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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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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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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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AllGrad Wash is used for sperm washing procedures such as in vitro washing and incubation of sperm in Assisted Reproduction techniques

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The provided document is a 510(k) premarket notification letter from the FDA for a device called "AllGrad Wash (Hepes Buffered Wash Medium)." This document does not describe acceptance criteria, a study that proves the device meets those criteria, or any details about AI/ML algorithms, sample sizes, ground truth, or expert adjudications.

It is a regulatory clearance document for a reproductive media product, not an AI/ML-driven medical device. Therefore, I cannot extract the requested information from this document.

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Used to slow the motility of spermatozoa for the use in ICSI procedure.

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The provided text is a 510(k) clearance letter for a medical device called PVP (Polyvinylpyrrolidone), used to slow the motility of spermatozoa for ICSI procedures. However, the document does not contain information regarding the acceptance criteria, specific performance study results, sample sizes (training or test), expert qualifications, adjudication methods, or MRMC studies that would typically be detailed in a device's performance evaluation.

The letter explicitly 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 indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than a detailed performance study against specific acceptance criteria. The FDA's 510(k) process often relies on demonstrating equivalence to an already approved device rather than requiring extensive de novo clinical trials with precise performance metrics and acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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HTF Plus (HTF with non-essential amino acids) is used as a holding media and a supplement for human gametes and embryos for assisted reproduction.

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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 the acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "HTF Plus - HTF with non-essential amino acids," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

The letter explicitly 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...". This means the submission primarily focused on demonstrating equivalence to an existing device, rather than providing detailed acceptance criteria or a specific study proving performance against such criteria.

The document includes:

• Trade/Device Name: HTF Plus - HTF with non-essential amino acids
• Regulation Number/Name: 21 CFR 884.6180, Reproductive media and supplements
• Regulatory Class: II
• Product Code: 85 MQL
• Indications for Use: HTF Plus (HTF with non-essential amino acids) is used as a holding media and a supplement for human gametes and embryos for assisted reproduction.
• 510(k) Number: K022334
• Date of Clearance: August 28, 2002

It does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information about standalone algorithm performance studies.
• Details on the type of ground truth used.
• Sample size or ground truth establishment for a training set.

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

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To be used for the softening of the embryo zona during assisted reproductive procedures

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance described by a study, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The document is a 510(k) clearance letter from the FDA for a device called "Acidified Tyrodes Solution." It primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance requirements.

The "Indications for Use" section states: "To be used for the softening of the embryo zona during assisted reproductive procedures." This indicates the intended purpose of the product but does not provide any performance metrics or study details.

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HTF Plus with HEPES (HTF with non-essential amino acids) is used as a holding media for human gametes and embryos for assisted reproduction.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "HTF Plus with HEPES" (also referred to as "HTF with non-essential amino acids"). This letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The letter only states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. This means that for this particular device (a reproductive media and supplement), the FDA's decision is based on its similarity to existing products, rather than a new study demonstrating its efficacy against specific pre-defined acceptance criteria.

Therefore, I cannot fulfill your request with the provided input. The information you are asking for typically comes from a detailed clinical study report or a different section of a 510(k) submission that outlines performance testing.

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