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This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The tested chemotherapy drugs and permeation times are as follows:

Bleomycin Sulfate 15 mg/mL, >240 minutes
Busulfan 6 mg/mL, >240 minutes
Carboplatin (Paraplatin) 10 mg/mL, >240 minutes
Carmustine (BCNU) 3.3 mg/mL, 1.9 minutes
Cisplatin 1.0 mg/mL, >240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes
Cytarabine HC1 100 mg/mL, >240 minutes
Dacarbazine (DTIC) 10 mg/mL, >240 minutes
Daunorubicin HC1 5 mg/mL, >240 minutes
Docetaxel 20 mg/mL, >240 minutes
Doxorubicin Hydrochloride 2 mg/mL, >240 minutes
Epirubicin HC1 (Ellence) 2 mg/mL, >240 minutes
Etoposide (Toposar) 20 mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240 minutes
Fluorouracil 50 mg/mL, >240 minutes
Gemcitabine 38 mg/mL, >240 minutes
Idarubicin HCl 1 mg/mL, >240 minutes
lfosfamide 50 mg/mL, >240 minutes
Irinotecan 20 mg/mL, >240 minutes
Mechlorethamine HC1 1 mg/mL, >240 minutes
Melphalan 5 mg/mL, >240 minutes
Methotrexate 25 mg/mL, >240 minutes
Mitomycin C 0.5 mg/mL, >240 minutes
Mitoxantrone 2 mg/mL, >240 minutes
Paclitaxel (Taxol) 6 mg/mL, >240 minutes
Rituximab 10 mg/mL, >240 minutes
Thiotepa 10 mg/mL, 3.7 minutes
Trisenox 1 mg/mL . >240 minutes
Vincristine Sulfate 1 mg/mL, >240 minutes

Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes

WARNING: Not for use with Carmustine or Thiotepa.

This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

I cannot fulfill this request. The provided text is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about acceptance criteria or a study proving a device meets acceptance criteria related to a medical imaging AI device or similar complex medical technology.

The text exclusively details the clearance of Latex Examination Gloves Powder Free (Ocean Blue and Natural White), citing regulation numbers, product codes, and the review process for market clearance. It mentions general controls, quality system regulations, UDI rules, and reporting of adverse events, all pertaining to the manufacturing and marketing of physical medical devices (gloves in this case), not performance studies of an AI algorithm or diagnostic device.

Therefore, I cannot extract the information required to answer your specific questions about acceptance criteria, study design, ground truth, or expert involvement, as this information is not present in the provided document.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

The document is a 510(k) Premarket Notification for "Latex Examination Gloves Powder Free". It does not describe an AI/ML medical device, therefore, the requested information for acceptance criteria and study details for such a device is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K152593) for patient examination gloves.

However, I can extract the acceptance criteria and performance of the device based on the non-clinical tests mentioned, as they serve a similar purpose of demonstrating safety and effectiveness for this medical device.

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, thickness, or tensile strength). However, the tests were performed "as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20." These standards typically define the sampling plans. The data provenance is Malaysia, as the applicant, Careglove Global SDN BHD, is located in Seremban, Negeri Sembilan, Malaysia. The tests are non-clinical and would be considered prospective in the sense that they were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device that requires expert ground truth for image or data interpretation. The ground truth for the glove's performance is established by objective measurements against established industry standards (ASTM D3578-05).

4. Adjudication method for the test set
Not applicable, as it's not an AI/ML device requiring human adjudication of performance. The performance is determined by direct physical and chemical measurements.

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
The ground truth is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-05 (Standard Specification for Rubber Examination Gloves)
• 21 CFR 800.20 (dealing with devices that prevent contamination)
• ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

These standards define the acceptable performance limits for the characteristics tested.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth for it. The ground truth for the device's performance is established by the aforementioned ASTM and ISO standards for physical characteristics and biocompatibility.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

LATEX EXAMINATION GLOVE POWDER FREE

This document is a 510(k) premarket notification letter from the FDA regarding a Latex Examination Glove Powder Free. It does NOT contain information about acceptance criteria, device performance, a study, or any of the specific details requested in your prompt (such as sample size, data provenance, ground truth, or MRMC studies).

This document is solely an approval letter for a medical device that falls under general controls.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Latex Examination Glove Powder Free, With Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein)

N/A

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This gloves disposible and intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.

SMARTTEX LATEX EXAMINATION GLOVE POWDER FREE (Green, blue and natural color)

This document is a 510(k) premarket notification decision letter from the FDA for a medical device, specifically SMARTTEX Latex Examination Gloves. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, which means it has met the regulatory requirements for general controls, but it does not detail any specific performance studies or their results.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a performance study report.

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