(162 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility (e.g., non-toxic, non-irritating, non-sensitizing) | Met ISO 10993 requirements for a surface-contacting device (breached/compromised surfaces, prolonged exposure). Cytotoxicity, irritation, sensitization, and acute systemic toxicity testing performed under GLP conditions per standard protocols. |
| Hemostatic Efficacy (comparable to predicate) | In two separate in vivo swine studies (femoral perforation injury and splenic capsular strip injury), the device successfully controlled bleeding at least as well as a competitive hemostatic product used as a reference. |
| Sterility (Sterility Assurance Level) | A sterility validation was completed following ISO 11137 requirements, demonstrating a 10^-6 SAL using the VDmax25 method. |
| Radiopacity (detectable via X-ray) | Determined acceptable via testing in accordance with ASTM F640-07 Method C, found equivalent to the ASTM Radiopacity Standard (aluminum sheet). |
| Technological Characteristics | Found to be technologically equivalent to the currently marketed ChitoGauze® XR product. |
| Safety and Efficacy Profile | Concluded to have a safety and efficacy profile substantially equivalent to the predicate device. |
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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