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8-global® Blastocyst Fast Freeze Kit - Based on S3:

• Media Intended for cryopreservation of human blastocysts. .
  12-global® Blastocyst Fast Freeze Thawing Kit - Based on S3
• Media intended for the thawing and recovery of human blastocysts that . have been cryopreserved using the &-global® Blastocyst Fast Freeze Kit - Based on $3.

Not Found

The provided document is a 510(k) summary for the global® Blastocyst Fast Freeze Kit and global® Blastocyst Fast Freeze Thawing Kit. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies as would be found in a clinical trial report or an academic publication on a diagnostic AI device.

Therefore, most of the information requested in your prompt is not present in this 510(k) submission.

Here's what can be inferred or stated based on the provided text, and where information is explicitly missing:

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

   • Not present. The document does not provide a table of acceptance criteria or performance metrics. The 510(k) process is about demonstrating substantial equivalence, not necessarily meeting pre-defined performance acceptance criteria with detailed statistical analysis.

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

   • Not present. There is no mention of a "test set" or any specific study data that would detail sample sizes, data provenance, or study design (retrospective/prospective).

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 present. As there's no mention of a test set or a study involving establishing ground truth, this information is not available.

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

   • Not present. No information on an adjudication method is available.

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 present. The device described is a cryopreservation and thawing media kit for blastocysts, not an AI-powered diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this product.

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

   • Not present. This device is not an algorithm or AI.

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

   • Not present. No specific ground truth methodology is mentioned as it's not relevant to this type of device submission. Performance claim, if any, would typically be related to viability post-thaw or pregnancy rates, which would be direct outcomes, but no such study is detailed here.

8. The sample size for the training set:

   • Not present. The device is not an AI/ML algorithm that requires a "training set."

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

   • Not present. Not applicable for this device.

In summary: The provided document is an FDA 510(k) clearance letter and an "Indications for Use" statement for a reproductive media kit. It does not contain the detailed study information, acceptance criteria, or performance data typically associated with the evaluation of AI or diagnostic devices, which your questions are geared towards. The focus of this document is regulatory clearance based on substantial equivalence to predicate devices, not on proving device performance through specific clinical studies with defined endpoints and ground truth.

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Global DMSO Blastocyst Vitrification Kit:

• Intended for the vitrification (ultra-rapid freezing) and cryostorage of . human blastocysts.
  Global DMSQ Blastocyst Vitrification Warming Kit
• . Intended for the recovery and rehydration of vitrified human blastocysts
• Intended for use with blastocysts that have been vitrified using the Global . DMSO Blastocyst Vitrification Kit.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for two devices: the "Global DMSO Blastocyst Vitrification Kit" and the "Global DMSO Blastocyst Vitrification Warming Kit." This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is primarily an approval notice, stating that the FDA has determined the devices are "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements and general information but does not delve into the specific performance data or studies that would typically be included in a 510(k) submission itself.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided input. The necessary information is not present in this document.

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LifeGlobal Protein Supplement is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance as it is a 510(k) clearance letter for a medical device called "LifeGlobal Protein Supplement". It primarily focuses on the regulatory approval and indications for use of the product. Therefore, I cannot extract the requested information to fill your table or answer your specific questions about study design and results.

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LifeGlobal ® Human Serum Albumin (HSA) is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.

Not Found

The provided text is a clearance letter from the FDA for a medical device called "LifeGlobal® Human Serum Albumin LG HSA." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot extract the requested information from this document. This document is a regulatory approval, not a technical report or study summary.

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LG Sperm Freezing Medium is intended to be used for the cryopreservation of human sperm.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "LG Sperm Freezing Medium." It is not a study report that describes acceptance criteria and device performance data.

Therefore, I cannot provide the requested information such as:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This document only states that the FDA found the device substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed study information you are looking for.

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The Workbench will be used as an accessory item during assisted reproductive procedures.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Workbench™ by ". This document only states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information.

It does not contain any information regarding:

• Acceptance criteria for the device's performance.
• Details of any study conducted to prove the device meets acceptance criteria (such as sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given input.

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Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUI) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen.

Sperm Preparation Media is a mineral essential media with glucose and penicillin. This product is provided in sterile bottles. This products as indicated in the label is For In Vitro Use Only.

This document is a Premarket Notification (510(k)) for a medical device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations that would typically be found in a clinical study report or a more detailed device performance section.

Therefore, I cannot extract the requested information from the provided text. The document focuses on the equivalence of the "GenX Sperm Preparation Media" to an existing product based on its ingredients and intended use, rather than presenting a detailed performance study with acceptance criteria.

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Ask a specific question about this device