only) Performance

This concept is not applicable to an intravascular catheter, which is a physical device, not an algorithm.

Missing:

• Information on standalone performance.

7. Type of Ground Truth Used

For an intrusive medical device like a catheter, "ground truth" would relate to its physical and biological performance (e.g., integrity, biocompatibility, flow rates, ease of insertion, safety mechanism activation). These are established through engineering tests, material analysis, and possibly bench and animal testing, rather than "expert consensus" on diagnostic cases or pathology. The document indicates that testing was "in accordance with the consensus standards and design control requirements." This implies standards for device performance, not clinical ground truth in the diagnostic sense.

Partial Answer:

• Type of Ground Truth: Established by adherence to "consensus standards and design control requirements" for physical, mechanical, and safety performance of the catheter. This would involve objective measurements and tests for criteria such as flow rate, cannula strength, safety mechanism activation, etc.
  Missing: Specific details of these ground truth determinations per standard.

8. Sample Size for the Training Set

The concept of a "training set" is for AI/ML models. This device is a physical product, not an AI/ML model, so there is no training set.

Missing:

• Sample size for the training set.

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

Similarly, this is not applicable for a physical medical device.

Missing:

• How ground truth for the training set was established.

In summary, the K100282 document focuses on demonstrating substantial equivalence of a physical medical device (intravascular catheter) to existing predicate devices. It states that performance testing was done according to standards, but does not provide granular details about specific acceptance criteria or performance results, nor does it involve the type of diagnostic study (with test sets, ground truth panels, and AI/ML metrics) that would typically be associated with the requested information points.

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I.V. Catheter for Single Use, including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

The proposed device, I.V. Catheter for Single Use including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. It is provided EO sterilized, latex free, prygon-free and DEHP-free. All types are available in four sized, which are 18G, 20G, 22G and 24G.

Type Straight Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and straight connector. Type Y I.V. Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and Y connector. And Type I I.V. Catheter for single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle handle and vent fitting, Type Straight and Type Y are closed system while Type I is open system.

The provided text describes a 510(k) summary for an I.V. Catheter for Single Use. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in efficacy studies for AI/software devices.

Therefore, much of the requested information, specifically related to acceptance criteria for device performance with specific metrics, study design for proving performance (e.g., sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance), and training set details, is not present in the provided document. The device is a physical medical device (I.V. catheter), not a software or AI device, which explains the absence of these types of details.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantitative acceptance criteria for device performance in the manner of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the statement that the device "met all design specifications" and was "substantially equivalent to the predicate device." The performance reported is that these design specifications were met during laboratory testing.

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

• Sample Size for Test Set: Not specified. The document only mentions "Laboratory testing was conducted." No specific number of units tested is provided.
• Data Provenance: Not specified. The testing was described as "Laboratory testing," implying internal testing by the manufacturer. The manufacturer is Weihai Jierui Medical Products Co., Ltd. in China.

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

Not applicable/Not specified. This information is typically relevant for studies validating diagnostic accuracy, often in AI or imaging devices, where human expert consensus forms the ground truth. Since this is a physical medical device (I.V. catheter), the "ground truth" would be objective measurements against design specifications, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple experts when establishing ground truth, which is not relevant for the type of testing described for this physical device.

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

No. This is a physical medical device, not a diagnostic or AI-powered system that would involve human readers interpreting cases. Therefore, an MRMC study is not relevant and was not performed.

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

No. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment would be the objective measurements against its physical and material design specifications (e.g., strength, flow rate, biocompatibility, sterilization efficacy) as confirmed through laboratory tests. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable. As described above, there is no training set for this type of device.

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