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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 or lower leg, including radial artery catheterization, pedal or tibial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

VasoStatTM Hemostasis Device is a 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, foot) and is secured to the skin with biocompatible 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.

The provided text describes a medical device called the "VasoStat™ Hemostasis Device" and its clearance through a 510(k) premarket notification. The document primarily focuses on establishing substantial equivalence to predicate devices for expanded indications for use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, prescriptive manner for the device's performance in a clinical study. Instead, the performance testing section mentions that the previous 510(k) (K123041) established the device's performance, and the current submission "leveraged" that data for the new indications. For the expanded indication (transpedal access), a retrospective evaluation was conducted, focusing on the device's ability to achieve hemostasis and low complication rates.

Based on the "Performance Testing" section and the "Summary of Substantial Equivalence," the implicit performance criteria are tied to effective hemostasis and low complication rates, demonstrated through retrospective evaluation for the new indication.

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

• Sample Size: Three hundred fourteen (314) patients.
• Data Provenance: The study was a retrospective evaluation. The country of origin is not explicitly stated. The patients underwent "transpedal access for peripheral vascular disease intervention."

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

The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the retrospective evaluation. The assessment of hemostasis, pseudo-aneurysm, and access site occlusion would typically be made by medical professionals, but this detail is not given.

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

The document does not specify any adjudication method used for the retrospective evaluation.

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

This device is a hemostasis device (a physical medical device), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is not applicable and was not performed.

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

As stated above, this is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

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

For the retrospective evaluation, the ground truth was based on clinical outcomes data observed in patients post-procedure, specifically:

• Achievement of hemostasis.
• Occurrence of pseudo-aneurysm.
• Occurrence of access site occlusion.

This data would have been recorded as part of routine clinical practice.

8. The sample size for the training set:

The document refers to a retrospective evaluation for the expanded indications, not a training set in the context of machine learning. The device itself is a physical medical device, not an algorithm that requires training. The performance data from the 314 patients effectively serves as the "test set" for the expanded indications.

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

As there is no "training set" in the machine learning sense for this physical device, this question is not applicable. The device's design and previous clearance (K123041) would have been based on established medical and engineering principles, and prior 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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