(256 days)
Rx Only (Pad and ribbon Configurations)
Under the supervision of a healthcare professional, ALGS6 Ag Alginate Wound Dressing may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second-degree burns.
For Over-the-Counter use (Pad Configuration), ALGS6 Ag Alginate Wound Dressing may be used for:
- Minor Abrasions
- Minor Lacerations
- Minor cuts
- Minor scalds and burns
ALGS6 Ag Alginate Wound Dressing is a highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad) dressing composed of calcium alginate fiber, Lyocell fiber and 1.7% ionic silver which allows for a maximum of 30.6 mg of silver for a 4-inch dressing (0.306 mg per square centimeter). Silver is present in the dressing as a preservative to prevent or inhibit growth of bacteria within the dressing. The dressing absorbs high amounts of wound fluid and the bacteria contained in the wound fluid. The absorbed wound fluid in the dressing creates a soft and cohesive gel which assists in maintaining a moist environment. The moist wound healing environment and control of dressing bacteria supports the body's healing process.
The provided document is a 510(k) summary for the ALGS6 Ag Alginate Wound Dressing, seeking substantial equivalence to a predicate device. It describes the device, its intended use, and comparative testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" as pass/fail thresholds for clinical performance or diagnostic accuracy. Instead, it demonstrates substantial equivalence to a predicate device by comparing various performance parameters. The "acceptance criteria" can be inferred as being "substantially equivalent" to the predicate device in the parameters listed.
| Parameter | Acceptance Criteria (inferred: Substantially Equivalent to Predicate) | Reported Device Performance (ALGS6 Ag Alginate Wound Dressing) | Proof of Criteria Met |
|---|---|---|---|
| Indications for Use (Rx Only) | Substantially Equivalent | Management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second-degree burns. | Stated as "Substantially Equivalent" to predicate device, which also manages these wound types. The listed indications for both are very similar, covering a wide range of acute and chronic wounds. |
| Indications for Use (OTC) | Substantially Equivalent | Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns. | Stated as "Substantially Equivalent" to predicate device, which has identical OTC indications. |
| Device Design | Substantially Equivalent | Highly absorbable, single layer, needle punched non-woven pad or ribbon dressing that can be cut or folded. | Stated as "Substantially Equivalent" to predicate device, which is also a highly absorbable, needle-punched non-woven pad dressing that can be cut or folded, though the predicate is described as two layers. The document argues this difference does not raise safety/effectiveness concerns. |
| Mechanism of Action | Substantially Equivalent | Conformable, highly absorbent hydrophilic dressing that forms a soft, cohesive gel on contact with wound exudate which maintains a moist environment for optimal wound healing; ionic silver inhibits bacterial colonization of the dressing. | Stated as "Same" as the predicate device. Both are hydrophilic dressings that gel in contact with exudate, providing a moist environment and using ionic silver for antibacterial effects. |
| Antibacterial Material | Substantially Equivalent | Ionic silver | Stated as "Same" as the predicate device. |
| Antibacterial Effectiveness within the Dressing | Substantially Equivalent | Greater than 4 log reduction for 8 organisms (4 gram positive, 4 gram negative). | Stated as "Substantially Equivalent." While the predicate tested log reduction for 3 organisms and Zone of Inhibition for 19, the subject device demonstrated a strong log reduction for a broader range of tested organisms. The implication is that this level of antibacterial effectiveness is comparable or superior in performance. |
| Hydrophilic Material | Substantially Equivalent | Alginate | Stated as "Substantially Equivalent." The document acknowledges the predicate uses sodium carboxymethylcellulose, but states that both materials perform the same primary function of absorption and moist wound healing, implying functional equivalence. |
| Method of Affixation | Substantially Equivalent | Covered and secured with an appropriate secondary dressing. | Stated as "Same" as the predicate device. |
| Wear Time per Dressing | Substantially Equivalent | Up to 7 days | Stated as "Substantially Equivalent." The predicate lists "Up to 7-14 days," but a 7-day wear time is considered within the range of equivalence. |
| Integral Removal | Substantially Equivalent | Yes | Stated as "Same" as the predicate device. |
| Single Use | Substantially Equivalent | Yes | Stated as "Same" as the predicate device. |
| Biocompatible | Substantially Equivalent | Yes | Stated as "Same" as the predicate device. This is supported by specific biocompatibility testing (irritation, sensitization, acute systemic toxicity, animal wound healing study, pyrogenicity testing, subchronic systemic toxicity study). |
| Sterilization | Substantially Equivalent | Gamma radiation (SAL 10-6) | Stated as "Same" as the predicate device. Supported by sterilization validation testing. |
| Primary Packaging | Substantially Equivalent | Foil pouch | Stated as "Same" as the predicate device. Supported by packaging testing. |
| Wound Healing Study | Non-inferiority to Predicate | Produced wound healing similar to the predicate device macroscopically and microscopically, and did not cause any delay in wound healing. | Animal wound healing study directly compared the subject device to the predicate device and found similar outcomes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and an animal wound healing study for performance evaluation. It does not mention human clinical trials or a "test set" in the context of diagnostic performance (e.g., patient images or data used to evaluate an AI algorithm).
- Bench Testing: The sample size for each specific bench test (e.g., absorbency, silver content) is not specified.
- Animal Wound Healing Study: The number of animals or wounds studied is not specified.
- Data Provenance: The location of the testing is not explicitly stated. The manufacturer is in China, and the correspondent is in the USA.
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)
This section is not applicable as the submission is for a wound dressing, not a diagnostic device that requires expert interpretation to establish ground truth for a test set. The wound healing study involved macroscopic and microscopic observation, likely by veterinary or histopathological experts, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the reasons stated above.
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
This section is not applicable as the device is a wound dressing, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a wound dressing, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing:
- Bench Testing: The "ground truth" for parameters like absorbency, silver content, pH, and antibacterial effectiveness is established by standardized laboratory methods and measurements.
- Wound Healing Study: The "ground truth" for wound healing was based on macroscopic and microscopic observations of the wounds in animals, likely involving histopathological analysis (a form of pathology).
- Biocompatibility Testing: The "ground truth" is based on standardized toxicity and reaction tests in biological systems (e.g., irritation, sensitization, systemic toxicity).
8. The sample size for the training set
This section is not applicable as the device is a physical wound dressing and does not involve an AI algorithm with a "training set."
9. How the ground truth for the training set was established
This section is not applicable as the device is a physical wound dressing and does not involve an AI algorithm with a "training set" or corresponding ground truth.
In summary, the provided document describes a 510(k) submission for a wound dressing, focusing on demonstrating substantial equivalence to a predicate device through a series of bench tests and an animal wound healing study. It does not involve AI, human reader studies, or diagnostic performance evaluation with expert consensus ground truth, which are typically found in submissions for AI/CADe medical devices.
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