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BRIGHTWAY™ Brand Nitrile Examination Glove ( Powder Free, Chlorinated, Black Color ) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

BRIGHTWAY™ Brand Nitrile Examination Gloves (Powder Free, Chlorinated, Black Colour)

Here's an analysis of the provided text regarding acceptance criteria and study information:

The provided text describes two distinct medical devices and their respective 510(k) submissions. I will analyze the information for each separately as they don't seem to be related.

Device 1: SafeTip Safety Syringe (KOGO402)

This document mentions testing in a very general way and does not provide specific acceptance criteria or detailed study information. It states:

"The Devon SafeTip Safety Syringe has been shown to meet internationally recognized standards for syringe performance and labeling characteristics. Simulated clinical use testing has demonstrated the performance of the SafeTip syringe and reliability of the safety feature in accordance with the FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005."

From this, we can infer that the device was tested against "internationally recognized standards for syringe performance" and the "FDA Guidance: Medical Devices with Sharps Injury Prevention Features: August 9, 2005." However, the specific metrics, thresholds, or details of the study itself are not present.

Given the information provided, it's impossible to fill out the requested table and answer many of the specific questions.

Device 2: BRIGHTWAY™ Brand Nitrile Examination Gloves (K060402)

This document is a 510(k) clearance letter for examination gloves. It does not contain any information about specific acceptance criteria or performance studies of the device. It primarily details the regulatory clearance process and refers to general controls. The "Indications for Use" section simply describes the intended use of the gloves.

Therefore, for this device, it's also impossible to fill out the requested table and answer the specific questions about acceptance criteria and studies.

Summary of Missing Information for BOTH Devices:

The provided texts are regulatory submission documents (or summaries thereof) that indicate a device has undergone testing and met certain standards, but they do not include the specific details of those tests, acceptance criteria, or study methodologies. To answer your questions fully, you would need access to the actual test reports or detailed study summaries that would have been part of the full 510(k) submission.

Attempting to fill what little can be inferred from the "SafeTip Safety Syringe" document, with heavy caveats:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not specified.
• Data provenance: "Simulated clinical use testing" is mentioned, implying controlled laboratory or simulated environment. Country of origin not specified, but the applicant (Devon Safety Products) is based in the USA.

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

• Not specified. Testing likely involved engineers and technicians, not medical experts establishing ground truth in the traditional sense for diagnostic AI.

4. Adjudication method for the test set

• Not applicable as the study involves functional performance testing, not expert interpretation.

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 a physical device performance study, not an AI diagnostic study involving human readers.

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

• Not applicable. This is a physical device performance study.

7. The type of ground truth used

• The "ground truth" would be the objective measurement of the device's functional performance against established engineering and safety standards (e.g., successful deployment of the safety sheath, accurate fluid delivery, material strength, etc.).

8. The sample size for the training set

• Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the AI/machine learning sense.

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

• Not applicable for the same reason as above.

Conclusion for both devices: The provided text is insufficient to answer most of your detailed questions regarding acceptance criteria and study specifics. This information is typically found in detailed test reports and clinical study summaries, not typically in the brief 510(k) summary or clearance letters themselves.

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