(98 days)
NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are intended for use under the care of a health care professional as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites.
The Hemostasis NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are sterile, topical wound dressings comprised of plant based polysaccharides. The hemostatic particles and foam quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
The provided text is a 510(k) summary for the NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge. It describes the device, its indications for use, and claims substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or an explicit study with detailed performance metrics.
However, based on the information provided, we can infer some aspects and highlight what is missing regarding the acceptance criteria and a detailed study.
Here's an analysis of the provided information against your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility: Meet ISO 10993 standards and FDA guidance for toxicology profiles. | "The NexState Topical Hemostat Powder and NexFoam Topical Hemostat Sponge passed biocompatibility requirements for their intended use." |
| Sterilization: Sterilized using a validated gamma radiation method. | "The NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge are sterilized using a validated gamma radiation method." |
| Physical and Functional Requirements: Meet design verification specifications. | "Design verification testing was performed on NexStat® Topical Hemostat Powder and NexFoam® Topical Hemostat Sponge to demonstrate physical and functional requirements were met." |
| Hemostasis Performance: Perform substantially equivalent to predicate devices (TraumArrest®/BleedArrest® [K070211] and HemaDerm™/MPHT™ [K033666]) in an animal model. | "Comparative hemostasis testing in an animal model demonstrated the devices performed substantially equivalent to predicate devices." |
Critique: The document states that the devices met these criteria without providing the specific quantitative thresholds for "passed," "validated," "met," or "substantially equivalent." For instance, it doesn't specify what level of hemostasis (e.g., time to hemostasis, volume of blood loss) was considered "substantially equivalent" to the predicates.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: This information is not provided in the document. The "comparative hemostasis testing in an animal model" doesn't specify the number of animals or the number of test applications.
- Data Provenance: The study was conducted as "comparative hemostasis testing in an animal model." The country of origin of the data is not specified, but given the submitter (Hemostasis, LLC) is located in St. Paul, Minnesota, and the submission is to the FDA, it is highly likely the data was generated in the United States. The study type is prospective in nature, as it was specifically conducted for this 510(k) submission to demonstrate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable as the ground truth was established through animal model performance testing, not human expert consensus on diagnostic images or clinical assessments requiring multiple expert reviewers.
4. Adjudication Method for the Test Set
- This information is not applicable as the ground truth was established through animal model performance testing, not human expert consensus.
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 type of study is relevant for AI/radiology devices where human reader performance is augmented by AI. The NexStat® and NexFoam® are topical hemostats, not AI-powered diagnostic tools.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a physical hemostat, not an algorithm. Its performance is inherent to its physical and chemical properties and interaction with blood, not an algorithmic output. The "animal model" testing is a standalone test of the device itself.
7. The Type of Ground Truth Used
- The primary ground truth for performance was established through direct observation and measurement of hemostasis in an animal model. This would likely involve metrics such as time to hemostasis, blood loss, and potentially the quality of the resulting clot, or comparison to a control/predicate device under controlled experimental conditions.
8. The Sample Size for the Training Set
- This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The "design verification testing" and "animal model" testing are evaluation studies, not training sets.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no "training set" for this physical medical device.
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