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The Bouffant Cap is a device intended to be worn by hospital personnel during procedures to protect both the patient and the hospital personnel from transfer of microorganisms, body fluids and particulate materials.

Bouffant Cap

The provided text is a letter from the FDA regarding the clearance of a "Bouffant Cap" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill the request using the provided input. The document is a regulatory approval letter, not a scientific study report.

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

CAP, BOUFFANT, NURSES SURGICAL WHITE, BLUE, & GREEN

This looks like a 510(k) clearance letter for a very low-risk device (nurses' bouffant cap) from 1997. It doesn't contain the extensive information you're asking for regarding acceptance criteria or detailed study results because such reports are typically not required for Class I devices cleared through predicate equivalence.

Here's why and what can be extracted:

Why the requested information is absent:

• Device Classification (Class I): Nurses' bouffant caps are classified as Class I devices. These devices are considered to pose the lowest risk to patients and users.
• 510(k) Clearance: For Class I and many Class II devices, the FDA clears them based on "Substantial Equivalence" to a legally marketed predicate device. This means the manufacturer demonstrates that their new device is as safe and effective as a device already on the market.
• Lack of Performance Studies: For low-risk devices like this, the FDA typically does not require comprehensive clinical studies or even extensive bench testing with detailed acceptance criteria and performance metrics. The demonstration of substantial equivalence often relies on:
  • Comparison of technological characteristics (materials, design, intended use).
  • Verification of manufacturing processes to ensure quality and consistency.
  • For something like a cap, basic safety (e.g., non-toxic materials, no sharp edges) and functionality (e.g., stays on, covers hair).

What can be extracted/inferred from the provided text:

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

   • Acceptance Criteria: Not explicitly stated in the provided documents. For a bouffant cap, criteria would be very basic, likely related to physical integrity, material composition, and fit.
   • Reported Device Performance: Not explicitly stated. The device is intended "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." The performance is implicitly assumed to be equivalent to existing predicate bouffant caps.

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

   • Not applicable/Not provided. Detailed test sets and data provenance for performance are not typically required for this type of clearance.

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/Not provided. There's no "ground truth" to establish for a device like this in the context of clinical performance.

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

   • Not applicable/Not provided.

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/software device.

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

   • Not applicable. This is not an AI/software device.

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

   • Not applicable. The "ground truth" for a bouffant cap would be its ability to physically contain hair and particulate matter, and its material safety, which are typically assessed through standard material testing and visual inspection, not complex clinical "ground truth."

8. The sample size for the training set:

   • Not applicable/Not provided. There is no AI model or complex algorithm requiring a training set for this device.

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

   • Not applicable/Not provided.

Summary based on the provided document:

The document is a 510(k) clearance letter confirming that the "Nurses Bouffant Cap" is substantially equivalent to a predicate device. This clearance is based on the device's classification as a low-risk, Class I device (Product Code: LYU) and the presumption that it meets general controls for manufacturing and labeling. Formal performance studies with detailed acceptance criteria, test sets, or expert ground truths, as would be required for higher-risk or novel devices, are not present in this type of regulatory submission. The "Indications For Use" state the device's purpose: "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." This functional intent is the closest equivalent to a performance goal, but no specific performance metrics are provided.

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Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.

Far-East Bouffant Caps are disposable devices, intended for medical purposes, that are worn by operating room personnel during surgical procedures to protect form surgical patient and operating room personnel from Burgioal patient and open commons and particulate materials.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is a letter from the FDA to Far East Science & Technology Development Company, Ltd., regarding the 510(k) premarket notification for "Far-East Bouffant Caps." It states the FDA's finding of substantial equivalence for the device. The "DEVICE INDICATION FOR USE" is also provided, describing the intended purpose of the bouffant caps.

However, it does not contain any technical study details or performance data that would allow me to answer your specific questions.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device