Search Results

Sperm Freeze is intended to be used as a cryopreservation medium for human sperm.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device named "Enhance Sperm Freeze" (later referred to as "Sperm Freeze"). This document does not contain any information about the acceptance criteria or a study that proves the device meets specific performance metrics.

Instead, this document focuses on:

• Substantial Equivalence: The FDA's determination that "Enhance Sperm Freeze" is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• Regulatory Information: Details about regulatory classification (Class II), applicable regulations, and requirements for marketing the device.
• Indications for Use: Stating that "Sperm Freeze is intended to be used as a cryopreservation medium for human sperm."

Therefore, I cannot provide the requested information from this document regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment. These details would typically be found in the 510(k) submission itself or a separate clinical/performance study report, not in the clearance letter.

Ask a specific question about this device

Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Enhance-S Plus" device.

The document is a 510(k) premarket notification letter from the FDA, indicating that the device "Enhance-S Plus" has been determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and responsibilities of the manufacturer. The "Indications for Use Statement" on the last page merely specifies the intended use of the device: "Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures."

Therefore, I cannot provide the requested information.

Ask a specific question about this device

Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

Not Found

This document is an FDA 510(k) clearance letter for a medical device called "Enhance-S Plus," which is described as a "Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures."

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed information requested in your prompt about how the device meets acceptance criteria.

The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the clearance is based on substantial equivalence to a pre-existing device, not on new performance studies demonstrating adherence to specific acceptance criteria.

Therefore, I cannot provide the requested table or detail any of the study-related information based on the provided text.

Ask a specific question about this device

Conceptions Technologies' Microtools are used in the laboratory as a microtool to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction procedures.

Microtools

The provided text is a 510(k) summary from 1999 for a device called "Microtools" which are described as tools for micromanipulation in assisted reproduction procedures. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The document is a regulatory approval letter and an indications for use statement, not a scientific study report.

Ask a specific question about this device

The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.

The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques.

The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception.

After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.

The Ovulon Monitor is an electronic biosensor designed for home use that vields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.

The provided text is related to the FDA clearance of the Ovulon Monitor, a fertility aid. Unfortunately, the document is a 510(k) clearance letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document confirms the device's clearance based on substantial equivalence to pre-existing devices, but it does not detail the specific performance studies and their results.

Ask a specific question about this device