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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).

• 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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D2 Hemostatic Dressing is intended for use as a hemostatic dressing for the temporary control of severely bleeding wounds such as surgical wounds and traumatic injuries.

The D2 Hemostatic Dressing is composed of kaolin (hemostatic agent) bound to a non-woven gauze (polyester-rayon substrate). D2 Hemostatic Dressing is provided in a sterile, intuitive, simple to use dressing format that conforms readily to the wound.

The provided text details the 510(k) summary for the Z-Medica, LLC D2 Hemostatic Dressing, which focuses on demonstrating substantial equivalence to a predicate device rather than defining acceptance criteria for novel performance claims. As such, the document does not explicitly state "acceptance criteria" for the device's performance in the typical sense of a target metric to be achieved. Instead, it describes comparative performance testing against a legally marketed predicate device to show that the D2 Hemostatic Dressing is "as safe and as effective" as the predicate.

However, based on the information provided, we can infer the "acceptance criteria" as the device demonstrating performance similar to the predicate devices in controlling bleeding.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not explicitly state the specific number of animals (swine) used in each "in vivo" efficacy study. It refers to these as "swine model" and "Yorkshire Swine femoral artery punch injury model."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: The "in vivo testing evaluated the efficacy" and "The results of bench and safety testing indicated" suggests these were prospective studies specifically conducted for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for the efficacy studies was likely objective measurements of bleeding control in animal models, not expert consensus on interpretations. For biocompatibility, it was based on standardized ISO testing protocols.

4. Adjudication method for the test set

Not applicable. As noted above, the ground truth was based on objective measurements and standardized testing, not expert adjudication of subjective assessments.

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

Not applicable. This device is a medical dressing, not an AI-powered diagnostic or assistive tool, so an MRMC study with human readers and AI assistance is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (hemostatic dressing), not an algorithm.

7. The type of ground truth used

• Biocompatibility: Ground truth was established through standardized international (ISO) testing methods (e.g., L929 Neutral Red Uptake, irritation, sensitization, systemic injection, genotoxicity, subcutaneous implantation assays).
• Hemostatic Efficacy: Ground truth was established through direct observation and measurement of bleeding control in "in vivo" animal (swine) models. This would imply objective metrics like time to hemostasis, amount of blood loss, or effectiveness in stopping bleeding.

8. The sample size for the training set

Not applicable. The D2 Hemostatic Dressing is a physical medical device, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device.

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