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INTENDED TO BE USED FOR GENERAL THE UNGINA PROCEDURES. IT is INSERTED INTO THE VAGINA TRUCTOURES THE INTERioR OF THE VAGINA.

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The provided text is related to a 510(k) premarket notification for a disposable vaginal speculum, not an AI/ML powered medical device. Therefore, the information requested about acceptance criteria, study design, expert involvement, and training/test set details, which are typical for AI/ML device evaluations, is largely not present in this document.

However, I can extract information relevant to the device and the regulatory process.

Device Information:

• Trade Name: KENTEX Disposable Vaginal Speculum
• Common Name: Disposable Vaginal Speculum
• Classification Name: Non Metal Vaginal Speculum
• Regulation Number: 21 CFR Part 884.4530
• Product Code: HIB
• Regulatory Class: II

Intended Use Statement (from the "Indications for Use" section):
"INTENDED TO BE USED FOR GENERAL VAGINA PROCEDURES. IT IS INSERTED INTO THE VAGINA TO ALLOW THE VISUALIZATION OF THE INTERIOR OF THE VAGINA."

Regarding your specific questions, based on the provided text, the following cannot be answered as they pertain to AI/ML device studies, which this is not:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Explanation for lack of AI/ML specific information:

The document describes a traditional medical device (a disposable vaginal speculum) undergoing the 510(k) clearance process. This process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through performance testing, material characterization, and compliance with recognized standards, rather than complex clinical studies involving AI algorithm performance metrics, ground truth establishment, or multi-reader studies. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination does not typically involve the types of studies you are asking about for AI/ML devices.

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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.

ISOLATION GOWN

This document is a 510(k) clearance letter from the FDA for Kentron's Isolation Gown (K971917). It states that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.

Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets criteria. It is a regulatory clearance letter, not a performance study report.

Therefore, I cannot provide the requested table and study details based on the provided text. The document focuses on regulatory approval based on substantial equivalence, not on specific performance metrics or clinical study results for the device itself.

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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.

Imprevious Isolation Gown

I’m sorry, but this document does not contain the information you are looking for regarding the acceptance criteria and study details for a device. The provided text is a letter from the FDA concerning a 510(k) premarket notification for an "Imprevious Isolation Gown," stating that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• The FDA's determination of substantial equivalence.
• Regulatory classifications and requirements (general controls, GMP).
• Information on labeling regulations and compliance.
• The intended use of the device (to protect patients and healthcare personnel from transfer of micro-organisms, body fluids, and particulate material).

There is no information about:

• Specific acceptance criteria tables or reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

This type of information is usually found in a separate study report or a more detailed section of a 510(k) submission, not in the FDA's decision letter.

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