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The Embryo Transfer Catheter is intended for introduction of in vitro fertilized embryo(s) into the uterine cavity.

The stylet is intended to be used with Vitrolife's Embryo Transfer Catheters to assist in uterine access of the guide during an embryo transfer procedure.

Vitrolife´s Embryo Transfer Catheter (ETC) Assortment consists of three embryo transfer catheters (ETCs), one pre-curved variant (Model 17500, 230 mm) and two straight variants (REFs 17501, 17502) in different lengths (180 mm and 230 mm); and two stylets (Stylets) (REFs 17510, 17511) in different lengths (180 mm and 230 mm). ETC and Stylet are sterile, single-use devices used to deliver in vitro fertilized embryos to the uterine cavity.

Embryo Transfer Catheter consists of:

• A guide, also referred as outer sheath. The guide is used to navigate through the cervix canal. The guide has a distance marking, a stopper and a rounded tip to facilitate proper positioning. The guide is available in two different variants:
  • Pre-curved - stiff
  • Straight - soft and malleable
• A catheter, also referred as inner catheter. The catheter is loaded with the embryo(s) in a small volume of transfer medium and inserted through the guide to gently deposit the embryo(s) into the uterine cavity. The transfer catheter is soft, flexible and approximately 50 mm longer than the guide. The tip of the catheter has an echogenic marking to enable ultrasound guidance.

Embryo Transfer Catheter Stylet consists of:

• A plastic-coated metal wire, which is malleable. The stylet is an accessory that can be used together with Vitrolife's guides to make them stiffer.

The 17500 variant includes a stylet. The 17501 and 17502 variants do not include stylets, but the stylet can be purchased separately.

The FDA Clearance Letter for Vitrolife Sweden AB's Embryo Transfer Catheter (ETC) Assortment primarily describes the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device. This letter does not describe an AI/ML-based device, nor does it detail studies involving human experts, ground truth adjudication, or MRMC studies typically associated with AI/ML medical devices.

Therefore, many of the requested details regarding acceptance criteria and study information (particularly points 2-9 related to AI/ML device testing) cannot be extracted from the provided text.

However, I can provide the acceptance criteria and reported performance for the non-clinical tests that were performed, as outlined in the document.

Summary of Device Acceptance Criteria and Performance (Based on Non-Clinical Testing):

The acceptance criteria for this device are based on its physical properties, sterility, biocompatibility, and functionality, demonstrating its substantial equivalence to an existing (predicate) device. The studies described are primarily bench performance tests, material tests, and sterilization/packaging validations.

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The device is intended to cover an ultrasound transducer and to act as a microbial barrier between the patient and the transducer during transvaginal procedures within assisted reproductive technology or gynecology, for clinical and hospital use by healthcare professionals in adult patients undergoing these procedures.

The Ultrasound Transducer Cover is an elastic cover made of thermoplastic polyurethane (TPU), which is placed over the ultrasound transducer during ultrasound quided procedures within assisted reproductive technology or gynecology. The Ultrasound Transducer Cover is provided sterile (ethylene oxide), for single use, and used with an ultrasound transducer probe to facilitate ultrasound scans.

The Ultrasound Transducer Cover is available in various sizes with different widths of the cover. This is to allow for use with various sizes of ultrasound transducer probe.

The provided text is a 510(k) summary for the Vitrolife Ultrasound Transducer Cover. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate safety and effectiveness.

However, the document does not contain information about:

• Acceptance criteria in the context of a statistical study with specific thresholds for performance metrics.
• A study proving the device meets acceptance criteria related to diagnostic accuracy, especially not for an AI/ML-enabled device as implied by the detailed questions about ground truth, expert consensus, MRMC studies, and standalone performance.
• Sample sizes for test sets or training sets in the context of an AI/ML study.
• Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types pertaining to an AI/ML diagnostic system.
• Training set size or how its ground truth was established.

The document is for a physical medical device (an ultrasound transducer cover) and focuses on biocompatiability, functional performance (e.g., leakage, ultrasound visibility), sterilization, and shelf-life testing, demonstrating substantial equivalence to a predicate device. It explicitly states "Clinical Testing: Not applicable."

Therefore, I cannot populate the requested table and provide answers for the specific points related to AI/ML device validation because the provided text does not contain this information.

The existing text is a regulatory submission for a simple medical device, not an AI/Machine Learning diagnostic device.

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Ultra RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos.

Ultra RapidWarm Blast is intended for warming vitrified human blastocyst stage embryos. The device consists of a single solution composed of a MOPS buffered solution containing gentamicin, human serum albumin (HSA) and sucrose.

The medium is aseptically filtered into gamma sterilized 5 mL PETG bottles with HDPE closures and a tamper evident seal. The medium can be used for up to 14 days after bottle opening.

The provided text describes the 510(k) summary for Vitrolife Sweden AB's Ultra RapidWarm™ Blast, a device indicated for warming vitrified human blastocyst stage embryos. The document focuses on demonstrating substantial equivalence to a predicate device (RapidWarm™ Blast, K101003).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document lists several specifications, particularly under "Summary of Non-Clinical Performance Testing," as part of the shelf-life testing. These serve as acceptance criteria for the device's performance.

2. Sample size used for the test set and the data provenance:

• Non-Clinical Testing (Shelf-life): The text indicates that shelf-life testing was conducted, including "aged samples demonstrating that medium in bottles can maintain their specifications after 14 days of simulated use conditioning after bottle opening." However, specific sample sizes (e.g., number of bottles, number of batches, number of MEA replicates) for these non-clinical tests are not explicitly stated in the provided document.
• Clinical Performance Testing:
  • Pilot Study: 86 cycles (52 blastocysts in the control group and 42 blastocysts in the treatment group).
  • Cohort Study: 868 cycles (578 blastocysts in the control group and 336 blastocysts in the treatment group).
  • Data Provenance: The clinical study was conducted in a university-based IVF center in France. The study design was prospective (pilot study followed by a cohort study).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information regarding the number of experts, their qualifications, or their role in establishing ground truth for either the non-clinical or clinical test sets. The clinical study compares treatment groups based on clinical endpoints like embryo survival, clinical pregnancy rate, and live birth rate, which are typically objectively measured outcomes rather than expert consensus on a subjective assessment.

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

The document does not describe any adjudication method for establishing ground truth or evaluating the results of the studies. Clinical outcomes (embryo survival, clinical pregnancy rate, live birth rate) are generally direct measurements and do not typically require adjudication in the same way as, for example, image interpretation by multiple readers.

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:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This device is a warming medium for embryos, not an AI-assisted diagnostic device that would involve human readers interpreting AI outputs. The clinical study compared different warming protocols (single-step vs. standard) using a surrogate device and clinical outcomes.

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

Not applicable. This device is a warming medium, not an algorithm. Its performance is evaluated through direct measurement of its specifications and clinical outcomes, not through an algorithm's output.

7. The type of ground truth used:

• Non-Clinical Testing: The ground truth for non-clinical performance (sterility, endotoxins, pH, osmolality, MEA) is based on laboratory analytical methods and established acceptance criteria/specifications. For MEA, it's the observed developmental success of embryos.
• Clinical Performance Testing: The ground truth for clinical performance is based on observed clinical outcomes data (embryo survival rate, clinical pregnancy rate, and live birth rate) from a prospective clinical study.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

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Gx-IVF™ medium is intended for preparation and handling of gametes, for in vitro fertilisation and intrauterine insemination.

Gx-TL™ medium is intended for culture of embryos from fertilisation to the blastocyst stage and for embryo transfer.

Gx-MOPS™ PLUS medium is intended for handling and manipulating oocytes and embryos in ambient atmosphere.

The subject devices are culture and handling media consisting of physiological salts, energy substrates, amino acids, buffering agents, nutrients supplements, antioxidants, gentamicin and human serum albumin. These devices have different applications in Assisted Reproduction Technology (ART) procedures handled by IVF professionals. The media are aseptically filtered into gamma sterilised PETG bottles with HDPE closure and a tamper evident seal and tested for pH, osmolality, embryo toxicity, endotoxins, and sterility.

This document describes the acceptance criteria and the study that proves the device meets those criteria for the Gx-IVF™, Gx-TL™, and Gx-MOPS™ PLUS media used in Assisted Reproduction Technology (ART).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the subject devices (Gx-IVF™, Gx-TL™, Gx-MOPS™ PLUS) are primarily defined by comparison to their predicate devices and specific performance tests. The tables below summarize the key criteria and reported performance for each device.

Gx-IVF™

Gx-MOPS™ PLUS

• Bacterial endotoxins testing per USP
• pH measurements per USP
• Osmolality per USP
• Mouse Embryo Assay (MEA)
• Shelf-life testing
• Open/close stability testing
• Transportation testing (ASTM D4169-16)
• Biocompatibility studies:
  • Cytotoxicity testing (ISO 10993-5:2009)
  • Tests for Irritation and Skin Sensitization (ISO 10993-10:2010, Guinea Pig Maximization Sensitization Test)
  • Tests for Irritation and Skin Sensitization (ISO 10993-10:2010, Vaginal Mucosal Irritation Study in Rabbits)

3. Number of Experts Used to Establish Ground Truth and Qualifications

This document describes technical performance and biocompatibility studies for medical devices (reproductive media and supplements). It does not involve human subject data or image analysis that would typically require expert consensus for ground truth establishment. Therefore, information regarding "number of experts" or their qualifications is not applicable in this context. The "ground truth" here is defined by established scientific and regulatory standards (e.g., USP for sterility, ISO 10993 for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable for this type of non-clinical, in-vitro performance testing where results are based on objective laboratory measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document describes the testing of in-vitro fertilization media, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not relevant or applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The devices are media for ART, not algorithms requiring standalone performance analysis.

7. The Type of Ground Truth Used

The ground truth for these devices is based on established scientific and regulatory standards and objective laboratory methods for determining chemical, physical, and biological properties. This includes:

• Regulatory Standards: USP , USP , USP , USP , ISO 13408-1:2008, ISO 13408-2:2018, ISO 10993-5:2009, ISO 10993-10:2010.
• Defined Acceptance Specifications: pH ranges, osmolality ranges, endotoxin limits, percentage of embryo development in MEA, absence of microbial growth, non-cytotoxic, non-sensitizing, non-irritating outcomes.
• Comparison to Predicate Devices: The performance of the subject devices is demonstrated to be substantially equivalent to that of the legally marketed predicate devices, implying the predicate devices' established safety and effectiveness serve as a benchmark.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI algorithm involved that would require a training set. The "training" in this context refers to manufacturing validation and quality control processes.

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

Not applicable, as no training set for an algorithm is involved.

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RapidVit™ Oocyte: Media for vitrification of human oocytes (MII).
RapidWarm™ Oocyte: Media for warming of vitrified human oocytes (MII).

Two sets of media are covered by this 510(k), the RapidVit™ Oocyte for vitrification of oocytes and the RapidWarm™ Oocyte for warming of vitrified oocytes. RapidVit™ Oocyte contains three medium solutions to be used sequentially during oocyte vitrification. RapidWarm™ Oocyte includes four medium solutions to be used sequentially during oocyte warming.

Here's a breakdown of the acceptance criteria and study information for the Vitrolife RapidVit™ Oocyte and RapidWarm™ Oocyte devices, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, it primarily presents data to show that the new device is as safe and effective as the existing one, rather than a full, comprehensive study report with all the details typically found in a clinical trial publication.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are mainly for non-clinical performance and a Mouse Embryo Assay (MEA). The clinical performance is reported as observed rates, not explicitly tied to specific numerical acceptance criteria within the document, although they are presented as evidence of successful function.

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

• Sample Size (Clinical Study): 593 oocytes from 64 donors.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is referred to as "A clinical study was conducted," which typically implies a prospective design, but this is not explicitly stated.

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

This information is not provided in the document. For a medical device like reproductive media, the "ground truth" for clinical performance is generally the observed biological outcomes (survival, fertilization, blastulation, pregnancy), which are objectively measurable laboratory and clinical endpoints rather than subjective expert interpretations of images or data. Therefore, a panel of experts for "ground truth" establishment in the typical sense (e.g., for diagnostic AI) might not be applicable here.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant when human experts are assessing a subjective outcome (e.g., classifying an image, making a diagnosis) and their agreement needs to be established or disagreement resolved. For the clinical outcomes measured in this study (oocyte survival, fertilization, pregnancy rate), the outcomes are objective biological events, not subjective interpretations. Therefore, an adjudication method in this context is not applicable and not mentioned.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., radiologists interpreting images) changes with or without AI assistance. The device in question is a media (liquid solutions) used in an in-vitro fertilization process, not an AI diagnostic tool or system that assists human interpretation.

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

No, a standalone "algorithm only" performance study was not done. This device is a biological media. Its performance is intrinsically tied to its use in a laboratory setting by human embryologists/clinicians performing the vitrification and warming procedures. The concept of an "algorithm only" performance is not applicable to this type of device.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was based on observed biological and clinical outcomes:

• Oocyte survival post-warming.
• Fertilization rates.
• Embryo development (Day 5 blastulation, Day 5/6 utilization).
• Clinical pregnancy confirmation by fetal heartbeat.

For the non-clinical tests (pH, osmolality, endotoxins, sterility, MEA), the ground truth was based on established laboratory assay results and conformity to specified criteria.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a biological media, not an algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set for this type of device.

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Cryopreservation device intended to be used to contain, vitrify and maintain human embryos and/or oocytes (MI).

Rapid-i™ Kit is a modified version of the predicate device (K140207). This device is a cryopreservation storage device intended for embryo/oocyte vitrification. Rapid-i™ Kit is provided sterile and is for single-use only. This device consists of the following items:

• Rapid-i Stick – A 80 mm long Polymethyl methacrylate (PMMA) stick with a 0.4 mm diameter hole located near the distal tip of the device. The hole on the stick is used to hold one to five embryos or oocytes for vitrification in a 30 nL drop of vitrification medium. Users suspend samples across the hole via surface tension. Therefore, the medium containing the samples only touches the periphery of the hole. The stick has one flat side that aids in correct orientation of the device during oocyte/embryo loading procedures.
• RapidStraw A 130 mm long Mediprene straw equipped with a stainless steel weight to maintain device orientation in liquid nitrogen (LN). The straw has a flared open end to allow for insertion of the Rapid-i Stick. This component functions as a protective sleeve around the Rapid-i Stick to prevent direct contact with LN during loading and after sealing the open end with an ultrasonic sealing device.
• Stainless steel rod - This 115 mm long stainless steel rod resides within RapidStraw during pre-cooling procedures in LN. It aids in keeping RapidStraw straight in LN during pre-cooling. Rod removal occurs 20-30 seconds prior to Rapid-i Stick loading into the RapidStraw.

Here is a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for the Rapid-i™ Kit (K181461).

Acceptance Criteria and Reported Device Performance

The device is a cryopreservation system for human embryos and oocytes. The acceptance criteria are implicitly tied to maintaining the viability and developmental potential of these biological materials after cryopreservation, demonstrated through various post-thaw outcomes.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • 2PN Embryos:

     • N = 1618 vitrified 2PN embryos.
     • N = 510 embryo transfers (418 transfers for embryos cultured 1-3 days, 92 transfers for embryos cultured 4-5 days).
     • Data provenance: Not explicitly stated beyond "Data from clinical studies using the Rapid-i™ Kit were used..." This suggests it could be retrospective collection from fertility clinics where the device was in use, but without further detail, it's difficult to confirm. The document does not specify country of origin for this particular dataset.
     • Study type: Prospective or retrospective collection based on the wording "Data from clinical studies." It is not described as a controlled clinical trial.

   • Oocytes:

     • Study 1: N = 593 vitrified oocytes; N = 54 blastocyst stage embryo transfers.
     • Study 2: Data on survival, fertilization rates, and N = 40 embryo transfers. (Exact N of vitrified oocytes not stated for this study, only percentages).
     • Published Article (Gook et al. 2016): N = 413 vitrified oocytes; N = 44 embryo transfers.
     • Data provenance: Similar to 2PN embryos, "Data from clinical studies." The published article indicates a clinical setting. The Gook et al. 2016 paper is from Australia. Thus, at least some of the oocyte data likely originates from Australia.
     • Study type: Prospective or retrospective collection from clinical practice.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is a medical device for assisted reproduction purposes. The "ground truth" (i.e., successful cryopreservation, pregnancy outcomes) is established through standard clinical and laboratory procedures performed by trained embryologists, reproductive endocrinologists, and other healthcare professionals in fertility clinics. This is not a diagnostic device where image interpretation by experts creates a "ground truth." The outcomes (survival, fertilization, pregnancy) are objective biological results.
   • Therefore, the concept of "experts used to establish ground truth" in the way it applies to AI diagnostic tools (e.g., radiologists annotating images) is not directly applicable here. The data points themselves (e.g., number of embryos surviving, number of pregnancies) are the ground truth, generated by the normal operations of an IVF clinic.

3. Adjudication method for the test set:

   • Not applicable in the context of this type of device and study design. Adjudication methods like "2+1" are typically used for establishing ground truth in diagnostic studies where there might be inter-reader variability in interpreting data (e.g., medical images). Here, the outcomes measured are direct biological results.

4. 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:

   • No. This is not an AI-assisted diagnostic device that involves human readers interpreting output. It is a cryopreservation device. The study is evaluating the device's performance in preserving reproductive cells, not assisting human interpretation.

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

   • Not applicable. This is a physical medical device (cryopreservation kit), not an algorithm or software. Its performance is inherent to its design and material properties in facilitating the cryopreservation process. Human interaction is required for its use (loading, vitrifying, warming).

6. The type of ground truth used:

   • Clinical Outcomes and Biological Performance Markers: The ground truth is established by the observed biological outcomes of human embryos and oocytes after being processed with the device. This includes:
     • Survival rates post-warming.
     • Fertilization rates for oocytes.
     • Developmental rates (cleavage, blastulation) for embryos.
     • Clinical pregnancy rates following embryo transfer (which are typically confirmed by ultrasound).
   • For non-clinical tests, ground truth was established by laboratory standards and assays (e.g., bacterial endotoxin testing, mouse embryo assay).

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set. The "training" for such a device would be its iterative design and manufacturing process, combined with quality control and verification, rather than a data-driven training set in the AI sense.

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

   • Not applicable, as no training set was used for an AI/machine learning model.

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Intended for flushing and/or aspiration of oocytes from ovarian follicles.

The Follicle Aspiration Set. Reduced Single Lumen proposed in this submission is intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. This product is comprised of the following components:

• A stainless steel needle .
• A silicone cork to be pushed into the opening of a sampling tube .
• A length of TPE-O tubing for aspiration and flushing ●
• An adapter for flushing .
  The subject device is provided sterile and is for single use only. It comes in four versions with the same design but different dimensions, as described below.

The provided text is a 510(k) summary for the Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen. This document demonstrates the device's substantial equivalence to a predicate device, rather than providing a detailed study report for meeting specific performance criteria typically associated with AI/ML-enabled devices.

Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable to this type of device and submission. This is a medical device clearance based on engineering performance and material compatibility, not on diagnostic accuracy derived from AI analysis of data.

However, I can extract the acceptance criteria and reported performance for the engineering and biological tests conducted.

Acceptance Criteria and Device Performance for Vitrolife Sweden AB Follicle Aspiration Set, Reduced Single Lumen

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test set (e.g., number of devices for endotoxin testing, number of embryos for MEA). The tests are typically laboratory-based engineering and biological assessments compliant with recognized standards. Data provenance is not described in terms of geographical origin or retrospective/prospective study design as would be relevant for clinical data. These are intrinsic performance tests of the device itself.

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

Not applicable. The "ground truth" for these types of tests is generally defined by the specific test method, instrument calibration, and adherence to international standards (e.g., ISO, ASTM, USP). There are no human "experts" establishing ground truth in the context of diagnostic interpretation for these performance evaluations. Qualified laboratory personnel perform and interpret the results according to the established protocols.

4. Adjudication Method for the Test Set

Not applicable. These are quantitative and qualitative laboratory tests with defined pass/fail criteria from international standards. There is no ambiguous "case" interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an aspiration set, primarily a mechanical and sterile instrument, not an imaging or diagnostic device that involves human interpretation of results.

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

Not applicable. This device is not an algorithm or AI-enabled system. Its performance is entirely mechanical, material-based, and biological compatibility.

7. The Type of Ground Truth Used

The ground truth is based on established international and national standards and methodologies for medical device performance, sterility, material safety, and biocompatibility. Examples include:

• Sterilization: ISO 11137-2:2013
• Endotoxin: USP
• Needle Properties: ISO 9626:2016
• Embryo Toxicity: Mouse Embryo Assay (MEA), a recognized biological test.
• Packaging Integrity: ASTM F1886/F1886M-09, ASTM F1929-12, ASTM F88/F88M-09

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning, so there is no "training set."

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

Not applicable. As there is no training set, this question is irrelevant to the device submission.

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Intended for flushing and/or aspiration of oocytes from ovarian follicles.

Follicle Aspiration Sets included in this submission are intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. Four types of Follicle Aspiration Sets are included in this submission, and are described in more detail below.

The Follicle Aspiration Sets are radiation sterilized and are for single use only. The materials used in these devices include: stainless steel, TPE-O tubing, silicone, medical grade adhesive, polypropylene, and methyl methacrylate acrylonitrile butadiene styrene.

Follicle Aspiration Set, Single Lumen: This device consists of a single-lumen stainless steel needle, aspiration tubing, and a silicone rubber cork for attachment to a collection tube. One version (17132) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. This device also includes an adapter for flushing of ovarian follicles and removal of blockages. The needles for the majority of the versions of this device type include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Double Lumen: This device consists of a double lumen stainless steel needle, tubing for flushing of ovarian follicles and removal of blockages, tubing for aspiration, and a silicone rubber cork for attachment to a collection tube. One version (17129) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. The needles for these versions of the device include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Single Lumen Luer with Tubing: This device consists of a single lumen stainless steel needle, and aspiration tubing with a luer connection at the end. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

Follicle Aspiration Set, Single Lumen, Luer: This device consists of a single lumen stainless steel needle with a luer connection at the base of the needle. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.

The provided text describes the Follicle Aspiration Set, outlining its design, intended use, and comparison to a predicate device. It also includes information about performance testing to establish substantial equivalence.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

• Sterilization Validation (ISO 11137-2:2013): International standard for radiation sterilization.
• Mechanical Testing (ISO 9626:2016, Tensile Strength): International and industry standards for needle properties and material strength.
• Biocompatibility Testing (ISO 10993-5, 10, 1): International standards for evaluating the biological effects of medical devices.
• Packaging Testing (ASTM F88/F88M, F1929, F1886/F1886M): American Society for Testing and Materials standards for package integrity.

These are objective, quantitative, and qualitative measures against defined standards or biological responses, rather than subjective ground truths established by human experts or outcomes data in a clinical trial.

8. The sample size for the training set

This information is not applicable. The device is a manufactured medical instrument, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no "training set" for this physical device.

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FreezeKit™ Cleave is intended for freezing of pronuclear (2PN) and cleavage-stage embryos.

ThawKit™ Cleave is intended for thawing of frozen pronuclear (2PN) and cleavage-stage embryos.

FreezeKit™ Cleave and ThawKit™ Cleave are devices used for freezing of pronuclear (2PN) and cleavage-stage embryos, and thawing of frozen pronuclear (2PN) and cleavage-stage embryos during in vitro fertilization (IVF) procedures.

The proposed devices are two separate kits, containing two and three solutions respectively. The two kits are marketed separately, yet are recommended to be used together to perform freezing and thawing. All solutions in both kits contain MOPS buffered solution, gentamicin as an antibacterial agent, human serum albumin and hyaluronan. The cryoprotectants 1,2 - propanediol and sucrose are included in the freezing solution, and only sucrose is included as a cryoprotectant in the thawing solutions.

The provided document is a 510(k) Premarket Notification for medical devices, specifically for "FreezeKit™ Cleave" and "ThawKit™ Cleave," which are reproductive media used for cryopreservation and thawing of embryos. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study with robust statistical analysis typically seen in PMAs or studies for AI/software as a medical device.

Therefore, the information required to fully answer the request (especially regarding AI/ML, human expert involvement, ground truth establishment, sample sizes for training/test sets, MRMC studies, and effect sizes) is not present in this document. The "clinical testing" described here is more akin to a performance evaluation rather than a comparative effectiveness study in the context of AI.

I will populate the table and answer the questions based only on the information available in the provided text. Where information is not available or not applicable, I will state "Not available in the provided text" or "Not applicable to this device/study type."

Acceptance Criteria and Device Performance Study

The study performed was a non-inferiority performance evaluation demonstrating that the subject devices (FreezeKit™ Cleave and ThawKit™ Cleave) perform comparably to predicate devices (Cook IVF Cryopreservation Kit and Cook IVF Thawing Kit) for their intended use. The core of this submission is to show substantial equivalence, not necessarily superior performance or to evaluate an AI algorithm.

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

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated in the provided text for either non-clinical or clinical testing. For the clinical evaluation, it mentions "human 2PN embryos and cleavage-stage embryos," but no number.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics).
• Retrospective or Prospective: Not explicitly stated for the clinical evaluation. Given the context of a 510(k) premarket notification for a new version of existing media, it's likely a controlled prospective performance study, but this is an inference.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable, as this is a device for media used in IVF, not an AI or diagnostic imaging device requiring expert interpretation. The "ground truth" would be the biological outcome (survival, development) measured directly or observed by trained embryologists/laboratory personnel.
• Qualifications of Experts: Not explicitly stated, though it would be assumed that the studies were conducted by qualified laboratory personnel and embryologists.

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

• Adjudication Method: Not applicable. The "results" are biological outcomes measured/observed, not subjective interpretations requiring adjudication among multiple readers.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is not an AI or imaging device that would involve human readers or AI assistance in interpretation.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. The device is a liquid medium, not an algorithm.

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

• Type of Ground Truth: For the non-clinical bench testing, the ground truth was derived from direct measurements (pH, osmolality, sterility, endotoxin levels) and established biological assays (Mouse Embryo Assay results: % expanded blastocyst, blastocyst cell number). For the clinical evaluation, the ground truth was "survival and development of frozen and thawed human 2PN embryos and cleavage-stage embryos." This would be best characterized as outcomes data and direct biological observations/measurements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a formulation of media, not an AI/ML device that requires a training set. The "training" for such a device would be the product development and optimization process, not data-driven machine learning.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The development of the media likely involved iterative testing to achieve optimal performance, and the "ground truth" at that stage would be the desired physical/chemical properties and embryo viability outcomes.

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The Rapid-i™ Kit is a cryopreservation device designed to contain 4-8 cell and blastocyst stage human embryos.

Rapid-iTM Kit, a cryopreservation device designed to contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos, consists of the following three items:
• 80 mm PMMA stick (Rapid-iTM)
• 135 mm Mediprene straw equipped with a stainless steel weight, (RapidStraw)
• 115 mm stainless steel rod inserted in the RapidStraw

Here's an analysis of the acceptance criteria and supporting studies for the Rapid-i™ Kit, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

*   **Sterilization:** No specific sample size given, but validation was performed according to ISO 11737-2:2009. (Page 5)
*   **Data Provenance:** Likely internal lab studies by Vitrolife Sweden AB, prospective.

• Design Validation (Comparative Studies, predicate device K090832):

  • "Effects of sealing before and after vitrification": Compared post-seal Rapid-i™ (predicate), pre-seal Rapid-i™ and HSV straw. No specific sample counts for embryos, but compared "different non-liquid nitrogen (LN2) contact vitrification methods of previously frozen day 1 embryos." (Page 8)
  • "A comparative mouse study": Compared post-seal Rapid-i™ (predicate), pre-seal Rapid-i™ and HSV straw, using "fresh F1 mouse embryos." (Page 8)
  • "A comparative Swiss outbred study": Compared post-seal Rapid-i™ (predicate) and pre-seal Rapid-i™ using "Swiss outbred mice." (Page 8)
  • "A vitrification study": No embryos used; visually verified vitrification of media. (Page 8)
  • Data Provenance: These were studies related to the predicate device (K090832) for design validation and likely conducted by or for Vitrolife. The nature of the studies suggests prospective experimental designs.

• Clinical Testing (Blastocyst Vitrification):

  • Patients: 426 patients with embryo transfer. (Page 10)
  • Data Provenance: Conducted at four sites. It appears to be retrospective collection of results from historical clinical use, stating "The clinical pregnancy rates range between 32% and 47%, and to date, birth of 124 children." and "Clinical blastocyst vitrification was conducted at four sites..." (Page 10)

3. Number of Experts and Qualifications for Ground Truth

• Nonclinical & Shelf-Life Testing (MEA, Endotoxin, Sterilization): No independent experts are explicitly mentioned for establishing ground truth for these tests. These are standard laboratory assays with predefined control samples and acceptance criteria.
• Design Validation (Comparative Studies on Mice/Embryos): No external experts are mentioned. Ground truth was based on defined measurable outcomes like blastocyst development, cell count, and visual assessment of vitrification.
• Clinical Testing: This section references "standard procedures" for embryo assessment and "clinical pregnancy rates" and "birth of 124 children." While embryologists and clinicians are inherently experts, the document does not specify how many or their specific qualifications for establishing ground truth in terms of a consensus panel for this specific submission. The "ground truth" here is objective clinical outcomes (pregnancy, live birth, survival rates) as reported by the clinics.

4. Adjudication Method

• There is no mention of an adjudication method (e.g., 2+1, 3+1) in the document. This type of adjudication is typically for subjective assessments (e.g., image interpretation). Given the nature of these tests (laboratory assays, survival rates, clinical outcomes), such a method would not commonly be applied.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. This type of study is more common for diagnostic imaging devices where human readers interpret data, and the comparison is how AI assistance changes their diagnostic accuracy. The Rapid-i™ Kit is a cryopreservation device, not a diagnostic tool requiring human interpretation for its primary function.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The Rapid-i™ Kit is a hardware device for cryopreservation, not an algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

• Nonclinical & Shelf-Life Testing: Objective laboratory measurements (e.g., growth in MEA, endotoxin levels, sterility confirmation).
• Design Validation: Objective experimental outcomes (e.g., blastocyst development rate, cell count, visual assessment of vitrification).
• Clinical Testing: Objective clinical outcomes (embryo survival rate, clinical pregnancy rate, live birth). This is a form of outcomes data.

8. Sample Size for the Training Set

• The concept of a "training set" is not applicable here as the Rapid-i™ Kit is a medical device (hardware) rather than an AI/ML algorithm that requires training data. The studies performed are for validating the product's functional performance and safety.

9. How Ground Truth for the Training Set Was Established

• As the device is not an AI/ML algorithm, there is no "training set" or ground truth for it in that context. The "ground truth" for evaluating the device's performance as a cryopreservation tool is established through the objective measurements and clinical outcomes described above.

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