(421 days)
The Dynarex Iodoform Packing Strip is a device used as an antibacterial barrier and for general use in wound packing and management. This Iodoform Packing Strip is indicated for external use only.
The Dynarex lodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex lodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively. The Dynarex lodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured.
The provided document is a 510(k) premarket notification for the Dynarex Iodoform Packing Strip. This document asserts substantial equivalence to a predicate device rather than presenting a study demonstrating the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in this type of submission.
Here's a breakdown of the available information based on the provided text, and where information is missing for your specific requests:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria/Performance: Not applicable. The document does not define specific performance acceptance criteria or report performance data for this device. The basis for clearance is "substantial equivalence" to a predicate device, meaning it is considered equally safe and effective.
2. Sample size used for the test set and the data provenance
- Sample Size/Data Provenance: Not applicable. No test set or study data is presented in this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts/Qualifications: Not applicable. No ground truth was established for a test set as no study was performed.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set or adjudication was performed.
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
- MRMC Study: No. This device is a physical product (Iodoform Packing Strip), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable. No ground truth was established as no study was performed.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/algorithm-based device; therefore, no training set was used.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable. No training set was used for this device.
Summary of Device and 510(k) Basis:
- Device Name: Dynarex Iodoform Packing Strip
- Intended Use: Device for general use in wound packing and management, as an antibacterial barrier. Indicated for external use only.
- Basis for Clearance: Substantial equivalence to already marketed predicate devices. The submission states: "The Dynarex Iodoform Packing Strip is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Iodoform Packing Strip is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively. The Dynarex Iodoform Packing Strip is a device for general use in wound packing and management and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured."
This type of 510(k) submission does not typically involve detailed performance studies against specific acceptance criteria, but rather a robust comparison to an existing, legally marketed device to demonstrate equivalence.
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