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This Powdered Latex Surgeon's Glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The glove is made of natural rubber latex. It is powdered with absorbable dusting powder. The sterility status is sterile. It meets all the requirements of ASTM D3577-0951. No colorant is added during manufacture of our Powdered Latex Surgeon's Glove. The color of our glove is ivory.

This document describes a 510(k) premarket notification for a medical device, specifically a Powdered Latex Surgeon's Glove. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a comprehensive study with acceptance criteria and a detailed statistical analysis typically associated with AI/ML devices or new therapies.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission. The device is a physical product (a glove), not a software algorithm or AI.

However, I can extract the relevant information regarding performance specifications and how the device meets established standards.

Device Name: Powdered Latex Surgeon's Glove (Suzhou Colour-way Enterprise Development Co., Ltd)

Predicate Device: Powdered Latex Surgeon's Glove (K062797)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating equivalence to a predicate device and meeting the requirements of established international standards (ASTM D3577-0951, ISO10993-10:2010, and ISO11137-2:2012).

Study Proving Device Meets Acceptance Criteria:

The submission explicitly states: "The Powdered Latex Surgeon's Glove manufactured by Suzhou Colour-way Enterprise Development Co., Ltd and the predicate device meet the technology characteristics of ASTM D3577-0951, ISO10993-10:2010 and ISO11137-2:2012 standards." This indicates that the new device underwent testing to demonstrate compliance with these standards, and a comparison against the predicate device based on the characteristics listed above.

Information Not Applicable to this 510(k) Submission (Device is a Physical Product, not AI/ML):

Given that this is a 510(k) submission for a physical medical device (latex gloves) and not an AI/ML software device, the following categories are not applicable (N/A):

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A – Testing is on physical properties and biocompatibility, not data sets.
• 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): N/A – Ground truth is established by physical measurements and standardized biochemical/biological tests, not expert interpretation of data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A – Applies to interpretation tasks, not physical product 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: N/A – Applies to AI/ML software.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A – Applies to AI/ML software.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A – Ground truth for physical properties are defined by test methods in the standards (e.g., force required to break, elongation percentage, chemical analysis results).
• 8. The sample size for the training set: N/A – Applies to AI/ML software.
• 9. How the ground truth for the training set was established: N/A – Applies to AI/ML software.

Summary of the Study (as presented in the 510(k)):

The "study" in this context is a series of tests performed to demonstrate that the Powdered Latex Surgeon's Glove manufactured by Suzhou Colour-way Enterprise Development Co., Ltd meets the specifications of ASTM D3577-0951, ISO10993-10:2010, and ISO11137-2:2012 standards, and that its technological characteristics (material, design, indications for use, and performance features like dimensions, tensile strength, elongation, water leak, and biocompatibility) are substantially equivalent to the identified predicate device (K062797). The specific details of the testing methodology (e.g., exact number of gloves tested for each property) are not provided in this summary but would be part of the full submission to show compliance with the cited standards. The conclusion explicitly states the device is "as safe and effective and performed as well as the referenced predicate device."

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The powdered latex surgeon's glove with protein content labeling claim (200 micrograms or less per gram) is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.

Powdered Latex Surgeon's Glove with Protein Content Labeling Claim (200 Micrograms or Less per Gram)

The provided text is a 510(k) clearance letter from the FDA for a powdered latex surgeon's glove. It does not contain any information about acceptance criteria or a study that proves a device meets such criteria.

The document primarily states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory determination, not a statement about specific performance metrics relative to acceptance criteria from a study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to the regulatory clearance of a physical medical device (gloves), not an AI/software device that would typically undergo the kind of performance studies described in your query.

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A powdered surgeon's glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Class I Surgeon's Gloves (Powdered) 79 KGO that meets all the requirements of ASTM D 3577-00. A powdered surgeon's glove is a disposable device made of natural rubber lates that bears powder to facilitate donning and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

This document (K031368) is a 510(k) premarket notification for Powdered Latex Surgeon's Gloves. It is a declaration of substantial equivalence to a predicate device, not a study demonstrating performance against detailed acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in this document. This K number pertains to a Class I device, which typically involves fewer rigorous testing requirements than higher-risk devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the way you might expect for a new, complex AI or imaging device. The "performance" here is primarily compliance with a recognized standard.

Here's the information that can be extracted or reasonably inferred from the provided text, along with what is not available:

1. A table of acceptance criteria and the reported device performance

• Note: The document states the device "meets all the requirements of ASTM D 3577-00". This ASTM standard defines the physical requirements for rubber surgeon's gloves, including dimensions, tensile strength, elongation, and watertightness. The specific numerical thresholds for these criteria are defined within ASTM D 3577-00, but are not listed in this 510(k) summary. The device's "performance" is simply its conformity to this standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in this document. Compliance with an ASTM standard would typically involve testing batches of gloves, but the number of gloves tested is not mentioned.
• Data Provenance: Not specified. This would involve product testing by the manufacturer (Cephas Medical Private Limited) which is located in India. The testing is likely prospective, as it's part of manufacturing quality control.

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. This is a manufacturing standard compliance notification for a low-risk device, not a diagnostic device requiring expert interpretation for ground truth. Ground truth for gloves (e.g., integrity, strength) is established by objective physical tests per the ASTM standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 3. Testing involves objective measurements against predefined limits in the ASTM standard, not subjective interpretation 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

• No. This is a surgeon's glove, not a diagnostic device or AI system. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. Not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the performance of these gloves (e.g., their physical integrity and strength) is established by objective physical measurements as defined by the ASTM D 3577-00 standard (e.g., tensile strength, elongation, freedom from holes).

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

pre-POWDERED LATEX SURGEON'S GLOVES

This document is a 510(k) clearance letter from the FDA for Sanrea Healthcare Private Limited's "Pre-Powdered Latex Surgeon's Gloves." It does not contain information on acceptance criteria, study data, or AI-related performance. Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This document is solely an FDA clearance for marketing the device based on substantial equivalence to a predicate device.

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