(129 days)
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.
N/A