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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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