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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.

2. Sample Sizes and Data Provenance

• Pre-clinical Study (Swine Model):

  • Sample Size: 10 pigs (5 treated with Plavix, 5 with Coumadin). 187 intra-abdominal vascular injuries were tested across these animals.
  • Data Provenance: United States (US), prospective animal model study.

• Trabattoni D, et al. (2010):

  • Sample Size: 40 human subjects.
  • Data Provenance: Outside US (OUS), prospective single-arm pilot trial.

• Trabattoni D, et al. (2011):

  • Sample Size: 200 human subjects (100 in QuikClot group, 100 in manual compression control group).
  • Data Provenance: Outside US (OUS), prospective randomized controlled trial.

• Politi L, et al. (2011):

  • Sample Size: 120 human subjects (Group 1 (QuikClot) n=50; Group 2 (control short time) n=20; Group 3 (control 2 hours) n=50). The study stopped enrolling Group 2 subjects due to unethically high bleeding rates.
  • Data Provenance: Outside US (OUS), randomized clinical trial.

• Post-Market Data:

  • Sample Size: 138 Product Evaluation Forms. (Number of patients not explicitly stated, but implies at least 138 instances of use).
  • Data Provenance: United States (US), real-world usage reports (retrospective collection of feedback forms).

3. Number of Experts and Qualifications for Ground Truth

• Animal Study: "One investigator" from a US site. Specific qualifications (e.g., veterinarian, surgeon) are not detailed. The ground truth (success/failure of bleeding cessation) was based on direct observation.
• Clinical Studies (Trabattoni and Politi): These were peer-reviewed clinical publications. The "ground truth" for outcomes like bleeding cessation, hemostasis time, ambulation, and adverse events would have been established by the study investigators (physicians/clinicians) based on direct observation, medical records, and established clinical protocols.
  • Trabattoni (2010): Three investigators from one OUS site.
  • Trabattoni (2011): Six investigators from one OUS site.
  • Politi (2011): Ten investigators from one OUS site.
  • Specific qualifications of these investigators (e.g., interventional cardiologist, years of experience) are not provided in this document, but being published implies they were qualified medical professionals.
• Post-Market Data: The "ground truth" for success/failure and complications was based on reports from "several health care institutions in the US." These would be the observations and assessments of the healthcare professionals using the device. Specific qualifications or number of individual experts are not given for this aggregated data.

4. Adjudication Method for the Test Set

The provided summary does not detail explicit adjudication methods for events or outcomes in the clinical studies (e.g., an independent clinical events committee). For the animal study, the single investigator would have determined success/failure. For the human studies, the study endpoints and assessment protocols would have guided the determination of outcomes by the investigators. It does not mention complex multi-reader/adjudicator processes.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned. The clinical studies (Trabattoni (2011) and Politi (2011)) were randomized controlled trials comparing the device to standard care (manual compression), but they do not appear to be structured as MRMC studies that typically evaluate reader performance on cases with and without AI assistance. The studies here compare device performance (QuikClot) against a traditional method (manual compression) from the perspective of patient outcomes.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only without human-in-the-loop performance) study was not done. The QuikClot Interventional-A Hemostatic Bandage is a physical medical device (hemostatic dressing), not an algorithm or AI. Its performance is intrinsically linked to its application by a human healthcare professional as an adjunct to manual compression. The studies assess the device's effectiveness when used by humans.

7. Type of Ground Truth Used

• Pre-clinical Animal Study: Direct observation of bleeding cessation in a live animal model (surgical wounds).
• Clinical Studies (Trabattoni and Politi): Clinical observations, measurements (hemostasis time, ambulation time), and documented adverse events by medical investigators. This aligns with clinical outcomes data and expert assessment.
• Post-Market Data: Real-world clinical outcomes and observations reported by healthcare professionals through product evaluation forms.

8. Sample Size for the Training Set

The provided document describes the QuikClot Interventional-A Hemostatic Bandage as a modified version of a previously cleared device (K090620), with the primary change being an expanded indication for use in anticoagulated patients. The device itself is a physical product (kaolin-impregnated gauze), not a machine learning model. Therefore, the concept of a "training set" for an algorithm doesn't apply directly.

The device's development and prior clearance (K090620 and K072474) would have involved earlier testing and validation. The studies described in this K120782 submission serve as the test set to demonstrate the safety and effectiveness of the device for the new indication (use in anticoagulated patients).

If we interpret "training set" loosely as the accumulated evidence that informs the device's design and previous clearances:

• The device's core technology (kaolin hemostatic properties) is based on fundamental scientific principles and earlier research not detailed here.
• The original QuikClot Hemostatic Dressings (K072474) and QuikClot Interventional Hemostatic Bandage (K090620) underwent their own performance testing, which would form a "training set" of evidence for the device's general efficacy before this specific extended indication.

Relevant "Training" (Prior Evidence) mentioned:

• K090620: QuikClot Interventional Dressings
• K072474: Original QuikClot Hemostatic Dressings

The specific sample sizes for these prior clearances are not provided in the K120782 document.

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

As explained above, since this is a physical medical device and not an AI algorithm, the concept of establishing ground truth for a "training set" in the machine learning sense doesn't apply. Instead, the prior evidence supporting the initial clearance of the QuikClot Interventional Hemostatic Bandage (K090620) and its predecessors (K072474) would have involved:

• Non-clinical (Bench and Animal) Testing: Biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, repeat exposure systemic toxicity), likely following ISO standards. These would have established the safety profile and basic hemostatic function.
• Clinical Data: The original submissions would have included clinical data to demonstrate the device's effectiveness for its initial indications. This would involve clinical observations, measurements, and adverse event reporting, similar to how ground truth was established for the "test set" studies presented in K120782.

The K120782 document focuses on adding a new indication to an already cleared and proven device. The studies presented within K120782 specifically address the safety and efficacy of the device (with its existing technology and design) when used in the new patient population (anticoagulated patients).

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