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For Over-the-Counter Use:

IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.

Prescription Use:

Under the supervision of a healthcare professional:

· IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative and donor sites), mechanically debrided wounds, and for second degree burns.

• IPM Wound Gel Bio/IPM Derm Gel Bio is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis.

IPM Wound Gel Bio/IPM Derm Gel Bio is a clear viscous, odorless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%.

Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid in IPM Wound Gel Bio and IPM Derm Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio and IPM Derm Gel Bio serves to maintain a moist environment. The maintenance of moist environment is widely recognized to positively contribute to wound healing process. IPM Wound Gel Bio/ IPM Derm Gel Bio helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Other ingredients in IPM Wound Gel Bio and IPM Derm Gel Bio are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%).

IPM Wound Gel Bio and IPM Derm Gel Bio are presented in the following packaging formats: -a carton box with 4 laminated tubes of 10g (0.35oz) -a carton box with one laminated tube of 75g (2.65oz).

IPM Wound Gel Bio and IPM Derm Gel Bio are exactly the same in all aspects and specifications; these are the same device with two (2) different trade names.

The provided text is a 510(k) summary for a medical device (IPM Wound Gel Bio/IPM Derm Gel Bio). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial report for an AI/ML medical device.

Therefore, the information required to directly answer your request regarding acceptance criteria, sample sizes, expert involvement, and statistical studies (like MRMC or standalone performance) is NOT present in the provided document. The document primarily discusses:

• Device Description: A clear viscous, odorless, aqueous gel composed principally of sodium hyaluronate.
• Intended Use: To maintain a moist wound environment and relieve dry waxy skin.
• Indications for Use (OTC): Minor burns (1st degree), minor abrasions, minor cuts, and dry waxy skin irritations.
• Indications for Use (Rx): Management of exudating wounds (leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds, 2nd-degree burns) and management/relief of burning, itching, and pain associated with dermatoses (atopic, allergic contact, radio-dermatitis).
• Comparison to Predicate Devices: Demonstrates that the proposed device is substantially equivalent to previously cleared devices (K123193 and K130781) by showing similar intended use, device description, shelf life, and that any differences in indications or hyaluronic acid source do not affect safety and performance.
• Biocompatibility and Stability: States that these tests were conducted on the predicate device and found acceptable, and since no changes were made to the formulation, re-testing was not required.

Based on the provided text, I cannot fill out the requested table or answer most of your detailed questions about a performance study, as this document is a regulatory submission for substantial equivalence, not a clinical study report.

Here's what can be inferred or stated from the document, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics but implied through the comparison to predicate devices. The "acceptance criteria" here are essentially that the device is "substantially equivalent" in terms of safety and effectiveness to the predicates.
• Reported Device Performance: No quantitative performance data (e.g., healing rates, pain reduction scores, error rates) from a dedicated study are reported. The "performance" is implicitly deemed equivalent to the predicates based on its composition and mechanism of action (maintaining a moist environment).

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

• Not applicable/Not provided. This document does not describe a test set or data from a clinical performance study. It relies on the substantial equivalence of the device's formulation and indications to previously approved devices.

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

• Not applicable/Not provided. No "ground truth" establishment in the context of a performance study is described. The FDA review process itself involves internal experts, but this isn't detailed in the submission itself.

4. Adjudication method for the test set:

• Not applicable/Not provided. No test set requiring adjudication is described.

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 topical wound gel, not an AI/ML medical device. An MRMC study is not relevant here.

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

• No. This is a topical wound gel, not an AI/ML medical device.

7. The type of ground truth used:

• Not applicable/Not provided. For this device, "ground truth" would be related to clinical outcomes (wound healing, symptom relief). However, no new clinical studies are presented. The basis for approval relies on the known effects of the ingredients and the equivalence to predicate devices that have already demonstrated safety and effectiveness.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.

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

• Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a wound gel, not a clinical trial report for an AI/ML device. Therefore, the specific details you requested regarding acceptance criteria, study design, and performance metrics for an AI/ML model are not present.

Ask a specific question about this device

"OTC": IPM Wound Gel Bio is indicated for management of minor burns (1st degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.
Rx: Under the supervision of a health care professional; • IPM Wound Gel Bio is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (postoperative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.

IPM Wound Gel Bio is a clear viscous, odorless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%. Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid is an extracellular matrix component of human skin. The Hyaluronic acid used in IPM Wound Gel Bio is derived from a synthetic source, more specifically from a bacterial fermentation process. IPM Wound Gel Bio serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. Other ingredients in IPM Wound Gel Bio are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%). IPM Wound Gel Bio is presented in carton boxes with 4 laminated tubes of 10g (0.35oz).

The provided text describes a 510(k) premarket notification for a medical device called "IPM Wound Gel Bio", which is a hydrogel wound dressing. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove meeting those criteria.

Therefore, the input does not contain the specific information requested about acceptance criteria and a study to prove the device meets these criteria. It focuses on comparing the new device's characteristics and intended use to already legally marketed predicate devices to establish substantial equivalence.

Here's a breakdown of why many of your questions cannot be answered from the provided text:

• Acceptance Criteria Table: No specific performance acceptance criteria are listed for the IPM Wound Gel Bio. The submission relies on establishing similarity to predicate devices.
• Device Performance: The document states that the device is "comparable to the predicates" in terms of quality, safety, and effectiveness due to similar indications and technological characteristics (except for the source of hyaluronic acid). However, no specific performance metrics of the IPM Wound Gel Bio are reported.
• Sample Size (Test Set), Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Sample Size, and Training Set Ground Truth: These questions relate to clinical or performance studies that would typically involve a test set, expert evaluation, etc. The provided 510(k) summary does not describe such a study for the IPM Wound Gel Bio itself. Instead, it refers to biocompatibility evaluations and a histological study done on one of its predicate devices (L.A.M. IPM Wound Gel).

Information that can be extracted related to the provided text:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not describe a test set or clinical study for "IPM Wound Gel Bio." It references biocompatibility tests conducted for the "bio fermented HA" (the new type of HA used in IPM Wound Gel Bio), which likely involved in vitro or in vivo animal testing. It also references a "Histological Study in Porcine" for the predicate device, L.A.M. IPM Wound Gel, which "demonstrated the effectiveness... on partial thickness wound healing." No sample sizes for these tests are provided, nor is the country of origin of the data or whether they were retrospective/prospective.

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 information is not provided. The document does not detail any expert consensus or ground truth establishment process for the IPM Wound Gel Bio in a clinical study context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided as there is no described test set with human adjudication.

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 MRMC comparative effectiveness study was done. This device is a hydrogel dressing, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is a physical medical device (wound gel), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For biocompatibility, the ground truth would be established through standard test methods and their interpretation against ISO and USP guidelines. For the histological study on the predicate device, it would involve pathological examination of tissue samples from porcine wounds. No ground truth is specified for a clinical study of "IPM Wound Gel Bio."

8. The sample size for the training set:
Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable.

Ask a specific question about this device

"OTC":

L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of minor burns (1ª degree burns), minor abrasions, minor cuts and helps to relieve dry waxy skin irritations associated with dry skin conditions.

Rx:

Under the supervision of a health care professional;

· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and for second degree burns.

· L.A.M. IPM Wound Gel/IPM Derm Gel is indicated for the management and relief of burning, itching and pain associated with various types of dermatoses; including atopic dermatitis, allergic contact dermatitis and radio-dermatitis.

L.A.M. IPM Wound Gel/IPM Derm Gel is a clear viscous, odourless, aqueous gel, composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. The proportion of sodium hyaluronate "w/w" in the formulation is 2.5%.

Hyaluronic acid is a molecule which is normally found in various parts of the body. Hyaluronic acid in L.A.M. IPM Wound Gel and IPM Derm Gel is derived from avian sources. L.A.M. IPM Wound Gel and IPM Derm Gel serves to maintain a moist wound environment. The maintenance of a moist wound environment is widely recognized to positively contribute to wound healing process. L.A.M. IPM Wound Gel/ IPM Derm Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Other ingredients in L.A.M. IPM Wound Gel and IPM Derm Gel are as follows: hydroxyethyl cellulose (1%), methylparaben (0.2%), as well as polyethylene glycol (3%) and purified water, USP (approx. 93%).

L.A.M. IPM Wound Gel and IPM Derm Gel are presented in carton boxes with 4 laminated tubes of 10g (0.35oz).

L.A.M. IPM Wound Gel and IPM Derm Gel are exactly the same in every aspect and specifications; they are the same device with two (2) different trade names.

The provided text describes a medical device called "L.A.M. IPM Wound Gel and IPM Derm Gel". However, the document does not contain information about a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, or reader improvement, as would be expected for a diagnostic or AI-driven device.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a common pathway for approval of Class I and Class II medical devices by the FDA. The acceptance criteria and "studies" mentioned relate to the device's technological characteristics, biocompatibility, and stability, rather than clinical performance studies with specific performance metrics against a ground truth.

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested format for performance studies:

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

The document does not provide a table of performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics against such criteria. The "acceptance criteria" discussed are related to:

• Biocompatibility tests: These tests ensure the device does not cause adverse biological reactions. The report states: "All of them meet the requirements of the ISO 10993 and resulted under the anticipated specifications."
• Stability testing: This confirms the product maintains its characteristics over its proposed shelf life. The report states: "stability testing conducted to support the proposed shelf life confirmed that aged product met the acceptance criteria."
• Substantial Equivalence: The primary "acceptance criterion" for marketing approval under a 510(k) is demonstrating that the device is as safe and effective as a legally marketed predicate device. The document argues that the device's technological characteristics, intended use, and indications are similar to its predicates.

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

Not applicable. The document does not describe a clinical performance study with a test set of data points (e.g., images, patient records). The "testing" mentioned is for biocompatibility and stability, which are laboratory-based and not clinical performance studies on a "test set" of patients or data in the context of AI or diagnostic devices.

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)

Not applicable. There is no mention of a test set requiring expert-established ground truth.

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

Not applicable. There is no mention of a test set or adjudication.

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 device is a wound gel, not an AI or diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. There is no ground truth, as this is not a diagnostic device.

8. The sample size for the training set

Not applicable. There is no training set for an AI model.

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

Not applicable. There is no training set for an AI model.

Summary of the document's "studies" and demonstration of "acceptance criteria":

The document focuses on establishing the safety and effectiveness of the L.A.M. IPM Wound Gel and IPM Derm Gel through the following:

• Biocompatibility Testing:
  • Tests conducted: Cytotoxicity Study, Modified ISO Acute Reactivity in Rabbits, ISO Acute Systemic Toxicity in Mouse, In Vitro Hemolysis, and ISO Sensitization.
  • Acceptance Criteria: Met the requirements of ISO 10993 and "resulted under the anticipated specifications."
  • Conclusion: "demonstrated similar results to the ones of its predicates, which is: the product safe and effective for its intended use."
• Stability Testing:
  • Purpose: To support the proposed shelf life.
  • Acceptance Criteria: "aged product met the acceptance criteria."
• Comparison to Predicate Devices (Substantial Equivalence):
  • Argument: The device is "similar in technological characteristics and indications to the predicates." It provides a moist environment and protective barrier, which is the same principle of operation as its predicates.
  • Indications for Use: The proposed indications for L.A.M. IPM Wound Gel/IPM Derm Gel "only includes indications that are already approved to the predicates."
  • Conclusion: Quality, safety, and effectiveness are demonstrated and comparable to the predicates, leading to a "Substantial Equivalence" determination by the FDA.

In conclusion, the provided text describes a medical device submission focused on substantial equivalence based on physical/chemical characteristics, biocompatibility, stability, and comparison to existing products, rather than a performance study for a diagnostic or AI device with specific acceptance criteria like sensitivity or specificity.

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OTC: L.A.M. IPM Wound Gel is indicated for the manugement of minor burns (16 degree burns), minor abrasions and minor cuts. Rx: Under the supervision of a healthcare professional L.A.M. IPM Wound Gel is indicated for the management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and 2nd degree burns

L.A.M. IPM Wound Gel is a clear viscous, odoricss, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-thecounter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts. Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.

The provided text is a 510(k) summary for a medical device called "L.A.M. IPM Wound Gel." It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on establishing new performance criteria or conducting studies to meet such criteria for novel devices. In this case, the document explicitly states: "There have not been any changes to L.A.M IPM Wound Gel (K020325) since FDA determined that it was substantially equivalent to ConvaTec's HA Absorbent Wound Dressing (K984388) and Fidia Pharmaceutical Corporation's Bionect® Hydrogel (K984413) on April 15, 2002."

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory filing focused on demonstrating equivalence and expanding indications, not on a new performance study.

Ask a specific question about this device