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OTC:
StatSeal Disc is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, for temporary external control of minor bleeding from minor wounds, minor cuts, minor lacerations and minor burns.

Rx:
StatSeal Disc is intended under the care of a health care professional for external temporary control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

Components - StatSeal Disc is composed of two main components: Potassium ferrate, and hydrophilic polymer.

Mechanism of Action - StatSeal Disc achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.

The provided document is a 510(k) premarket notification for the StatSeal Disc, which aims to demonstrate its substantial equivalence to predicate devices. It does not contain acceptance criteria for specific performance metrics nor a detailed study proving the device meets acceptance criteria in the manner typically described for AI/ML medical devices.

The document focuses on:

• Substantial Equivalence: Arguing that the StatSeal Disc is substantially equivalent to existing predicate devices (Biolife, L.L.C.; PRO QR (Quick Relief) ® Powder (K080210) and Hemaderm (K021678)) based on identical claims, mechanism of action, and composition.
• Performance Testing Summary: Briefly listing types of tests performed (biocompatibility, in vitro, in vivo) without providing acceptance criteria or detailed results.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth, expert involvement, and comparative effectiveness studies (typical for AI/ML device evaluations) cannot be extracted from this document.

However, I can provide the available information:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary criterion is "substantial equivalence" to predicate devices, implying similar safety and effectiveness.
• Reported Device Performance:
  • Biocompatibility: "All required biocompatibility testing was conducted on PRO QR Powder (K080520) with no adverse results." Since StatSeal Disc and PRO QR Powder have identical composition, "no change in biocompatibility is expected."
  • In vitro Testing: Studies performed include "Absorption Study, Scanning Electron Microscopy (SEM) Comparison, Hemostatic Properties of StatSeal Disc, Disintegration Study, Friability Study." No specific performance results or acceptance criteria are provided.
  • In-vivo Testing: "A comparative Study Evaluating Vascular Access Hemostasis Properties of StatSeal Disc in GottinGen Minipigs." No specific performance results or acceptance criteria are provided. The conclusion states "StatSeal Disc induces hemostasis by fluid dehydration, protein coagulation and agglomeration."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified for any of the studies listed.
• Data Provenance: Not specified. The in-vivo study involved "GottinGen Minipigs," which are laboratory animals.

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)

• Not applicable/Not provided. The studies conducted are laboratory and animal studies, not human clinical trials requiring expert ground truth for diagnostic or prognostic purposes, and no mention is made of human expert review as a ground truth.

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

• Not applicable/Not provided.

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 medical device for hemostasis, not an AI/ML diagnostic or prognostic tool involving human readers.

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

• Not applicable. This is a medical device, not an algorithm. The in-vivo study assessed the device's performance in minipigs, which can be considered "standalone" in the sense that the device's intrinsic function was evaluated.

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

• For the in-vivo study in minipigs, the ground truth would inherently be physiological measurements of hemostasis (e.g., time to hemostasis, blood loss) directly observed and quantified in the animals, rather than expert consensus or pathology in the human diagnostic sense. Specific metrics are not detailed in this summary.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that uses training sets.

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

• Not applicable. This is not an AI/ML device.

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OTC: PRO QR Powder for minor external bleeding from wounds and procedures is intended for use as a topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. Rx: PRO QR Powder for moderate to severe external bleeding wounds is intended for emergency use of temporary external treatment for controlling moderate to severe bleeding.

Components - QR Powder is composed of two main components: potassium iron oxyacid salt, and a hydrophilic polymer. Mechanism of Action - QR Powder achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, QR Powder quickly forms a strong seal that completely covers the wound.

The document provided is a 510(k) premarket notification for the PRO QR (Quick Relief)® Powder, indicating substantial equivalence to already marketed predicate devices. Unfortunately, the document does not contain the specific acceptance criteria and detailed study results in a format that directly addresses all the points requested.

Here's an attempt to extract relevant information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, AUC, or other quantitative measures typically found in a clinical study report for AI/CADe devices. Instead, it relies on demonstrating substantial equivalence through various studies.

Missing Information/Not Applicable (N/A) for AI/CADe Specifics:

The questions you've posed (sample size for test set, experts, adjudication, MRMC, standalone performance, training set details) are highly specific to studies evaluating Artificial Intelligence (AI) or Computer-Aided Detection (CADe) devices, especially those involving image interpretation. The device described in this 510(k) (PRO QR Powder) is a topical hemostatic agent, not an AI/CADe device. Therefore, many of the requested data points are not applicable to this type of medical device submission.

Here's why and what can be inferred for the relevant parts:

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

• N/A for typical test set as this is not an AI/CADe device.
• For the animal studies: "swine model" is mentioned for three studies. The exact number of swine used is not specified in the summary.
• Data provenance: "swine model" indicates animal studies. The country of origin is not specified but generally, such studies for US FDA submissions are conducted in accredited facilities in the US or internationally under GLP (Good Laboratory Practice) standards.

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

• N/A, as ground truth involving human expert interpretation is not relevant for this device. Animal study outcomes would be assessed by veterinarians or researchers experienced in animal models of hemorrhagic injury.

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

• N/A, as adjudication is typically for discordant interpretations in human reader studies, not for the performance of a topical hemostatic agent. The assessment in animal models would follow specific experimental protocols.

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:

• N/A, no MRMC study was conducted as this is not an AI/CADe device.

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

• N/A, as this is not an AI/CADe algorithm. The device's performance is standalone in its application as a hemostatic agent.

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

• For animal studies assessing hemostasis, the ground truth would likely involve direct observation of bleeding cessation, measurement of blood loss, and potentially physiological parameters (e.g., blood pressure) and survival rates. Histologic assessment was mentioned for the porcine wound model (biocompatibility).

8. The sample size for the training set:

• N/A, 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, as there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a hemostatic powder, not an AI/CADe device. Therefore, a direct mapping to your specific questions about AI/CADe acceptance criteria, study design, and performance metrics is not possible. The submission focuses on demonstrating safety and efficacy through biocompatibility tests, in vitro studies, and animal models, and ultimately, substantial equivalence to previously cleared predicate devices.

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PRO QR Powder is intended for use to stop minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied. It is intended to be distributed as a Professional Use (Non-Prescription) Device.

Components - The PRO QR product is composed of two main components: potassium iron oxyacid salt and a hydrophilic polymer.

Mechanism of Action - The PRO QR achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PRO QR (Quick Relief) Powder, based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K070520 does not explicitly list numerical acceptance criteria or performance metrics in a typical table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Sorbastace, K965034) based on shared intended use, satisfactory biocompatibility, high absorbency, and sterility.

However, based on the performance testing mentioned, we can infer some general performance goals:

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

• Test Set Sample Size: The document only mentions "A swine model of lethal, arterial extremity injury" for the animal study. It does not specify the sample size (number of animals or wounds) used in this model.
• Data Provenance: The animal study was conducted in a "swine model," indicating an animal study, not human data. The document does not specify the country of origin for the data. The study is prospective in nature, as it involves active animal experimentation.

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

The document does not provide any information regarding the number or qualifications of experts used to establish a ground truth for the animal study. Animal model outcomes (e.g., successful hemostasis) would typically be assessed by veterinary or medical researchers, but specifics are absent here.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers evaluating medical images or data, which is not applicable to this device (a wound dressing powder).

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

This question is not applicable to the PRO QR Powder. "Standalone" performance generally refers to the performance of an AI algorithm operating independently. The PRO QR Powder is a physical medical device, not a software algorithm. Its performance is inherent in its physical properties and interaction with biological systems.

7. The Type of Ground Truth Used

For the animal study, the ground truth would have been physiological outcomes related to hemostasis and wound management, observed directly in the swine model (e.g., cessation of bleeding, time to hemostasis, blood loss measurements).

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. PRO QR Powder is a physical device, not an AI algorithm that undergoes training. The development and testing of such a device rely on material science, chemical properties, and biological studies, not machine learning training sets.

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

This question is not applicable for the same reason as point 8. There is no training set or associated ground truth for a physical medical device like PRO QR Powder.

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