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510(k) Data Aggregation
(27 days)
The pad is used to cover wounds
The pad is composed of the same type of materials as the predicate device. The non-woven outer-wrap has been tested according to the Intensified Shelasnski Repeated Insult Patch Test and is neither a skin irritant nor a skin sensitizer. The pads are available in the same sizes and similar weights.
The provided document is a 510(k) summary for the Hospeco ABD pad, a wound dressing device seeking substantial equivalence to a predicate device. This document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way you've described for an AI/ML-based medical device.
The document focuses on demonstrating that the Hospeco ABD pad is substantially equivalent to an existing legally marketed device (Kendall's Tendersorb ABD pad) based on similar materials, manufacturing, and intended use. The "Supporting Data and Conclusions" section primarily addresses sterilization validation and material testing for skin irritation, not clinical performance metrics typically associated with AI/ML device studies.
Therefore, I cannot populate the table or answer most of your questions as the document does not contain the requested information.
Here's an attempt to address your questions based on what is in the provided text, and where it's not present, I will state that:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "The wound dressing is substantially equivalent to the existing legally marketed device." (Predicate: Kendall's Tendersorb ABD pad) |
| Material Composition | Composed of "the same type of materials as the predicate device." |
| Skin Irritation/Sensitization | Non-woven outer-wrap tested according to Intensified Shelasnski Repeated Insult Patch Test; "neither a skin irritant nor a skin sensitizer." |
| Sterility Assurance Level (SAL) | Evaluated using AAMI Method 1 for microbiological validation of gamma irradiation sterilization. Bioburden established and minimum irradiation dose determined for "providing a sterility assurance level of 10⁻⁶." |
| Quarterly Dose Audit | "A quarterly dose audit will be performed on the product." |
| Sizes and Weights | Available "in the same sizes and similar weights" as the predicate device. |
| Technological Characteristics (Non-woven barrier) | Non-woven wax-cured polyester used as a barrier and to wrap the pad "instead of non-woven polypropylene" (this is a difference but deemed acceptable for equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document primarily refers to material testing and sterilization validation, not a clinical "test set" for performance evaluation in the context of an AI/ML device.
- Data provenance: Not specified.
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)
- Not applicable/not specified. This type of ground truth establishment is not relevant for this device's type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not specified.
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 is not an AI/ML-based device, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the skin irritation test: The "ground truth" would be the observed skin reactions (or lack thereof) in human subjects or in-vitro models according to the Intensified Shelasnski Repeated Insult Patch Test standard.
- For sterilization: The "ground truth" is the verified sterility assurance level of 10⁻⁶ through microbiological testing (bioburden determination and irradiation dose validation) as per AAMI Method 1.
- For material similarity: Comparison to the predicate device's materials.
8. The sample size for the training set
- Not applicable/not specified. This is not an AI/ML-based device and thus does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable/not specified. This is not an AI/ML-based device.
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