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The inflation device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter.

The inflation device consists of barrel, threaded plunger assemble with a handle, a trigger, pressure gauge, an outer shell assembly that retains the internal components, and a pressure connecting tubing with rotating adapter. Also enclosed is a stopcock to aid in preparation and use of device. The inflation device is 20 mL disposable device capable of producing a maximum pressure of 30 atm.

The inflation device is sterilized by EO.

The provided text describes a 510(k) premarket notification for an "Inflation Device". This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic performance. Therefore, many of the requested elements are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or a specific clinical outcome. Instead, it refers to compliance with established international standards for medical devices and device specifications.

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

• Sample Size: The document does not specify a "test set" in the context of clinical data. The tests performed are bench tests on the device itself (e.g., for mechanical properties, material testing). The number of units tested per bench test is not detailed.
• Data Provenance: Not applicable as no human data is used. The tests are performed on the manufactured device.

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

• Not applicable. There is no ground truth established by experts in this context as it's a device performance study, not a diagnostic accuracy study relying on human interpretation.

4. Adjudication Method

• Not applicable. No expert review or adjudication process is described as it's not a clinical study involving human assessment.

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

• No. This is a 510(k) submission for a physical medical device, not an AI software or diagnostic imaging tool. Therefore, a MRMC comparative effectiveness study is not performed or relevant.

6. Standalone Performance

• Yes, in a way. The "standalone" performance here refers to the device's ability to meet its technical specifications and regulatory standards independently. The non-clinical bench tests assess the device's functional and safety characteristics in a standalone manner.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance is compliance with established international standards (ISO) and the manufacturer's own validated specifications. For example, for conical fittings, the ground truth is adherence to ISO 594-1 and ISO 594-2 standards. For biocompatibility, it's the outcome of tests against ISO 10993 standards.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

• Not applicable.

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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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Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.

The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.

The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.

The Y-connector kit is single use disposable device. It including Y connector, Insertion tool and torque device. It is mainly use for PTCA or PTA procedures to create the entrance and minimize blood loss when intervention device are inserted into the human vascular system.

The Y connector with a rotating luer lock, a sidearm and a hemostasis valve that is designed to provide a port for interventional system. The seal of hemostasis valve can be opened by pushing the switch cap, and closed by releasing switch cap.

The insertion tool is used to facilitate placement of a guide wire tip through the Y connector.

The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.

The provided text describes a 510(k) premarket notification for a medical device called the "Y-connector Kit." This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical study proving novel performance criteria. Therefore, the information regarding acceptance criteria and a study proving device meeting those criteria will be based on the substantial equivalence claims and bench testing performed.

Here's an analysis of 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 with corresponding performance data in a quantitative manner as one might find in a clinical trial. Instead, it describes compliance with design specifications and recognized standards. The "acceptance criteria" are implied by the standards and performance characteristics of the predicate device.

Implied Acceptance Criteria and Reported Device Performance:

Study that Proves the Device Meets Acceptance Criteria:

The document describes "Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device." It also mentions "Biocompatibility testing and reference 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 the sample sizes for the bench tests. It only states that "Bench tests were conducted."

• Sample size: Not specified.
• Data provenance: The tests were conducted internally by Shanghai Kindly Medical Instruments Co., Ltd. (China). The data is presumably prospective (i.e., designed specifically for this 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)

This type of information (experts, their qualifications, and ground truth establishment) is typically relevant for clinical studies, especially those involving subjective interpretation (e.g., imaging diagnosis). Since this submission primarily relies on bench testing and substantial equivalence, there is no mention of experts establishing a ground truth for a test set in the context of clinical performance. The "ground truth" for the bench tests would be the established engineering and biological standards.

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

Not applicable for a submission based on bench testing and substantial equivalence, which does not involve subjective human interpretation of clinical data 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

Not applicable. This is a medical device submission for a physical y-connector kit, not an AI software/algorithm, and no MRMC study was performed or needed.

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

Not applicable. This is a medical device submission for a physical y-connector kit, not an algorithm.

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

For the bench tests, the "ground truth" would be the established scientific and engineering principles codified in the referenced ISO standards (ISO 594-1, ISO 594-2, ISO 10993 series) and the functional performance characteristics of the predicate device. For biocompatibility, the ground truth is defined by the acceptable levels of biological response as outlined in the ISO 10993 standards.

8. The sample size for the training set

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

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

Not applicable, as there is no training set for a physical medical device.

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The Angiography syringe is used to inject contrast media into the heart, great vessels, and coronary arteries during angiographic procedures.

The Angiography Syringe are plastic , single-use, disposable syringes to be offered in 6ml, 8ml, 10ml, 12ml size. As manual control syringe, each configuration includes bilateral, external finger rings located on the proximal barrel shaft. The proximal thumb rings located on the plunger, in tandem with the external finger rings on the barrel, allows for single handed movement to create aspiration and/or expulsion of fluids. The angiography syringe has two tip fitting: fixed adapter and rotating adapter

The provided text is a 510(k) summary for a medical device (Angiography Syringe) and does not describe the specific type of study, acceptance criteria, or expert involvement typically associated with AI/ML-based medical devices or diagnostic tools.

The document discusses "acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols," but these are for the mechanical and material properties of the syringe itself, not for diagnostic performance in the way a clinical study for AI would be evaluated.

Therefore, many of the requested details cannot be extracted from this document, as they are not applicable to the type of device and study presented.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document lists standards that the device complies with, which implicitly serve as acceptance criteria for those specific tests. However, it does not provide quantitative "reported device performance" against these criteria in a table format, other than stating compliance.

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

• Sample Size: Not specified for non-clinical bench tests. The document states "Bench tests were conducted."
• Data Provenance: Not applicable. These are laboratory bench tests, not clinical data. The manufacturer is Shanghai Kindly Medical Instruments Co., Ltd., China.

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 is a medical device (syringe), not an imaging or diagnostic AI/ML device requiring expert ground truth for its performance evaluation. The ground truth for its mechanical and biological safety is established by adherence to engineering and biocompatibility standards.

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

• Not applicable. There is no human interpretation or adjudication involved in the performance testing of a syringe against engineering or biocompatibility standards.

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

• Not applicable. 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. This is not an AI/ML device.

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

• Not applicable in the context of diagnostic performance. The "ground truth" for this device's performance is established by the specifications in the cited ISO standards for its physical and material properties (e.g., fit of luer connections, sterility, biocompatibility).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Summary of the Study Proving the Device Meets Acceptance Criteria (as described in the document):

The study to prove the device meets acceptance criteria was primarily non-clinical bench testing. The manufacturer conducted various tests to verify that the Angiography Syringe met all device specifications and was substantially equivalent (SE) to a predicate device.

• Tests Performed:

  • Compliance with ISO 594-1:1986 (Conical Fittings)
  • Compliance with ISO 594-2:1998 (Lock Fittings)
  • Compliance with ISO 7886-1:1993 (Sterile Hypodermic Syringes)
  • Biocompatibility Testing (referencing ISO 10993 standards):
    • In Vitro Hemolytic Properties
    • In Vitro Cytotoxicity
    • Skin Irritation
    • Skin Sensitization
    • Acute Systemic Toxicity
    • Pyrogenicity

• Conclusion: The test results demonstrated that the proposed devices comply with the listed standards, indicating that they met the predetermined acceptance criteria for design verification and validation. The document explicitly states, "Clinical Test: It is not applicable."

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