(120 days)
OTC: NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.
Rx: NuStat is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions, surgical wounds (operative, dermatological, etc.) and traumatic injuries.
The Nustat XR Hemostatic Dressing is a hemostatic wound dressing that composed of continuous filament silica and bamboo cellulose. The distribution of cellulose and silica fibers in each dressing is 65% silica fiber, 35% cellulose.
The dressings are available in various sizes in either Tyvek or LDPE pouched configurations and are available with or without the Radiopaque thread.
The dressings are either z-folded or rolled into a medical grade Tyvek pouch or LDPE pouch which is then sterilized using gamma irradiation to a sterility assurance level of 10-6.
The NuStat® range of hemostatic wound dressings have a number of hemostatic properties which enhance the ability of the dressing to temporarily control bleeding. The cellulose and continuous filament silica influence the contact activation pathway of the coagulation cascade by absorbing blood fluids, resulting in the localized concentration of platelets and clotting factors. The negatively charged fibers of the continuous filament silica simulate the negative ions secreted by activated platelets, which further influence the coagulation cascade. The radiopaque element allows for detection via x-ray.
The provided text describes the Nustat XR Hemostatic Dressing and its substantial equivalence to predicate devices, but does not explicitly state specific acceptance criteria or a dedicated study proving the device meets those criteria in a quantitative manner.
Instead, the performance testing section details various tests conducted to demonstrate substantial equivalence to predicate devices. This means the device is considered safe and effective because it performs as well as or similarly to a device already legally marketed.
However, based on the provided text, I can extract and infer information to address your request as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not provided, I will construct a table based on the performance tests described, indicating what was evaluated and the general outcome (which is "passing" or "substantially equivalent" in relation to predicate devices).
| Acceptance Criteria Category (Inferred) | Specific Test Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-5: Cytotoxicity (MEM Elution) | Passing results |
| ISO 10993-10: Sensitization (Guinea Pig Maximization) | Passing results | |
| ISO 10993-10: Irritation (Intracutaneous Reactivity Test) | Passing results | |
| ISO 10993-4: Hemolysis | Passing results | |
| ISO 10993-11: Acute Systemic Toxicity | Passing results | |
| Hemostatic Effectiveness | Activated Partial Thromboplastin Time (aPTT) comparison | Demonstrated substantial equivalence to two predicate devices, indicating similar performance in influencing the coagulation cascade. |
| Animal Testing (Swine femoral model) - Primary Endpoints: | Demonstrated adequate performance to show substantial equivalence to the predicate for the conditions tested. |
- Immediate hemostasis upon release of manual pressure (T0)
- Hemostasis at 60 minutes
- Re-bleeding during the 60-minute observation period |
| Product Stability/Integrity | Age-Testing (Packaging integrity per ASTM F2096) | Package remained intact after accelerated aging conditions. |
| | Age-Testing (aPTT on aged product) | Demonstrated that the product was functioning and was substantially equivalent to the predicate device after accelerated aging. |
| Radiopacity | Imaging analysis for radiopaque thread | Met the requirements of ASTM F640-07. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The text does not specify sample sizes (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation).
- Laboratory Verification Testing (aPTT): The text does not specify the number of samples tested for aPTT.
- Animal Testing (Swine femoral model): 15 swine were used. The data provenance is a "complex penetrating femoral artery groin injury" model, which is a common experimental model for hemostatic devices. The country of origin for the study is not specified but is presumably where the company is based or where the contract research organization operates. This is a prospective study since devices were randomized and assigned to animals and observed for specific endpoints.
- Age-Testing & Radiopacity: Sample sizes are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information provided about experts establishing "ground truth" in the classical sense for this type of submission.
- For biocompatibility and laboratory verification, the "ground truth" is typically defined by established laboratory standards and predicate device performance.
- For the animal study, the "ground truth" for endpoints like hemostasis and re-bleeding would be directly observed by the study personnel (e.g., veterinarians, researchers) involved in the experiment. Their qualifications are not explicitly mentioned but would be assumed to be appropriate for conducting animal studies and assessing physiological responses.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for any of the performance tests. The animal study results would likely be determined by direct observation and measurement by the study team.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices, especially those involving AI for image analysis, where human readers interpret results. The Nustat XR is a physical hemostatic dressing, so MRMC studies involving AI assistance are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This concept is relevant for AI-powered diagnostic or interpretive algorithms. The Nustat XR is a physical medical device.
7. The Type of Ground Truth Used
- Biocompatibility: Established ISO standards and laboratory methods define successful outcomes.
- Laboratory Verification (aPTT): Comparison against the performance of legally marketed predicate devices serves as the "ground truth" for substantial equivalence.
- Animal Testing: Direct physiological observation (immediate hemostasis, hemostasis at 60 minutes, re-bleeding) in the swine model serves as the ground truth.
- Age-Testing: ASTM F2096 standards for packaging integrity and comparison to predicate device aPTT for product function.
- Radiopacity: ASTM F640-07 requirements for radiopaque elements.
Essentially, the "ground truth" for this device's performance demonstration is based on established scientific methods, biological responses in a live animal model, engineering standards, and direct comparison to predicate devices, rather than human expert consensus on interpretations of data.
8. The Sample Size for the Training Set
There is no mention of a "training set" as this device is not an AI/machine learning algorithm. The closest equivalent would be the data generated during the product development and manufacturing process, but this is not organized as a "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical device.
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