Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device