(13 days)
Talymed™ is indicated for the management of wounds including:
Diabetic ulcers Venous ulcers Pressure wounds Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Second degree burns Surgical wounds-donor sites/grafts, post-mohr's surgery, post-laser surgery, and other bleeding surface wounds, Abrasions, lacerations Traumatic wounds healing by secondary intention Chronic vascular ulcers Dehisced surgical wounds.
Talymed" is a sterile wound matrix comprised of shortened fibers of poly-Nacetylglucosamine, isolated from microalgae.
This document is a 510(k) summary for Talymed™, a hydrophilic wound dressing. It is important to note that a 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study in the way a novel AI algorithm might. Therefore, the information provided will reflect this regulatory context.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" and "device performance" are typically framed around demonstrating equivalence to a predicate device. The primary "performance characteristic" is its intended use and physical properties being comparable and safe.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Findings) |
|---|---|
| Intended Use Equivalence: Talymed™ has essentially the same intended use as predicate devices. | Talymed™ is indicated for the management of wounds including: Diabetic ulcers, Venous ulcers, Pressure wounds, Ulcers caused by mixed vascular etiologies, Full thickness and partial thickness wounds, Second degree burns, Surgical wounds-donor sites/grafts, post-mohr's surgery, post-laser surgery, and other bleeding surface wounds, Abrasions, lacerations, Traumatic wounds healing by secondary intention, Chronic vascular ulcers, Dehisced surgical wounds. This matches the broad indications of wound dressings. |
| Biocompatibility: All materials are biocompatible, and no new adverse effects were introduced. | Results of scientific testing ensured that all materials are biocompatible and no new adverse effects were introduced. (Specific test results are not detailed in this summary, but are implied to be part of the full 510(k) submission). |
| Physical Properties: Physical properties are appropriate for the intended use. | Results of scientific testing ensured that physical properties are appropriate for the intended use. (Specific property measurements and comparative data are not detailed here, but implied to be part of the full submission). |
| Safety: The device is safe and effective when used as intended. | The FDA’s substantial equivalence determination implies that the device is considered safe and effective for its stated indications, based on the comparison to predicate devices and submitted data. |
2. Sample size used for the test set and the data provenance
The document does not specify a test set sample size or data provenance in the way one would for a clinical trial validating a novel AI device. The 510(k) process relies on:
- Comparison to predicate devices: The "test set" here is primarily the characteristics of the new device and how they compare to legally marketed predicate devices (Marine Polymer Technologies, Taliderm K070557 and Cook Biotech Int. Oasis Wound Matrix K061711).
- Scientific testing: The summary states "Results of scientific testing have ensured that all materials are biocompatible... and physical properties are appropriate." This refers to laboratory-based tests (e.g., cytotoxicity, irritation, sensitization for biocompatibility; tensile strength, absorbency for physical properties) rather than a clinical "test set" on patients. The sample sizes for these lab tests would be determined by relevant ISO standards or internal protocols, but are not disclosed in this summary.
- Data Provenance: Not applicable in the context of clinical data for a "test set" as described. The "data" are results from laboratory tests and a comparison of the device's design and intended use to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert annotation to establish ground truth for a diagnostic AI. The "ground truth" for a 510(k) for a wound dressing is:
- The known safety and performance of the predicate devices.
- The established scientific principles for biocompatibility and material properties.
4. Adjudication method for the test set
Not applicable. There is no "adjudication method" in the context of a 510(k) for physical device characteristics. The assessment is a regulatory review comparing the device to predicates and relevant standards.
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
Not applicable. This is a wound dressing, not an AI-assisted diagnostic device. Therefore, no MRMC study, human reader assistance, or AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (wound dressing), not an algorithm or AI.
7. The type of ground truth used
The "ground truth" in this 510(k) context consists of:
- Predicate Device Performance: The established safety and effectiveness profile of the predicate devices (Taliderm K070557 and Oasis Wound Matrix K061711) for their specified indications.
- Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for evaluating the biological safety of medical devices.
- Material Science Principles: General scientific understanding and established test methods for evaluating the physical and chemical properties of materials used in medical devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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