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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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Prometheus ChitoGauze® XR PRO is a hemostatic dressing for the external, temporary control of severely bleeding wounds

Prometheus ChitoGauze® XR PRO is composed of standard polyester/ravon blend nonwoven medical gauze with a radiopaque filament that is coated with chitosan. The dressing is z-folded to the appropriate size and vacuum sealed in a pre-printed foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10-6.

The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding. The radiopaque filament allows for easy detection via X-ray to prevent the dressing from being inadvertently left on the wound.

This document describes the premarket notification (510(k)) and substantial equivalence determination for Prometheus ChitoGauze® XR PRO. It is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

Based on the provided text, the device is considered "unclassified" and the 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria of a novel device. Therefore, a direct analogy to the requested acceptance criteria for an AI/ML device is not fully applicable. However, I can extract and structure the information related to its acceptance and the studies that supported its clearance.

Here's an interpretation of the requested information based on the provided text:

Device: Prometheus ChitoGauze® XR PRO

Regulatory Path: 510(k) Pre-market Notification, relying on Substantial Equivalence

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

As this is a 510(k) based on substantial equivalence to a predicate device (HemCon® ChitoGauze® / ChitoGauze® XR and reference device HemCon GuardaCare™ XR), the "acceptance criteria" are primarily met by demonstrating that the new device is as safe and effective as the predicate. The performance data presented focuses on biological safety and functional equivalence to the predicate.

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

• Biocompatibility Testing: The specific "sample sizes" (e.g., number of animals for in vivo tests, replicates for in vitro tests) are not explicitly stated in the document, only that tests were performed "per standard protocols" under GLP conditions.
• In Vivo Efficacy Testing: Two separate in vivo studies were conducted using swine models. The number of swine or specific test replicates per study is not provided.
  • Study 1: Tested 4 inch by 4 yard size to control bleeding in a 6mm femoral perforation injury in a swine.
  • Study 2: Measured the ability of a two inch by two inch 8-ply size to control bleeding in a splenic capsular strip injury in a swine.
• Radiopacity Testing: Performed per ASTM F640-07 Method C. Specific number of samples tested not specified.
• Sterility Validation: Performed per ISO 11137. Specific number of samples not specified.

Data Provenance: The studies were prospective (conducted specifically for this submission). The origin of the biological models (swine) or test materials is not specified, but it implies laboratory-controlled conditions.

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

This is not applicable in the context of this device. The "ground truth" for non-clinical performance (e.g., hemostasis, biocompatibility) is established through standardized laboratory testing methods and biological models, not through expert human review of medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. This device does not involve human interpretation or adjudication of outputs in the way an AI/ML diagnostic device would. Performance is measured through objective laboratory and animal model endpoints.

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 is a hemostatic dressing, not an AI/ML diagnostic assistance device. Therefore, no MRMC study was performed.

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

Not applicable. This is not an AI/ML algorithm. Its "performance" is its physical and biological function to control bleeding.

7. The type of ground truth used

The "ground truth" for the performance studies was:

• Biocompatibility: Established by adherence to ISO 10993 standards and observed biological responses (e.g., absence of cytotoxicity, irritation, sensitization).
• Hemostatic Efficacy: Established by direct observation and measurement of bleeding control in established animal models (swine femoral perforation and splenic capsular strip injuries), comparing against a reference product.
• Sterility: Established by microbiology testing confirming a 10^-6 Sterility Assurance Level.
• Radiopacity: Established by physical testing against a standardized aluminum sheet.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set. The "design" and "development" would involve standard engineering and material science, not machine learning training.

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

Not applicable (as above).

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