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QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the primary endpoint of the study, which was "successful control of bleeding." The reported performance directly addresses this.

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

• Sample Size: 603 patient cases.
  • Internal uses: 404
  • External uses: 199
• Data Provenance: Retrospective observational study of real-world data (RWD) from medical records. The data was collected from healthcare professionals at 74 individual sites across 27 states in the United States.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. It mentions "healthcare professionals from 74 individual sites...who performed the clinical procedures in which the device was used." This implies that the ground truth (successful control of bleeding, adverse events) was established by the treating healthcare professionals at the point of care, rather than a separate panel of experts reviewing the cases.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). Given it's a retrospective observational study where healthcare professionals recorded outcomes at the time of treatment, formal adjudication by a separate group of experts is unlikely to have occurred. The "ground truth" appears to be based on the clinical assessment and documentation by the treating clinicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The device is a hemostatic dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.

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

This section is not applicable. The device is a physical medical device (hemostatic dressing), not an algorithm or software. Its performance is inherent in its physical action and chemical properties, not in a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used was clinical outcomes data (successful control of bleeding, rates of hematoma, thrombus formation, and thromboembolism) as recorded in the medical records by treating healthcare professionals.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of this study. The device is a physical product, and the study described is for clinical performance evaluation, not for training a machine learning model.

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

As there is no mention of a "training set" or a machine learning model, this question is not applicable.

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The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.

The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.

The document provided is a 510(k) Summary for the Ax-Surgi Surgical Hemostat and outlines the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device. However, it does not detail acceptance criteria in the form of specific quantitative metrics for comparison with the device performance. Instead, it lists studies and their general positive outcomes ("Pass," "Non-cytotoxic," "successful safety and performance assessment").

Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific quantitative metrics. The document describes a series of tests performed and provides a qualitative outcome for each.

Here's an analysis of the provided information related to the other requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not present quantitative acceptance criteria. Instead, it lists various tests and their qualitative outcomes.

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

• Animal Studies (Test Set): Two animal studies were conducted:
  • Pilot Study: "To evaluate the safety and performance of chitosan hemostatic dressing in non- heparinized porcine hepatic resection model (48hr and 28 days non-GLP)" - Sample size is not explicitly stated, but it's a "pilot study."
  • Pivotal Study: "Evaluation of Safety and Hemostatic Performance of the Ax-Surgi Chitosan Surgical Hemostat in a Liver Resection Model in Swine, 48 Hours and 28 Day." - Sample size is not explicitly stated.
• Data Provenance: The animal studies were conducted in a porcine (swine) model. Information on the country of origin or whether the data was retrospective/prospective is not provided, although preclinical animal studies are typically prospective.

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. The studies are described as animal studies assessing physiological outcomes (hemostasis, inflammation, toxicity, adhesion), which would typically be assessed by veterinarians, pathologists, and researchers involved in the study, but the specific number and qualifications are not listed.

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

• This information is not provided in the document. The adjudication method for the preclinical animal studies is not specified.

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, an MRMC comparative effectiveness study involving human readers or AI assistance was not mentioned. The device is a surgical hemostat, not an imaging or diagnostic AI device. The comparison was to a "standard of care" in animal models.

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

• This question is not applicable as the device is a physical hemostat, not an algorithm or AI system.

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

• For the animal studies, the ground truth was established through direct observation of physiological outcomes (e.g., successful hemostasis, inflammation, adhesion formation, systemic/local toxicity) and histopathological examination of tissues over observation periods (48 hours and 28 days). This would align with pathology and direct outcomes data from the animal model.

8. The sample size for the training set:

• This information is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training set" concept does not apply to the development and testing of this type of hemostat.

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

• This information is not applicable, as explained in point 8.

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QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

Cardiac surgical procedures: for temporary control of mild and moderate bleeding in cardiac surgical procedures, as well as in patients displaying class III or class IV bleeding.

Bone surfaces following sternotomy: to control bleeding from bone surfaces following a sternotomy.

QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes and configurations. The device is available in single or multipacks.

The document provided is a 510(k) summary for the QuikClot Control+® Hemostatic Dressing, seeking approval for expanded indications. It does not describe an AI medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and MRMC studies related to AI performance cannot be extracted from this document.

However, I can provide the clinical acceptance criteria and the summary of the clinical study presented in the document for the QuikClot Control+® Hemostatic Dressing in relation to its expanded indications.

Here's the information based on the provided text, structured as closely as possible to your request, but acknowledging the device is not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Study Participants):
  • Total Randomized Subjects: 231
  • QuikClot Control+® (Test Article): 153 subjects
  • Standard Gauze (Control): 78 subjects
  • Additional Roll-in Subjects (not randomized, treated with QuikClot Control+®): 21 (3 per site)
• Data Provenance: The study was a "prospective, randomized, open-label, multicenter, pivotal, evaluation." The country of origin is not explicitly stated, but clinical trials for FDA submissions are often conducted in the US or include international sites adhering to Good Clinical Practice (GCP) guidelines.

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

This information is not applicable as the study involves a physical medical device (hemostatic dressing) and direct clinical observations of bleeding, not an AI output requiring expert ground truth establishment for diagnostic accuracy. The "ground truth" here is the direct clinical observation of hemostasis by the surgical team.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves direct clinical observation of hemostasis, not AI output requiring expert adjudication.

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

This information is not applicable as the device is not an AI medical device and therefore no MRMC study was performed in the context of AI assistance to human readers.

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

This information is not applicable as the device is not an AI medical device.

7. The type of ground truth used

The "ground truth" for the clinical study was based on direct clinical observation of hemostasis (grade 0 bleed) by the surgical team during elective cardiac surgical procedures.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI medical device and therefore does not have a "training set" in the context of machine learning.

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

This information is not applicable as the device is not an AI medical device.

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QuikClot Control+® Hemostatic Dressing is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes. The device is available in single or multipacks.

This document is a 510(k) summary for the QuikClot Control+ Hemostatic Dressing, which is a device used for temporary control of internal organ space bleeding and severely bleeding wounds. The summary focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information about acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications but doesn't present them in a direct table format with explicit acceptance criteria values alongside reported performance values. Instead, it states that the device "meets the required specifications" generally. Here's a reconstructed table based on the provided text:

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

• Sample Size:
  • Bench Testing: Not specified for each test (tensile strength, elongation, clotting, kaolin release).
  • Biocompatibility Tests: Sample sizes are inherent to the specific ISO 10993 tests mentioned (e.g., L929 cells for cytotoxicity, guinea pigs for sensitization, rabbits for implantation, mice for genotoxicity). Specific numbers are not provided in this summary.
  • Preclinical Animal Study: "Three GLP large animal (swine), to include a survival model" and "one non-GLP study." The specific number of animals per GLP study is not detailed beyond "three."
• Data Provenance: The studies are preclinical (animal studies) and bench tests. The document does not specify country of origin for the studies, but they were conducted under GLP (Good Laboratory Practice) for the animal studies, indicating a controlled and ethical environment. They are inherently prospective for the purpose of this submission.

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

This information is not provided in the document. The studies described are preclinical animal studies and bench tests, not human reader studies requiring expert adjudicated ground truth. The "ground truth" for these studies is derived from direct measurements, observations, and histological/pathological analyses by qualified laboratory personnel and veterinarians within the study protocols.

4. Adjudication Method for the Test Set

This is not applicable as the studies are preclinical animal studies and bench tests, not clinical studies involving human interpretation or adjudication.

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

There is no mention of an MRMC comparative effectiveness study or any AI component in this document. The device is a hemostatic dressing, not an AI-powered diagnostic or assistive tool.

6. 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 dressing and does not involve any algorithm or AI.

7. The Type of Ground Truth Used

• For Biocompatibility: Laboratory results (e.g., cell viability, tissue reactions, genetic mutations) from established ISO 10993 standard test methods.
• For Bench Testing: Direct physical measurements (e.g., tensile strength, elongation), in vitro clotting assays, and chemical analysis for kaolin release.
• For Preclinical Animal Study:
  • Physiological observations: Direct assessment of hemostasis (cessation of bleeding).
  • Laboratory analyses: Blood chemistry (hematology, serum, coagulation panel results).
  • Pathological examinations: Macroscopic and microscopic tissue/organ examinations by veterinary pathologists for adhesion, thromboembolism, and kaolin migration.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical device and does not involve machine learning or a training set.

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

This is not applicable as the device is a physical medical device and does not involve machine learning or a training set.

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NuStat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

The NuStat is a hemostatic wound dressing that is composed of continuous filament silica and bamboo cellulose rayon fiber and is provided with radiopaque thread. The distribution of cellulose and silica fibers in each dressing is 65% silica fiber and 35% bamboo cellulose rayon fiber. The dressings are available in various sizes and provided sterile in either foil, Tyvek, or LDPE pouched configurations. The NuStat hemostatic wound dressings have a number of hemostatic properties that enhance the ability of the dressing to temporarily control bleeding. NuStat Hemostatic Dressing's mode of action is via absorption of fluid, which results in a physical aggregation of blood cells and clotting factors at the site of application. The radiopaque element allows for detection via x-ray.

The document describes a 510(k) premarket notification for a medical device called NuStat®, a non-absorbable, hemostatic gauze for temporary internal use. The submission seeks to expand the prescription (Rx) indication for use for the device. The study proves the device's substantial equivalence to a legally marketed predicate device (Z-Medica, LLC's D2 Dressing, DEN160012) and its identity to a reference device (Beeken Biomedical, LLC's NuStat XR, K160578).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or pass/fail thresholds for each test, but rather describes the performance evaluated against the "special controls for the non-absorbable, hemostatic gauze for temporary internal use as identified in 21 CFR 878.4454" and substantial equivalence to the predicate/reference devices. Therefore, the "acceptance criteria" are implied by the successful testing results and determination of substantial equivalence.

2. Sample Sizes and Data Provenance

• Sample Size for Test Set (Pre-market Studies):

  • Pilot Study: "Pilot study to Develop and Refine a Survival Mode of Severe Hemorrhage for the Evaluation of the NuStat Internal Hemostatic Dressing (NuStat XR)" - ANS 2319 (number of animals not specified)
  • Pivotal GLP Study: "Evaluation of the NuStat Trauma Pad XR Dressing When Applied to a Linear Resection Defect, 48 Hours and 28 Day"- FP-SS (number of animals not specified, but GLP implies rigorous standards)
  • Biocompatibility/Toxicity Tests: Various ISO 10993 tests (number of animals or in vitro samples not specified, but these are standardized tests).
  • In-vitro Clot Assessment: (number of bench tests not specified).
  • Particulate Release Testing: (number of tests not specified).
  • Swell Percent/Tensile/Tear Strength/Stability: (number of tests not specified).

• Data Provenance:

  • The animal studies (Pilot and Pivotal GLP studies) were conducted using a pig model of liver resection.
  • Other tests include standardized ISO 10993 biocompatibility and toxicity tests (e.g., mice for acute systemic toxicity, rabbits for pyrogenicity and sub-acute systemic toxicity/implantation).
  • The studies were prospective for the purpose of demonstrating safety and effectiveness for a 510(k) submission.
  • The country of origin is not explicitly stated, but as a US FDA submission, it's typically expected that these studies conform to international good laboratory practices (GLP) and are conducted in reputable facilities, often in the US or internationally accepted sites.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of human experts to establish ground truth in the context of device performance, as this device (hemostatic gauze) is assessed directly through in-vivo (animal model) and in-vitro laboratory testing for its physical and biological performance characteristics. The "ground truth" is established by direct measurement and observation of the device's hemostatic capabilities, radiographic visibility, biological interactions, and physical properties in these controlled experimental settings.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, often by multiple human readers or experts, to resolve discrepancies and establish a consensus ground truth. This is not applicable here as the device's performance is determined by direct physiological and material science measurements in animal models and laboratory settings, rather than subjective human assessment of ground truth.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is specifically designed for diagnostic devices, particularly those involving medical imaging where human interpretation of AI outputs is a key component. NuStat is a therapeutic hemostatic device, not a diagnostic AI system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. NuStat is a physical medical device (hemostatic gauze), not an algorithm or AI system. Its performance is inherent to its physical properties and biological interactions, not a computational output that would require a "standalone" algorithmic evaluation.

7. Type of Ground Truth Used

The "ground truth" for evaluating NuStat's performance was established through:

• Direct Physiological Measurement/Observation (in-vivo): In the pig model studies, the ability of the device to achieve hemostasis within a specific time (3 minutes), the absence of vascular obstruction/embolization, and the lack of infection were directly observed and measured. Radiographic visibility was visually assessed.
• Pathology/Histology: Likely used in the pivotal GLP study and local effects after implantation study to assess inflammation, adhesions, local toxicity, and the presence or absence of issues like vascular obstruction or embolization. The document mentions "assessments customized to the intended use" in the pivotal GLP study.
• Standardized Laboratory Testing (in-vitro): For biocompatibility, cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, endotoxin, interaction with blood, genotoxicity, in-vitro clot assessment, particulate release, swell percent, tensile strength, tear strength, and stability, the ground truth was established by adherence to recognized international standards (ISO, USP) and the measured outcomes of these tests.

8. Sample Size for the Training Set

Not applicable. NuStat is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI development. The "training" for this device would refer to the research and development phases where the material composition and design were optimized.

9. How Ground Truth for the Training Set Was Established

Not applicable, as explained in point 8.

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