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High Pressure Tubing is indicated for use in PTCA surgery to connect the angiographic catheter and the angiographic syringe to deliver contrast media.

High Pressure Tubing is designed as a connecting line for injection of contrast media during coronary angiographic procedures. The device has a pressure resistance of 1200psi (8.3MPa); It is divided into two series according to the luer connector combination. ETM series consists of tubing and rotating male luer connecters, and the ETF series consists of tubing and rotating male luer connecter; The rotating male luer connector and female luer connector are made of polycarbonate and silica gel; The tubing is made of polyurethane, and the middle of the tube wall also contains nylon braided wire, which does not contact with outside. The High is for single use only, non-pyrogenic, sterilized by EO gas and the sterilization process is validated.

The question asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. However, the provided text is a 510(k) Pre-market Notification for a "High Pressure Tubing" device, which describes its comparison to a predicate device and includes information about performance testing, but it does not contain information typically found in a study proving an AI/ML device meets acceptance criteria.

Specifically, the document discusses a medical device that is a physical product (High Pressure Tubing) used in PTCA surgery. It does not mention any AI or machine learning components. Therefore, information regarding "sample sizes used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," or "how ground truth for training set was established" is completely absent and not applicable to this document.

The document primarily focuses on establishing substantial equivalence to a predicate device by comparing technological characteristics and presenting results of biocompatibility and bench testing.

Based on the provided text, the following information can be extracted regarding the physical device's performance testing, which is analogous to "acceptance criteria" and "device performance" for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the bench testing section):

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

• Not Applicable. The document describes performance and bench testing of a physical medical device, not a software or AI/ML device. Specific sample sizes for each test are not provided, nor is data provenance in the context of clinical studies (e.g., country of origin, retrospective/prospective). The tests were conducted to assure reliable design and performance.

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

• Not Applicable. This information is relevant for AI/ML device validation where human experts establish ground truth. For this physical device, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 10993, ISO 8536-4, ISO 80369-7, ISO 80369-20).

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

• Not Applicable. Adjudication methods are used in clinical studies or expert reviews for AI/ML devices to resolve discrepancies in ground truth establishment. This document pertains to physical device testing.

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

• Not Applicable. MRMC studies are specific to AI/ML devices involving human readers. This document is about a physical high-pressure tubing.

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

• Not Applicable. This concept is only relevant for AI/ML algorithms.

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

• Not Applicable. For this physical device, "ground truth" is adherence to established engineering specifications and international standards for medical device safety and performance.

8. The sample size for the training set:

• Not Applicable. This device is a physical product and does not involve AI/ML models that require training data.

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

• Not Applicable. This device is a physical product and does not involve AI/ML models that require training data.

In summary, the provided document is a 510(k) Pre-market Notification for a conventional (non-AI/ML) medical device. Therefore, most of the questions related to AI/ML device validation are not applicable. The "acceptance criteria" and "device performance" for this specific device are demonstrated through adherence to relevant international standards and successful completion of biocompatibility and bench testing as listed above.

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The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.

The High Pressure Tubing is a sterile, single use device which can withstand injection pressure to 1200psi. The High Pressure Tubing is composed of tubing with connector at each end. The connector is a female-male combination and rotating adapter. The High Pressure Tubing is supplied sterile by Ethylene Oxide and disposable device. The material of tube is PU with polvamides liner, and the appearance is braided.

The provided document describes the 510(k) premarket notification for a medical device called "High Pressure Tubing." The submission argues for the substantial equivalence of the proposed device to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the format typically associated with a clinical or analytical performance study of a diagnostic or AI device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing against established standards and a comparison of technological characteristics.

However, we can infer some criteria and reported performance from the "Non-clinical Test Conclusion" and the comparison table.

The document states: "Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device. The test result demonstrates that the proposed devices comply with the following standards: ISO 594-1:1986, ISO 594-2:1998, ISO 8536-4:2010."

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 provide details on the sample size used for the bench testing (e.g., number of tubing samples tested for pressure, luer compatibility, etc.). It only mentions that "Bench tests were conducted." The provenance of this test data (country of origin, retrospective/prospective) is also not specified beyond the fact that the manufacturer is "Shanghai Kindly Medical Instruments Co., Ltd."

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

This information is not applicable and not provided. The device is a piece of medical tubing, not a diagnostic or AI device requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its physical and functional specifications meeting industry standards, which is assessed through engineering and materials testing, not expert clinical review.

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

This information is not applicable and not provided. As explained above, the assessment is based on objective measurements against engineering standards, not subjective expert judgment requiring 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 information is not applicable and not provided. The device is medical tubing, not an AI or diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This information is not applicable and not provided. The device is medical tubing, not an algorithm. Standalone algorithm performance studies are not relevant.

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

The "ground truth" for this device is based on established engineering and medical device standards (ISO standards) and the device's own predetermined specifications (e.g., withstand 1200psi). It's essentially "compliance with specified physical and performance characteristics."

8. The sample size for the training set

This information is not applicable and not provided. The device is medical tubing; there is no "training set" in the context of machine learning or AI that would be relevant here.

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

This information is not applicable and not provided. As there is no training set for this type of medical device, the establishment of ground truth for such a set is not relevant.

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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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