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LifeGlobal Global Total: Culture of human embryos from zygote to blastocyst, and embryo transfer

LifeGlobal Global Total for Fertilization: Human oocyte culture and fertilization

LifeGlobal Global Total w/HEPES: Human oocyte and embryo washing and manipulation, fertilization by intracytoplasmic sperm injection (ICSI), and embryo transfer

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I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a reproductive media device, not an AI/ML device.

The letter confirms substantial equivalence but does not describe the specific performance studies, acceptance criteria, or ground truth methodologies that would be relevant for an AI/ML product. The document focuses on regulatory compliance and classification of a medical device (reproductive media), not on the evaluation of an AI algorithm's performance.

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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.

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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.

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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.

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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.

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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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The SunIVF Universal™ Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional invitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation.

The SunIVF Micromanipulation™ Dish is intended to be used to hold human sperm, oocytes and embryos during their manipulation in in vitro procedures of assisted human reproduction, including fertilization by intracytoplasmic sperm injection, assisted hatching, and biopsy.

The SunIVF ICSI™ Dish is intended to be used to hold human oocytes and sperm during the procedure of fertilization by intracytoplasmic sperm injection.

The SunIVF Freezing Dish 1 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.

The SunIVF Freezing Dish 2 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.

The SunIVF Vitrification Dish is intended to be used to hold human oocytes and embryos during the procedures of vitrification.

The SunIVF Rotational Dish is intended to be used to hold human oocytes and embryos during handling and culture.

The SunIVF General Flat Dish – 35 X 10 mm is intended to be used for washing and handling of human oocytes and embryos.

The SunIVF General Flat Dish – 60 X 15 mm is intended to be used for washing and handling of human oocytes and embryos.

The SunIVF General Flat Dish – 90 X 17 mm is intended to be used for washing and handling of human oocytes and embryos.

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This FDA 510(k) clearance letter for the SunIVF line of assisted reproduction labware (K080395) does not contain the detailed information requested regarding acceptance criteria and a study to prove device performance.

The document is a clearance letter, which states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It does not include:

1. A table of acceptance criteria and reported device performance: This type of information would typically be found in the manufacturer's 510(k) submission, not in the FDA's clearance letter.
2. Sample size used for the test set and data provenance: Again, this data is part of the submission, not the clearance letter.
3. Number of experts and their qualifications for ground truth: This information is not provided.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study results: This type of study is more common for diagnostic imaging AI devices, not for labware. It is not mentioned here.
6. Standalone (algorithm only) performance: Not applicable as this is labware, not an algorithm.
7. Type of ground truth used: Not applicable as this is labware, not a diagnostic device relying on ground truth.
8. Sample size for the training set: Not applicable as this is labware, not an AI/ML algorithm.
9. How ground truth for the training set was established: Not applicable.

Explanation Based on Document Content:

The document primarily focuses on:

• Device Identification: Listing the various SunIVF dishes (Universal, Micromanipulation, ICSI, Freezing 1 & 2, Vitrification, Rotational, General Flat dishes) and their product code (MQL, Class II).
• Intended Use: For each dish, it describes its purpose in assisted human reproduction procedures (e.g., holding sperm, oocytes, and embryos during manipulation, culture, IVF, ICSI, cryopreservation).
• Substantial Equivalence: The core of the 510(k) clearance, indicating that the FDA found the device to be as safe and effective as a predicate device already on the market. This often means the new device shares similar technological characteristics and intended uses with existing devices, and as such, does not require new clinical studies to prove performance in the same way a novel device might.
• Regulatory Compliance: Advising the manufacturer of their ongoing responsibilities under the Act (e.g., registration, listing, good manufacturing practices).

Conclusion:

To obtain the detailed information requested about acceptance criteria and performance studies, one would need to access the full 510(k) submission (K080395) made by GenX International, Inc. to the FDA, which is a much more comprehensive document than this clearance letter. The clearance letter itself merely confirms that the FDA concluded the device is substantially equivalent based on the information provided in that submission.

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

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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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global®: fertilization, embryo culture and transfer medium is intended for the use during fertilization, culture of human embryos and transfer.

global®: fertilization, embryo culture and transfer medium

The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "global®: fertilization, embryo culture and transfer medium." It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

This document is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices. It does not elaborate on the specific performance studies, acceptance criteria, or statistical details typically found in a clinical study report or a more comprehensive section of a 510(k) submission.

Therefore, I cannot extract the requested information from the provided text.

To answer your request, I would need a document that includes sections like:

• Performance Data / Clinical Data: Details on studies conducted.
• Acceptance Criteria: Specific thresholds for device performance.
• Study Design: Information on sample size, data provenance, ground truth establishment, etc.
• Results: Reported device performance metrics.

In summary, none of the requested information (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, ground truth type, training set sample size, training set ground truth method) is present in the provided FDA letter.

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LG Paraffin Oil PG is designed for use as an overlay when culturing in microdrops of media to prevent evaporation and to isolate media from changes of pH and osmolarity. Also for use as an overlay during the micromanipulation techniques of ICSI and assisted hatching.

Micromanipulation Media System: LG Hyaluronidase, LG Paraffin Oil

The provided text is a 510(k) premarket notification letter from the FDA to International, Inc. for LG Hyaluronidase and LG Paraffin Oil. It grants clearance for these reproductive media and supplements.

The document does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The letter is solely an FDA clearance document and does not detail the testing performed by the manufacturer.

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HTF with HEPES is used as a holding media for human gametes and embryos for assisted reproduction. global with HEPES is used as a holding and transfer medium for human gametes and embryos for assisted reproduction. PGD Biopsy Media is used as a holding medium for human gametes and embryos for assisted reproduction during the cell biopsy procedure used for pre-implantation genetic diagnosis.

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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 device performance.

The document is a 510(k) clearance letter from the FDA for reproductive media. It confirms that the devices (HTF with HEPES, Global with HEPES, and PGD Biopsy Media) are substantially equivalent to legally marketed predicate devices.

While it states that the FDA reviewed a "premarket notification of intent to market the device," it does not include the details of any specific study, acceptance criteria, or performance data. Such information would typically be found within the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot populate the table or provide answers to the questions regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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