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Amazing+ Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Amazing Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.

The provided text is a 510(k) Summary for a medical device: "Amazing+ Latex Examination Powder Free Gloves." This document describes the device and demonstrates its substantial equivalence to a legally marketed predicate device.

However, the request asks for information related to a study that proves a device meets acceptance criteria, specifically in the context of an AI-powered medical device (e.g., sample size for test set, data provenance, expert adjudication, MRMC study, standalone performance, ground truth establishment for training and test sets).

The provided 510(k) Summary does not describe an AI medical device. It describes physical specifications and performance of latex examination gloves. Therefore, many of the requested fields are not applicable to this type of device.

Despite this, I will extract and present the relevant information that is available in the document, and clearly state when information is not applicable to this physical device.

Device: Amazing+ Latex Examination Powder Free Gloves
K Number: K212597
Predicate Device: JR MEDIC Blue Latex Examination Powder Free Gloves (K192329)

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

Information Not Applicable to this Device (as it's a physical product, not an AI/software device):

Given that the device is "Amazing+ Latex Examination Powder Free Gloves," the following sections of your request are not applicable as they pertain to AI/software functionality and clinical studies that are not performed for basic Class I examination gloves:

• 2. Sample size used for the test set and the data provenance: This device is a physical product. Testing involves laboratory measurements on physical samples (e.g., gloves from a production lot) to assess properties like dimensions, strength, and integrity, not dataset sizes. The provenance is from "Amazing Rubber Products Pvt. Ltd." in Cochin, Kerala, India. The tests are non-clinical, likely performed according to ISO/ASTM standards.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by standardized measurement methods (e.g., ASTM standards), not expert opinion or consensus.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Physical measurements do not require 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. This is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for device performance is based on the specified ASTM and ISO standards for physical and chemical properties and biocompatibility testing.
• 8. The sample size for the training set: Not applicable. There is no "training set" for physical examination gloves; manufacturing process controls ensure consistent product.
• 9. How the ground truth for the training set was established: Not applicable. See above.

Summary of Non-Clinical Performance Data (Reiterated from document):

The performance test data of the non-clinical tests meet the following standards:

• ASTM D 3578-2019 Standard Specification for Rubber Examination Gloves
• ASTM D 5151-2019 Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D 6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
• ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber

Clinical Testing Summary:

• "This section is not applicable because clinical data not needed for gloves." (As stated in the document).

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Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.

The document provided is a 510(k) premarket notification for "Latex Examination Powder Free Gloves." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data against established standards for medical gloves, rather than clinical studies using AI.

Therefore, the requested information regarding AI study details (sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, how ground truth for training was established) is not applicable to this submission, as it does not involve an AI/ML powered device.

However, I can extract the acceptance criteria and device performance based on the non-clinical tests described.

1. Table of Acceptance Criteria and Reported Device Performance

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Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free.

The provided text describes the 510(k) summary for the "Latex Examination Powder Free Gloves" device (K202377). This document focuses on demonstrating substantial equivalence to a predicate device (K192329) based on non-clinical performance data, as it is a Class I medical device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, ground truth establishment with experts, or similar clinical evaluation methods are not applicable here.

The "device" in this context is a pair of medical examination gloves, not an AI/software device. The "study" refers to non-clinical tests performed to demonstrate the physical and chemical properties of the gloves meet established standards.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Latex Examination Powder Free Gloves (K202377)

The acceptance criteria for this device are established by adherence to recognized ASTM standards for rubber examination gloves. The study proving the device meets these criteria involves laboratory testing of various physical and chemical properties of the gloves.

1. Table of Acceptance Criteria and Reported Device Performance:

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Blue Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are blue in color and are powder free.

The document provided describes the acceptance criteria and the study results for the Blue Latex Examination Powder Free Gloves (K192329). This is a medical device, specifically examination gloves, and the studies evaluate physical properties and biocompatibility.

Here's the requested information:

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

2. Sample size used for the test set and the data provenance

The document provides specific values for various measurements (e.g., length, width, thickness, tensile strength, ultimate elongation, residual powder content, extractable protein content) across different glove sizes (Small, Medium, Large, X-Large, XX-Large). For tests like Water Tightness (AQL 1.5 achieved) and Biocompatibility testing (Primary Skin Irritation, Dermal Sensitization, In vitro cytotoxicity, Material mediated Pyrogenicity), the methodology implies testing on a statistically significant sample, but the exact sample sizes are not explicitly stated in the provided text for each test.

The data provenance is from non-clinical tests conducted by JR Engineering & Medical Technologies (M) SDN.BHD. in Malaysia. The study is a prospective assessment of the device's adherence to established ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes non-clinical testing of physical and chemical properties of a medical device (gloves), not studies requiring expert interpretation of medical images or conditions to establish a ground truth. The "ground truth" here is defined by established engineering and medical device standards (e.g., ASTM, ISO).

4. Adjudication method for the test set

This is not applicable for the type of testing described (physical and chemical properties testing against standards). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for medical image interpretation or diagnostic accuracy assessments where human expert consensus is required.

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

This is not applicable. The document describes the performance of an examination glove, not an AI-powered diagnostic or assistive technology.

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

This is not applicable. This document evaluates a physical medical device (gloves), not a software algorithm.

7. The type of ground truth used

The ground truth used for these tests is based on established industry standards and specifications:

• ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves
• ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
• ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber
• ISO 10993-10:2010(E) for Primary Skin Irritation and Dermal Sensitization
• ISO 10993-5:2009(E) for In vitro cytotoxicity
• ISO 10993-11:2017(E) / USP for Material mediated Pyrogenicity

8. The sample size for the training set

This is not applicable as this pertains to a physical product's performance validation, not a machine learning model.

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

This is not applicable (see #8).

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