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The RadAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, brachial, dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in patients on anticoagulation therapy.

The RadAR™ Vascular Compression Devices consist of a strap with a housing with controls for device securement and adjustment, and a compression pad. The product is designed to reduce blood flow in the subject blood vessel compressed by the pad, while allowing blood flow in other vessels in the arm or the leg to promote hemostasis at the vascular puncture site. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow into the compressed blood vessel during puncture site hemostasis. This device is not life supporting or life sustaining. The product is provided individually packaged. It is a sterile, single use device.

This FDA 510(k) summary for the RadAR™ Vascular Compression Devices (K142122) explicitly states that no new testing was deemed required, and no performance testing or clinical evaluations were submitted for this 510(k).

The basis for the device's acceptance is its substantial equivalence to previously cleared predicate devices, specifically:

1. The RadAR™ Vascular Compression Devices cleared under 510(k) K092503 (itself).
2. The HemoBand® manufactured by Innovations for Access, Inc. (K081740).

Therefore, based on the provided document, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: No new performance data was presented.
2. Sample size used for the test set and the data provenance: No new test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set was used.
4. Adjudication method for the test set: Not applicable as no new test set was used.
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 physical medical device, not an AI/software device involving human readers.
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: Not applicable as no new testing was performed for this submission.
8. The sample size for the training set: Not applicable as no new testing was performed for this submission.
9. How the ground truth for the training set was established: Not applicable as no new testing was performed for this submission.

The document indicates that the current 510(k) submission (K142122) is primarily to revise the indications for use for the RadAR™ Vascular Compression Devices. The manufacturer leveraged information and testing from the previous clearance (K092503) for the same device to support the substantial equivalence claim for the expanded indications.

Conclusion stated in the document:
"Previous testing on the submitted RadAR™ Vascular Compression Device has demonstrated that this device is as safe and as effective as the predicate devices."

This means the acceptance criteria and performance data for this device are implicitly tied to the previous 510(k) clearances and the performance characteristics of the predicate devices. The current submission did not involve new studies to generate new performance data.

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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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