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This product is intended to be worn by operating room personnel to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Protection Plus Earloop Procedure Mask. This document is a regulatory approval for a medical device and does not contain information about acceptance criteria or a study proving device performance in the way you've requested (e.g., for an AI/algorithm).

The questions you've asked are typically relevant to the validation of AI-powered medical devices, specifically regarding their performance metrics, ground truth establishment, and clinical study designs.

Since the provided text is for a physical medical mask and not an AI device, I cannot extract the information you've requested. The document confirms that the mask is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval, not a separate performance study with associated metrics as you've outlined.

Therefore, I cannot populate the table or answer the specific numbered questions based on the input provided.

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A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for an "Earloop Procedure Mask", which primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

It details:

• The applicant, device name, regulation number, and classification.
• The FDA's review and determination of substantial equivalence.
• General controls and additional controls that may apply to the device.
• Contact information for specific advice from the FDA.
• The "Indications for Use" for the surgical mask, stating its purpose to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate materials.
• A checkbox indicating "Over-The-Counter Use".

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, or ground truth establishment.
• Details about expert involvement, adjudication methods, or MRMC studies.
• Standalone algorithm performance or training set details.

Therefore, I cannot fulfill your request based on the provided text.

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An Earloop Procedure Mask is a disposable device intended for medical purposes that is r in Larrey i rexaminer's mouth and nose to prevent contamination between examiner and patient.

Earloop Procedure Mask ( BLUE, YELLOW)

This document is a 510(k) clearance letter for the Isosafe™ EarLoop Procedure Mask from the FDA. It declares the device substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it contain any of the specific details requested in the prompt.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• Regulatory classifications and requirements.
• Contact information for compliance and assistance.
• A brief "Statement of Indications for Use" (page 2, Exhibit IV).

Therefore, I cannot extract the requested information, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
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 is a regulatory approval, not a performance study report.

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An Earloop Procedure Mask is a disposable device intended for medical purposes that is worn over the examiner's mouth and nose to prevent contamination between examiner and patient.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for an "Isosafe Earloop Procedure Mask."

It states that the device is "substantially equivalent" to previously marketed devices and permits the company to market it. However, it does not describe specific acceptance criteria (like performance metrics or thresholds) for the device itself, nor does it detail any specific study conducted by the manufacturer to demonstrate performance against such criteria.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed presentation of performance data from a specific study.

Ask a specific question about this device