(267 days)
Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy™ fabrics is intended for use by patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis.
The device that is the subject of this 510(k) premarket notification is generally described as Institutional Bedding made with DermaTherapy™ fabrics. Institutional bedding in this case refers to bed linens, generally comprised of a flat top sheet, a fitted or flat bottom sheet, and pillow cases that encase pillows on beds used in hospitals and/or in other healthcare or home settings.
DermaTherapy fabrics are plain-weave constructions of 100% contineous-filament yarns. The preferred embodiment of the technology involves 100% nylon yarns in one direction of the fabric, with 100% polyester yarns in the other direction. The polyester varns have a non-round fiber cross-section to create micro-channels to facilitate moisture wicking and rapid drying. The yarns used in DermaTherapy fabrics are commercially available products, typically used in women's lingerie or intimate apparel. Once woven, DermaTherapy fabrics are treated with a durable antimicrobial treatment to control bacteria and fungi growth on the fabrics. The antimicrobial treatment applied to DermaTherapy fabrics is a commercially available technology commonly used in the textile industry.
The provided text describes a 510(k) premarket notification for "Institutional Bedding made with DermaTherapy™ fabrics". It specifies the intended use, device description, and a brief summary of performance data. However, it does not provide specific acceptance criteria in a table format, nor does it detail a study proving the device meets quantifiable acceptance criteria in the manner typically expected for more complex medical devices like AI algorithms.
The document states: "A clinical study was performed and included 37 subjects with mild atopic dermatitis. Results showed statistically significant improvements in the severity of atopic dermatitis, eczema, the level of itching, and perceived quality of life after eight weeks of using DermaTherapy bedding." This is the core of the performance data.
Given the information, I can synthesize what's available and point out the missing elements to answer your request.
Missing Information:
The document does not provide the following details that would be crucial for a comprehensive answer to your request, especially concerning AI device studies:
- A clear table of specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, AUC thresholds).
- Any details about the "statistical significance" beyond the statement itself (e.g., p-values, confidence intervals, effect sizes).
- Sample sizes for test or training sets in the context of an AI device, as this is a textile product.
- Data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are concepts relevant to AI/diagnostic device evaluation, not typically for medical bedding.
- The type of ground truth and how it was established with the level of detail requested.
Here's the information derived from the provided text, structured to best answer your request, with a clear indication of what is not present:
Acceptance Criteria and Study Details for "Institutional Bedding made with DermaTherapy™ fabrics"
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Statistical Significance in: | Statistically significant improvements in: |
| - Severity of atopic dermatitis (implied reduction) | - Severity of atopic dermatitis |
| - Eczema (implied reduction) | - Eczema |
| - Level of itching (implied reduction) | - Level of itching |
| - Perceived quality of life (implied improvement) | - Perceived quality of life |
| Biocompatibility | Conforms with FDA recognized standards for biocompatibility. |
| Bench testing for physical properties (e.g., moisture wicking) | All bench tests showed satisfactory results. |
Note: The document does not specify quantitative thresholds for "statistically significant improvements" or "satisfactory results". The acceptance criteria are inferred from the reported outcomes.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 37 subjects.
- Data Provenance: The document does not explicitly state the country of origin but implies a single clinical study conducted for the 510(k) submission. It is a prospective clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This is not applicable in the context of this device (medical bedding) and the type of study performed. The outcomes (severity of atopic dermatitis, eczema, itching, quality of life) would likely have been assessed by clinicians or through self-reported questionnaires, not by "experts establishing ground truth" in the diagnostic sense. The document does not specify who conducted the assessments.
4. Adjudication Method for the Test Set
- This is not applicable as the study involved clinical outcomes on human subjects rather than expert review of diagnostic cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, particularly those involving image interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No, this is not a software/AI device, so the concept of standalone algorithm performance is not applicable. The device itself is "Institutional Bedding made with DermaTherapy™ fabrics".
7. The Type of Ground Truth Used
- The "ground truth" in this context would be the clinical assessment of the subjects' conditions (severity of atopic dermatitis, eczema, level of itching, and perceived quality of life) by qualified healthcare professionals or through validated patient-reported outcome measures. The document does not specify the exact assessment tools or methodologies.
8. The Sample Size for the Training Set
- This concept is not applicable as this is not an AI or machine learning device. There is no "training set." The study involved 37 subjects for evaluating the direct effect of the bedding.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI algorithm.
§ 880.6190 Mattress cover for medical purposes.
(a)
Identification. A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.(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.