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The SB Knife Jr2 is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47702, MD-47702L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.

SB Knife Jr2 under application (Hereinafter "the Subject Device" is a single-patient use EtOsterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The Subject Device is designed to connect with Olympus and ERBE connectors and uses the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.

The Subject Device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1-6 and IEC 60601 2-18 by ISO 17025 accredited laboratory.

The Subject Device consists of two models as follows:

MD-47702 Working Length: 1970 mm
MD-47702L Working Length: 2320 mm

The provided text is a 510(k) summary for the SB Knife Jr2, a medical device. It does not contain the information typically found in a study proving a device meets specific acceptance criteria based on performance.

Specifically, the text describes:

• The device and its intended use.
• A comparison to a predicate device (SB Knife®).
• Differences between the subject device and the predicate device, particularly regarding type, shape, structure, presence of a rotating operation portion, and materials.
• Non-clinical testing performed (transportation, shelf-life, packaging, sterilization, electromagnetic compatibility, electrical safety, biocompatibility).
• A statement that clinical testing was not performed.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from the provided text. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through technological comparison and non-clinical performance, rather than providing a detailed study of the device's performance against pre-defined acceptance criteria for a new clinical claim or feature that requires such a study.

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K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.

The K-SHIELD Zen is a sterile, single use winged blood collection set consisting with a cannula, flexible tube, connection parts and the Press Button anti-needle stick protector designed to minimize accidental needlestick injuries when accessing peripheral veins to collect patient blood. The Press Button anti-needle stick protector stores the needle within the housing when the activation button is pressed after blood collection procedure.

This product has a variety of Needle gauge sizes (21G, 23G, 25G) and a lineup of 3 types of connection parts, Luer connector (PBM), Multiple Sample Luer Adapter (PBMA) and Preattached Holder (PBMH). During blood collection, the Luer connector is connected to a syringe. Multiple Sample Luer Adapter and Pre-attached holder are connected to vacuum blood collection tubes / blood culture bottles to obtain multiple samples. The different configurations (connection options) are chosen by the user based on facility blood collection procedure.

The mechanism of action for the device, all configurations, is blood collection using syringes or vacuum blood collection tubes / blood culture bottles to assist the user with obtaining blood from a patient.

The K-SHIELD Zen is a single use, disposable Ethylene Oxide Sterilized medical device. Sterilization Validation was conducted per ISO 11135: 2014 – Sterilization of Health-Care Products – Ethylene Oxide –Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.

The K-SHIELD Zen is considered blood path, indirect, limited contact (

The provided document is a 510(k) summary for the K-SHIELD Zen blood collection device. It details the device's characteristics, intended use, and a comparison to a predicate device, along with performance data.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, it references conformity to recognized standards and provides "PASSED" as the performance result for specific tests. The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The performance data presented supports this claim by showing compliance with biological safety and sterilization standards.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for the Biocompatibility (DEHP Extraction) or EtO Residuals tests. It only states that these tests were conducted.
• Data Provenance: The tests are described as "Non-Clinical Bench Performance Data," implying in-vitro or laboratory testing. The country of origin for the testing data is not explicitly stated. The manufacturer is SB-KAWASUMI LABORATORIES, INC., based in Japan, so it's plausible the tests were conducted there or by a recognized lab. The data is retrospective in the sense that it was generated prior to this submission for the purpose of demonstrating equivalence.

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

This information is not applicable to this type of device and submission. The tests performed are objective chemical and biological evaluations based on recognized standards (ISO 10993-17, ISO 10993-18, ISO 10993-7). Ground truth, in the context of expert consensus, is typically relevant for interpretative devices (e.g., AI in radiology), not for a blood specimen collection device's bench testing. The "truth" is determined by the measured values against established standard limits.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Bench tests are typically passed or failed based on objective measurements against predefined limits, not through expert adjudication.

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

This information is not applicable. The K-SHIELD Zen is a physical medical device (blood collection set), not an AI algorithm or a diagnostic imaging system that would involve human readers or MRMC studies.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. The K-SHIELD Zen is a physical medical device and does not involve any standalone algorithms.

7. Type of Ground Truth Used

For the performance tests described:

• Biocompatibility (DEHP Extraction) and EtO Residuals: The ground truth is established by the limits specified in the harmonized ISO standards (ISO 10993-17, ISO 10993-18, ISO 10993-7). The device "passes" if its measured chemical concentrations are below these pre-defined, scientifically established safety limits.

8. Sample Size for the Training Set

This information is not applicable. The K-SHIELD Zen is a physical medical device and is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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Female luer type
· The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with syringes when transferring blood specimen from a syringe to blood collection tube or blood culture bottle.

Male luer type
· The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

The Kawasumi Multiple Sample Adapter with Pre-attached Holder (MBCH) is a sterile, single use device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a luer adapter. There are two types of the device with difference in luer adapter type; male luer adapter type and female luer adapter type. The predicate device (K190485) is the male luer type and the proposed device is the female luer type, and the subject of this special 510(k) premarket notification submission.

• The male luer adapter type is used to collect blood specimen into blood collection tube by . connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. (predicate [Item number MBCH-01])
• The female luer adapter type is used to transfer blood from a syringe into blood collection tube . or blood culture bottle. After drawing patient blood into a syringe, connect the female luer adapter of the device to the syringe. When inserting a tube, the blood is transferred into the tube using tube's vacuum. (subject [Item number MBCH-02])

The device is sterilized using Ethylene Oxide. The device is a prescription-use device intended to be used in hospitals or healthcare facilities.

The provided text describes a 510(k) summary for the Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH), specifically focusing on the newly introduced female luer type (MBCH-02) and comparing it to the legally marketed male luer type (MBCH-01) as the predicate device. The information details the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of devices tested) for each non-clinical test. The testing is described as "Non-Clinical Performance Testing," suggesting laboratory-based assessments rather than clinical studies with patient data. Therefore, there is no information on data provenance in terms of country of origin or retrospective/prospective nature.

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 to the provided document. The device is a blood specimen collection device, and the testing described is non-clinical performance testing against established standards (e.g., ISO, USP, ASTM, IEC). There is no mention of experts establishing a "ground truth" related to medical diagnosis or interpretation for this type of device and testing.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers or experts evaluate cases to establish a consensus-based ground truth. The presented tests are objective, laboratory-based performance assessments.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the Kawasumi Multiple Sample Adapter.

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

This information is not applicable. The device is a physical medical instrument (blood specimen collection adapter), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests is defined by the referenced industry standards and in-house specifications (e.g., ISO 80369-7:2021 for luer connectors, USP for particulate contamination). The device's performance is measured against the criteria established in these standards.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.

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K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.

The K-SHIELD Zen is a winged blood collection set consisting with a cannula, flexible tube, connection parts and the Press Button anti-needle stick protector designed to minimize accidental needlestick injuries when accessing peripheral veins to collect patient blood. The Press Button anti-needle stick protector stores the needle within the housing when the activation button is pressed after blood collection procedure.

This product has a variety of Needle gauge sizes (21G, 23G, 25G) and a lineup of 3 types of connection parts, Luer connector (PBM), Multiple Sample Luer Adapter (PBMA) and Preattached Holder (PBMH). During blood collection, the Luer connector is connected to a syringe. Multiple Sample Luer Adapter and Pre-attached holder are connected to vacuum blood collection tubes / blood culture bottles to obtain multiple samples. The different configurations (connection options) are chosen by the user based on facility blood collection procedure.

The mechanism of action for the device, all configurations, is blood collection using syringes or vacuum blood collection tubes / blood culture bottles to assist the user with obtaining blood from a patient.

The device is intended for the Adult population only. Do not use in pediatric age groups, including newborn, neonate, or children.

The K-SHIELD Zen is a single use, disposable Ethylene Oxide Sterilized medical device. Sterilization Validation was conducted per ISO 11135: 2014 – Sterilization of Health-Care Products – Ethylene Oxide –Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices.

The K-SHIELD Zen is considered blood path, indirect, limited contact (

Here's a breakdown of the acceptance criteria and the studies mentioned for the K-SHIELD Zen device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not present specific quantitative acceptance criteria with corresponding performance metrics in a single, clear table. Instead, it lists various tests with a consistent "Test Results: PASSED" outcome, implying that the device met the requirements of the specified standards.

Implicit Acceptance Criteria (Based on Test Type) and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each individual performance test (test set). It simply states that "Non-Clinical Bench Performance Testing was conducted on the K-SHIELD Zen [subject device]."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the nature of bench testing and the company's location (Japan with a US correspondent), it's highly likely to be prospective laboratory bench testing conducted at the manufacturer or a contract testing organization.

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 to this type of device and study. The "ground truth" for the performance tests of a blood collection device (like sharps injury prevention, biocompatibility, sterility) is established by adherence to recognized international standards (e.g., ISO, ASTM, USP) and verified by standardized laboratory testing methods, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies where subjective human interpretation of data (e.g., image analysis for disease detection) requires consensus or a tie-breaking mechanism. The tests described are objective, pass/fail bench tests.

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

An MRMC comparative effectiveness study was not conducted and is not applicable to this device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images, often with AI assistance. The K-SHIELD Zen is a blood collection device, not an AI-powered diagnostic tool.

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

A standalone algorithm performance study was not conducted and is not applicable. The K-SHIELD Zen is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests of the K-SHIELD Zen device is the defined requirements and specifications laid out in recognized international and national standards (e.g., ISO, ASTM, USP), as well as internal in-house testing methods. These standards specify acceptable limits for various physical, chemical, and biological properties, and the device's performance against these limits constitutes the ground truth for "passing" or "failing" a test.

8. The sample size for the training set

This information is not applicable. The K-SHIELD Zen is a physical blood collection device. It is not an AI/ML algorithm that requires a "training set" to learn from data. Its performance is evaluated through engineering and laboratory testing against established specifications.

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

This information is not applicable for the same reason as point 8.

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The Kawasumi Multiple Sample Adapter with Pr-Attached Holder (MBCH) is a sterile, non-invasive device used for connection with a female luer system and non-needle devices in order to collect blood specimen to blood collection tube.

The Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) is a sterile, singleuse device consisting of a plastic holder with a non-patient contacting stainless steel cannula covered with a rubber sheath and a male luer adapter which is attached into the holder. This device is used to collect blood specimen by connecting to female luer connectors of vascular access devices such as peripheral, central catheter, Huber needle, etc. As this device can be connected to various devices with female luer adapter, it is called "multiple sample adapter".

When blood is collected, the blood collection tube is placed over the cannula, pushing the rubber sheath back, allowing blood flow. After obtaining the correct amount of blood, the blood collection tube is removed from the holder. When the blood collection tube is removed, the rubber sheath extends back over the cannula and stopping blood flow. Blood collection may be continued by connecting additional blood collection tubes, if required.

The device is sterilized using Ethylene Oxide. The device is a prescription-use device intended to be used in hospitals or healthcare facilities.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them, based on the requested information.

It's important to note that this document is a 510(k) summary for a medical device (blood specimen collection adapter), not an AI/ML software device. Therefore, many of the typical questions for an AI/ML device, such as those related to AI model training, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission. The 'device' here refers to a physical, non-digital product.

Acceptance Criteria and Study Proving Device Performance

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

The document doesn't provide a direct "acceptance criteria" table with specific quantitative limits for each test. Instead, it describes various performance tests conducted to demonstrate substantial equivalence (SE) to a predicate device. The general acceptance criterion for all tests is "meets design requirements and specifications" and "confirm performance," ultimately aiming to show comparable function and performance to the predicate device, thereby demonstrating substantial equivalence in terms of safety and effectiveness.

Here's an interpretation based on the "Non-Clinical Testing" section and "Technological Characteristics" comparison, outlining the tests performed to demonstrate that the device meets its design requirements and is substantially equivalent:

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

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of devices) used for each individual test. It lists the types of tests performed. For physical device testing, sample sizes are typically determined by relevant ISO standards or internal quality protocols.
• Data Provenance: The document does not specify the country of origin of the data. Given the "Kawasumi Laboratories, Inc." address in Tokyo, Japan, it is highly likely that testing was performed by or for the manufacturer, potentially in Japan or at contract labs globally.
• Retrospective or Prospective: These are non-clinical, controlled laboratory tests on manufactured devices, so the terms "retrospective" or "prospective" as they apply to clinical studies or real-world data collection are not applicable.

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

• This is a review of a physical medical device. The "ground truth" is established through engineering and laboratory testing against established physical, chemical, and biological standards (e.g., ISO, USP, ASTM). It does not involve human expert interpretation of data in the way an AI/ML device would. Therefore, the concept of "experts establishing ground truth" in this context is not applicable.

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

• Not applicable for a physical device undergoing laboratory testing. This concept is relevant for human interpretation tasks, often in AI/ML performance evaluations.

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 is a physical blood collection device, not an AI/ML radiology or diagnostic aid. MRMC studies are for evaluating diagnostic accuracy with and without AI assistance.

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

• Not applicable. This is not an algorithm or software device.

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

• The "ground truth" for this device's performance is defined by adherence to established international standards (ISO, ASTM, USP) for physical properties, chemical properties, sterility, biocompatibility, and functional performance of medical devices. The predicate device's performance also serves as a benchmark for comparative testing to demonstrate equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for a physical medical device.

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The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to a surgically implanted port. This device is designed utilizing a non-coring Huber needle to access the implanted port. The K-Shield Advantage PAIS has an integral safety device intended to protect against accidental needle stick injuries and infection caused by blood borne pathogens. Upon removal from the port, the anti-needlestick protector (ANSP) covers the needle tip protecting against accidental needle stick injuries. The devices are disposable ethylene oxide sterilized medical devices which are constructed from non-coring needle (Huber needle), wing, tubing (either micro bore or standard bore), clamp, female conical fitting and locking cap. The device has optional injection site (needle injection, needleless access connector (NAC), or no injection site) and anti-needle stick protector (ANSP).

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety device used to administer solutions to surgically implanted ports. The device was modified from a previously cleared version (K123344), with minor enhancements to strengthen the safety device feature, improve the gripping point for easy cannulation, and reduce the bulkiness of the needle cap.

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:

2. Sample Size and Data Provenance (Test Set):

• Needle Cap Evaluation: N=30 for each cap type (straw cap and T-cap). The data provenance is not explicitly stated but is implicitly from bench testing conducted by Kawasumi Laboratories, Inc.
• Simulated Use Testing: N=599 "effective samples." Data provenance is from simulated use testing conducted by Kawasumi Laboratories, Inc.

3. Number of Experts used to establish the ground truth for the test set and their qualifications:

This information is not provided in the document. The tests performed are primarily bench and simulated use tests based on established international and in-house standards, not expert assessments of performance.

4. Adjudication method for the test set:

This information is not applicable as the tests are objective measurements against defined criteria, not subjective human assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (infusion set), not an imaging or diagnostic AI device that would typically involve human readers.

6. Standalone (algorithm only without human-in-the-loop performance) study:

No, a standalone study was not done. This refers to algorithmic performance, which is not relevant for a physical medical device. The "standalone" concept applies to AI/software as a medical device (SaMD).

7. Type of ground truth used (test set):

The "ground truth" for the test set is established by objective technical standards and in-house criteria for physical performance characteristics (e.g., tensile strength, leak test, cap removal force) and functional activation (ANSP). For the simulated use testing, the ground truth is the observable proper activation of the ANSP.

8. Sample size for the training set:

This information is not applicable. This device is a physical product, not an AI/machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.

The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. The device is not intended for blood transfusion. The Kawasumi Laboratories Blood Drawing Kit (BDK) System consists of a Blood Drawing Kit device that is designed with an integral Antineedle Stick Protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein and may incorporate a needleless access connector site used for blood sampling. The Blood Drawing Kit System is a single use, disposable Ethylene Oxide Sterilized medical device. The Kawasumi Laboratories Blood Drawing Kit (BDK) System is a sterile, single-use device that consists of the following components: Needle Protector, Cannula, Hub, Wing, Antineedle Stick Protector "K-Shield", Tubing, Needleless Access Connector (NAC) Y-Site, Clamp, Blood Bag Unit Reservoir.

The provided text describes a 510(k) summary for the Kawasumi Laboratories Blood Drawing Kit (BDK) System. It lists various non-clinical performance tests conducted to demonstrate substantial equivalence to a predicate device, but it does not include acceptance criteria or reported device performance in a table format, nor does it detail a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML device.

The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device (K001043) by showing similar technological characteristics and by conducting standard performance and biocompatibility tests for medical devices. It does not describe a study that uses a 'test set' with 'ground truth' established by experts, as would be relevant for an AI/ML device's performance evaluation.

Therefore, many of the requested details (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set size, and ground truth establishment for training) are not applicable to the information provided in this document, which pertains to a traditional medical device (a blood drawing kit) rather than an AI/ML-powered one.

However, I can extract the information provided about the non-clinical performance testing which serves as the "study" for this device, and list the categories of tests that were performed.

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

The document does not provide a table of acceptance criteria with specific numerical targets and corresponding reported device performance values. Instead, it lists categories of non-clinical tests that were performed to demonstrate substantial equivalence. The implication is that the device passed these tests, thereby meeting the implicit acceptance criteria for each test type, which are typically defined by the referenced standards.

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
sample sizes for the individual non-clinical performance tests nor the data provenance. These tests are typically conducted in a laboratory setting by the manufacturer or a contract research organization.

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. The device is a traditional physical medical device (blood drawing kit), not an AI/ML device that requires expert-established ground truth for a test set.

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

Not applicable. This is not an AI/ML device for which adjudication methods for expert disagreement would be relevant.

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 is a traditional medical device; MRMC studies relate to AI/ML image interpretation or diagnostic tools.

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

Not applicable. This is a traditional medical device; standalone algorithm performance is relevant for AI/ML devices.

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

For a blood drawing kit, "ground truth" would relate to meeting physical, chemical, and biological performance specifications outlined in recognized standards. This is demonstrated through objective laboratory testing rather than expert consensus on diagnostic outcomes. The "ground truth" is adherence to established engineering and medical device standards.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

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

Not applicable. This is a traditional medical device, not an AI/ML device.

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The devices are used to administer solutions to a surgically implanted port.

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to a surgically implanted port. This device is designed utilizing a non-coring Huber needle to access the implanted port. The K-Shield Advantage PAIS has an integral safety device intended to protect against accidental needle stick injuries and infection caused by blood borne pathogens. Upon removal from the port, the Anti- Needlestick Protector (ANSP) covers the needle tip protecting against accidental needle stick injuries. The devices are disposable ethylene oxide sterilized medical devices which are constructed from non-coring needle (Huber needle), wing, tubing (either micro bore or standard bore), clamp, female conical fitting and locking cap. The device has optional injection site (needle injection, needleless access connector (NAC), or no injection site) and/or anti-needlestick protector (ANSP).

The provided 510(k) summary for the K-Shield Advantage Port Access Infusion Set (K123344) does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

The summary describes the device, its intended use, and states that "Bench testing was performed and confirms that the device meets design requirements and specifications." It also mentions compliance with EN ISO 8536-4:2007. However, it does not provide a table of quantitative acceptance criteria, detailed performance metrics, or the specifics of the bench testing study (like sample size, ground truth establishment, or expert involvement) that would allow for a complete answer to your request.

Therefore, I cannot extract the information required to populate the table and answer the specific questions about the study design, sample sizes, expert involvement, or adjudication methods, as this level of detail is not present in the provided text.

Based solely on the provided text, here's what information can be gleaned, though it is limited:

Summary of Available Information Regarding Performance and Testing:

• Acceptance Criteria/Performance: The document broadly states that the device "meets design requirements and specifications" and "complies with the International standard EN ISO 8536-4: 2007-Infusion equipment for medical use -Part 4: Infusion sets for single use, gravity feed mainly". No specific quantitative acceptance criteria or performance metrics are listed in a table.
• Study Type: "Bench testing was performed."
• Safety Feature: The device includes an "Anti-Needlestick Protector (ANSP)" intended to "protect against accidental needle stick injuries." While this is a key safety feature, the document doesn't provide performance data for it (e.g., efficacy rates of the ANSP).
• Biocompatibility: Materials are evaluated per ISO 10993-1:2009 and "have been determined to be biocompatible."
• Sterilization: Validation was conducted per EN ISO 11135-1:2007.

Missing Information:

All the specific points you requested (Table of acceptance criteria and reported device performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone study details, type of ground truth, training set sample size, ground truth for training set) are not present in the provided 510(k) summary. These details are typically part of a more extensive test report that would be submitted to the FDA but are often summarized or omitted from the public 510(k) summary document itself.

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The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single use. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.

The K-Shield Port Access Infusion Set with High Pressure Tubing is a sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries. The set can withstand injection pressures to 300 psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors.

Here's an analysis of the acceptance criteria and study information for the Kawasumi Laboratories Port Access Infusion Set with High Pressure Tubing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical testing data to determine the safety and effectiveness of the high-pressure tubing and its substantial equivalence to predicate devices. The acceptance criteria are implied by the "Pass" result for each test, indicating the device successfully met the established standards.

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

• Sample Size: The document does not explicitly state the sample size used for each specific test. For non-clinical tests like material and performance evaluations, typically multiple samples are subjected to each test.
• Data Provenance: The tests were performed internally by Kawasumi Laboratories, or according to international standards (ISO, ASTM, ISTA, EN). The country of origin for the studies is implied to be Japan, where Kawasumi Laboratories, Inc. is based, or potentially other locations if testing was outsourced. The data is retrospective in the sense that it was generated prior to the 510(k) submission, but it represents prospective testing conducted to evaluate the device's performance.

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

This section is largely not applicable as the studies described are non-clinical engineering and materials tests, not studies involving human subjects or expert assessment of clinical images/diagnoses. The "ground truth" for these tests is defined by the specific parameters and requirements of the international standards (e.g., ISO, ASTM) and Kawasumi's internal validation protocols. No human experts were involved in establishing "ground truth" in the way understood for medical diagnostic devices.

4. Adjudication Method for the Test Set:

This section is not applicable as the tests are objective, pass/fail engineering and material science evaluations against defined standards. There is no subjective interpretation or need for 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:

This is not applicable. The device is an infusion set with high-pressure tubing, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study was conducted, and the concept of "human readers improve with AI" does not apply.

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

This is not applicable. The device is a physical medical device (infusion set), not an algorithm or software. No standalone algorithm performance study was done.

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

The "ground truth" for the non-clinical tests is based on:

• Defined Standards and Specifications: The reference to ISO, ASTM, ISTA, and EN standards indicates that the ground truth is the performance criteria established within these internationally recognized specifications.
• Engineering Specifications: Kawasumi's internal tests (flow rate, pinch clamp pressure) would have had pre-defined, measurable specifications as their ground truth.
• Essentially, the ground truth is quantifiable, objective measurements against established benchmarks for material properties, pressure resistance, and functionality.

8. The Sample Size for the Training Set:

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are validated against established engineering principles and standards.

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

This is not applicable for the reasons stated above. The "ground truth" for the device's design and manufacturing is established through adherence to recognized engineering standards, material science principles, and quality control processes, not through a "training set" with established ground truth in the AI sense.

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(1) The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector is a single use, sterile set designed for vascular access for dialysis. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.

(2) The K-Shield Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile set designed for vascular access for blood withdrawal. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles

(3) The K-Shield Phlebotomy Set with Antineedle Stick Protector is a single use, sterile set designed for vascular access for blood withdrawal. The antineedle stick device is an integral, active safety device intended to minimize accidental needles stick injuries when used to shield needles

Name: Kawasumi A.V. Fistula Set

Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.

Name: Kawasumi Laboratory Blood Drawing Kit

Intended Use: This is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

Name: Kawasumi Laboratories Phlebotomy Set

Intended Use: This device is intended to be used to access a patient's vein and as a monduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, and K-Shield Phlebotomy Set with Antineedle Stick Protector are sterile, single use devices commonly used to access a patient's vascular system for dialysis and blood withdrawal. The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector and K-Shield Phlebotomy Set with Antineedle Stick Protector devices are comprised of a needle and wing assembly with tubing and a female luer connector. The K-Shield Blood Drawing Kit is comprised of a needle and wing assembly, tubing and a blood collection bag. The devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.

The provided document describes modifications to existing devices (K-Shield Arterial Venous Fistula Set, K-Shield Blood Drawing Kit, and K-Shield Phlebotomy Set with Antineedle Stick Protector) and their substantial equivalence to predicate devices, rather than an AI/ML device that requires performance metrics like accuracy, sensitivity, and specificity against specific acceptance criteria.

The document focuses on non-clinical testing for safety and effectiveness, particularly related to the anti-needle stick protector mechanism. Therefore, much of the requested information regarding AI/ML device performance, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable or available in this document.

However, I can extract the relevant acceptance criteria and results from the non-clinical testing described.

Acceptance Criteria and Reported Device Performance

Non-Applicable Information for this Device (as per the provided document):

The following information is typically relevant for AI/ML device studies, but is not provided or not applicable to this 510(k) submission which describes a modification to a medical device with an anti-needle stick protector:

• Sample size used for the test set and the data provenance: Not specified for the internal tests. The "simulated use study" doesn't provide a quantitative sample size for users. No mention of data provenance (country, retrospective/prospective) for these types of engineering tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these tests is defined by the physical function of the device (e.g., whether the wing activates, deactivates, or the locking mechanism can be defeated).
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for these engineering tests.
• 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 diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the "PASS" results is based on the device's mechanical function meeting design specifications. For the simulated use study, the ground truth was the absence of needle sticks and user feedback.
• The sample size for the training set: Not applicable. No AI/ML model.
• How the ground truth for the training set was established: Not applicable. No AI/ML model.

Summary of the Study:

The study described is a series of non-clinical bench tests and a simulated use study to ensure the modified anti-needle stick protector functions correctly and does not introduce new safety concerns. The "study" aims to demonstrate substantial equivalence to predicate devices, focusing on the mechanical and safety features of the device rather than diagnostic accuracy or human performance improvement.

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