(196 days)
InterDry Textile with Silver is a skin protectant indicated for management of skin folds and other skin-to-skin contact areas. InterDry Textile with Silver reduces microbial colonization in the fabric.
Interdry Textile with Silver is a non-sterile skin protectant comprised of polyester knit textile substrate indicated for management of skin folds and other skin-to-skin contact areas and is offered as a 25.4 cm x 365.8 cm fabric piece, although other sizes may be available. The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Interdry Textile with Silver is a single patient use product that is custom cut from a multiuse package.
The provided text describes a 510(k) summary for the "Interdry Textile with Silver" device, which is a skin protectant. The performance testing section mentions "Biocompatibility testing" and "Antimicrobial testing". However, it does not provide detailed acceptance criteria with specific numerical targets, nor does it present a detailed study with a defined sample size, ground truth, or statistical analysis in the way typically expected for an AI/ML device.
It's important to note that K061615 is for a medical textile, not an AI/ML device. Therefore, the questions about AI/ML specific criteria (e.g., test set sample size, experts for ground truth, MRMC study, training set size) are not applicable to this submission. The "study" mentioned here refers to standard biocompatibility and antimicrobial efficacy tests for a medical textile.
Here's an attempt to answer the questions based on the available information, noting the limitations due to the nature of the device:
Acceptance Criteria and Device Performance for Interdry Textile with Silver (K061615)
This 510(k) submission is for a medical textile, not an AI/ML device. Therefore, many of the requested details, particularly those related to machine learning model evaluation, are not applicable. The reported performance relates to the physical and biological characteristics of the textile.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Attribute | Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Irritation (typical for ISO 10993) | Suitable for intended use without adverse biological reactions | "Results of the Organization for biocompatibility tests demonstrate that the device is suitable for its intended use." |
| Antimicrobial Efficacy (Device itself) | Reduction of microbial colonization within the fabric | Effective microbial barrier to the device itself | "Antimicrobial testing was performed which showed that Interdry Textile with Silver provides an effective microbial barrier to the device itself." |
| Material Equivalence/Comparison to Predicate | Design, Function, Intended Use | Substantially equivalent to predicate in design, function, and intended use; additional feature does not affect safety/effectiveness. | "Substantially equivalent in design, function and intended use to the SurePress device." "The additional antimicrobial feature... does not affect the safety and effectiveness of the device." |
| Physical Properties | Moisture management, low coefficient of friction | Provides moisture management to keep skin dry; reduces skin-to-skin friction. | "The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction." (Describes device function, not a specific test result here) |
Note: Specific numerical acceptance criteria for biocompatibility and antimicrobial tests are not provided in this summary. These would typically be detailed in the full submission, referencing standards like ISO 10993 for biocompatibility and specific microbiological test standards.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. For biocompatibility tests, sample sizes are dictated by the specific ISO 10993 test methods (e.g., animal tests, in-vitro cell cultures). For antimicrobial testing, sample sizes are typically small, involving various microbial strains and replicates.
- Data Provenance: Not explicitly stated but inferred to be laboratory-generated data from testing performed to industry standards. This is likely prospective testing conducted in controlled environments. Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this type of device. "Ground truth" in the context of biocompatibility and antimicrobial testing is established by standard laboratory protocols and expert interpretation of results, not by a consensus of medical experts reviewing patient data. The "experts" would be the scientists and toxicologists performing and interpreting the laboratory tests according to established scientific principles and standards.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical outcome or image interpretation studies. For laboratory tests, results are interpreted based on predefined criteria in the test standard, often without external adjudication beyond internal quality control and peer review of results.
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
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used
- Ground Truth for Biocompatibility: Established by adherence to standardized testing protocols (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation) and comparison against established biological reactivity scales. The "truth" is whether the material elicits a harmful biological response above acceptable thresholds.
- Ground Truth for Antimicrobial Efficacy: Established by quantitative microbiological assays that measure the reduction in microbial counts when in contact with the material, compared to control samples. The "truth" is the measured inhibition or kill rate of specific microorganisms.
8. The sample size for the training set
- Not applicable. There is no AI/ML model to train for this device.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model to train for this device.
§ 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.