(379 days)
OTC: PRO QR Powder for minor external bleeding from wounds and procedures is intended for use as a topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. Rx: PRO QR Powder for moderate to severe external bleeding wounds is intended for emergency use of temporary external treatment for controlling moderate to severe bleeding.
Components - QR Powder is composed of two main components: potassium iron oxyacid salt, and a hydrophilic polymer. Mechanism of Action - QR Powder achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, QR Powder quickly forms a strong seal that completely covers the wound.
The document provided is a 510(k) premarket notification for the PRO QR (Quick Relief)® Powder, indicating substantial equivalence to already marketed predicate devices. Unfortunately, the document does not contain the specific acceptance criteria and detailed study results in a format that directly addresses all the points requested.
Here's an attempt to extract relevant information and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, AUC, or other quantitative measures typically found in a clinical study report for AI/CADe devices. Instead, it relies on demonstrating substantial equivalence through various studies.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Summary) |
|---|---|
| Biocompatibility: | The device underwent comprehensive biocompatibility testing including Cytotoxicity, Sensitization, Irritation (skin and mucosal surface), Acute Systemic Toxicity, Ames Mutagenicity, Endotoxin, Pyrogen, Analysis of Hydrophilic Polymer for Styrene, Ethylstyrene and DVB, Histologic Assessment of Acute PRO QR Exposure in a Porcine Wound Model; IR Analysis of QR Powder and hydrophilic polymer for cellulose, XRD and XRF for potassium iron oxyacid salt impurities. The conclusion states that "PRO QR Powder is safe and effective." |
| Hemostasis Efficacy: (for moderate to severe bleeding) | "QR Powder has been shown in testing to be equivalent to, if not better than, the QuikClot Powder predicate device in rapid hemorrhage control in a swine model of lethal arterial extremity." |
| Safety Advantage: (vs. predicate) | "In addition study results for safety showed that QR Powder provided a significant advantage over QuikClot." |
| Efficacy in vascular access procedures: | "Safety and efficacy was also demonstrated for bleeding control in vascular access procedures using a swine model both acutely and subchronically (2 weeks)." |
| Physical/Chemical Properties (In vitro): | In vitro testing included Absorption Study, Acid Base Interaction Study, Scanning Electron Microscopy (SEM) Analysis, Potassium (K) and Iron (Fe) Extraction, Gravimetric Determinations of PRO QR, Hemostatic Properties of PRO QR Powder as a function of its Quantitative Stability-Indicating Moisture and Potassium Iron Oxyacid Salt content. The conclusion states: "PRO QR Powder induce hemostasis by fluid dehydration, protein coagulation and agglomeration the same as PRO QR (K070520) predicate device." |
| Substantial Equivalence to Predicate Devices (K070520, K021678, K013390): | "PRO QR Powder has substantially equivalent indications to the HemaDerm (K021678) and QuikClot (K013390) predicates... PRO QR Powder (K080210) uses the same safe and effective technology as PRO QR (K070520)." The devices are similar in materials, absorbency, sterility, and single-use functionality. |
Missing Information/Not Applicable (N/A) for AI/CADe Specifics:
The questions you've posed (sample size for test set, experts, adjudication, MRMC, standalone performance, training set details) are highly specific to studies evaluating Artificial Intelligence (AI) or Computer-Aided Detection (CADe) devices, especially those involving image interpretation. The device described in this 510(k) (PRO QR Powder) is a topical hemostatic agent, not an AI/CADe device. Therefore, many of the requested data points are not applicable to this type of medical device submission.
Here's why and what can be inferred for the relevant parts:
2. Sample size used for the test set and the data provenance:
- N/A for typical test set as this is not an AI/CADe device.
- For the animal studies: "swine model" is mentioned for three studies. The exact number of swine used is not specified in the summary.
- Data provenance: "swine model" indicates animal studies. The country of origin is not specified but generally, such studies for US FDA submissions are conducted in accredited facilities in the US or internationally under GLP (Good Laboratory Practice) standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A, as ground truth involving human expert interpretation is not relevant for this device. Animal study outcomes would be assessed by veterinarians or researchers experienced in animal models of hemorrhagic injury.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A, as adjudication is typically for discordant interpretations in human reader studies, not for the performance of a topical hemostatic agent. The assessment in animal models would follow specific experimental protocols.
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:
- N/A, no MRMC study was conducted as this is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A, as this is not an AI/CADe algorithm. The device's performance is standalone in its application as a hemostatic agent.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For animal studies assessing hemostasis, the ground truth would likely involve direct observation of bleeding cessation, measurement of blood loss, and potentially physiological parameters (e.g., blood pressure) and survival rates. Histologic assessment was mentioned for the porcine wound model (biocompatibility).
8. The sample size for the training set:
- N/A, as this device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- N/A, as there is no training set for this type of device.
In summary: The provided document is a 510(k) summary for a hemostatic powder, not an AI/CADe device. Therefore, a direct mapping to your specific questions about AI/CADe acceptance criteria, study design, and performance metrics is not possible. The submission focuses on demonstrating safety and efficacy through biocompatibility tests, in vitro studies, and animal models, and ultimately, substantial equivalence to previously cleared predicate devices.
N/A