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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 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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