Search Results

Bed linens made with DermaTherapy® fabrics are intended for use by patients 18 years of age and older in hospital settings who are susceptible to pressure ulcers. The DermaTherapy Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient's skin.

DermaTherapy uses a silk-like fabric to minimize moisture, friction, and shear between the skin and the bedsupport surface. Continuous-filament yarns woven into the silk-like synthetic DermaTherapy fabric provide a smooth surface, free of broken or discontinuous fibers. This enhanced smoothness helps minimize the potential for irritation and abrasion of sensitive skin.

DermaTherapy Bed Linens consists of pillow cases, top flat sheets, and underpads. The subject devices are made from DermaTherapy fabrics which are plain-weave constructions of 100% continuous-filament yarns. The polyester yarns 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 apparel.

The only technological difference in the fabric construction between the subject device and the predicate device is the addition of a secondary static-dissipative polyester yarn at 0.8% of the total fabric weight. The static-dissipative yarn is incorporated to reduce the potential for static electricity that may occur during institutional laundering processes. The company has made no other modifications to the fabric or the manufacturing process of turning the fabric into the final product.

This document describes data for a medical device called "DermaTherapy Bed Linens," which are intended to reduce the likelihood of pressure ulcers in hospital patients. Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for each performance characteristic. Instead, it lists the "Performance Characteristics" and the "Test Method / Standard" used to evaluate the device. The conclusion states that "bench testing demonstrated that the device met performance specifications" and "demonstrated substantially equivalent device performance." It also includes clinical study results showing a reduction in pressure ulcer incidence.

Given the information, the table below will combine the performance characteristics (which can be inferred as criteria for evaluation) and the clinical performance results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Clinical Test Set): A total of 2,009 study subjects across three studies.
  • Study 1: 307 patients
  • Study 2: 275 patients
  • Study 3: 1,427 patients
• Data Provenance: The studies were conducted in an "acute care setting at multiple healthcare sites," implying they were conducted in clinical environments. The document does not specify the country of origin but is submitted to the FDA, suggesting it is either US-based or intended for US market approval. The nature of "clinical trials" and "comparison of data between study and control groups" suggests these were prospective studies.

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)

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the clinical studies (e.g., diagnosis of pressure ulcers).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method used for the clinical test set.

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

• This device is bed linens, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
• The clinical studies performed were comparative effectiveness studies of the bed linens themselves, showing a reduction in pressure ulcer incidence. The "effect size" can be inferred from the percentage reduction in pressure ulcers in the DermaTherapy group compared to the control group (e.g., Study 1 showed an 8.3% absolute reduction: 12.3% - 4.6%).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This point is not applicable as the device is not an algorithm or AI-powered system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the clinical studies, the ground truth was the incidence of facility-acquired pressure ulcers. This is a form of outcomes data, likely determined through clinical assessment and documentation within the hospital settings.

8. The sample size for the training set

This is not applicable. The device is not an AI algorithm that requires a "training set" in the machine learning sense. The "training" that occurs is the manufacturing process of the linens to meet specific physical characteristics.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Ask a specific question about this device