(232 days)
Collagen/Ag Wound Gel is an absorbent wound dressing that provides a moist wound environment and affects the proliferation of bacteria which have been absorbed into the wound gel. Collagen/Ag gel is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites.
Pressure ulcers (Stages I - IV) Venous stasis ulcers Diabetic ulcers Ulcers resulting from arterial insufficiency Surgical wounds Traumatic wounds First and second degree burns Superficial wounds Grafted wounds and donor sites
Hydrolyzed Collagen/Ag Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Collagen/Ag gel is the identical hydrolyzed collagen wound gel formulation with 1.0% silver oxide added to inhibit the growth of microbes that are absorbed into the wound gel. The addition of silver oxide to the HyCure® formulation does not affect the safety or efficacy of Collagen/Ag gel. HyCure® Hydrolyzed Collagen Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Collagen/Ag Wound gel is provided in a patient ready dispensible tube.
The provided text describes the 510(k) premarket notification for "Hydrolyzed Collagen/Ag Wound Gel," a medical device. However, it does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a new study to prove efficacy and safety according to defined acceptance criteria, the manufacturer argues that their new device is as safe and effective as other similar devices already on the market.
Therefore, many of the requested details about acceptance criteria, study data, sample size, ground truth, and expert involvement are not applicable to this type of regulatory submission as presented. The submission relies on non-clinical data for specific aspects (cytotoxicity and microbial control) rather than broad clinical performance studies.
Here's an attempt to answer the questions based on the provided text, flagging where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Overall Performance) | Reported Device Performance |
|---|---|
| Overall Clinical Effectiveness | Not applicable. The document states: "Collagen/Ag gel has not been studied in a clinical setting." Substantial equivalence is claimed based on similarity to predicate devices and non-clinical data for specific aspects. |
| Cytotoxicity (ISO 10-993 guideline) | Indicated a grade 1 cytotoxic grade (Exhibit I). |
| Microbial Control within Hydrogel | In vitro evaluation (Exhibit II) supported claims; Collagen/Ag gel was found to control bacterial growth within the hydrogel. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for overall device performance. For the cytotoxicity and microbial control evaluations, specific sample sizes are not mentioned.
- Data Provenance: The in vitro evaluations (cytotoxicity, microbial control) are non-clinical studies. The country of origin for these specific tests is not stated in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth establishment for overall device performance is described. The cytotoxicity and microbial control evaluations would have been conducted in a laboratory setting, not typically requiring "experts" in the sense of clinicians establishing ground truth for patient outcomes.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not done. The document explicitly states: "Collagen/Ag gel has not been studied in a clinical setting."
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, for specific aspects. While not an "algorithm," the in vitro tests for cytotoxicity and microbial control were standalone evaluations of the device's properties, without human interaction with the wound gel in a clinical setting.
7. The Type of Ground Truth Used
- Not applicable for overall device performance. For the non-clinical tests:
- Cytotoxicity: The ground truth would be based on established laboratory standards and observation of cell viability/response to the material.
- Microbial Control: The ground truth would be based on quantitative microbiological assays measuring bacterial growth inhibition in vitro.
8. The Sample Size for the Training Set
- Not applicable. There is no mention of a training set as this is not an AI/Machine Learning device. The regulatory submission focuses on demonstrating substantial equivalence and presents non-clinical data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no training set is relevant to this submission.
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