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HSA is intended as a protein supplement for in-vitro mammalian-cell culture media. These procedures include in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a 510(k) premarket notification letter from the FDA regarding a device named "Enhance-HSA." It states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must comply with. The "Indications for Use Statement" indicates that "HSA is intended as a protein supplement for in-vitro mammalian-cell culture media," listing procedures like in vitro fertilization, gamete washing, embryo culture, micromanipulation, and embryo cryopreservation.

This type of document confirms regulatory clearance but does not typically include detailed performance study results or acceptance criteria.

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ENHANCE HTF with HEPES is a medium that is used for in vitro procedures involving the manipulation of gametes and embryos not requiring the use of a CO2 incubator.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "ENHANCE HTF with HEPES," which is a reproductive media and supplement. This document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with an AI/ML medical device.

The letter pertains to a traditional medical device and primarily confirms its substantial equivalence to previously marketed predicate devices under the 510(k) pathway. This pathway does not involve the elaborate performance studies common for AI/ML devices, nor does it typically detail acceptance criteria in the manner requested.

Therefore, most of the requested information cannot be extracted from this document as it is not relevant to the type of device and regulatory pathway described.

Information that CANNOT be extracted from the provided document:

• A table of acceptance criteria and the reported device performance: This document does not specify performance acceptance criteria or report device performance data.
• Sample size used for the test set and the data provenance: Not applicable; this is not a study assessing performance against a test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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 applicable; this is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI/ML device.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable; this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

What the document does indicate about the device:

• Device Name: ENHANCE HTF with HEPES
• Regulation Number: 21 CFR 884.6180
• Regulation Name: Reproductive media and supplements
• Regulatory Class: II
• Product Code: 85 MQL
• Indications For Use: ENHANCE HTF with HEPES is a medium that is used for in vitro procedures involving the manipulation of gametes and embryos not requiring the use of a CO2 incubator.
• Regulatory Pathway: 510(k) Premarket Notification, cleared based on substantial equivalence to predicate devices.

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Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.

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This document is a 510(k) premarket notification decision letter from the FDA for "Sperm Wash Medium & Sperm Wash Medium with Gentamicin". It does not contain information about acceptance criteria or a study proving device performance in the way requested for AI/medical device performance.

Therefore, I cannot provide the details about acceptance criteria or a study from the provided text. The letter primarily states the device's substantial equivalence to a predicate device and outlines regulatory requirements.

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Phosphate Buffered Saline With Cations and Phenol Red (PBSW) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).

Phosphate Buffered Saline (PBS) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).

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I am sorry, but this document is an FDA 510(k) clearance letter for a medical device (Phosphate Buffered Saline solutions) and does not contain the information requested about acceptance criteria, study details, or ground truth.

The document primarily focuses on:

• Confirming that the device, PBS and PBSW, is substantially equivalent to a legally marketed predicate device.
• Stating its indications for use (in vitro procedures like oocyte recovery, gamete washing, micromanipulation, embryo transfer, and cryopreservation).
• Providing regulatory information and contact details.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

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Hyaluronidase in HTF Medium is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.

Hyaluronidase in HTF Medium; Hyaluronidase in EBSS Medium

This document is a 510(k) premarket notification from the FDA, specifically approving a device called "Hyaluronidase in HTF Medium" for use in intracytoplasmic sperm injection (ICSI) procedures. It does not contain information about acceptance criteria, study details, or device performance metrics like accuracy, sensitivity, or specificity.

The document is primarily an approval letter and a statement of the device's intended use. It confirms that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document. To fulfill your request, I would need a different type of document, such as a clinical study report, a scientific paper, or a detailed device performance specification sheet.

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Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures. It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Water for Tissue Culture, Model 1500" or "Water for Assisted Reproduction Procedures". This document clears the device for market but does not contain the specific acceptance criteria or details of a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a detailed clinical study in the way a PMA (Pre-Market Approval) submission would.

Therefore,Based on the provided text, the following information about acceptance criteria and a detailed study is not available:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter or the Indications for Use statement.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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: This is irrelevant as the device is "Water for Assisted Reproduction Procedures," not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Irrelevant as the device is "Water for Assisted Reproduction Procedures," not an AI diagnostic device.
7. The type of ground truth used: Not provided, as the nature of the device (water) doesn't typically require 'ground truth' in the same way a diagnostic imaging device would. The focus is on purity and sterility.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

Summary of what the document does provide:

• Device Name: Water for Tissue Culture, Model 1500 (also referred to as Water for Assisted Reproduction Procedures)
• Intended Use: For use in assisted reproduction procedures; specifically for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos in IVF or other assisted reproduction procedures, and as a final rinse for labware or other assisted reproduction devices that will contact gametes or embryos.
• Regulatory Class: Class II
• Procode: 85 MTW
• Regulatory Mechanism: 510(k) clearance, indicating substantial equivalence to a predicate device.

To obtain the detailed acceptance criteria and study data, one would typically need to review the full 510(k) summary and submission documents which are usually publicly available on the FDA website, but are not part of the provided text.

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