(113 days)
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
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility: Device must be non-cytotoxic, non-irritating, non-sensitizing, non-toxic (systemic), non-mutagenic, and non-toxic (subcutaneous implantation) as per ISO 10993 guidelines. | Cytotoxicity: Non-cytotoxic (L929 Neutral Red Uptake according to ISO 10993-5:2009) |
| Irritation: Non-irritating (ISO 10993-10:2010) | |
| Sensitization: Non-sensitizing (ISO 10993-10:2010) | |
| Systemic Injection (intraperitoneal and intravenous injection): Non-toxic (ISO 10993-11:2006) | |
| Genotoxicity: Non-mutagenic (ISO 10993-3:2003) | |
| Subcutaneous implantation: Non-toxic (ISO 10993-6:2007) | |
| Hemostatic Efficacy: Device performance in controlling bleeding in various wound types (superficial, subcutaneous, splenic, mesenteric, liver, severe traumatic injury) must be similar to legally marketed predicate devices (QuikClot eX and HemCon GuardaCare™ XR Surgical). | Comparison Testing in Swine Model: The performance of D2 Hemostatic Dressing was similar to the predicate devices (QuikClot eX and HemCon GuardaCare™ XR Surgical) in controlling bleeding from wounds such as superficial and subcutaneous injuries, injuries/lacerations to spleen, mesentery, and liver. Conclusion: D2 Hemostatic Dressing is effective in controlling bleeding from wounds. |
| Comparison Testing in Swine Femoral Artery Punch Injury Model: The performance of D2 Hemostatic Dressing was similar to the predicate devices (GuardaCare®) in controlling bleeding from severe traumatic injury. Conclusion: D2 Hemostatic Dressing is effective in controlling bleeding from severe traumatic injury. |
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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