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Indications for Use: Media for freezing of blastocyst stage embryos

MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.

The provided text describes a premarket notification for the G-FreezeKit Blast™ device, an Assisted Reproduction Media. However, it does not contain the specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification, predicate device.
• Description and Intended Use: MOPS buffered media for freezing blastocyst stage embryos.
• Technological Characteristics: Comparison to a predicate device, noting similar cryopreservation ingredients (Glycerol and Sucrose) and a difference in antibiotic (Penicillin G vs. Gentamicin).
• Regulatory Information: FDA 510(k) clearance, substantial equivalence determination, and general controls.

Therefore, I cannot populate the requested table or answer most of the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness.

The document states that the device is "substantially equivalent" to a legally marketed predicate device (Blastocyst Freeze Media Kit, K000309). This typically means that the device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. The basis for substantial equivalence is often a comparison of technical specifications, safety data, and potentially performance data, but the specific details of such a study are not included in this summary.

Based on the provided text, the following information can be extracted or inferred:

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

   • Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., survival rates, developmental rates). The implicit acceptance criterion is "substantial equivalence" to the predicate device.
   • Reported Device Performance: Not reported in terms of specific performance metrics within this document. The document only states its technological characteristics are "similar" to the predicate, and it contains cryopreservation ingredients and an antibiotic.

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

   • Not specified in the provided text.

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 specified in the provided text. This type of detail is generally not included in a 510(k) summary for a media device.

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

   • Not specified in the provided text.

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 applicable. This device is an Assisted Reproduction Media, not an AI-assisted diagnostic or imaging device.

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

   • Not applicable. This is a media product, not an algorithm.

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

   • The "ground truth" for a device like this would typically involve laboratory studies demonstrating embryo viability, survival, and developmental potential after cryopreservation and thawing using the media, compared to the predicate device. However, the specific type and details of such data are not provided in this summary.

8. The sample size for the training set:

   • Not applicable/Not specified. For a media product, there isn't typically a "training set" in the machine learning sense. Performance data would be generated through laboratory experiments.

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

   • Not applicable/Not specified for the reasons above.

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Intended Use: Medium for In Vitro Fertilization Procedures
Indications for Use: Media for thawing of blastocyst stage embryos

MOPS buffered media. For use in sequence after the addition of G-MM™ or HSA-solution™ and pre-equilibration at +20 ± 5°C and ambient atmosphere.

This document is a 510(k) premarket notification for the G-ThawKit Blast™ Assisted Reproductive Media. It does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The document primarily establishes substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from the provided text. To answer your query, a document containing the detailed results of performance studies and acceptance criteria for the G-ThawKit Blast™ would be needed.

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Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Perfadex® is a clear, sterile, non-pyrogenic, extracellular type solution for hypothermic flushing and storage of isolated lungs. The solution is slightly acidic (pH5.5) to permit long shelf life and is adjusted shortly before use to pH 7.4. The solution is slightly hypertonic (osmolarity 295 mOsm/L) and has a low buffering capacity. The composition of Perfadex® is thus consistent with that of an extracellular solution.

Perfadex® is filled into 1 or 2.8 liter PVC (Viaflex) bags, each of which is sealed in an outer polypropylene bag.

Manufacturing, control and sterilization is performed at an FDA inspected plant owned and operated by Fresenius Kabi Norge AS in Halden, Norway. The product is stored at room temperature.

Perfadex® is supplied with pre-filled, sterile, non-pyrogenic, syringes of THAM (tromethamine USP) for pH adjustment of the solution prior to use.

The pre-filled syringes of THAM are manufactured, packaged, labeled and controlled by Vitrolife UK Ltd., Edinburg, UK.

The provided document is a 510(k) Summary for a medical device called Perfadex® Solution for Lung Perfusion. This type of document is for regulatory clearance of a medical device and describes its intended use and its substantial equivalence to a previously marketed device. It does not contain information about studies proving the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes, ground truth establishment, expert adjudication).

The document focuses on:

• Identification of the device: Perfadex® Solution for Lung Perfusion.
• Its intended use: flushing, storage, and transportation of isolated lungs for transplantation.
• Device description: composition, packaging, manufacturing, and sterilization.
• Predicate device: K000881, also Perfadex® Solution for Lung Perfusion.
• Claim of substantial equivalence to the predicate device, specifically noting the addition of pre-filled THAM syringes for pH adjustment as the main difference.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or information about studies related to performance metrics, sample sizes, expert involvement, or comparative effectiveness with or without AI assistance, as this information is not present within the provided text.

This document's purpose is to demonstrate that the new version of Perfadex® is as safe and effective as the previously cleared version, primarily through demonstrating material and compositional equivalence. It is not a clinical study report describing performance against specific, quantifiable acceptance criteria for diagnostic accuracy or clinical outcomes.

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