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The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Dressing may be used for management of:

• 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 (21 CFR 801 Subpart C):

• The gel-e Bandage may be used for the management of:
• Minor cuts
• Minor scalds and 1st degree burns
• Abrasions
• Lacerations

Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosanbased patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosanbased patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal.

The gel-e Bandage is intended for use as a primary dressing for a variety of chronic and acute wounds. It secured onto skin by manually pressing the adhesive strips on either side of the patch. Dressings are individually packed into aluminum foil pouches and terminally sterilized to achieve an SAL of 10-6.

The Gel-e Bandage (gel-e, Inc.) K172010 is a medical device and therefore the acceptance criteria are not based on performance metrics such as accuracy or sensitivity, but rather on demonstrating substantial equivalence to a legally marketed predicate device. The study that "proves" the device meets acceptance criteria is a 510(k) Pre-market Notification submission to the FDA, which includes various tests and comparisons to establish substantial equivalence.

Here's the breakdown of how the device meets its "acceptance criteria" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" are primarily established through demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The performance is reported in terms of various testing results compared to the predicate.

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

The provided text does not specify the sample sizes used for the various tests (comparative animal testing, bench testing, biocompatibility, packaging, sterilization validation, shelf-life stability).

The data provenance is from the manufacturer, gel-e, Inc., as part of their 510(k) submission to the FDA. The data is pre-clinical, meaning it was generated in a controlled laboratory setting (bench, animal models) rather than human clinical trials. The country of origin of the data is not explicitly stated but is implicitly the country where gel-e, Inc. operates and where the testing facilities are located.

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

This type of information is not applicable to a 510(k) submission for a wound dressing based on substantial equivalence. The "ground truth" for these tests relates to established scientific methods and pass/fail criteria for biocompatibility, physical properties, etc., not subjective expert interpretation of medical images or patient outcomes. The FDA reviews the testing methodology and results against recognized standards.

4. Adjudication Method for the Test Set

This concept is not applicable to the type of pre-clinical testing described. Adjudication methods like 2+1 or 3+1 typically refer to resolving discrepancies in expert interpretations (e.g., radiologists reviewing images). For the described tests, results are objective measurements (e.g., pH value, absorbency, successful sterilization) or observations (e.g., presence/absence of cytotoxicity) and do not require expert adjudication in that context.

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 was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use AI as an aid. The Gel-e Bandage is a physical wound dressing and does not involve AI or human readers for interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone algorithm performance study was not done. As mentioned, this device is a physical wound dressing and does not involve any algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for the various tests includes:

• Established scientific standards and specifications: For biocompatibility (ISO standards for cytotoxicity, irritation, etc.), physical properties (pH, moisture content, absorbency), packaging integrity, and sterility (10^-6 SAL).
• Validated animal models: For comparative animal testing, where the "ground truth" would be the observed biological response to the device in comparison to a control or accepted standard.
• Reference predicate device performance: The "ground truth" for substantial equivalence is that the device's performance is comparable to or better than the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. The Gel-e Bandage is not an AI/machine learning device, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth established for one.

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Hemogrip™ Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.

The Hemogrip™ Patch Hemostasis Pad is a non-invasive topical bandage intended to promote hemostasis when in contact with a bleeding wound. Hemogrip™ Patch is composed of a soft, sterile, palmitoyl-N-acetylglucomasine substrate/backing coated with a freeze-dried layer of poly N-acetylglucosamine (chitosan). The environment of use for the Hemogrip™ Patch is at a healthcare facility/hospital under the direction of a healthcare professional.

The Hemogrip™ Patch Hemostasis Pad promotes the control of bleeding wounds in patients. This is achieved by applying proximal pressure to the puncture site and placing a Hemogrip™ Patch over the puncture site using a sterile folded gauze. Firm compression is applied over the puncture site until hemostasis is achieved. Proximal pressure can be released after 2 to 3 minutes. Once hemostasis is achieved, pressure is released and a dry gauze is placed over the Hemogrip" Patch. The site is then covered with an appropriate dressing. Within 24 hours, Hemogrip™ Patch should be soaked with water and gently removed.

The Hemogrip™ Patch is sterilized via y-irradiation and is for single use only.

The provided document is a 510(k) summary for the Hemogrip™ Patch, a topical hemostasis pad. It focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.

Therefore, the information requested, particularly regarding acceptance criteria, specific performance metrics (like sensitivity, specificity, or AUC), sample sizes for test/training sets, expert adjudication details, and MRMC studies, is not available in this document. The document describes a non-clinical animal study to demonstrate performance similarity, and biocompatibility testing.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

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

The document does not explicitly define acceptance criteria in terms of quantitative performance metrics for human use, such as time to hemostasis, success rates in a clinical population, or statistical thresholds. Instead, the performance evaluation is based on demonstrating similarity to a predicate device in an animal model and meeting biocompatibility standards.

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

• Test Set Sample Size: Not explicitly stated as a number of animals. The study refers to "a controlled acute swine model," implying multiple animals were used, but the exact count is not provided.
• Data Provenance: The study was an "animal study... in a controlled acute swine model of splenic hemorrhage." The location of the study (e.g., country of origin) is not specified. It is a prospective animal study as it involved conducting tests for the purpose of this submission.
  • No human data (retrospective or prospective) for a "test set" is mentioned for performance evaluation.

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

• Not applicable. This was an animal study evaluating hemostasis, not a study requiring human expert assessment of images or clinical outcomes that would typically establish ground truth for a diagnostic device. The "ground truth" here would be the observed hemostatic outcome in the animal model.

4. Adjudication method for the test set

• Not applicable. See point 3.

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. This is a physical medical device (hemostasis patch), not an AI/software medical device.

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

• N/A. This is a physical medical device. Performance relates to its physical interaction with wounds, not an algorithm.

7. The type of ground truth used

• The ground truth for the hemostasis performance study was the observed hemostatic outcome in the acute splenic hemorrhage swine model.
• For biocompatibility, the ground truth was meeting the criteria specified by ISO 10993 standards (e.g., absence of cytotoxicity, irritation, sensitization, or acute systemic toxicity).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. See point 8.

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