(576 days)
Prescription use: ATD is intended for temporary external use to control traumatic bleeding. Over-The-Counter-Use: ATD is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
ATD is composed of an absorbent pad of carboxymethyl cellulose impregnated with ionic silver and then uniformly coated with silicon particles for the purpose of promoting rapid hemostasis. The hemostatic mechanism of silicon in ATD is through, contact pathway activation (intrinsic) of clot formation. The device is provided as a sterile 10 cm x 100 cm strip that is Z-folded and vacuum packed. The dressing is placed directly on the site of bleeding with applied pressure as long as necessary or until the time of definitive care.
The provided FDA 510(k) summary for the Advanced Trauma Dressing (ATD) mainly focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and explicitly proving device performance against them. The information provided is typical for a 510(k) submission, emphasizing comparison with existing cleared devices.
Therefore, many of the requested details about specific acceptance criteria and a detailed study proving performance against them, especially for AI/ML devices (which this is not), are not present in the provided text.
However, I can extract and infer some information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a medical device (a trauma dressing), the "acceptance criteria" are generally framed as demonstrating substantial equivalence to a predicate device. The performance is reported in comparison to the predicate devices.
| Acceptance Criteria (Inferred for 510(k)) | Reported Device Performance (ATD vs. Predicate) |
|---|---|
| Intended Use Equivalence: Same indications for use as predicate devices. | ATD has the "same intended use" as QuikClot®eX (K072474) and Aquacel® Ag (K080383). |
| Technological Characteristics Equivalence: Similar materials and mechanism of action. | ATD consists of the "same absorbent material (carboxymethyl cellulose) and contains the same concentration of silver ions as Aquacel® Ag." ATD is coated with an "equivalent hemostatic agent (slicon vs silicate based particles) that are in the same size regime as QuikClot®eX," resulting in an "identical mechanism of action." |
| Performance Equivalence: Comparable hemostatic properties and biocompatibility. | "Bench and animal testing has demonstrated equivalency of performance between ATD and the predicate devices." ATD showed "equivalent hemostatic properties to QuikClot-eX in bench top coagulation studies and in 3 separate injuries performed on swine." ATD also demonstrated "biocompatibility through the same four biocompatibility tests" as QuikClot-eX. |
| Sterilization Equivalence: Same sterilization method as predicate. | ATD is "provided sterile by gamma sterilization which is the same as the predicate." |
| Safety and Effectiveness: No new questions of safety or effectiveness raised compared to predicates. | "no new questions of safety or effectiveness have been raised." |
2. Sample size used for the test set and the data provenance
- Test Set Description: The performance data primarily comes from:
- Bench top coagulation studies.
- 3 separate in vivo porcine models of acute bleeding.
- Sample Size: The exact sample size for the bench studies and the number of animals used in the porcine models (e.g., how many pigs, how many injuries per pig) are not specified in the provided document.
- Data Provenance: The study was conducted by Nanosys, Inc. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but animal studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document as it's not relevant for a medical device 510(k) submission that relies on physical and biological performance testing rather than expert-derived ground truth (as might be the case for an AI/ML diagnostic device).
4. Adjudication method for the test set
This information is not provided. Given the nature of the in vivo and bench testing (e.g., measuring clotting time, bleeding volume), formal expert adjudication methods like 2+1 or 3+1 are typically not applicable. The assessment would likely be based on quantitative measurements.
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
No, an MRMC comparative effectiveness study was not done. This device is a trauma dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical trauma dressing, not an algorithm.
7. The type of ground truth used
For this device, the "ground truth" for performance evaluation was established through:
- Quantitative measurements in bench top coagulation studies: This would involve objective metrics of clotting.
- Physiological outcomes in in vivo porcine models: This would involve direct observation and measurement of bleeding control in a live animal model (e.g., time to hemostasis, total blood loss).
8. The sample size for the training set
This question is not applicable. The device is a physical trauma dressing and does not involve a training set as an AI/ML algorithm would.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
N/A