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The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration. Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds: Pressure sores, Diabetic ulcers, Leg ulcers, Donor sites and graft sites, Surgical wounds, Skin abrasions and lacerations, 1st and 2nd degree burns, Trauma wounds. Over-the-counter use: The Maxiocel Chitosan Wound Dressing is indicated for the management of Minor cuts, Minor scalds and 1st-degree burns, Abrasions, Lacerations and to provide a barrier against bacterial penetration.

The Maxiocel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing is provided both in prescription (Rx) and over-the-counter (OTC) forms. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days. Dressings are individually packed in moisture-proof pouches and terminally sterilized using gamma radiation to achieve a SAL 10t. The Maxiocel Chitosan Wound Dressing can be manufactured in different sizes and are currently available in the following sizes. 18" x 18" (45 cm x 45 cm), 8"x 12" (20 cm x 30cm), 6" x 6" (15 cm x 15 cm), 4" x 4" (10 cm x 10 cm), 2" x 4" (5 cm x 10 cm), 2"x 2" (5 cm x 5cm), 1"x2" (2.5 cm x 5cm), 1"x1" (2.5 cm x 2.5 cm), 1" x 12" (2.5 cm x 30 cm).

The provided text describes information about the Maxiocel Chitosan Wound Dressing, but does not contain information related to acceptance criteria, device performance in terms of specific metrics like sensitivity or specificity, or the methodology of a study proving such performance against acceptance criteria.

The document is a 510(k) summary for an FDA submission, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria using metrics typically associated with AI/algorithm performance (like sensitivity, specificity, or AUC).

Therefore, I cannot fulfill the request as it asks for information not present in the provided text, specifically:

• A table of acceptance criteria and the reported device performance: No such table or metrics are provided. The "performance data" section details bench tests, biocompatibility tests, and bacterial barrier tests, but these are not presented as acceptance criteria with numerical performance results against them.
• Sample sized used for the test set and the data provenance: Not mentioned, as it's not an AI/algorithm performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned for this type of device submission.
• Adjudication method: Not applicable/not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical wound dressing, not an algorithm.
• The type of ground truth used: Not applicable/not mentioned in the context of AI/algorithm performance. The ground truth for the non-clinical tests is the established scientific methods and standards used for those specific tests.
• The sample size for the training set: Not applicable, as this is not an AI/algorithm.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm.

The document primarily focuses on:

• Biocompatibility testing: Passed, indicating non-cytotoxic, non-sensitizer, non-irritant, non-toxic, and compliant with bacterial endotoxin limits.
• Heavy metal testing: Met USP-232 limits.
• Bench performance testing: Mentioned tests like Appearance, Moisture Content, Absorbency, pH, Dispersion Test, Fluid Retention Test, and Tensile Strength. No specific numerical results or acceptance criteria are given for these, only that the "Subject Device performs as intended."
• Bacterial Barrier Testing: Demonstrated capacity to act as a barrier to bacterial penetration by showing "No bacterial growth was observed in the plates containing the Maxiocel Chitosan Wound Dressing" compared to control plates with cotton gauze that showed bacterial growth. The sample size was n=3 for test samples and n=3 for control samples.
• Sterilization and Packaging validation: Gamma radiation per ISO 11137-2, sterility assurance level (SAL) of 10^-6, and validated 3-year shelf life through real-time stability studies including seal strength, dye penetration, sterility, bacterial endotoxin, and bench performance tests.

In summary, the provided document does not contain the specific information requested about acceptance criteria and study details for an AI/algorithm-based device. It details non-clinical safety and performance testing for a wound dressing.

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Prescription: The Axiostat Gauze is intended for use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations.
Over-the-Counter: The Axiostat Gauze is indicated for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

The Axiostat Gauze is a single-use, non-absorbable non-woven hemostatic gauze. It is made of non-woven fabric derived from chitosan, which is a natural polymer. Chitosan is known for its mucoadhesive and hemostatic properties. When applied directly to a wound the dressing controls bleeding and can be removed after the clotting has occurred. The dressing should be removed within 24 hours. The dressing is not intended to be implanted. The Axiostat Gauze is individually packed in a moisture proof packaging and terminally sterilized by gamma radiation to a sterility assurance level (SAL) of 10-6.

Here's an analysis of the acceptance criteria and study information for the Axiostat Gauze, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Animal Studies: The text states "all test animals" but does not specify the exact number.
• Other tests (Biocompatibility, Bench, Heavy Metal, Residual Solvent, Sterilization, Shelf-life): The text does not provide specific sample sizes for these tests.
• Data Provenance: The animal study followed an existing methodology ("Safety Evaluation of New Hemostatic Agents... in Swine; Kheirabadi, et al., J Trauma. 2010 Feb;68(2):269-78."), indicating a prospective, controlled experimental design in a swine model. The other tests are non-clinical, laboratory-based tests. The country of origin for the data is not specified, other than the manufacturer being Advamedica Inc. in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• The document does not mention using experts to establish ground truth for any of the performance tests. The ground truth for these tests is based on established scientific standards, protocols, and measurements (e.g., ISO standards, USP monographs, in-vitro assays, animal study observations).

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the test set. Given the types of tests (biocompatibility, bench, animal study observations), adjudication by experts, as might be seen in imaging studies, is not applicable or mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting diagnostic images or information, often with and without AI assistance, to assess performance and clinical utility. The Axiostat Gauze is a physical medical device (hemostatic gauze), not a diagnostic AI tool, so an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is not applicable as the Axiostat Gauze is a physical medical device and not an algorithm or AI system.

7. The Type of Ground Truth Used

• For Biocompatibility, Heavy Metal, and Residual Solvent Tests: The ground truth is established by regulatory standards and recognized scientific methodologies (e.g., ISO 10993 series, USP 161, USP 232, USP 30 ).
• For Bench Performance Tests: The ground truth is based on defined physical and chemical properties measured against specified acceptance criteria (e.g., color, moisture content, absorbency, pH, tensile strength, integrity, in-vitro clotting parameters).
• For Animal Studies: The ground truth is physiological observation and measurement of hemostasis (cessation of bleeding) and the absence of rebleeding in a live animal model, following a published experimental protocol.

8. The Sample Size for the Training Set

• This question is not applicable as the Axiostat Gauze is a physical medical device and not a machine learning model that requires a training set.

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

• This question is not applicable for the same reason as above.

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The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.

The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.

The document provided is a 510(k) Summary for the Ax-Surgi Surgical Hemostat and outlines the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device. However, it does not detail acceptance criteria in the form of specific quantitative metrics for comparison with the device performance. Instead, it lists studies and their general positive outcomes ("Pass," "Non-cytotoxic," "successful safety and performance assessment").

Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific quantitative metrics. The document describes a series of tests performed and provides a qualitative outcome for each.

Here's an analysis of the provided information related to the other requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not present quantitative acceptance criteria. Instead, it lists various tests and their qualitative outcomes.

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

• Animal Studies (Test Set): Two animal studies were conducted:
  • Pilot Study: "To evaluate the safety and performance of chitosan hemostatic dressing in non- heparinized porcine hepatic resection model (48hr and 28 days non-GLP)" - Sample size is not explicitly stated, but it's a "pilot study."
  • Pivotal Study: "Evaluation of Safety and Hemostatic Performance of the Ax-Surgi Chitosan Surgical Hemostat in a Liver Resection Model in Swine, 48 Hours and 28 Day." - Sample size is not explicitly stated.
• Data Provenance: The animal studies were conducted in a porcine (swine) model. Information on the country of origin or whether the data was retrospective/prospective is not provided, although preclinical animal studies are typically prospective.

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 described as animal studies assessing physiological outcomes (hemostasis, inflammation, toxicity, adhesion), which would typically be assessed by veterinarians, pathologists, and researchers involved in the study, but the specific number and qualifications are not listed.

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

• This information is not provided in the document. The adjudication method for the preclinical animal studies is not specified.

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 comparative effectiveness study involving human readers or AI assistance was not mentioned. The device is a surgical hemostat, not an imaging or diagnostic AI device. The comparison was to a "standard of care" in animal models.

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

• This question is not applicable as the device is a physical hemostat, not an algorithm or AI system.

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

• For the animal studies, the ground truth was established through direct observation of physiological outcomes (e.g., successful hemostasis, inflammation, adhesion formation, systemic/local toxicity) and histopathological examination of tissues over observation periods (48 hours and 28 days). This would align with pathology and direct outcomes data from the animal model.

8. The sample size for the training set:

• This information is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training set" concept does not apply to the development and testing of this type of hemostat.

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

• This information is not applicable, as explained in point 8.

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The Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites. vascular procedure sites and sites involving percutaneous catheters, tubes and pins.

The Axiostat Patch is a sterile, single use, non-absorbable hemostatic dressing. It is composed of chitosan a well-known natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied directly to a wound with firm pressure, the dressing controls bleeding and provides a barrier against bacterial penetration. The hemostatic dressing can be removed after the clotting has occurred but should not remain on for more than 24 hours. The hemostatic dressing is not intended to be implanted. The Axiostat Patch is individually packaged in moisture proof packs and terminally sterilized using gamma irradiation.

The provided text describes the Axiostat Patch, a hemostatic dressing, and outlines the non-clinical studies performed to demonstrate its safety and performance for its intended use. However, it does not contain information related to acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI-powered medical device.

The document details the following types of studies for a physical medical device (hemostatic patch):

• Biocompatibility testing: Performed according to ISO 10993-1:2009 for surface devices, including tests for cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, and bacterial endotoxin.
• Heavy metal testing: To ensure the finished, sterilized product met USP-232 limits.
• Bench performance testing: Including appearance, moisture content, absorbency, pH, integrity, tensile strength, and in vitro blood clotting.
• Barrier to bacteria testing: Evaluated the patch's ability to act as a barrier against gram-positive and gram-negative bacteria.
• Animal studies: Evaluated hemostasis in a vascular injury wound model in swine.
• Sterilization and packaging validation: Including seal strength, dye penetration, sterility, bacterial endotoxin, and bench performance tests to validate a 5-year shelf life.

Since the provided text does not describe an AI medical device or its performance criteria, I am unable to answer most of your specific questions related to AI device acceptance criteria, sample sizes for test/training sets, expert involvement in ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, I cannot populate the table or provide details for points 2-9 as the provided document does not contain this information for an AI device.

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Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions.

Axiostat is a single use, hemostatic dressing made of 100% chitosan is a wellknown natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied on the bleeding site with firm pressure, the Axiostat Chitosan Hemostatic Dressing acts as a mechanical barrier against bleeding. The Axiostat is intended for a maximum duration of use of 24 hours, including bandage changes that may be needed. Axiostat is individually packaged in foil bags and sterilized using gamma irradiation. Axiostat is provided in six different sizes for over the counter use as listed below.

This looks like a 510(k) premarket notification for a medical device. Based on the provided text, the device is the Axiostat Chitosan Hemostatic Dressing. Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a 510(k) for a medical device, which means the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. The document explicitly states that the device is substantially equivalent to the predicate device Chito-SAM™ Active (K133121).

The acceptance criteria are not explicitly numerical thresholds for performance metrics (like sensitivity/specificity for AI, for example), but rather a demonstration that the Axiostat Chitosan Hemostatic Dressing is as safe and effective as the predicate device.

Here's a table summarizing the comparison:

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

Since this is a hemostatic dressing (a physical device, not an AI/software device), the "test set" concept as used in AI/software evaluation (e.g., for sensitivity/specificity) doesn't directly apply here. Instead, it refers to the samples used in non-clinical testing.

• Biocompatibility testing: "performed per the requirements of ISO 10993-1:2009, under the section 'surface devices used in breached and compromised surfaces with limited exposure (. The sample sizes for these tests are not provided.

Data Provenance: The studies are non-clinical (laboratory and animal studies) conducted by Advamedica for their device. The country of origin for the data is not specified but would likely be the location of the testing laboratories. These are prospective tests conducted specifically for this device submission.

3. Number of Experts and Qualifications for Ground Truth

This question is typically relevant for studies involving subjective human assessment, particularly in fields like radiology where experts establish "ground truth" for AI models. For a hemostatic dressing, the "ground truth" is established by direct measurement and observation in laboratory and animal studies, rather than expert consensus on interpretive tasks. Therefore, this section is not applicable in the same way it would be for an AI device. The ground truth is objective (e.g., cytotoxicity present/absent, metal levels, pH value, successful hemostasis).

4. Adjudication Method for the Test Set

As explained above, the concept of an adjudication method (like 2+1 or 3+1 for human readers) is not applicable here because the "test set" involves non-clinical studies with objective measurements rather than subjective expert interpretation for ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This is not applicable for this type of device. An MRMC study is typically used for diagnostic or interpretive devices (often AI) to assess how human readers' performance changes with or without AI assistance. The Axiostat Chitosan Hemostatic Dressing is a physical therapeutic device, not an interpretive one.

6. Standalone Performance Study (Algorithm Only)

This is not applicable as the Axiostat Chitosan Hemostatic Dressing is a physical product, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth for the non-clinical studies relies on:

• Standardized laboratory assays: For biocompatibility tests (e.g., cytotoxicity, irritation, hemolysis, pyrogenicity), heavy metal analysis, and bench performance tests (e.g., pH, tensile strength, absorbency).
• In-vivo observation and measurement: For the rabbit hemostasis study, where the ability of the dressing to control bleeding is directly observed and measured within a living system.
• Validated microbiological and physical testing: For sterility assurance level (SAL), package integrity, and shelf-life studies.

Essentially, the ground truth is based on objective scientific measurements and observations according to established standards (ISO, USP, ASTM).

8. Sample Size for the Training Set

This is not applicable. The concept of a "training set" is specific to machine learning algorithms. This device is a physical product, and its development and testing do not involve machine learning.

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

As section 8 is not applicable, this section is also not applicable.

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