Search Results

QuikClot Interventional-A Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 7 Fr. in patients on drug/induced anti-coagulation treatment.

The QuikClot Interventional-A Hemostatic Bandage that is the subject of this submission is described in detail in K090620 in that it is made of a soft, white, kaolin-impregnated gauze. QuikClot® Interventional-A Hemostatic Bandage may be provided in a kit form that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® bandage (K973036) or equivalent. The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by l 1/2"wide by 1/2" thick multi-layer pad.

Here's an analysis of the acceptance criteria and supporting studies for the QuikClot Interventional-A Hemostatic Bandage, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative format typical for regulatory submissions (e.g., "sensitivity must be > X%", "specificity must be > Y%"). Instead, it presents performance metrics from pre-clinical animal studies and clinical studies. The implicit acceptance criterion is that the device demonstrates efficacy in controlling bleeding in anticoagulated patients, comparable to or superior to control methods, with an acceptable safety profile.

Ask a specific question about this device

QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.

QuikClot® Interventional™ hemostatic bandage is a kit that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® 4" x 4-3/4" bandage (reference K973036). The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by 1 ½" wide by ½" thick multi-layer pad. The pad is held secured in place by stitching with polyester thread. QuikClot® Interventional™ hemostatic bandage is packaged in a plastic tray within a peelable foil pouch and irradiated to a SAL of 104.

The QuikClot® Interventional™ hemostatic bandage is intended for topical application as an adjunct to manual compression for the local management and control of surface bleeding from vascular access sites, percutaneous catheters, or tubes utilizing introducer sheaths up to 12 Fr.

Here's an analysis of the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 25 vascular access procedures.
• Data Provenance: Pre-clinical porcine model testing (animal study). The country of origin is not specified but it is an animal-based study, not human. Given the context of a 510(k) submission, it is retrospective to the submission date.

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

• The document does not specify the number or qualifications of experts used to establish the ground truth for the pre-clinical porcine model testing. Given it's an animal model, the ground truth would typically be established by veterinarians, researchers, or technicians competent in animal surgery and hemostasis assessment.

4. Adjudication method for the test set:

• The document does not explicitly state an adjudication method. In a pre-clinical animal study, adjudication is often implicitly handled by the experimental design, observation protocols, and direct measurement of bleeding cessation by the researchers.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hemostatic bandage, not an AI-powered diagnostic or assistive tool, so such a study would not be applicable.

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

• No, a standalone (algorithm only) performance study was not done. This device is a physical hemostatic product, not an algorithm.

7. The type of ground truth used:

• The ground truth used was the observed cessation of bleeding (hemostasis) in the pre-clinical porcine model following vascular access procedures. This is a direct outcome measurement.

8. The sample size for the training set:

• This information is not applicable and therefore not provided. The QuikClot® Interventional™ hemostatic bandage is a physical medical device, not an AI or machine learning model that requires a "training set." The studies conducted were for performance validation.

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

• This information is not applicable for the same reason as point 8.

Ask a specific question about this device

Not Found

Not Found

I apologize, but the document you provided is an FDA notification letter regarding an administrative change to a device's product code. It does not contain any information about acceptance criteria, device performance studies, or clinical trial details. Therefore, I cannot extract the requested information.

To answer your request, I would need a document that describes the device's performance characteristics and the studies conducted to demonstrate its effectiveness and safety.

Ask a specific question about this device

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.

Ask a specific question about this device

QuikClot Sport™ & QuikClot Sport Silver™ are intended for temporary external use to stop bleeding of superficial wounds. minor cuts, and abrasions.

QuikClot Sport™ and QuikClot Sport Silver™ are OTC versions of Z-Medica's prescription product: QuikClot 1st Response™ (K061767). These new devices consist of mesh bags containing zeolite beads. The devices are vacuum-packed in multi-layer pouches to ensure sterility and efficacy.

The provided documents describe the substantial equivalence determination for QuikClot Sport™ and QuikClot Sport Silver™ (K070010) to predicate devices. The study detailed is an in-vitro comparison to demonstrate non-inferiority in efficacy and to show antimicrobial properties.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Efficacy Test (Clotting Time): Not explicitly stated. The document refers to "in-vitro test data measuring the clotting time of whole blood." The number of samples (e.g., individual blood samples, replicates) is not specified.
• Sample Size for Antimicrobial Test: Not explicitly stated. The document mentions "cultures of S. aureus, E. coli, P. aeruginosa, and C. albicans." The number of replicates or separate experiments is not provided.
• Data Provenance: The studies were in-vitro (laboratory-based) tests. The country of origin is not specified, but the submission is to the U.S. FDA by Z-Medica Corporation, a U.S.-based company. The data is retrospective in the sense that it supports a 510(k) submission based on prior testing.

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

Not applicable. The studies described are in-vitro laboratory tests and did not involve human subjects or expert assessment for establishing ground truth in a clinical context.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical ground truth established by experts requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The studies described are in-vitro laboratory tests, not human reader studies.

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

Yes, the studies were standalone in-vitro laboratory tests of the device's properties. There was no human-in-the-loop component as it's a topical hemostatic agent, not an AI or diagnostic algorithm.

7. The Type of Ground Truth Used

• Efficacy (Clotting Time): The ground truth was based on objective, quantitative measurements of clotting time in whole blood under laboratory conditions, compared to the performance of a predicate device and blood without zeolite.
• Antimicrobial Properties: The ground truth was based on objective, quantitative measurements of microbial reduction (log reduction) in bacterial and fungal cultures.
• Biocompatibility: Compliance with ISO 10993-1:1997 likely involved a battery of standardized in-vitro and/or in-vivo tests with defined endpoints, rather than a single "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The descriptions are for physical devices (clotting sponges).

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

Not applicable, as there was no training set.

Ask a specific question about this device

This device is intended for temporary external use to control traumatic bleeding.

QuikClot 1st Response™ and QuikClot ACS+™ are essentially the same device, but in two different sizes. Both devices are mesh bags containing zeolite beads. The devices are vacuum packed in multi-layer pouches to ensure sterility and efficacy.

This document ([K061767](https://www.accessdata.fda.gov/cdrh_docs/reviews/[K061767](https://510k.innolitics.com/search/K061767).pdf)) is a 510(k) summary for the QuikClot 1st Response™ & QuikClot ACS+™ devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance against a clinical endpoint. Therefore, the information provided below is extracted from the 510(k) summary regarding the studies conducted to support substantial equivalence, particularly focusing on the safety improvement and non-inferiority in efficacy.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

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

• Heat Reduction Studies:

  • In-vitro: "an excess of zeolite was mixed with water." No specific numerical sample size is given for the in-vitro heat test.
  • In-vivo (preclinical animal wound model): "Care givers that evaluated the product in a preclinical animal wound model..." While an animal model is mentioned, the exact number of animals or trials within this model is not specified.
  • Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. It is retrospective data as it supports a 510(k) submission.

• Clotting Time Studies:

  • In-vitro: No specific numerical sample size for the samples tested (e.g., number of blood samples, replicates) is given for the in-vitro clotting time test. It compares "the zeolite formulation used in the predicate device," "the reformulated zeolite," and "whole blood without zeolite."
  • Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. Retrospective data.

• In-vivo Efficacy Studies:

  • "In-vivo testing in various swine models..." No specific numerical sample size (number of swine or trials) is provided.
  • Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. Retrospective data.

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

• Heat Reduction (In-vivo): "Care givers that evaluated the product in a preclinical animal wound model experienced a peak temperature of 106 F and agreed that the risk of burns was eliminated."

  • Number of Experts: Not specified beyond "Care givers" (plural).
  • Qualifications: Referred to as "Care givers." No specific qualifications (e.g., type of medical professional, years of experience) are provided.

• Other Studies (Biocompatibility, Clotting Time, In-vivo Efficacy): The document does not describe the use of human experts to establish "ground truth" for the test sets in these studies in the way a clinical trial might, but rather relies on objective measurements (temperature, clotting time) or expert interpretation of animal model outcomes, which is inherent in pre-clinical research.

4. Adjudication Method for the Test Set

• Heat Reduction (In-vivo): For the in-vivo heat assessment, it states "Care givers...agreed that the risk of burns was eliminated." This implies a consensus or agreement among the unspecified number of caregivers. It does not describe a formal adjudication method like 2+1 or 3+1.
• Other studies: Adjudication methods are not applicable nor described for the objective measurements in the other pre-clinical tests.

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 document describes pre-clinical testing for a device modification, focusing on safety (heat reduction) and non-inferiority in efficacy in lab and animal models, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical product (hemostatic dressing), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Biocompatibility: Demonstrated by passing ISO Standard 10993-1:1997. The ground truth is adherence to the standard's requirements, likely via lab testing and analysis by qualified personnel.
• Heat Reduction:
  • In-vitro: Objective temperature measurements. The ground truth is the peak temperature recorded.
  • In-vivo: Direct observation and subjective feedback ("warm," "risk of burns eliminated") from "Care givers" in a preclinical animal model.
• Clotting Efficacy: Objective measurement of clotting time in a controlled in-vitro setting. The ground truth is the time to clot formation.
• In-vivo Efficacy: Outcomes from "various swine models." The specific endpoints for "substantial equivalence" are not detailed but would typically involve measures of blood loss, time to hemostasis, or survival rates compared to the predicate device in controlled injury models.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable, as there is no "training set" for this physical medical device.

Ask a specific question about this device

QuikClot ACS - "Advanced Clotting Sponge" ™, is intended for emergency use only as an external traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

The new mesh bags containing beads of QuikClot® Brand Hemostatic Agent, also called QuikClot ACS™ - "Advanced Clotting Sponge", are intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.

The beads inside the mesh bags consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion.

Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function.

The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.

Used in conjunction with direct pressure, QuikClot ACS™ reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.

This application for Special 510(k) clearance concerns the same hemostatic agent, in bead form, but the beads have been placed inside a synthetic mesh bag in order to facilitate easier application and removal of the product. This device modification retains the benefits of the previous device modification, granules vs. beads, but instead of removing individual beads from a wound medical personnel only need to remove the mesh bag containing the beads.

The provided text is a 510(k) summary for the QuikClot ACS™ - "Advanced Clotting Sponge". It details the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain detailed acceptance criteria or a study designed to explicitly prove the device meets specific performance metrics against those criteria in a tabular format as requested.

Instead, it focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, much of the requested information regarding acceptance criteria and detailed study results cannot be extracted directly from this document.

However, I can extract the available information and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in a tabular format. The document describes the device's mechanism of action and states that "Tests demonstrated that the QuikClot ACS™ product performs at least as well as the current granular product in the swine femoral artery model." This implies a comparative performance but does not list specific acceptance criteria or quantitative performance metrics.

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

• Sample Size for Test Set: Not specified for the swine femoral artery model.
• Data Provenance:
  • Country of Origin: United States (Hartford Hospital in Connecticut, Portsmouth Naval Hospital in Virginia, the Naval Medical Research Center (NMRC) in Maryland, and Uniformed Services University of the Health Sciences (USUHS) in Maryland).
  • Retrospective or Prospective: Not explicitly stated, but "In-Vivo testing on swine was performed" suggests a prospective study.

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

This information is not provided. The "ground truth" in this context would likely be the objective measurement of hemostasis in the swine model, rather than expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

This information is not provided.

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

A MRMC comparative effectiveness study was not performed or described, as this device is a physical product (clotting sponge) and not an imaging or diagnostic AI tool. The study described is an in-vivo animal model comparison, not a human reader study.

6. Standalone Performance Study (Algorithm Only)

This is not applicable as the device is a physical product, not an algorithm. The in-vivo swine study could be considered a "standalone" performance study for the device itself.

7. Type of Ground Truth Used

The ground truth implicitly used for the in-vivo swine studies would be objective physiological measurements of hemostasis and blood loss in the animal model. The document states "Tests demonstrated that the QuikClot ACS™ product performs at least as well as the current granular product in the swine femoral artery model," indicating that direct measurements related to clotting and bleeding control were the basis of evaluation.

8. Sample Size for the Training Set

This is not applicable as the device is a physical product, not an AI/ML algorithm that requires a training set. The development of the product would have involved various design and testing phases, but not a "training set" in the context of machine learning.

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

This is not applicable as the device is a physical product, not an AI/ML algorithm.

Ask a specific question about this device

QuikClot® Brand Hemostatic Agent is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.

The new bead form of QuikClot® Brand Hemostatic Agent, also called "Advanced Beaded Formulation", is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss. The beads consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion. Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation. Used in conjunction with direct pressure, QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.

The provided document is a 510(k) premarket notification for a medical device (QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation). It describes the device, its intended use, and claims substantial equivalence to a predicate device.

However, the document does not contain the acceptance criteria and study details as typically understood for AI/ML device performance evaluation studies. The information present pertains to the regulatory clearance process for a physical hemostatic agent, not an AI/ML algorithm.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training) are not applicable or cannot be extracted from this document as these are specific to AI/ML device evaluations.

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics within a table in this document. The document relies on equivalence to a predicate device.
• Reported Device Performance:
  • Claimed Performance: "performs at least as well as the current granular product in the swine femoral artery model."
  • Mechanism of Action: Accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site, and the exothermic adsorption process increases temperature, which increases clotting rates and platelet aggregation/adhesion.
  • Clinical Goal: "reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds."

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

• Sample Size: "In-Vivo testing on swine was performed". No specific number of subjects (swine) is given in this summary.
• Data Provenance:
  • Country of Origin: Performed at the Portsmouth Naval Hospital in Virginia (USA).
  • Retrospective or Prospective: Implied to be prospective in-vivo testing as it was "performed" for this submission.

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

• Not Applicable. This is for an in-vivo animal study of a physical device, not an AI/ML algorithm requiring expert interpretation of data.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 for a physical medical device, not an AI/ML algorithm.

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

• Not Applicable. This is for a physical medical device.

7. The type of ground truth used

• Ground Truth: The "ground truth" in this context would likely be direct physiological measurements of hemostasis and blood loss in the swine model, assessed by animal researchers/veterinarians. No specific methodology for ground truth establishment (e.g., pathology, outcomes data) is detailed beyond "In-Vivo testing on swine."

8. The sample size for the training set

• Not Applicable. This refers to a physical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. See point 8.

Summary of what is present:

• Device: QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation (a physical hemostatic product).
• Indication: Emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
• Study Type: In-Vivo testing on swine.
• Outcome Claim: Performs at least as well as the predicate (granular) product in the swine femoral artery model.
• Basis of Clearance: Substantial equivalence to a legally marketed predicate device (QuikClot® Brand Hemostatic Granules, K013390).
• Additional Tests (for biocompatibility, likely related to the predicate): Agar Overlay Cytotoxicity Test, Water Adsorption Rate, Skin Sensitization, Skin Irritation, Intracutaneous Test, Muscle Implant, Long-Term Muscle Implant.

To reiterate, the provided text is a 510(k) summary for a physical hemostatic agent and does not contain the detailed performance study information typically requested for AI/ML devices.

Ask a specific question about this device