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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

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.

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