(121 days)
Repliderm™ Wound Dressing cartilage powder is a collagen based powder intended for use in the management of pressure ulcers (stages I - IV), stasis ulcers, 1st and 2nd degree burns, diabetic ulcers, foot ulcers, post surgical incisions, radiation dermatitis, cuts, abrasions, irritations of the skin, partial thickness wounds and skin conditions associated with peristomal care.
Repliderm™ Wound Dressing has also been shown to be useful for wound exudate absorption.
Repliderm™ Wound Dressing is a collagen based product containing approximately 73% protein, 18% carbohydrates, and 5% other cartilage components. The particles, average particle size of approximately 35 microns, are composed of the natural three-dimensional network of macromolecular chains of cross-linked collagen, which is large enough to allow substances with a molecular weight of less than 1,000 to freely enter. Substances with a molecular weight of 1,000 to 5,000 enter the particles less freely, while those substances with larger molecular weights remain in the interspaces between the particles.
Each gram of wound dressing powder can absorb approximately 3-4 ml of fluid. Its other wound healing properties derive from an average 35 micron particle size, combined with the materials biocompatibility and biodegradation characteristics.
The provided text describes information about a wound dressing product named Repliderm™ Wound Dressing.
However, it does not contain the specific details required to complete your request in the format you've outlined for "acceptance criteria" and "device performance" in a table that typically applies to diagnostic devices and their quantitative metrics (like sensitivity, specificity, AUC).
The document is a 510(k) summary for a medical device (wound dressing), which focuses on demonstrating substantial equivalence to existing predicate devices, rather than a detailed performance study with defined acceptance criteria for quantitative metrics.
Here's an analysis of what information is available based on your request, and what is missing:
The nature of this device (a wound dressing) means its "performance" is described qualitatively through wound healing characteristics rather than typically quantitative metrics like those for diagnostic devices. Therefore, I cannot create a table of "acceptance criteria" and "reported device performance" in the way you might expect for a diagnostic AI device.
Here's what can be extracted based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, a formal table with quantitative acceptance criteria and corresponding reported device performance, typical for AI/diagnostic devices, is not present. The "performance" here is demonstrated through qualitative observations and comparisons to controls/predicate devices.
| Performance Characteristic (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| Wound Exudate Absorption | "Repliderm™ Wound Dressing was found to absorb 3½-4 times its weight of simulated wound exudate in an in vitro analytical study. This study shows that Repliderm™ Wound Dressing is an effective exudate absorbing material." |
| Dermal Irritation/Sensitivity | Pig Study: "No evidence of dermal irritation or dermal sensitivity was histologically observed in any skin sample associated with the cartilage powder treatment." |
| Acute Systemic Toxicity | Pig Study: "No evidence of acute systemic toxicity was observed for any animal examined, during the post-wounding sampling period." |
| Wound Healing/Re-epithelization | Pig Study: "Wound healing/re-epithelization comparable to predicate device." |
| Tensile Strength (Wounds) | Rat Studies: "Topical application of bovine cartilage powder (20-30 mg) resulted in greater wound tensile strength." "Incisions treated with cartilage powder had statistically significantly greater tensile strength compared to control wounds." "Calf bovine cartilage powder with a particle size of 20 microns resulted in greater tensile strength as compared to 70 micron particles." Human Studies: "The treated wounds were statistically stronger in 12 of 15 wound pairs as evidenced by the increased tensile strength." |
| Rate of Wound Healing (Histological) | Rat Studies: "Wounds treated with cartilage powder reached their maximum on the seventh day. Control wounds exhibited mature scar tissue by the eighth postoperative day while the cartilage wounds continued to show cellular activity until the twenty-first day. The initial acceleration of wound healing caused by cartilage powder is manifested histologically by earlier and greater endothelial and fibroblastic proliferation with concomitant production of reticulum fibers and collagen." Human Studies: "Biopsies samples from paired wounds in another volunteer study showed histologically evident increases wound healing rates were noted." |
| Time to Complete Healing | Rat Studies: "The mean time to complete healing was statistically significantly longer in the control group as compared to the cartilage powder group." |
| Biocompatibility | "Collectively, the results of the testing, along with the absence of irritation or cytotoxicity in the porcine wound healing study, summarized above, demonstrate that Repliderm™ Wound Dressing meets the biocompatiblity requirements for a Wound Dressing (Draft Guidance for the Preparation of a Premarket Notification for a Wound Dressing, 1993)." |
| Initiation of Granulation Process (Chronic Non-Healing Ulcers) | Human Studies: "Cartilage powder applied to chronic non-healing ulcers initiated the granulation process and formed a granulating bed over the wound in all but two cases. Once granulation was initiated, the healing process was self-sustaining in all instances." |
2. Sample Size and Data Provenance (for test set)
- Animal Studies (Pig Skin Wound Healing Study): The sample size for the pig study is not explicitly stated. The provenance is not specified beyond "pig." It is a prospective study (designed to compare wound healing and observe irritation/toxicity).
- Animal Studies (Rat Studies: Tensile Strength, Histological, Time to Complete Healing): Sample sizes for the rat studies are not explicitly stated. The provenance is not specified beyond "rats." These appear to be prospective experimental studies.
- Human Clinical Studies:
- Tensile Strength Evaluation: "Two wounds, one treatment site and one control site, per human volunteer were evaluated." "12 of 15 wound pairs," suggesting a minimum of 15 human volunteers for this specific tensile strength evaluation. The provenance is not specified. It is a prospective study.
- Histological Evaluation: "Biopsies samples from paired wounds in another volunteer study showed histologically evident increases wound healing rates were noted." Sample size (number of volunteers) not specified. Provenance not specified. It is a prospective study.
- Acute toxicity and surgical and non-healing chronic wound healing: "all but two cases" (for granulation), implied multiple cases but no specific number. Provenance is not specified. It describes clinical observations.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Animal Studies: The text mentions "histologically observed" for irritation and "histologic study" for wound healing. This implies evaluation by veterinary pathologists or similar experts. However, the number and specific qualifications (e.g., "veterinary pathologist with X years of experience") are not provided.
- Human Studies: For histological evaluation, it states "Biopsies samples... showed histologically evident increases." This implies evaluation by human pathologists. The number and specific qualifications are not provided.
- Clinical Observations (e.g., granulation process): These would typically be established by treating clinicians, but their numbers and qualifications are not provided.
4. Adjudication Method for the Test Set
The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth in any of the studies. The nature of the observations (histology, clinical healing) suggests expert evaluation, but the process of resolving discrepancies or forming consensus is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was NOT done. This type of study typically applies to diagnostic imaging devices where multiple readers interpret cases with and without AI assistance to assess performance improvement. The described device is a wound dressing, and the studies focus on its biological effects rather than diagnostic interpretation.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was NOT done. This concept is irrelevant for a physical wound dressing product. "Standalone" performance is usually for AI algorithms, assessing their output without human intervention.
7. Type of Ground Truth Used
- In Vitro Study: Measurement of exudate absorption. The "ground truth" is the measured absorption capacity.
- Pig Skin Wound Healing Study:
- Histology: Expert histological observation for dermal irritation, sensitivity, and re-epithelization.
- Clinical Observation: Observation of acute systemic toxicity.
- Rat Studies:
- Tensile Strength Evaluations: Objective mechanical measurement of tissue strength.
- Histological Evaluation: Expert histological observation of wound healing progress (cellular activity, proliferation, collagen production).
- Time to Complete Healing: Objective measurement of healing duration.
- Human Clinical Studies:
- Tensile Strength Evaluations: Objective mechanical measurement of tissue strength.
- Histological Evaluation: Expert histological observation of healing rates.
- Clinical Observation: Observation of granulation process in chronic ulcers and healing after surgical applications.
- Biocompatibility: Based on histological observations (absence of irritation/cytotoxicity) and adherence to a "Draft Guidance for the Preparation of a Premarket Notification for a Wound Dressing, 1993."
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here because Repliderm™ Wound Dressing is a physical medical device, not an AI algorithm that undergoes machine learning training. The studies conducted are performance and safety evaluations, not model training.
9. How the Ground Truth for the Training Set Was Established
- As the concept of a "training set" for an AI algorithm is not applicable, this question is not relevant to the provided document.
N/A