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A non-metal disposable vaginal speculum is an instrument that is used to expose the interior of the vagina.

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The provided text is a 510(k) premarket notification letter from the FDA to Cypress Medical Products regarding their Disposable, Non-Metal Vaginal Speculum. This type of document confirms substantial equivalence to a legally marketed predicate device, but it does not contain the detailed study results, acceptance criteria, or ground truth information requested in your prompt.

Specifically, the letter 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 (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's performance was compared to existing, legally marketed devices, but the specifics of those comparative studies (acceptance criteria, sample sizes, ground truth establishment, etc.) are not described in this letter. A 510(k) submission generally includes this information, but the letter itself is just the FDA's decision.

Therefore, I cannot provide the requested table and study details based solely on the text given. The document does not describe a new study proving the device meets specific acceptance criteria in the manner you've outlined. 510(k) clearance is typically based on demonstrating substantial equivalence, often through a combination of design characteristics, materials specifications, and sometimes limited performance data compared to a predicate, rather than a full-scale clinical trial with detailed acceptance criteria and ground truth as might be seen for novel AI/diagnostic devices.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Sterile Synthetic Vinyl Examination Gloves

I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Synthetic Vinyl Patient Examination Gloves" and pertains to regulatory approval, not device performance studies or acceptance criteria. Therefore, I cannot extract the table of acceptance criteria, device performance, or details about any study as this information is not present in the given text.

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An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.

An Aneroid Sphygmomanometer is a non-invasive medical device intended to measure the systolic and diastolic blood pressures by means of a manually inflatable cuff and a manometer analog gauge.

The provided text is a 510(k) clearance letter from the FDA for an Aneroid Sphygmomanometer. It declares the device substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The letter only states that the device is "substantially equivalent" to a predicate device and can therefore be marketed. To provide the requested information, a different type of document (e.g., a summary of safety and effectiveness, or a full study report) would be needed.

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

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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.

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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.

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