(168 days)
The Kimberly-Clark* KC100 Surgical Gowns are sterile, single use devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
The Kimberly-Clark* KC100 Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of microorganisms, body fluids and particulates. Kimberly-Clark's KC100 Surgical Gowns are comprised of a single layer of SMS (spunbond/meltblown/spunbond polypropylene) fabric. The gowns consist of 100% polyester cuffs sewn to the end of the sleeves using polyester thread. The gowns also have a manual closure system.
The provided text describes a 510(k) summary for Kimberly-Clark KC100 Surgical Gowns. This document is a premarket notification for a medical device and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing studies about AI algorithms or software performance.
As such, the requested information regarding AI device acceptance criteria and study details (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set sample size, and ground truth establishment for training set) cannot be extracted from the provided text because it pertains to the approval of physical surgical gowns, not an AI/ML device.
However, I can provide the acceptance criteria and study information related to the surgical gowns themselves based on the text:
1. Table of Acceptance Criteria and Reported Device Performance (for KC100 Surgical Gowns):
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Material Properties | Barrier properties (e.g., fluid resistance, microbial barrier) | Met acceptance criteria |
| Tensile and tear strength | Met acceptance criteria | |
| Alcohol repellency | Met acceptance criteria | |
| Flammability | Met acceptance criteria | |
| Linting | Met acceptance criteria | |
| Biocompatibility | Cytotoxicity | Met acceptance criteria (in compliance with ISO 10993 methods) |
| Irritation | Met acceptance criteria (in compliance with ISO 10993 methods) | |
| Sensitization | Met acceptance criteria (in compliance with ISO 10993 methods) |
2. Study that Proves the Device Meets Acceptance Criteria:
The study conducted was a bench testing to demonstrate that the KC100 Surgical Gowns are identical to and meet the same acceptance testing criteria as their predicate device (K091097 proMedical Surgical Gowns).
- Sample size used for the test set and the data provenance: The document does not specify exact sample sizes for each test. It states "Testing included..." implying a standard set of tests for medical devices of this type. The provenance of the data is not explicitly stated beyond being conducted for the Kimberly-Clark Corporation. This would be considered internal company testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical product performance tests, not AI-driven diagnostic tests requiring expert ground truth for interpretation.
- Adjudication method for the test set: Not applicable for physical product testing described.
- 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 for a physical medical product, not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for a physical medical product, not an AI device.
- The type of ground truth used: The "ground truth" here is objective measurements against established international standards (like ISO 10993 for biocompatibility) and performance specifications for surgical gowns.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text concerns the regulatory approval of physical surgical gowns based on equivalence to a predicate device through standard product performance and biocompatibility testing, not an AI device.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.