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Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.

This FDA 510(k) summary provides information for a medical device called "Zeolite Hemostatic Gauze" (K211570). The document asserts substantial equivalence to a predicate device, QuikClot® eXTM (K072474), and references another device, QuikClot (K013390).

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from various standards and internal specifications, as indicated by the non-clinical test conclusions. The reported device performance is presented as meeting these requirements.

Study Details Proving Device Meets Acceptance Criteria

1. Sample Size used for the test set and the data provenance:

   • Physical performance testing: "Three discrete batches of subject device were tested." No further details on the number of units per batch or the provenance (country, retrospective/prospective) are provided beyond the manufacturer being in China.
   • Sterile barrier packaging testing: No specific sample size is provided beyond stating "sterile barrier packaging testing were performed." Provenance is assumed to be from the manufacturer in China.
   • Sterilization and shelf life testing: No specific sample size is provided for these tests, except for "aging samples" for shelf life. Provenance is assumed to be from the manufacturer in China.
   • Biocompatibility testing: No specific sample sizes for in vitro tests (cytotoxicity, sensitization, irritation, systemic toxicity) are provided. Provenance is assumed to be from the manufacturer in China.
   • Animal Study: 16 animals were selected for hemostatic testing: 8 for the subject device and 8 for the predicate device. The model used was a pig. Provenance is not specified beyond the manufacturer being in China, implying the study was conducted there. The study is prospective in nature as it involves active testing.

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

   • For physical performance, sterile barrier packaging, sterilization, shelf life, and biocompatibility, the acceptance criteria are based on established international and national standards (e.g., ASTM, ISO, USP, DIN). The "ground truth" here is the adherence to these standard specifications demonstrated through validated test methods, rather than expert interpretation of data. No external experts are mentioned for establishing ground truth for these tests.
   • For the animal study, the "ground truth" for hemostatic effectiveness is the measured outcome in the pig model. The document does not specify if external experts were used to establish the ground truth (e.g., blinded assessment of bleeding time/volume) or the qualifications of those who evaluated the results.

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

   • No adjudication method is mentioned for any of the non-clinical tests or the animal study. Test results are reported directly against the specified standards or internal criteria.

4. 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 or human reader study was mentioned. This device is a passive hemostatic gauze, not an AI-assisted diagnostic or therapeutic device that would involve human readers.

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

   • This is not applicable as the device is a physical hemostatic gauze, not an algorithm. Performance testing (physical, biocompatibility, sterilization, and animal study) represents the "standalone" performance of the physical device.

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

   • Physical Performance, Sterile Barrier, Sterilization, Shelf-life: Ground truth is defined by published industry standards and specifications (e.g., ASTM, ISO, USP, DIN) and the results obtained from validated testing methods.
   • Biocompatibility: Ground truth is established by the results of tests conducted according to ISO 10993 series and USP standards, indicating the absence of adverse biological responses.
   • Animal Study: The ground truth for hemostatic efficacy is derived from direct observation and measurement of bleeding control in a live animal model (pig). This is a form of outcomes data within the controlled environment of an animal study.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through conventional non-clinical and pre-clinical testing.

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

   • Not applicable, as there is no training set for this type of 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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WoundStat™ wound dressing for OTC is indicated for temporary external use to control bleeding from minor cuts and abrasions of the skin.

WoundStat™ is a clay-based, granufar hemostatic agent that is poured on a moderate to severe wound and held in place until it adheres to the wound and hemostasis is achieved. The device is packaged in a foil package and is provided sterile.

This document is a 510(k) premarket notification for WoundStat™, a wound dressing intended for over-the-counter (OTC) use to control bleeding from minor cuts and abrasions. It's an administrative update to a previous 510(k) K071936 which originally cleared WoundStat™ for prescription (Rx) use.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define specific performance acceptance criteria (e.g., stopping bleeding within X seconds for Y% of cases) for the OTC version of WoundStat™. Instead, the core of the submission relies on demonstrating substantial equivalence to its own previously cleared Rx version and other legally marketed OTC hemostatic agents.

The reported device performance, therefore, is primarily that:

• Mechanism of action is unchanged from the Rx version.
• It is demonstrated to be as safe and effective as the WoundStat™ for Rx use (K071936).
• It is similar to other legally marketed OTC wound management devices in terms of intended use and effectiveness for temporary external use to control bleeding from minor cuts and abrasions.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not describe a new clinical study or test set specifically for this OTC 510(k) submission. Instead, it leverages the previous clearance of WoundStat™ for Rx use (K071936). The basis for "as safe and effective" likely stems from data or analyses provided in the K071936 submission. Without access to K071936, the specifics of its test set sample size and data provenance cannot be determined from this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This document does not mention the use of experts to establish a ground truth for a new test set for the OTC clearance. The assessment is based on comparison to existing cleared devices and the previous Rx clearance. Any expert involvement would have been part of the K071936 submission or the development of the predicate devices.

4. Adjudication Method:

Not applicable, as no new specific test set or clinical study requiring adjudication is described in this document for the OTC clearance.

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

Not applicable. This document is for a medical device (wound dressing), not an AI/imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical wound dressing, not an algorithm or software. Its performance is inherent to its physical and chemical properties when applied.

7. Type of Ground Truth Used:

For this OTC submission, the "ground truth" implicitly relies on:

• Previous FDA clearance of its own Rx version (K071936): This implies that the Rx version was found safe and effective based on its own ground truth (e.g., animal studies, clinical data on hemostasis).
• Established safety and effectiveness of predicate OTC devices: The comparison to other legally marketed OTC hemostatic agents (QuikClot Sport™, CELOX, BleedArrest™, BloodStop) suggests that the "ground truth" for these devices' performance in controlling minor bleeding is generally accepted by the FDA for OTC applications.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a physical device.

Summary of Device Meeting Acceptance Criteria:

The device, WoundStat™ for OTC use, meets the "acceptance criteria" by demonstrating substantial equivalence to its own previously cleared prescription version (K071936) and other legally marketed OTC hemostatic agents. The study proving this essentially refers back to the data and rationale provided in the K071936 submission, along with a revised labeling conforming to OTC regulations (21 CFR 801 Subpart C). The core logic is that if the Rx version was safe and effective for its broader indications, and the mechanism of action remains the same, then the OTC version with more limited indications (minor cuts and abrasions) and appropriate labeling is also safe and effective. No new clinical trials or performance studies are described in this specific 510(k) update for the OTC clearance.

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Prescription Use: QuikClot® eX™ is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: QuikClot® eX™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.

QuikClot® eX™ consists of standard non-woven medical gauze that has a clay mineral (Kaolin) bound to the gauze with Glycerin. Kaolin promotes hemostasis in a similar mechanism as QuikClot® Hemostatic Agent (K013390), but without the associated heat generation and risk of burning. QuikClot® eX™ is packaged as a four ply square sponge 4" x 4" sealed in a foil pouch and irradiated to a SAL of 10-6. The foil package has the same material composition and construction as the QuikClot® Hemostatic Agent package.

This document is a 510(k) summary for the QuikClot® eX™ device, which describes its substantial equivalence to predicate devices based on in-vitro, in-vivo, and biocompatibility testing. It is a regulatory submission, not a study report, and therefore does not contain acceptance criteria in the typical sense of a clinical trial or algorithm performance study.

Here's an analysis of the provided information in the context of your request:

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

The document does not explicitly state numerical acceptance criteria in the format of a table. Instead, it describes the data used to support substantial equivalence and implies that "effectiveness" and "safety" are the underlying criteria.

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

The document does not explicitly state specific sample sizes for the "test set" in the context of an AI-driven device. However, it mentions:

• In-vitro testing: "whole sheep's blood" - no specific quantity mentioned. Provenance: laboratory.
• In-vivo testing: "swine model transection of the femoral vessels" and "liver, spleen and mesenteric injuries" - no specific number of animals mentioned. Provenance: laboratory/animal study.

This is a pre-market notification (510(k)) for a medical device (hemostatic gauze), not an AI algorithm. Therefore, "test set" and "data provenance" as typically understood in AI studies (e.g., country of origin of patient data, retrospective/prospective) are not applicable or detailed in this type of submission. The data provenance is from laboratory and animal studies.

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

This information is not provided in the document. For a physical device like a hemostatic gauze, the "ground truth" would be objectively measured physiological outcomes (e.g., time to hemostasis, blood loss, tissue healing) rather than expert interpretation of images or data needing adjudication.

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

Not applicable and not mentioned. Adjudication methods are typically used in studies where human readers provide interpretations (e.g., radiology studies). Here, the "ground truth" is measured directly through laboratory and animal experiments.

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 and not mentioned. This type of study is for evaluating the impact of AI algorithms on human reader performance, which is not relevant for a physical hemostatic device.

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

Not Applicable. This device is not an algorithm. Its performance is inherent to its physical and chemical properties.

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

The ground truth for the "studies" mentioned appears to be based on:

• In-vitro: Direct measurement of clotting time in sheep's blood.
• In-vivo: Direct observation and measurement of hemostasis (stopping bleeding) in a swine model, and assessment of tissue injuries (liver, spleen, mesenteric).
• Safety: Biocompatibility testing results (laboratory tests) and lack of heat generation.

These are essentially direct physiological outcomes data from controlled laboratory and animal experiments.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set."

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

Not applicable. No training set for an AI algorithm is mentioned or relevant here.

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