(52 days)
HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), minor cuts and lacerations.
HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
Medafor. Inc.'s HemaDerm™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells.
The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
This document describes the HemaDerm™ containing Hemadex™ Clotting Beads, a device intended for use as a topical dressing for the temporary treatment of severely bleeding wounds and for the local management and control of bleeding from percutaneous access sites.
Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in numerical thresholds for performance metrics. Instead, it relies on demonstrating equivalence to predicate devices and showing effectiveness and safety through various studies. The reported performance is qualitative and framed around achieving "accelerated rate of bleeding control" and "effectively control bleeding."
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance (HemaDerm™) |
|---|---|---|
| Efficacy | Accelerated rate of bleeding control | "demonstrated an accelerated rate of bleeding control in the presence of the particles" |
| Effective control of bleeding | "The device has been shown to effectively control bleeding." | |
| Safety | Biocompatibility | "Biological testing per ISO 10993-1 and FDA G95-1 demonstrates the biological compatibility of HemaDerm™." |
| Sterility | "Sterilization validation of the Cobalt-60 gamma irradiation process per AAMI / ANSI / ISO 11137 and EN552 demonstrate a sterility assurance level (SAL) of 1 X 10-6." | |
| Equivalence | Equivalent performance to predicates | "will perform in a manner equivalent and similar to the predicates." |
| Physiological Appropriateness | Physiologically appropriate | "demonstrated to be procedurally and physiologically appropriate in medical applications." |
2. Sample Size Used for the Test Set and Data Provenance:
- Human Clinical Investigation: The document mentions "A non-significant risk clinical investigation using human subjects."
- Sample Size: The exact sample size for the human clinical investigation is not specified.
- Data Provenance: The document does not explicitly state the country of origin, but given the 510(k) submission to the FDA, it is highly likely to be prospective data collected within the United States.
- Animal Studies: "Animal testing using various animal models."
- Sample Size: The exact sample size for the animal studies is not specified.
- Data Provenance: Not specified, but generally, animal studies for FDA submissions are conducted under controlled conditions, likely prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Human Clinical Investigation: The study involved a "side by side comparison of HemaDerm™ and a control of normal clotting." The ground truth for bleeding control would likely be established by the healthcare professionals directly observing and managing the wounds.
- Number of Experts: Not specified.
- Qualifications of Experts: Implied to be "health care professional[s]" as the product is intended for use under their care. No specific qualifications (e.g., years of experience, specialty) are provided.
4. Adjudication Method for the Test Set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "side by side comparison" in the human clinical investigation suggests direct observation and assessment by the healthcare professionals involved in the study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
- No, an MRMC comparative effectiveness study was not explicitly described. The human clinical investigation mentioned was a "side by side comparison... and a control of normal clotting," which is a comparative study, but not specifically an MRMC study with multiple readers assessing performance against AI assistance.
- Effect Size: Not applicable, as an MRMC study with AI assistance was not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. HemaDerm™ is a medical device (clotting beads), not an AI algorithm. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used:
- Human Clinical Investigation: The ground truth for efficacy appears to be based on clinical observation and assessment by healthcare professionals (e.g., direct observation of bleeding cessation, time to hemostasis, comparison to normal clotting). This could be categorized as expert clinical assessment and observation.
- Animal Studies: The ground truth for efficacy in animal models would be based on direct observation of bleeding control and potentially other physiological markers within the animal models.
- Biocompatibility: Ground truth established against ISO 10993-1 and FDA G95-1 standards (biological compatibility criteria).
- Sterilization: Ground truth established against AAMI / ANSI / ISO 11137 and EN552 standards for sterility assurance level.
8. The Sample Size for the Training Set:
- Not applicable. HemaDerm™ is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, HemaDerm™ is a physical medical device.
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