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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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QuikClot® Radial® 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 (a) patients on druq/induced anti-coagulation treatment and (b) patients not on druq/induced anti-coaqulation treatment.

The QuikClot® Radial® consists of a rolled hemostatic dressing to be used in conjunction with Tegaderm™, Coban™, or equivalent adhesive bandage (not supplied). The roll is a soft, white, sterile, hydrophilic, kaolin-impregnated gauze. Kaolin is a hemostatic agent that functions to stop bleeding in anti-coagulated patients, and is used in the same form and amount as in the predicate device. The kaolin is bound to the gauze in the same manner as in the predicate device. The QuikClot® Radial® is configured in 0.75" diameter x 1.5" length. The device is packaged for aseptic removal in a peelable foil pouch. The dressing is a single-use device that has suface contact with breached or compromised skin for a limited duration (≤24 hours).

The provided text describes the 510(k) premarket notification for the QuikClot® Radial® device, which is a hemostatic dressing. However, it does not contain specific acceptance criteria or a detailed study report that would typically lay out acceptance criteria and then demonstrate performance against them. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the information provided, specifically addressing your numbered points, and highlighting what is not present in the document:

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

This information is not present in the provided document in the form of a table of specific acceptance criteria. The document states that the device achieved "successful hemostasis without occurrence of re-bleeding or radial artery occlusion" and that the "mean time to achieve successful hemostasis was significantly shorter" in one study. These are performance observations, but not defined acceptance criteria against which the device was measured for regulatory clearance in this specific document.

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 Sizes:
  • Study 1: 30 patients
  • Study 2: 20 patients
• Data Provenance: The studies were described as "confirmatory clinical studies performed by the company." The provenance (country of origin) is not explicitly stated. They were prospective studies as patients were "randomized into cohorts."

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)

This information is not present in the document. The studies assessed clinical outcomes directly, observed by the study personnel, rather than relying on a separate ground truth established by experts.

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

This information is not present in the document. Clinical studies typically have protocols for assessing outcomes, but the specific adjudication method for the test set is not detailed here.

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 is not applicable as the device is a hemostatic dressing, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.

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 hemostatic dressing. The device is used by humans but it does not have a "standalone" algorithmic performance in the way an AI diagnostic tool would. Its performance is intrinsic to its physical and chemical properties and how it interacts with the patient's physiology.

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

The "ground truth" for the clinical studies appears to be the directly observed clinical outcomes data related to hemostasis, re-bleeding, and radial artery occlusion. In Study 1, it also included the "mean time to achieve successful hemostasis."

8. The sample size for the training set

This is not applicable as the device is a physical hemostatic dressing, not an AI or machine learning algorithm that requires a training set.

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

This is not applicable as the device is a physical hemostatic dressing, not an AI or machine learning algorithm.

Summary of Device Performance (from the document, without explicit acceptance criteria):

• Study 1 (30 patients):
  • Achieved successful hemostasis without re-bleeding or radial artery occlusion in all patients treated with QuikClot® Radial®.
  • Mean time to achieve successful hemostasis was significantly shorter for QuikClot® Radial® compared to the standard of care (TR Band).
  • No major complications reported.
• Study 2 (20 patients):
  • Achieved successful hemostasis without re-bleeding or radial artery occlusion in all patients treated with QuikClot® Radial®.
  • No major complications reported.

In essence, the document confirms the device's safety and efficacy based on two small clinical studies and its substantial equivalence to an existing predicate device with a history of clinical data. It emphasizes that differences between the subject and predicate devices do not raise new safety or effectiveness concerns.

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D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

The D2 Hemostatic Dressing is composed of kaolin (hemostatic agent) bound to a non-woven gauze (polyester-rayon substrate). D2 Hemostatic Dressing is provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound.

The provided text details the 510(k) summary for the Z-Medica, LLC D2 Hemostatic Dressing, which focuses on demonstrating substantial equivalence to a predicate device rather than defining acceptance criteria for novel performance claims. As such, the document does not explicitly state "acceptance criteria" for the device's performance in the typical sense of a target metric to be achieved. Instead, it describes comparative performance testing against a legally marketed predicate device to show that the D2 Hemostatic Dressing is "as safe and as effective" as the predicate.

However, based on the information provided, we can infer the "acceptance criteria" as the device demonstrating performance similar to the predicate devices in controlling bleeding.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the specific number of animals (swine) used in each "in vivo" efficacy study. It refers to these as "swine model" and "Yorkshire Swine femoral artery punch injury model."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: The "in vivo testing evaluated the efficacy" and "The results of bench and safety testing indicated" suggests these were prospective studies specifically conducted for the 510(k) submission.

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

Not applicable. The ground truth for the efficacy studies was likely objective measurements of bleeding control in animal models, not expert consensus on interpretations. For biocompatibility, it was based on standardized ISO testing protocols.

4. Adjudication method for the test set

Not applicable. As noted above, the ground truth was based on objective measurements and standardized testing, not expert adjudication of subjective assessments.

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 medical dressing, not an AI-powered diagnostic or assistive tool, so an MRMC study with human readers and AI assistance 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 (hemostatic dressing), not an algorithm.

7. The type of ground truth used

• Biocompatibility: Ground truth was established through standardized international (ISO) testing methods (e.g., L929 Neutral Red Uptake, irritation, sensitization, systemic injection, genotoxicity, subcutaneous implantation assays).
• Hemostatic Efficacy: Ground truth was established through direct observation and measurement of bleeding control in "in vivo" animal (swine) models. This would imply objective metrics like time to hemostasis, amount of blood loss, or effectiveness in stopping bleeding.

8. The sample size for the training set

Not applicable. The D2 Hemostatic Dressing 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 there is no "training set" for this type of device.

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QuikClot® Hemostatic Dressing is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions.

It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

The QuikClot Hemostatic Dressing utilizes a layered clay hemostat, kaolin USP, which is bound to medical gauze using glycerin USP. QuikClot Hemostatic Dressings are provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound. The QuikClot Hemostatic Dressing that is the subject of this submission is described in detail in K072474.

The provided text describes a 510(k) premarket notification for the QuikClot Hemostatic Dressing. The submission aims to obtain a new indication for a previously cleared device, the QuikClot eX, and asserts substantial equivalence to a predicate device, the HemCon ChitoFlex Surgical Dressing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state quantitative acceptance criteria or a specific table detailing "reported device performance" against those criteria in the way a typical diagnostic or AI device study would. Instead, the "acceptance criteria" are implied by the requirements for demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and efficacy.

The device performance is described qualitatively and through the results of specific tests.

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

The document mentions "in vivo testing" for efficacy and various biocompatibility tests. However, it does not specify the sample sizes for these tests (e.g., number of animals or specific experimental units). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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)

This information is not applicable as the device is a hemostatic dressing, not a diagnostic device requiring expert interpretation for ground truth establishment. The efficacy and safety are assessed through biological and physiological measurements.

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

This information is not applicable as the device is a hemostatic dressing and does not involve adjudication by multiple experts for interpretive results.

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 a hemostatic dressing and does not involve human readers or AI assistance.

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 a hemostatic dressing and does not involve algorithms or human-in-the-loop performance.

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

For the safety testing (biocompatibility), the "ground truth" is established through standardized laboratory assays and observations as defined by ISO 10993 series and FDA guidance (G95-1). The conclusions (e.g., "Non-cytotoxic," "Non-irritating," "Non-toxic") are direct results of these validated tests.

For efficacy, the "ground truth" for "achieving hemostasis in traumatic wounds" would be based on physiological measures, such as time to cessation of bleeding, blood loss, or other objective endpoints observed during the "in vivo testing." While the specific metrics are not detailed, it would be direct observation of physiological outcomes.

8. The sample size for the training set

This information is not applicable as the device is a medical device (hemostatic dressing) and does not involve a "training set" in the context of machine learning or AI models. The development and testing paradigm are based on traditional medical device validation.

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

This information is not applicable for the same reason as above; there is no "training set" for this type of medical device.

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