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"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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Over-the-counter use of L.A.M. IPM Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healtheare professional. L.A.M. IPM Wound Gel is suitable for oxuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the managemont of mechanically or surgically debrided wounds.

L...A.M. IPM™ Wound Gel is a clear viscous, odorless, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. Over-the-counter use of I.A.M. IPM™ Wound Gel is suitable for minor abrasions and minor cuts. Under the supervision of a healtheare professional, J.A.M. IPM™ Wound Gol is suitable for exuding wounds such as log ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.

The provided text is insufficient to answer the request. The document is a 510(k) summary for a wound gel and primarily discusses regulatory approval based on substantial equivalence to existing predicate devices. It mentions biocompatibility testing and "Clinical experience in 27 patients" but does not provide details about acceptance criteria, specific performance metrics, the design of a study to prove these criteria, sample sizes for test or training sets, ground truth establishment methods, or the involvement of experts, MRMC studies, or standalone algorithm performance.

Therefore, I cannot extract the requested information from the given text.

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