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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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