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The SperSort™ Sperm Sorting Chip is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

The SperSort™ Sperm Sorting Chip is used to prepare motile sperm for assisted reproductive technology (ART) procedures. The device separates motile sperm from the semen based on the mobility (i.e., swim-up nature) of motile sperm. The SperSort™ Sperm Sorting Chip consists of an upper collection chamber and a lower semen sample chamber. The chambers are separated by porous filter which allow motile sperm to pass from the lower chamber to the upper chamber. Both the semen sample injection port and sperm collection port are located on the upper cover. The semen sample injection port directly connects to the lower chamber, while the sperm collection port is connected to the upper chamber. The SperSort™ Sperm Sorting Chip accommodates a 1.9 mL semen sample. Liquefied semen is added to the lower chamber and cleared sperm washing medium (1.5 mL) is added to the upper chamber. Following incubation for 30 minutes at 37°C, the isolated sperm are gathered from the collection port. The SperSort™ Sperm Sorting Chip is a radiation-sterilized device with a sterility assurance level (SAL) of 10-9. They are individually packaged and for single use only.

The FDA 510(k) summary for the SperSort™ Sperm Sorting Chip (IPG02) provides information on its acceptance criteria and non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a single table, but can be inferred from the performance testing section and comparison with the predicate device.

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The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.

The Minvitro® Vitrification Straw (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are intended for use in closed vitrification procedures to contain and maintain human oocytes (MI), 4-8 cell embryos, and blastocyst stage embryos, and they are intended for use in professional healthcare facilities. The subject devices are for single use, disposable and supplied sterile.

The Minvitro® Vitrification Straws (MVT-VSN series: MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) are all composed of a cap with a balancing head, a handle, a carrier sheet with a fine tip at the end. The oocytes or embryos are loaded on the carrier sheet, and in which, the fine tip of carrier sheet is flat with a triangular-shaped area for oocyte/embryo loading. The subject devices are sterilized using ethylene oxide (EO) to a sterilization assurance level of 106, are singleuse, and have a 2-year shelf-life.

The subject devices are available in five colors: MVT-VSNR. MVT-VSNY. MVT-VSNB. MVT-VSNG, and MVT-VSNP corresponding to Red, Yellow, Blue, Green, and Purple, respectively, all identical in size.

The Minvitro® Vitrification Straw (K241454) is a cryopreservation storage device. It underwent non-clinical performance testing to demonstrate its substantial equivalence to the predicate device, Cryotop® US-flash (K181469).

Here's an overview of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• Predicate device's specifications: For tests like cooling/warming rates, the predicate device's performance characteristics served as a benchmark for comparison.
• Pre-defined biological endpoints: In the case of the Mouse Embryo Assay, the development of embryos to the blastocyst stage at a certain percentage defines the biological "ground truth" for toxicity and suitability.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the context of algorithm development. The tests described are for a physical medical device.

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

Not applicable for the same reason as above.

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The SwimCount® Harvester is intended for preparing motile sperm cells from semen for use in the treatment of infertile couples by Intracytoplasmic Sperm Injection (ICSI), In Vitro Fertilization (IVF) and Intrauterine Insemination (IUI) procedures.

The SwimCount® Harvester (1 mL and 3 mL) is a sperm separation device used to prepare sperm samples for Assisted Reproductive Technology (ART) procedures. The SwimCount® Harvester separates the sperm sample by allowing motile sperm cells to pass the SwimCount® Harvester's membrane system. The SwimCount® Harvester has a design/technology that utilizes the motility of the sperm cells (i.e. swim-up nature) to separate the motile sperm cells from the rest of the sperm population.

The SwimCount® Harvester has two processing volumes, 1 mL and 3 mL. The device consists of 3 compartments: 1) Sample compartment (1 mL or 3 mL), 2) Medium/Harvest compartment (0.8 mL for both device versions), and 3) Microporous polycarbonate (PC) filter membrane (10 um pore size).

Each device version has a Semen Inlet port that communicates with the lower sample compartment. The sample compartment is separated from the upper collection compartment by the microporous filter membrane. Semen is added to the lower compartment through the sample inlet port and cleared sperm separation medium (not provided) is added to the upper collection compartment through the Medium Inlet port. After incubation, the separated motile sperm cells are collected from the upper collection compartment through the Harvest Outlet port and used for subsequent assisted reproduction fertilization procedures.

The SwimCount® Harvester is supplied to the user as sterile (radiation), with a sterility assurance level of (SAL) of 10 6. The devices are individually packed and for single use only.

The provided text describes the 510(k) summary for the SwimCount® Harvester, a device for preparing motile sperm cells. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided information:

1. Table of acceptance criteria and the reported device performance

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cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is a sterile, single-use, closed assisted reproduction storage device for use in vitrification procedures to contain and maintain oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is composed of an injection molded body with an extended loading tip (4.45 inches long with a 0.65 inch loading tip), an injection molded cap (1.76 inches), and a total device combined length of 5.05 inches. Visible marks are on the distal loading tip, body, and at the opening of the cap, to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The body and cap include a taper design that create a seal when assembled prior to plunging the device in liquid nitrogen for vitrification and for subsequent storage. The device is provided in five different colors: red, yellow, green, blue, and purple. The subject devices are radiation sterilized to a sterilization assurance level of 10-6 and have a one-year shelflife.

A detailed response outlining acceptance criteria and device performance based on the provided text for the cryo-GO Vitrification Device (K241341):

Acceptance Criteria and Device Performance for cryo-GO Vitrification Device (K241341)

The provided documentation, a 510(k) Summary, focuses on demonstrating substantial equivalence to a predicate device (VitriGuard, K200815) rather than explicitly stating pre-defined, quantitative acceptance criteria for all aspects of performance with a dedicated clinical study. However, some functional performance criteria are implicitly accepted through comparison with the predicate device or established standards. The non-clinical performance data section presents the studies undertaken to support the device's safety and effectiveness.

Here’s a breakdown based on the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study Proving Device Meets Acceptance Criteria:

The "cryo-GO Vitrification Device" underwent non-clinical performance testing to demonstrate its safety and effectiveness, supporting its substantial equivalence to the predicate device. The studies were primarily bench testing and in-vitro biological assays.

2. Sample Size and Data Provenance for Test Set:

The provided document describes non-clinical performance testing rather than a "test set" in the context of AI/machine learning or a clinical trial with patient data. Therefore, the concept of sample size and data provenance as typically applied to such studies does not directly align.

• Sample Size: Not explicitly stated as a single "test set" sample size. The testing involved multiple units of the device for various engineering and biological tests (e.g., numerous devices for sterility validation, package integrity, shelf-life testing, and a sufficient number of mouse embryos for the MEA).
• Data Provenance: The data comes from laboratory testing performed by the manufacturer, FUJIFILM Irvine Scientific, Inc. The nature of the studies implies that they were prospective bench and in-vitro experiments designed to evaluate the device's physical, chemical, and biological performance. There is no indication of country of origin of "data" in the sense of patient data, as this was a non-clinical submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This was a submission for a physical medical device (cryopreservation device), not an AI/software device requiring expert human readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for performance was established through standardized laboratory testing methods (e.g., ISO, ASTM, USP, FDA guidance documents).

4. Adjudication Method for Test Set:

Not applicable. As noted above, this was non-clinical bench and in-vitro testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations to reconcile discrepancies among human readers or expert panels.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is not an AI algorithm or a diagnostic imaging tool that would involve human readers interpreting cases. Therefore, an MRMC study and analysis of AI assistance improving human readers were not performed.

6. Standalone (Algorithm Only) Performance:

Not applicable. The "cryo-GO Vitrification Device" is a physical medical device for cryopreservation, not a software algorithm.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance was based on:

• Standardized Laboratory Test Results: Measurements and observations against established industry standards (e.g., ISO 11137 for sterility, ASTM standards for package integrity and accelerated aging, USP for endotoxin).
• Biological Activity/Functionality: The Mouse Embryo Assay (MEA) provides a biological "ground truth" for the device's non-toxicity and suitability for embryo culture, as defined by the "≥ 80% expanded blastocyst within 96 hours" criterion endorsed by the FDA guidance.

8. Sample Size for Training Set:

Not applicable. This is a physical device, not an AI/machine learning model, so there is no concept of a "training set."

9. How Ground Truth for Training Set Was Established:

Not applicable, for the same reason as point 8.

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The G-Vitri™ Vitrification Straw is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.

Not Found

The provided document is an FDA 510(k) clearance letter for the G-Vitri™ Vitrification Straw, a medical device used in assisted reproduction. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical study report or a detailed validation study.

The letter primarily focuses on:

• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Outlining regulatory requirements and general controls for the device.
• Defining the Indications for Use for the G-Vitri™ Vitrification Straw.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report submitted as part of the 510(k) application.

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The SpermAlign Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) procedures.

SpermAlign is a sperm separation device used to prepare motile sperm for assisted reproductive technology (ART) procedures. Separation is achieved through a fluid filled microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilizes a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and sperm washing media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in intracytoplasmic sperm injection (ICSI) or in vitro fertilization (IVF) procedures.

SpermAlign is sterilized using X-Ray irradiation and has a sterility assurance level (SAL) of 10-6. The devices are individually packaged and for single use only.

The provided document is a 510(k) summary for the SpermAlign Sperm Separation Device, indicating substantial equivalence to a predicate device. While it details several non-clinical performance tests, it does NOT contain the specific information requested about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML medical device, particularly regarding test sets, expert adjudication, MRMC studies, or standalone algorithm performance. The device described appears to be a physical labware device, not an AI/ML software device.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML performance, sample sizes for AI/ML test/training data, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document.

However, I can extract information regarding the non-clinical performance studies conducted for this physical device:

A table of acceptance criteria and the reported device performance (for physical device tests):

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The Nest VT Vitrification Device is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos.

The subject devices, Cook Nest VT Vitrification Devices, are sterile, single-use assisted reproduction storage devices for use in vitrification procedures to contain and maintain oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos. The Cook Nest VT Vitrification Devices are composed of a stick (124.5 mm) and cap (38.5 mm) design with a combined length of 136.5 mm, a 35 mm space for notations, and a 6 mm long loading well. Visible marks are on the distal tip end, on the body of the stick and at the opening of the cap, which are created through laser etching to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The stick and cap include a taper design that create a seal when assembled. All the subject devices included in this submission are identical except for their color. There are 5 different colors: blue, purple, red, yellow, and green. The subject devices are sterilized using gamma radiation to a sterilization assurance level of 10-9, are one-time use, and have a 2 year shelf-life. During the vitrification procedure, the oocytes or embryos are loaded on the tip of the stick and the stick is capped prior to plunging the device in liquid nitrogen and for subsequent storage.

The provided document is a 510(k) summary for the "Nest VT Vitrification Device". It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance testing. However, it does not contain information on a study proving the device meets acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance, or the establishment of ground truth by multiple experts.

The document describes the device as a "cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos and blastocyst stage embryos." The performance testing discussed (sterilization, endotoxin, cooling/warming rates, MEA testing, package integrity, mechanical performance) are related to the physical and biological compatibility of the device itself, not to an AI or diagnostic algorithm's performance.

Therefore, I cannot fulfill your request as the provided text does not describe a study involving an AI or algorithm, nor does it detail acceptance criteria and performance data for such a system. The questions you posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are relevant to the evaluation of AI/ML-based medical devices, which this document does not concern.

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The LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

The LensHooke CA0 Sperm Separation Device and LensHooke CA1 Sperm Separation Device are used to prepare motile sperm from semen based on the mobility of motile sperm. The LensHooke Sperm Separation Device has a base and filter layers to separate and process the semen sample. The LensHooke Sperm Separation Device has two models, CA0 with one filter layer and CA1 with two filter layers. Liquefied semen (1 mL) is added to the base and sperm washing medium is added to the filter via a filter port. After incubation, the separated sperm are collected from the filter layer via the filter port. The subject devices are radiation-sterilized with a sterility assurance level (SAL) of 10 °. The LensHooke Sperm Separation Devices are individually packaged and for single-use only.

The device in question is the LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample size for the "test set" in terms of number of donor semen samples used for the Human Sperm Survival Assay (HSSA) or the Sperm Separation Performance study. It mentions using "donor sperm" and "donor semen samples" without specifying the quantity.

• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The studies described are primarily benchtop or laboratory performance tests, not clinical studies involving expert interpretation of results to establish ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are technical performance tests and not clinical studies requiring expert adjudication of case interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The studies described are focused on the device's technical performance in isolating motile sperm and maintaining sperm viability, not on comparing reader effectiveness with and without AI assistance.

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

Yes, the studies described are standalone performance evaluations of the device (LensHooke CA0/CA1 Sperm Separation Device) without human-in-the-loop performance considerations. The device is a physical product designed for sperm separation, not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth for the performance studies was established through:

• Laboratory measurements and assays: For HSSA, this involves measuring sperm motility percentage using established laboratory methods. For endotoxin, it's quantitative measurement against a standard. For sterility, it's confirmation of a specific SAL.
• Comparison to control samples: In the HSSA, the motility of sperm exposed to the device was compared to that of a control group (sperm not exposed to the device).
• Direct measurement of output characteristics: For sperm separation performance, the percentage of motile and progressively motile sperm in the output samples was directly measured and compared to the input samples.
• Industry standards and specifications: For physical tests like package integrity and transportation simulation, the ground truth is adherence to the specified ASTM and ISTA standards.

8. The Sample Size for the Training Set:

This information is not applicable. The LensHooke CA0/CA1 Sperm Separation Device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as the device is not an AI/machine learning algorithm requiring a training set.

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The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.

The EmbryoSlide+ ic8 dish is single use, sterile for embryo culture, handling, and preparation for transfer during assisted reproduction technology procedures. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has eight culture wells. Each well holds a single embryo in 20µL of culture medium. In addition, four rinsing wells are available, each rinsing well holding 25-30μL medium. The culture area of the dish, comprising both the culture wells, must be covered with 1.6mL culture oil overlay to minimize osmolarity changes during culture in a dry environment.

I am sorry but this document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. This document is an FDA 510(k) premarket notification for a medical device (EmbryoSlide+ ic8 dish) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.

While it mentions some specifications and testing performed (e.g., sterility, endotoxin testing, mouse embryo assay), it does not detail a formal study designed to prove the device meets specific acceptance criteria in the way you've outlined. The information provided is for regulatory clearance based on substantial equivalence, not a detailed clinical or comparative effectiveness study report.

Therefore, I cannot provide the requested table and detailed study information based on this document.

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The SureStrip Virification Straw is cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell stage embryos, or blastocyst stage embryos.

The SureLock Vitrification Straw is a cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII) or 1-cell stage embryos.

Not Found

The provided text includes a 510(k) clearance letter for the SureStrip Vitrification Straw and SureLock Vitrification Straw. However, this document does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

The document states that the devices are substantially equivalent to legally marketed predicate devices, which means they do not require new performance studies to demonstrate safety and effectiveness for a 510(k) clearance.

Therefore, I cannot provide the requested information from the given text.

The information I would have looked for, but is absent, includes:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Details on experts used for ground truth.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If standalone performance was evaluated.
7. Type of ground truth used.
8. Sample size and ground truth establishment for a training set.

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