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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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The ChitoGauze™ FUSION™ Wound Packing Kit is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

ChitoGauzeXR is composed of polyester/rayon blend non-woven medical gauze coated with chitosan and with a radiopaque filament attached. The legally marketed ChitoGauzeXR dressing has been modified to co-package the ChitoGauzeXR hemostatic dressing with uncoated polyester/rayon blend non-woven medical gauze (also referred to as "uncoated gauze") to create the ChitoGauze FUSION Wound Packing Kit.

ChitoGauze FUSION may be produced in multiple sizes within the scope of the currently validated sizes of the ChitoGauze family of dressings. Both the ChitoGauzeXR and the uncoated gauze are Z-folded to the appropriate size and contain a radiopaque element. To visually distinguish between the two, the ChitoGauzeXR dressing contains one radiopaque yarn and the uncoated gauze contains two radiopaque yarns. The dressings are co-packaged in a pouching configuration consisting of an inner dispenser pouch and outer pouch. The inner nylon/LDPE pouch will hold both gauze components and is intended to allow controlled dispensing of the gauze dressings through a hole on top. Because there is a hole on tope, this pouch is not intended to act as a sterile barrier. The outer foil pouch is intended to provide a barrier to protect the product and maintain product sterility.

The ChitoGauze FUSION Wound Packing Kit is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 to the power of -6.

The hemostatic properties of chitosan enhance the ability of the ChitoGauzeXR to control bleeding. The uncoated gauze is intended to be used as a backing or securement dressing and to absorb excess fluid. The co-packaging of the two gauze types provides an added level of convenience to the user and facilitates ease-of-use. The radiopaque filament allows for easy detection via x-ray to prevent the dressing from being inadvertently left on the wound.

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria, device performance, or details of a study proving the device meets acceptance criteria. The document is a 510(k) summary for an administrative change related to a medical device's product code, and it describes the device and its intended use, but it does not contain specific acceptance criteria, detailed study results, or information about AI/ML algorithm performance.

Here's a breakdown of what the document does contain, which highlights why I cannot fulfill your request as stated:

• Device Description: It describes the ChitoGauze™ FUSION™ Wound Packing Kit, a modified version of ChitoGauze™XR, which co-packages the hemostatic dressing with uncoated gauze.
• Intended Use/Indications for Use: "The ChitoGauze™ FUSION™ Wound Packing Kit is a hemostatic dressing for the external, temporary control of severely bleeding wounds."
• Technological Characteristics: States that the modification (co-packaging) does not affect the fundamental scientific technological characteristics of the original ChitoGauze™XR.
• Non-Clinical Performance Data:
  • Biocompatibility: Mentions testing per ISO 10993 confirmed no effect from co-packaging.
  • In Vivo Efficacy: Describes two swine studies for hemostatic efficacy against a competitive product, showing the device controlled bleeding "at least as well." Specific quantitative results (e.g., stopping time, blood loss reduction) are not provided, nor are sample sizes for these studies.
  • Reduction of Microorganisms: Provides a table of log reduction data for various microorganisms, demonstrating antibacterial effectiveness. It explicitly states, "The clinical utility of these results is unknown."
  • Sterility: Mentions sterility validation per ISO 11137:2006 to a 10⁻⁶ SAL.
  • Radiopacity: Mentions testing per ASTM F640-07 Method C and found it equivalent to an ASTM standard.
• Clinical Performance Data: Explicitly states, "No clinical data was required for evaluation of this device."
• Conclusion: Reaffirms that the modification is not a change to intended use or fundamental technology.

Therefore, I cannot provide the requested information because:

1. Acceptance Criteria and Performance Table: The document does not specify formal acceptance criteria or present device performance in a way that allows for a direct comparison against such criteria. The non-clinical tests describe performance, but not against pre-defined thresholds for "acceptance."
2. Sample Size and Data Provenance (for test set): While two in vivo swine studies are mentioned, specific sample sizes (number of animals or injury sites) are not provided. The data provenance is "swine" (animal studies), not human. It is non-clinical.
3. Number of Experts and Qualifications: Not applicable, as no human reader studies are mentioned.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable. This device is a medical dressing, not an AI/ML diagnostic or assistive tool. There is no mention of human readers improving with or without AI assistance.
6. Standalone Performance: Not applicable, as this is not an AI/ML algorithm. The performance data presented (e.g., sterilization, radiopacity, antimicrobial activity) is for the physical device itself.
7. Type of Ground Truth: For the in vivo efficacy studies, the "ground truth" would implicitly be the observed bleeding control in the animal models, compared to a reference product. For the antimicrobial study, it's the measured log reduction against specified bacterial strains.
8. Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there's no "training set."
9. Ground Truth for Training Set: Not applicable.

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ChitoGauze™XR is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. This submission for ChitoGauze™XR adds a radiopaque filament to models of various dimensions of the legally marketed dressing. The ChitoGauze™XR dressings are z-folded to the appropriate size and packaged in a single heat-sealed foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10 - 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.

The provided document is a 510(k) summary for the medical device ChitoGauze™ XR, a hemostatic dressing. It describes the device, its intended use, and the non-clinical performance data supporting its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes various non-clinical tests performed to demonstrate the device's characteristics and equivalence. The "acceptance criteria" are implied by successful completion and equivalence to standards or predicate devices.

1. Ability of 4-inch by 4-yard size to control bleeding in a 6mm femoral perforation injury in swine.
2. Ability of a 2-inch by 2-inch 8-ply size to control bleeding in a splenic capsular strip injury in swine.
   In both cases, the device successfully controlled bleeding at least as well as the competitive product used as a reference. |
   | Reduction of Microorganisms | Tested for reduction against 25 different species (e.g., Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, Escherichia coli, Clostridium difficile).
   Achieved high log reductions, generally >4.0 and often >5.0, demonstrating antibacterial effectiveness. (Note: "The clinical utility of these results is unknown" is stated, suggesting this is a characteristic rather than a strict performance benchmark for clinical outcome). |
   | Sterility | Sterility validation completed following ISO 11137:2006 requirements to demonstrate a 10⁻⁶ Sterility Assurance Level (SAL) using the VDmax 5 method. |
   | Radiopacity | Determined via testing performed in accordance with ASTM F640-07 Method C. The product was found to be equivalent to the radiopacity of the ASTM Radiopacity Standard (101x76x0.9 mm 99+% 1100 alloy aluminum sheet) and was therefore determined to be acceptable. |
   | Clinical Performance | No clinical data was required for evaluation of this device. |
   | Fundamental Scientific Technology | The modification (addition of radiopaque filament) is stated to not alter the fundamental scientific technological characteristics of the original ChitoGauze, ensuring equivalence to the predicate device. Additionally, it did not change the intended use. |

2. Sample Size Used for the Test Set and the Data Provenance:

• In Vivo Efficacy:
  • The document mentions "two separate in vivo studies" using "swine" models. It does not specify the exact number of animals (sample size) used in each study or the total number, nor does it specify the country of origin.
  • The studies were designed and conducted to establish hemostatic efficacy. These would be considered prospective animal studies.
• Reduction of Microorganisms:
  • No specific sample size for each microorganism test is provided, but it implies laboratory testing against listed species. This is non-clinical, in vitro data.
• Radiopacity:
  • No specific sample size (number of dressings tested) is given for radiopacity testing. This is non-clinical, bench testing.
• Sterility & Biocompatibility:
  • These are standardized tests (ISO 11137, ISO 10993). While validation requires specific sample sizes of test materials, these are not detailed in the summary. This is non-clinical, laboratory/bench testing.

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 studies are primarily non-clinical (animal models, lab tests) where an "expert consensus" for ground truth in the human diagnostic context typically doesn't apply. For the animal studies, the "ground truth" would be direct observational outcomes of bleeding control by the researchers/veterinarians involved in the study.

4. Adjudication Method for the Test Set:

• This information is not provided and is generally not applicable to the types of non-clinical tests described (e.g., animal model bleeding control, microbial reduction, radiopacity measurement). Adjudication usually refers to resolving disagreements among human readers or evaluators in diagnostic studies.

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 document describes a medical device (hemostatic dressing), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effect size data is presented.

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

• Not applicable. As stated above, this is not an AI algorithm.

7. The Type of Ground Truth Used:

• Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and specific test results (e.g., cytotoxicity, sensitization).
• In Vivo Efficacy: Ground truth is direct physiological observation of bleeding control in a standardized animal model compared to a reference product.
• Reduction of Microorganisms: Ground truth is quantifiable log reduction values obtained from standardized microbiological assays.
• Sterility: Ground truth is defined by achieving a 10⁻⁶ SAL demonstrated via ISO 11137 procedures.
• Radiopacity: Ground truth is measured radiopacity shown to be equivalent to a defined ASTM standard.
• Clinical Data: No clinical data was required or provided, so no clinical ground truth was established for this submission.

8. The Sample Size for the Training Set:

• Not applicable. This document describes the testing and performance of a physical medical device (hemostatic dressing), not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no AI algorithm, there is no training set or ground truth establishment method for it.

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ChitoGauze™ is a hemostatic dressing for the external, temporary control of severely bleeding wounds. ChitoGauze™ is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

The ChitoGauze dressing is composed of standard polyesterfrayon blend non-woven medical gauze that is coated with chitosan. This submission adds models of various dimensions to the legally marketed four inch by four yard (4" x 4 yds) dressing. ChitoGauze dressings are z-folded and packaged in a peelable foil pouch. The pouched dressing is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic properties of chitosan enhance the ability of the medical gauze to control bleeding.

The provided text is a 510(k) summary for the ChitoGauze™ wound dressing, which focuses on an administrative change regarding the device's product code and the addition of various dimensional sizes to the already legally marketed dressing.

Based on the content, this document does not contain the kind of information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, accuracy, or reader study results. The provided text is a regulatory filing, not a clinical study report.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. Acceptance Criteria Table & Reported Device Performance: This document does not define quantitative acceptance criteria for device performance (e.g., how effectively it stops bleeding in a clinical or simulated setting) nor does it report device performance against such criteria. The "Log Reduction" table (Image 5) shows antibacterial effectiveness, but this is a characteristic, not a primary hemostatic performance metric with predefined acceptance limits for market clearance in this context. The 510(k) summary explicitly states for the changes under review (addition of various sizes) that "Changing the dimensional size of the dressing has no effect upon the technological characteristics."

2. Sample Size, Test Set, and Data Provenance: Not applicable. There is no specific test set data for performance outlined for the current submission, as it relates to adding new sizes of an already cleared device.

3. Number of Experts & Qualifications for Ground Truth: Not applicable. No ground truth was established for performance metrics in this submission using experts.

4. Adjudication Method: Not applicable. No adjudication process for performance data is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is not mentioned as it's not relevant to the administrative change and size additions. The device is a wound dressing, not an AI-assisted diagnostic tool.

6. Standalone Performance Study: Not applicable in the context of typical AI/diagnostic device performance. The non-clinical performance data section (Image 5) discusses "Biocompatibility" and "Reduction of Microorganisms" testing, but these are not 'standalone performance' in the sense of an algorithm's output. The antibacterial effectiveness is presented as a characteristic.

7. Type of Ground Truth Used: Not applicable for performance. The "ground truth" for the antibacterial resistance test would be the measured log reduction against known strains (Image 5), but this isn't presented as meeting a specific acceptance criterion for market clearance on its own, especially for hemostatic claims.

8. Sample Size for Training Set: Not applicable. This document does not pertain to an AI/machine learning model, so there is no training set.

9. How Ground Truth for Training Set Was Established: Not applicable.

Summary from the Document:

The provided 510(k) K092357 is an update (superseding a previous letter with an administrative change) and an amendment for adding various dimensional sizes to the ChitoGauze™ wound dressing. The core message is that the changes are administrative (product code) and dimensional, and do not alter the fundamental scientific technology or intended use of the device.

The "Non-Clinical Performance Data" section (Image 5) briefly mentions:

• Biocompatibility: Demonstrated per ISO 10993. The document states "Changing the dimensional size of the dressing has no effect upon the biocompatibility."
• Reduction of Microorganisms: An eight-ply version of ChitoGauze™ was tested against various bacterial species, showing log reductions typically >4.0 or >5.0. It explicitly states, "The clinical utility of these results is unknown."
• Sterility: A sterility validation was completed following ISO 11137:2006 to demonstrate a 10⁻⁶ SAL (Sterility Assurance Level) using the VDmax 25 method. "Changing the dimensional size of the dressing has no effect upon the sterility validation."

The "Clinical Performance Data" section (Image 6) explicitly states: "No clinical data was required for evaluation of this device."

Therefore, this document does not contain the detailed information requested about acceptance criteria and a study proving the device meets them in the context of clinical performance metrics typically associated with diagnostic or AI-powered devices. It focuses on demonstrating that new sizes of an existing device maintain the same safety and performance characteristics as the original cleared device.

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ChitoGauze™ is intended to be a hemostatic wound dressing.

Indications for Use (Rx):
ChitoGauze is a hemostatic dressing for the external, temporary control of severely bleeding wounds.

Indications for Use (OTC):
ChitoGauze is intended for temporary external use to stop bleeding of minor wounds, minor cuts and minor abrasions.

The ChitoGauze dressing is composed of standard polyester/rayon blend non-woven medical gauze that is coated with chitosan. The four inch by four yard (4" x 4 yds) dressing is z-folded and packaged in a peelable 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 provided text is a 510(k) summary for the ChitoGauze™ device. It describes the device, its intended use, and non-clinical performance data to demonstrate substantial equivalence to predicate devices. However, the document does not contain acceptance criteria or a study that specifically proves the device meets such criteria in the format of a clinical trial or algorithm performance study with specified metrics like sensitivity, specificity, or AUC.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices by showing similar technological characteristics and non-clinical performance.

Here's an analysis based on the provided text, addressing your questions where possible:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., stopping bleeding within X minutes for Y% of cases). The evaluations are primarily geared towards demonstrating substantial equivalence through biocompatibility, in vivo efficacy compared to other dressings, reduction of microorganisms, and sterility.

A table summarizing the performance data reported would look like this:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Biocompatibility: Sample sizes are not specified, standard for ISO 10993.
• In Vivo Efficacy: The term "extreme trauma model" implies animal testing, but specifics of the model (e.g., animal species, number of animals) and thus sample size are not provided. The data provenance is not stated (e.g., country, retrospective/prospective).
• Reduction of Microorganisms: For each microorganism, the "Log Reduction" values are given. This is typically done through in vitro laboratory testing. Sample sizes (number of replicates) are not specified. Data provenance (country, retrospective/prospective) is not provided.
• Sterility: This is a validation process against a standard, not a data set in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this submission. The device is a hemostatic dressing, and its performance evaluation does not involve image interpretation or diagnostic tasks that would require human experts to establish ground truth in the way described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to this submission, as there is no mention of human expert adjudication for the types of tests described (biocompatibility, in vivo efficacy, microbiology, sterility).

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

This is not applicable. The device is a hemostatic dressing, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant here.

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

This is not applicable, as the device is not an algorithm or AI system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and accepted biological safety profiles.
• In Vivo Efficacy: Ground truth for "efficacy" in stopping bleeding would be direct observation or objective measurement within an animal model, not expert consensus or pathology on a human.
• Reduction of Microorganisms: "Ground truth" is the quantitative measurement of bacterial survival after exposure to the device, typically through standard microbiology laboratory techniques (e.g., colony counting).
• Sterility: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶ using validated methods and industry standards (ISO 11137:2006).

8. The sample size for the training set

This is not applicable, as there is no AI algorithm being developed or "trained" for this device.

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

This is not applicable, as there is no AI algorithm being developed or "trained" for this device.

In summary:

The provided document is a 510(k) summary for a medical device (hemostatic dressing). It focuses on demonstrating substantial equivalence to existing devices through non-clinical laboratory and animal studies, rather than clinical trial data with specific acceptance criteria and detailed performance metrics characteristic of AI/diagnostic device submissions. The submission explicitly states: "No clinical data was required for evaluation of this device."

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