(69 days)
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Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing
The provided text does not contain information about specific acceptance criteria, device performance metrics, or a formal study designed to "prove" the device meets such criteria in terms of quantitative measures like sensitivity, specificity, or accuracy.
The text describes:
- Device: Carrasyn™ Hydrogel Wound Dressings.
- Purpose of filing: Standardization and clarification of previously cleared indications for labeling.
- Safety assessment: Biocompatibility tests (Primary Dermal Irritation, Primary Eye Irritation) in animal models, conducted under GLP regulations. These tests demonstrated the dressings are not primary dermal or eye irritants.
- Clinical Experience: Two observational studies (not formal clinical trials with specific endpoints or acceptance criteria to evaluate device performance) involving:
- Four patients with radiation dermatitis.
- 30 patients with diabetic ulcers (Grades III or IV, treated for 10 weeks).
- Outcomes of clinical experience: These studies "evaluated the acceptability of Carrasyn™ Hydrogel Wound Dressing to both the patients and clinicians, to wound and skin appearance, and to the wound healing environment." They "concluded that Carrasyn™ wound dressings are safe and effective for their intended use."
Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided document sections. The document focuses on safety testing (biocompatibility) and reporting on limited clinical experience for labeling purposes, rather than a study designed to establish quantitative performance metrics against acceptance criteria.
Here's how I would attempt to answer based only on the provided text, while acknowledging the severe limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Biocompatibility | Not a primary dermal irritant | Carrasyn™ wound dressings are not primary dermal irritants. |
| Not a primary eye irritant | Carrasyn™ wound dressings are not primary eye irritants. | |
| Clinical Acceptability | Acceptable to patients and clinicians | Evaluated as acceptable to both patients and clinicians. |
| Wound & Skin Appearance | Positive impact on wound & skin appearance | Evaluated positively regarding wound and skin appearance. |
| Wound Healing Environment | Positive impact on wound healing environment | Evaluated positively regarding the wound healing environment. |
| Overall Safety & Effectiveness | Safe for intended use | Concluded to be safe for intended use. |
| Effective for intended use | Concluded to be effective for intended use. |
Explanation: The "acceptance criteria" above are inferred from the types of evaluations mentioned ("evaluated the acceptability," "concluded that Carrasyn™ wound dressings are safe and effective"). No specific quantitative thresholds or predefined success criteria are provided in the text.
Summary of Study Information (Based on provided text):
- No formal study with defined quantitative acceptance criteria to prove device performance was described in the provided text. The clinical "studies" mentioned were observational and focused on acceptability and qualitative outcomes.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- For biocompatibility tests: "standard animal models" (specific number not given).
- For clinical experience: 4 patients with radiation dermatitis, 30 patients with diabetic ulcers (total 34 patients).
- Data Provenance: Not explicitly stated, but clinical experience likely from the US where the sponsor is located. Type: Retrospective or prospective is not specified for the clinical experience, but it seems to describe observed outcomes. Biocompatibility tests were prospective animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Biocompatibility: Likely conducted by laboratory technicians and assessed by toxicologists/pathologists as per GLP, but specific numbers and qualifications are not mentioned.
- Clinical Experience: "clinicians" (plural) are mentioned as evaluators, but the specific number or their qualifications (e.g., dermatologists, wound care specialists) are not provided. The term "experts" is not explicitly used.
4. Adjudication method for the test set:
- Not specified for either the biocompatibility tests or the clinical experience.
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 type of study (MRMC with AI assistance) is not mentioned in the provided text. The device is a wound dressing, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. Not applicable as this is a physical wound dressing, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Scientific standards for primary dermal and eye irritation (observed biological reactions in animal models).
- Clinical Experience: Clinician and patient observations/feedback on acceptability, wound and skin appearance, and wound healing environment. This could be considered a form of "outcomes data" or expert observation, but not formal "ground truth" for a performance metric.
8. The sample size for the training set:
- Not applicable/Not provided. There is no mention of machine learning or an AI algorithm that would require a dedicated training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided (see point 8).
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MAR 2 1 1996
Device Name:
| Classification Name: | Dressings, wound and burns, hydrogel |
|---|---|
| Common Name: | Hydrogel Wound Dressings |
| Proprietary Names: | Carrasyn™ Hydrogel Wound DressingCarraGauze™ PadsCarraGauze™ StripsCarrasyn™ FDG Pads |
| Device Sponsor: | Carrington Laboratories, Inc.2001 Walnut Hill LaneIrving, TX 75038-4404Registration No: 162544 |
Regulatory Classification: Unclassified. (Product code MGO)
Summary of Safety and Effectiveness:
This 510 (k) Premarket Notification provides for the standardization and clarification of previously cleared indications for the labeling of Carrasyn™ wound dressings. Carrasyn™ Hydrogel Wound Dressing was originally marketed pursuant to 510 (k) Number K902345. The additional wound dressings that are included in this labeling standardization and clarification include CarraGauze™ pads (K915001), CarraGauze™strips (K925002) and Carrasyn™ FDG pads (K944427).
Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.
Since the products are for topical use, the safety of these wound gels was established through standard biocompatibility tests. These biocompatibility tests were conducted in standard animal models with preparations of the Carrasyn™ wound dressings. These tests included Primary Dermal Irritation testing and Primary Eye Irritation testing. These studies demonstrated that Carrasyn™ wound dressings are not primary dermal irritants or primary eye irritants. These studies were conducted in conformance with Good Laboratory Practices (GLP) regulations of the United States Food and Drug Administration (21 CFR, Part 58).
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Clinical experience to date has been gained during the course of two studies that involved four patients with radiation dermatitis and 30 with diabetic ulcers. Grades III or IV diabetic ulcers of the foot were treated with Carrasyn™ Hydrogel Wound Dressing for 10 weeks. Acute and subacute radiation dermatitis was treated for various times with Carrasyn™ Hydrogel Wound Dressing. These studies evaluated the acceptability of Carrasyn™ Hydrogel Wound Dressing to both the patients and clinicians, to wound and skin appearance, and to the wound healing environment. These studies concluded that Carrasyn™ wound dressings are safe and effective for their intended use.
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