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The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.

The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial artery post percutaneous puncture. The radial compression device is fixed on the arm and the square pad of the device is pressed against the puncture site. The square cushion is adjusted to apply pressure and temporarily compress the puncture site of the radial artery to achieve rapid hemostasis. The product is primarily composed of a plate, turn cap, screw rod, hook and loop band, tapered cushion, and square cushion. The Radial Compression Device is available in one model, RC-001.

This document describes a 510(k) premarket notification for the Ningbo DIZENGENS Medical Science Co., Ltd. Radial Compression Device (K232577). The document presents a summary of non-clinical performance testing to support the claim of substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results in the format requested.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance with specific metrics.
• Sample sizes used for a "test set" in the context of an algorithm's performance.
• Data provenance, number of experts, adjudication method, or ground truth details for an AI/algorithm study.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample size or ground truth establishment for a "training set."

The document primarily focuses on non-clinical performance testing for a physical medical device (a radial compression device), not an AI/software algorithm. The tests conducted are typical for a physical medical device.

Here's a breakdown of what is provided and what elements are missing or not applicable based on the provided text, in the context of your request for AI/algorithm study details:

1. Table of Acceptance Criteria and Reported Device Performance:

• Provided: A list of performance tests conducted. For each test, it states "All testing met the requirements and passed."
• Missing from provided text: Specific numerical acceptance criteria for each test and the corresponding numerical results obtained by the Radial Compression Device. For example, for "Bond strength testing," it doesn't state "Acceptance criteria: > X N, Result: Y N."

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

• Not Applicable in the provided text: This question is relevant for AI/algorithm performance evaluation. The document describes tests for a physical device (e.g., visual inspections, bond strength, biocompatibility), not an AI model. Therefore, there's no "test set" of data in the context of AI.

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

• Not Applicable in the provided text: This question is relevant for AI/algorithm performance. Ground truth for a physical device's non-clinical performance tests is typically established through established engineering standards, laboratory procedures, and physicochemical measurements, not through expert consensus on images or clinical data.

4. Adjudication method for the test set:

• Not Applicable in the provided text: This is relevant for AI/algorithm performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No: The document does not mention any MRMC study, as it's for a physical device and not an AI assistant.

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

• No: The device is a physical Radial Compression Device, not an algorithm.

7. The type of ground truth used:

• Implicitly: For the physical device tests, the "ground truth" is based on engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility and sterilization), and validated laboratory measurements. For instance, biocompatibility is evaluated per ISO 10993, and sterilization per ISO 11135.
• Missing from provided text: No explicit mention of ground truth in the context of expert consensus, pathology, or outcomes data, as these are typically for diagnostic AI/software.

8. The sample size for the training set:

• Not Applicable: There is no AI/algorithm training set.

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

• Not Applicable: There is no AI/algorithm training set.

Summary of Provided Non-Clinical Performance Testing:

The provided document lists the following non-clinical performance tests conducted for the Radial Compression Device:

• Visual inspections
• Dimensional inspections
• Bond strength testing
• Turn Cap and Screw Function
• Distribution and Packaging Tests
• Device and Packaging Aging Evaluation
• Pressure applied at puncture site (to demonstrate adequate compression)
• Biocompatibility evaluation per ISO 10993 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis)
• Sterilization (EO gas, SAL of 10-6 per ISO 11135, EO/ECH residuals assessment per 10993-7)

For all of these tests, the document states: "All testing met the requirements and passed."

Conclusion:

The provided text serves as a 510(k) summary for a physical medical device. It details non-clinical performance testing for that physical device to establish substantial equivalence. It does not provide the information requested regarding acceptance criteria and studies for an AI/algorithm device, as the product is not an AI/algorithm.

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The TR Band® is a compression device indicated to apply compression in order to achieve hemostasis while allowing the user to maintain patency of the radial artery after a transradial procedure (patent hemostasis).

The TR BAND® Radial Compression Device is a tourniquet style device consisting of a plastic belt with hook and loop adjustable fastener on each end, two compression balloons, and an injection port. The device also contains a TR Band Inflator.

After a transradial catheterization procedure, the TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port.

The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band.

With the two compression balloons (large and small) the pressure is applied for efficient compression for hemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the hemostasis process.

The TR Band is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

The provided text is a 510(k) Summary for the TR BAND® Radial Compression Device (K213531). It describes a submission for modifications to the Indications for Use and minor changes to the design of an existing device.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152525 TR BAND® Radial Compression Device) and a reference device (K173563 ARC Adjustable Radial Cuff Compression Device).

Crucially, this submission explicitly states that it does not include data from clinical tests. Therefore, it does not describe a study that proves the device meets specific performance criteria based on clinical outcomes, nor does it establish ground truth for a test set using expert consensus, pathology, or outcomes data, as would be expected for an AI/ML medical device.

Based on the provided text, the device's acceptance is based on non-clinical performance testing and a comparison to a predicate device, not on a clinical study evaluating its effectiveness with human subjects or AI performance metrics.

Therefore, I cannot fill in most of the requested fields related to a clinical study, AI performance, or ground truth establishment. However, I can extract information regarding the non-clinical acceptance criteria and the testing done to meet them.

Here's the information that can be extracted and a clear explanation of what is not present:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)

The document primarily focuses on demonstrating substantial equivalence to a predicate device by showing that the modified device has the same intended use, technology, materials, and comparable performance through non-clinical testing.

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

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

• Sample Size: Not explicitly stated for specific non-clinical tests. Standard engineering and quality testing typically uses a defined number of units, but this detail is not provided in a summary document like this.
• Data Provenance: The tests were conducted internally by Terumo Medical Corporation or by their contracted sterilization facility (Steris Isomedix Services Inc.). The data is from non-clinical, laboratory-based performance testing of the device prototypes/production samples. It is not patient or clinical data.

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

• N/A. This submission relies on non-clinical engineering and performance testing against established standards and equivalence to a predicate device, not on expert-based clinical ground truth.

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

• N/A. Not applicable, as there is no clinical test set requiring expert 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:

• No. An MRMC study was not conducted. This device is a mechanical compression device, not an AI/ML-driven diagnostic or assistive tool.

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

• N/A. Not applicable. This is not an algorithm-only device.

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

• Ground truth in this context is based on engineering specifications, adherence to recognized industry standards (e.g., ASTM, ISO), and direct comparison to the performance characteristics of the legally marketed predicate device. There is no "clinical ground truth" established in this submission.

8. The sample size for the training set:

• N/A. Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.

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

• N/A. Not applicable.

Summary of Study Type:

The "study" described in this 510(k) summary is a non-clinical performance and engineering validation study focused on demonstrating substantial equivalence to a predicate device. It involves:

• Bench testing: Evaluating physical and functional characteristics (e.g., tensile strength, leak tests, dimensions).
• Sterilization validation: Ensuring the device can be consistently sterilized to required levels.
• Packaging integrity testing: Verifying the packaging maintains sterility and protects the device.
• Shelf-life testing: Confirming the device retains its properties over its stated shelf life.
• Risk analysis: Identifying and mitigating potential risks associated with the device.

The statement "This 510(k) does not include data from clinical tests" (page 10) explicitly confirms that the acceptance of this medical device (based on this specific submission) is not predicated on human clinical trial data or performance in a patient population to demonstrate its effectiveness or safety. Instead, it relies on the similarity to a device already deemed safe and effective, supported by robust non-clinical testing.

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The PreludeSYNC is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.

The PreludeSYNC™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It consists of a soft wristband with a secure hook and loop fastener and a clear curved backer plate that provides optimal visualization of the puncture site and ease of placement. The inflatable bulb delivers adjustable compression of the puncture site. A check valve and tubing allow for easy inflation and deflation with the accompanying 20ml syringe inflator. PreludeSYNC is available in a variety of graphic designs and in two band sizes: regular (24cm) and long (29cm).

This document is a 510(k) Summary for the PreludeSYNC™ Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission and device. This document primarily outlines bench testing and biocompatibility testing conducted to ensure safety and function in comparison to a predicate, not to establish diagnostic accuracy or human performance improvement.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each test and then report the exact performance. Instead, it lists the types of performance and biocompatibility tests conducted, implying that the device "meets the requirements" as part of the substantial equivalence determination.

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

• Sample Size: Not specified for individual tests. The testing methodology is outlined by referencing various ISO and ASTM standards (e.g., ISO 594-1, ISO 594-2, ISO 2233:2001, ISO 11607-1:2006, ASTM D4169-09, ASTM F1980-11, ISO 11135:2014, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006). These standards would dictate the sample sizes for the specific tests, but the document itself does not report these numbers directly.
• Data Provenance: Not applicable in the context of clinical data. This is bench and biocompatibility testing of a physical device.

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

• Not applicable. Ground truth, in the sense of expert review for diagnostic accuracy, is not relevant for this type of device and testing. The "ground truth" for the performance tests would be the measurement against established engineering or material specifications, and for biocompatibility, the results of standardized biological assays.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication process is described for these types of engineering and biocompatibility tests.

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

• No. This is a physical medical device (radial compression device), not an AI or diagnostic imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

6. Standalone (Algorithm Only) Performance Study

• No. This is a physical medical device, not an algorithm or software. "Standalone performance" in this context refers to the device's physical function and safety, without human-in-the-loop, which is addressed by the bench and biocompatibility testing.

7. Type of Ground Truth Used

• The "ground truth" for these tests are:
  • Engineering Specifications: For dimensions, tensile strength, leak tests, burst tests, etc.
  • Material Science Standards: For absorbency, transparency, ink adherence.
  • Biological Assay Results: For cytotoxicity, sensitization, irritation, and systemic toxicity, as defined by the ISO 10993 series of standards.
  • Functional Objectives: For simulated use, ensuring the device performs its intended mechanical function.

8. Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

• Not applicable. There is no training set.

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The TR BAND® Radial Compression Device is a compression device to assist hemostasis of the radial artery after a transradial procedure.

The TR BAND® Radial Compression Device is a tourniquet style device consisting of a plastic belt with hook and loop adjustable fastener on each end, two compression balloons, and an injection port. The device also contains a TR Band Inflator. After a Transradial catheterization procedure, the TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port. The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band. With the two compression balloons (large and small) the pressure is applied for efficient compression for hemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the hemostasis process. The TR Band is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

The provided text is a 510(k) summary for the TR BAND® Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study to establish new acceptance criteria and prove device performance against them.

Therefore, the document does not describe acceptance criteria for clinical performance or a study that proves the device meets such criteria. It explicitly states under section "H. CLINICAL TESTS (807.92(b)(2))": "This 510(k) does not include data from clinical tests."

Instead, it relies on non-clinical tests to demonstrate substantial equivalence to a previously approved predicate device (K070423 – TR BandTM). The acceptance criteria mentioned are related to these non-clinical tests, such as biocompatibility, sterilization, and material performance.

Here's an analysis of the information provided, focusing on what is available:

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

The document lists performance tests and states "All testing met acceptance criteria." However, it does not provide specific quantitative acceptance criteria or detailed reported performance results in a table format for each test. Instead, it refers to compliance with standards.

Here's a summary of the non-clinical tests that were performed and implied acceptance criteria (compliance with standards):

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

• Sample Size for Test Set: Not specified for the non-clinical tests. Non-clinical studies (e.g., sterilization validation, biocompatibility) typically use statistically relevant sample sizes according to the specific test standard, but these are not explicitly stated in the summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Since these are largely lab-based non-clinical tests conducted by Terumo Medical Corporation (Elkton, MD, USA) and Steris Isomedix Services Inc. (South Plainfield, NJ), the data can be considered laboratory testing data. The studies are prospective in the sense that they were designed and executed to test the device's conformance.

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 as the submission explicitly states no clinical tests were performed. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome, usually confirmed by experts. The non-clinical tests rely on established scientific methods and standards, not expert consensus on medical diagnoses.

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

• Not applicable as no clinical studies were performed.

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 device is a radial compression device, not an AI-powered diagnostic tool, and no clinical studies were conducted.

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

• Not applicable. This is a physical medical device, not an algorithm, and no clinical studies were conducted.

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

• Not applicable as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established scientific principles, test methods defined in ISO/ASTM standards, and the physical properties/performance of the device itself.

8. The sample size for the training set:

• Not applicable, as this is not a machine learning/AI device, and no clinical studies or training sets were mentioned.

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

• Not applicable, as this is not a machine learning/AI device, and no clinical studies or training sets were mentioned.

In summary: The provided FDA 510(k) summary is for a physical medical device (TR BAND® Radial Compression Device) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than establishing new clinical acceptance criteria or conducting clinical performance studies. The document explicitly states that no clinical data was included in this 510(k) submission.

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The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.

AIR-BAND™ is a sterile, single use, 6-month shelf life, disposable device. It has a clear medical grade polyurethane window and bulb that facilitates visualization of the puncture site, a clear medical grade PVC flexible tube, and a pressure sensitive, self-adhesive peel backing. A luer valve on the end of the fill tube enables a luer lock syringe to be connected to inflate and deflate the bulb with air to provide compression of the transradial puncture site.

The provided text describes the Datascope Corp.'s AIR-BAND™ Radial Compression Device, including its intended use, design characteristics, and performance data used for its 510(k) submission. However, it does not contain the specific acceptance criteria or a detailed study that proves the device meets those criteria in the format requested.

The document states that "Bench top testing was used to demonstrate substantial performance equivalence to the predicate devices." and lists the types of testing conducted:

• Biocompatibility Testing
• Pressure Equivalence to Predicate (TR Band)
• Packaging Performance
• Product Stability (Shelf Life)
• Product Sterilization

It concludes that "The results of all testing demonstrate that the AIR-BAND™ Radial Compression Device is as safe, as effective, and performs as well as the predicate devices."

Based on the provided information, I can only provide limited details about the acceptance criteria and study as they are not explicitly detailed in the prompt in the format requested.

Here's an attempt to answer the questions based on the available text:

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

The document does not explicitly state numerical acceptance criteria and reported numerical performance values in a table format. It generally states that "Bench top testing was used to demonstrate substantial performance equivalence to the predicate devices" for the listed tests.

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 mentions "Bench top testing," but does not specify the sample sizes for these tests. It also does not provide information about the country of origin or whether the data was retrospective or prospective.

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 provided in the document. The testing described is benchtop, not clinical, so "ground truth" in the context of expert review for clinical performance is not applicable here.

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

This information is not provided in the document. As the testing was benchtop, a clinical adjudication method would not 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

No MRMC study was mentioned. The device is a physical medical device (radial compression device), not an AI/software product, so this type of study is not applicable.

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

This question is not applicable as the device is a physical medical device, not an algorithm.

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

For the benchtop tests, the "ground truth" would be established by validated test methods and specifications relevant to each test (e.g., biocompatibility standards, pressure measurement standards, packaging integrity standards, sterilization standards). No expert consensus, pathology, or outcomes data are mentioned as ground truth.

8. The sample size for the training set

This information is not provided and is not applicable, as the device is 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 provided and is not applicable, as the device is not an AI/machine learning model.

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