(329 days)
The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric.
Stav Fresh Skin Fold Management Textile is a non-sterile skin protectant indicated for management of skin folds and other skin-to-skin contact areas, such as extremities, and is offered as a 25.4 cm x 365.8 cm fabric piece (other sizes may also be available). The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Stay Fresh Skin Fold Management Textile is a single patient use product that is custom cut from a multiuse package. Polyester fabrics are well known to wick moisture away from skin as well as provide a low friction surface.
The provided text describes a 510(k) summary for a medical device (Stay Fresh Skin Fold Management Textile) and associated FDA correspondence. However, it does not contain the detailed information requested regarding specific acceptance criteria, a study proving those criteria were met, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/algorithm-based device study.
The document states that the device was subjected to "extensive testing to assess the biocompatibility and the performance of the Stay Fresh Skin Fold Management Textile was shown to provide moisture management and antimicrobial properties." This is a general statement and does not provide the specifics of a study suitable for answering the questions.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific quantitative thresholds for properties like moisture management or bacterial reduction.
- Reported Device Performance: The text generally states the device "was shown to provide moisture management and antimicrobial properties." No specific metrics or values are given.
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: Not mentioned.
- Data Provenance: Not mentioned.
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 as this is a textile product, not an AI/diagnostic device requiring expert ground truth in that sense. The "testing" mentioned doesn't involve medical image interpretation or similar.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for this type of device and testing.
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/algorithm-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an AI/algorithm-based diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "moisture management and antimicrobial properties" testing, the ground truth would likely be based on established laboratory methods and standards for measuring these properties (e.g., absorbency tests, microbiological assays). However, the specific methods are not detailed.
8. The sample size for the training set
- Not applicable, as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI/machine learning model.
Summary Table (with available information):
| Criterion/Information | Description from Provided Text |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Acceptance Criteria: Not explicitly stated as quantitative thresholds. |
| Reported Performance: "The performance of the Stay Fresh Skin Fold Management Textile was shown to provide moisture management and antimicrobial properties." (No specific metrics or quantitative results provided). | |
| 2. Test Set Sample Size & Data Provenance | Sample Size: Not mentioned. |
| Data Provenance: Not mentioned. | |
| 3. Number of Experts & Qualifications (for ground truth) | Not applicable (not an AI/diagnostic device requiring expert ground truth). |
| 4. Adjudication Method (for test set) | Not applicable (not an AI/diagnostic study). |
| 5. MRMC Comparative Effectiveness Study | No, not an AI/algorithm-based diagnostic device. |
| 6. Standalone Algorithm Performance Study | No, not an AI/algorithm-based diagnostic device. |
| 7. Type of Ground Truth Used (for performance claims) | Likely established laboratory methods for moisture management (e.g., absorbency) and antimicrobial properties (e.g., microbiological assays). Specifics not provided. |
| 8. Training Set Sample Size | Not applicable (not an AI/machine learning model). |
| 9. How Ground Truth for Training Set Was Established | Not applicable (not an AI/machine learning model). |
§ 880.5300 Medical absorbent fiber.
(a)
Identification. A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.