(392 days)
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Plus Medical Chemotherapy Gowns are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling and administration. The gowns are a closed back design, single use, disposable medical device provided sterile and non-sterile gowns are to be sold in bulk to re-package:r/e-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
The provided document does not describe a study involving an AI/ML device, therefore, much of the requested information cannot be extracted. The document is a 510(k) premarket notification for a medical device (Plus Medical Chemotherapy Gown) that is not an AI/ML product. It primarily focuses on the regulatory clearance process for this medical gown, particularly its barrier protection and resistance to chemotherapy drugs.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Test Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 for Liquid Barrier Performance. | Plus Medical Chemotherapy Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. |
| No breakthrough at the Standardized Breakthrough Rate of 0.1 ug/cm²/minute, up to 480 minutes, for various chemotherapy drugs per ASTM F739-12. | All 12 tested chemotherapy drugs (Carmustine, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin HCI, Etoposide, Fluorouracil, Methotrexate, Mitomycin C, Paclitaxel, Thio Tepa, Vincristine Sulfate) showed >480 minutes of breakthrough time. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for testing or data provenance for the performance data of the Plus Medical Chemotherapy Gown. The tests mentioned (ANSI/AAMI PB70:2012 and ASTM F739-12) are likely conducted on samples of the gown material under controlled laboratory conditions, not on patient data.
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, as this is a medical gown, not an AI/ML diagnostic device requiring expert review of medical images or data. The "ground truth" for the gown's performance is established through standardized laboratory testing protocols, not expert consensus on medical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary. The performance is determined by physical and chemical testing.
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 device is not an AI/ML product and therefore no MRMC study or assessment of AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical gown, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the Plus Medical Chemotherapy Gown is established by adherence to recognized industry standards and test methods:
- ANSI/AAMI PB70:2012: Liquid barrier performance is measured against the specifications of this standard.
- ASTM F739-12: Resistance to permeation of chemotherapy drugs is measured according to this standard test method.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth.
§ 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.