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The CoSeal™ Arterial Compression Band is a compression device that indicated to assist hemostasis of the radial artery after a transradial procedure, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist. minimizing the loss of blood.

The CoSeal™ Arterial Compression Band ("CoSeal Band") is a hemostasis device which works by providing controlled compression on the radial artery without completely occluding blood flow or significantly compressing other structures. It consists of a Velcro belt attached with a balloon, and an injection port. The device also includes a separated syringe (inflator) for injecting air.The CoSeal band is a device that is sterile, for single use, and has a 24month shelf life with one adjustable wristband for different patient size.

Here's an analysis of the CoSeal™ Arterial Compression Band's acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria (e.g., "hemostasis in X% of cases," "leakage rate below Y%"). Instead, it states that the performance testing "demonstrated the safety and effectiveness of the CoSeal™ Arterial Compression Band is equivalent to the predicate devices." This implies the acceptance criterion was "equivalence to predicate devices" in the tested areas.

The reported device performance is qualitative, indicating successful completion of the tests.

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

The provided document does not specify the sample size used for any of the performance tests (leak test, performance test, packaging, shelf life, sterilization, biocompatibility). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not mention the use of experts or the establishment of ground truth for any of the conducted performance tests. These tests (leak, packaging, sterilization, biocompatibility, product stability) are typically laboratory-based engineering and material science tests, not clinical studies requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

As the performance tests described are laboratory-based and do not involve human interpretation of clinical data in the context of ground truth, an adjudication method (like 2+1, 3+1) is not applicable and therefore not mentioned.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The studies described are performance tests of the device itself, not studies comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The CoSeal™ Arterial Compression Band is a physical medical device (hemostasis device), not an algorithm or AI software. Therefore, the concept of a "standalone" algorithm performance study is not applicable to this device. The performance tests conducted are inherently "standalone" in the sense that they evaluate the device itself.

7. Type of Ground Truth Used

For the performance tests listed:

• Leak Test, Performance Test, Packaging Performance, Product Stability (Shelf Life), Product Sterilization, Biocompatibility Testing: The ground truth for these tests would be established by engineering specifications, validated test methods, and industry standards (e.g., biocompatibility standards like ISO 10993, sterilization standards, packaging integrity standards). The tests themselves define what constitutes a "pass" or "fail" based on these established benchmarks. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. Since the CoSeal™ Arterial Compression Band is a physical medical device and not an AI/ML product, there is no training set in this context.

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

As there is no training set for this device, this question is not applicable.

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The VasoStat™ Hemostasis Device is indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

The VasoStat™ Hemostasis Device is an ergonomic, simple device that is adhered to the patient's skin directly over a percutaneous vascular puncture site and allows the application of adjustable compression to the puncture site to achieve hemostasis. The device is composed of a flexible thermoplastic base that has the ability to conform to the patient's anatomy (e.g. lower arm, upper arm, etc.) and is secured to the skin with biocompatible, hypoallergenic adhesive pads. A plunger component passes through the base, applies targeted pressure to the puncture site through a ratcheting mechanism, and can be adjusted with one hand to apply the appropriate pressure necessary to promote hemostasis. VasoStat has the ability to vary the amount of pressure applied to the puncture site to promote hemostasis while minimizing the risk of thrombosis. The device design and materials ensure that the product is comfortable for the patient to wear while their puncture site stops bleeding. Once hemostasis is achieved (in approximately 15 to 45 minutes), the device is easily removed and discarded.

Here's a breakdown of the acceptance criteria and study information for the VasoStat™ Hemostasis Device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in a pass/fail format. Instead, it demonstrates substantial equivalence by comparing the VasoStat™ Hemostasis Device's performance, particularly hemostasis time, to a legally marketed predicate device. The primary performance metric mentioned is time to hemostasis.

1. Table of Acceptance Criteria and Reported Device Performance

None explicitly stated as quantifiable acceptance criteria in the document. However, the study aimed to show performance comparable to the predicate.

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

• Sample Size: Not explicitly stated as a number of animals. The study was conducted on a "domestic swine model."
• Data Provenance: Prospective (in vivo assessment), animal model (domestic swine). The country of origin is not specified but is implicitly assumed to be within the US, given the submission to the FDA.

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

Not applicable. The study involved a direct measurement of hemostasis time in an animal model, not expert evaluation of images or clinical outcomes that would require ground truth establishment by multiple experts.

4. Adjudication method for the test set

Not applicable. This was an in vivo animal study measuring the time to hemostasis, not a study requiring adjudication of expert interpretations.

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 physical hemostasis device, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.

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.

7. The type of ground truth used

The "ground truth" for this study was the observed time to achieve hemostasis in the swine model, directly measured by the investigators of the study. This aligns with outcomes data (i.e., the clinical outcome of stopping bleeding).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As noted in #8, there is no training set for a physical medical device.

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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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The Radial Artery Compression Tourniquet Device is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, haemodialysis, and in patients on anticoagulation therapy.

The Radial Artery Compression Tourniquet devices consist of a plastic belt with an adjustable fastener on each end, two compression balloons, tubing and a unilateral valve. The plastic belt has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist and are made of clear plastic which allows the physician to view the access site during the haemostasis process. The inflation device introduces air through the unilateral valve filling two compression balloons (large and small) at the same time. The top small balloon is layered and internally connected to the bottom large balloon. The result of the balloon inflation is the haemostasis of the puncture site within the patient's wrist.

The provided text describes the Radial Artery Compression Tourniquet and its substantial equivalence to predicate devices, but it does not contain the specific information requested in points 1 through 9 regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.

The document details the device's description, intended use, contraindications, warnings, and cautions. It also mentions "Tests Conducted," which include:

• Biocompatibility: Assessed against ISO 10993 Biological Evaluation of Medical Devices - Part 10 for Irritation and Sensitization and Part 5 Tests for Cytotoxicity. It states that the device "has been shown to meet the acceptance criteria, and did not raises additional safety and effectiveness concerns."
• Performance: A "side-by-side comparison of the predicate TR Band®, Terumo Corporation, K070423 performance of the balloon’s maintenance of internal pressure was performed with the Lepu’s device." The conclusion is that "The balloon profile performance characteristics of both devices are very similar when factoring the balloon size and volume inflation difference and do not impose any additional safety or performance issues."

However, this information is for a physical medical device (a tourniquet) and not for an AI/algorithm-based device. Therefore, the requested details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth for training was established are not present in the provided text.

Based on the provided text, the answer to the specific questions regarding acceptance criteria and a study proving the device meets those criteria for an AI/algorithm would be:

1. Table of acceptance criteria and reported device performance: Not applicable for an AI/algorithm performance study. The document mentions biocompatibility acceptance criteria (meeting ISO 10993 standards) and performance comparison of balloon pressure maintenance to a predicate device, concluding similarity.
2. Sample size for the test set and data provenance: No test set information for an AI/algorithm is provided.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for an AI/algorithm.
4. Adjudication method: Not applicable for an AI/algorithm.
5. Multi reader multi case (MRMC) comparative effectiveness study: No MRMC study is mentioned.
6. Standalone performance: No standalone (algorithm only) performance is mentioned.
7. Type of ground truth used: Not applicable for an AI/algorithm. For the physical device, the "ground truth" for biocompatibility was meeting ISO standards, and for performance, it was comparable balloon pressure maintenance to a marketed predicate.
8. Sample size for the training set: No training set information for an AI/algorithm is provided.
9. How the ground truth for the training set was established: Not applicable for an AI/algorithm.

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