(94 days)
The Kimberly-Clark* MicroCool* Surgical Gown, Breathable High Performance, KC 400 (hereinafter referred to as "MicroCool* Surgical Gown") are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The MicroCool* Surgical Gowns meet the Level 4 requirements of the AAMI PB70: 2003 Liquid Barrier classifications.
The MicroCool* Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.
The MicroCool* Surgical Gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric. The fabric is a threelayer lamination that resists tearing and penetration by liquids. The gown is constructed from a spunbond/film/spunbond design and is adhesively laminated. The spunbond layers are comprised of nonwoven polypropylene. The film layer is a multi-layer polypropylene olefin, breathable film. A fluorochemical treatment is added to the film to retard penetration by low surface tension fluids. A polyolefin hot melt adhesive is used to laminate the Spunbond facing lavers to the film layer to complete the composite. A new sleeve design was incorporated to meet Level 4 of the AAMI Liquid Barrier classifications.
The request is for information regarding acceptance criteria and a study proving device performance, relevant to a medical device. However, the provided text describes a Kimberly-Clark MicroCool Surgical Gown, which is a physical product (surgical apparel), not a diagnostic algorithm or AI device that would typically have the requested criteria like "test set," "ground truth," "MRMC study," or "training set."
Therefore, the specific information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 for an AI/algorithm-based device is not applicable to this submission.
Here's the closest interpretation of the provided text in relation to the request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ANSI/AAMI PB70: 2003 Level 4 Liquid Barrier) | Reported Device Performance |
|---|---|
| Liquid Barrier Classification: Level 4 (highest level) | Meets Level 4 requirements of AAMI PB70: 2003 Liquid Barrier classifications. |
| Resistance to penetration by blood-borne pathogens (ASTM1671:2003, using Phi-X174 bacteriophage) | Meets requirements of ASTM1671:2003. |
| Flame Resistance | Meets requirements of Flame Resistant CPSC 1610 Class 1. |
| Biocompatibility (ISO 10993 for surface devices with limited contact with breached or compromised surfaces) | Meets biocompatibility requirements of ISO 10993. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This device is a physical product, not an algorithm, so "test set" in the context of data provenance is not relevant. The testing involved physical samples of the gowns. The document does not specify the number of gowns or material samples tested for each criterion, nor their provenance in the sense of data origin.
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. "Ground truth" in the context of expert review is for classification or diagnostic tasks. For physical product performance, the "ground truth" is defined by the objective performance standards themselves (e.g., AAMI PB70, ASTM1671, CPSC 1610, ISO 10993) and measured through standardized laboratory tests. The experts involved would be laboratory technicians or engineers performing the tests, but no "ground truth" establishment by medical experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for reconciling disagreements among human readers or expert reviewers in diagnostic studies. For standardized physical product testing, the results are typically quantitative measurements against defined thresholds, not subjective interpretations requiring adjudication.
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. An MRMC study is for evaluating diagnostic performance, often involving AI assistance to human readers. This device is a surgical gown, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This concept applies to AI algorithms, not physical medical devices like surgical gowns.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Performance standards and laboratory test results. For this device, the "ground truth" is established by the specified industry standards (e.g., AAMI PB70 Level 4 for liquid barrier, ASTM1671 for viral penetration, CPSC 1610 for flame resistance, ISO 10993 for biocompatibility). The device's performance is objectively measured against these established-in-standard criteria in a laboratory setting.
8. The sample size for the training set
- Not applicable. This concept applies to machine learning models, not physical products.
9. How the ground truth for the training set was established
- Not applicable. This concept applies to machine learning models, not physical products.
§ 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.