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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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NuStat is indicated to temporarily control bleeding in minor cuts, lacerations, punctures, abrasions and incisions.

NuStat XR is a single-use hemostatic wound dressing applied externally with mechanical compression to temporarily control bleeding in lacerations, punctures, abrasions and incisions.

The NuStat® range of hemostatic wound dressings are textiles composed of continuous filament silica and bamboo cellulose. This submission adds a radiopaque filament to the NuStat XR models of the legally marketed dressing. The dressings are produced in various sizes to accommodate different wound sizes, ranging from a width of 2" to 8" and length of 2" to 60". The dressings are either z-folded or rolled into a medical grade Tyvek pouch which is then sterilized using gamma irradiation to a SAL 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® Hemostatic Dressing, an unclassified medical device. While it mentions performance data, this primarily pertains to biocompatibility, sterility, and radiopacity, and does not include a study proving the device meets acceptance criteria related to its primary function of controlling bleeding. The document explicitly states that efficacy testing was not required for this submission.

Therefore, many of the requested sections about acceptance criteria and a study proving device performance in that context cannot be directly extracted from the provided text. However, I can provide information based on what is available:

1. A table of acceptance criteria and the reported device performance

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

The document does not provide specific sample sizes for the biocompatibility, sterility, or radiopacity tests. It implies these were standard tests performed according to recognized international standards. Data provenance is not specified, but these are likely laboratory tests conducted for regulatory submission.

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. The tests described (biocompatibility, sterility, radiopacity) are typically performed in a laboratory setting by qualified technicians following established protocols, rather than requiring expert consensus on a ground truth in the way a diagnostic AI model might.

4. Adjudication method for the test set

Not applicable for the types of tests described (biocompatibility, sterility, radiopacity). These are objective measurements against defined standards.

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 study is not mentioned. This device is a hemostatic dressing, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical hemostatic dressing, not an algorithm or AI product.

7. The type of ground truth used

For the biocompatibility, sterility, and radiopacity tests, the "ground truth" would be the established scientific and regulatory standards/benchmarks as defined by ISO and ASTM, against which the device's performance was measured. For example, for sterility, the ground truth is a 10⁻⁶ SAL.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device.

Key Clarification from the Document Regarding Efficacy:

The document explicitly states: "In vivo and in vitro testing to evaluate the efficacy of the NuStat® range of dressings was not required as the addition of a radiopaque element does not affect the performance of the device as a hemostatic wound dressing." This indicates that for this specific 510(k) submission (K142363), the efficacy of the hemostatic function was considered established through the predicate device (Stasilon FR K072890), and the new submission focused on the safety aspects related to the radiopaque element and general device properties. Therefore, the document does not contain a study "proving the device meets acceptance criteria" for its primary hemostatic function.

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