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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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SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.

The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.

The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method

Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)

at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

SWEDEN & MARTINA SURGICAL TRAYS are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.

The Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations.

The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method

Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles)

at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

This FDA 510(k) clearance letter for the SWEDEN & MARTINA SURGICAL TRAYS focuses on establishing substantial equivalence for a medical device that organizes, sterilizes, and transports dental surgical instruments. It is not an AI/ML powered device, and therefore the majority of the requested information (related to AI model performance, training data, ground truth, expert adjudication, etc.) is not applicable to this document.

The document primarily addresses the device's functionality related to steam sterilization.

Here's the relevant information that can be extracted:

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

The document provides information on the validated sterilization parameters. It doesn't present a table with explicit "acceptance criteria" versus "reported performance" for the device itself in the typical sense of a diagnostic or predictive AI model. Instead, it describes the conditions under which the device's sterilization function was validated.

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

• Sample size: Not explicitly stated in terms of a "test set" for performance evaluation in the context of AI. The validation was likely performed on representative samples of the surgical trays following established sterilization protocols.
• Data provenance: Not explicitly stated. However, the validation was "completed by" the manufacturer, Sweden & Martina S.p.A., and is part of their submission to the FDA. The tests would have been performed in a laboratory or clinical setting to a recognized standard.

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

Not applicable. This is not an AI/ML device where expert ground truth is typically established. The "ground truth" here is adherence to sterilization standards and physical integrity of the device after sterilization.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device requiring adjudication.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device relates to the effectiveness of sterilization and the structural integrity of the trays after undergoing the specified sterilization cycles. This would be established through:

• Microbiological testing: E.g., using biological indicators or process challenge devices (PCDs) to confirm sterility after the cycle.
• Physical and functional integrity testing: Inspecting the trays for damage, deformation, or impaired function after repeated sterilization cycles.
• Adherence to recognized standards: Compliance with international or national standards for sterilization (e.g., ISO, AAMI).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable.

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The Extroducer Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature. The Extroducer Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally.

The Extroducer™ Infusion Catheter System is a minimally invasive device for administering diagnostic or therapeutic solutions through the vascular wall directly to perivascular tissue of adult patients. At the selected site, the device is used to penetrate through the vascular wall into the tissue requiring treatment. The diagnostic or therapeutic solution is then delivered through the device. The device is sterile and designed for single patient use only. The device is to be used in hospital operating theaters and catheterization labs under normal clinical conditions, only by physicians trained in its use. The duration of use is no more than 60 minutes. The Extroducer™ Infusion catheter system consists of two main parts: An infusion needle with a needle hub and radiopaque marker and An outer protective sheath to protect the needle during positioning of the device, with a haemostatic valve to secure the infusion needle during use.

The provided text is a 510(k) premarket notification for a medical device called the "Extroducer Infusion Catheter System." It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data and an animal study.

The request asks for information regarding acceptance criteria, study details, and ground truth establishment, which are typical for an AI/ML-based device submission, especially those involving diagnostic image analysis. However, the provided text describes a physical medical device (an infusion catheter system) and its non-clinical and animal testing. It does not involve any AI/ML components, image analysis, or human reader studies.

Therefore, many of the requested details, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "standalone (algorithm only) performance," are not applicable to this type of device and submission.

The document focuses on demonstrating that the new device has similar technological characteristics, indications for use, and performance to a legally marketed predicate device, thereby proving "substantial equivalence."

Based on the provided text, here is the information that is available or can be inferred, and an explanation of why other requested information is not present:

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

The provided text does not contain a formal table of acceptance criteria with specific quantitative thresholds. Instead, it lists the types of non-clinical tests performed to demonstrate functionality and safety, implying that the device met the expected performance for each test to claim substantial equivalence.

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

• Sample Size: The document does not specify exact sample sizes for the individual non-clinical (bench) tests. For the animal study, a specific sample size is not mentioned, but it is implied to be a prospective study conducted for the purpose of this submission.
• Data Provenance: The Smartwise Sweden AB is based in Tullinge, Sweden. The non-clinical tests would have been performed in a laboratory setting, likely in Sweden or a contracted test facility. The animal study would have been performed as part of the pre-clinical development process. The exact country of origin for the data is not specified beyond the applicant's location. The studies are prospective as they were conducted specifically for this application.

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)

This question is not applicable. This is a physical medical device. Ground truth as typically understood for AI/ML diagnostic devices (e.g., based on expert image review) is not relevant here. The "ground truth" for the performance of this device is established through the physical and biological testing conducted (e.g., measured dimensions, observed mechanical performance, histological findings from animal studies).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) provide independent assessments that need to be reconciled for ground truth establishment. This is not a human reader study. The "adjudication" for the non-clinical tests would be adherence to pre-defined test protocols and pass/fail criteria. For the animal study, it would involve standard veterinary and pathology assessments.

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 question is not applicable. An MRMC study is relevant for AI/ML diagnostic tools that assist human readers. This device is a physical infusion catheter; it does not involve AI assistance for human readers.

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

This question is not applicable. This device does not have an algorithm component for diagnostic performance. Its "standalone" performance is measured by its physical, mechanical, and biological properties through non-clinical and animal testing.

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

The "ground truth" for this device's performance is established through:

• Engineering/Bench Test Measurements: Direct physical measurements (e.g., dimensions, flow rates, strengths).
• Observed Performance in Bench Tests: Qualitative and quantitative observations of mechanical function (e.g., trackability, leakage, kinking).
• Pathology and Clinical Pathology from Animal Models: Histological analysis, gross pathology findings, and blood work from the animal study to confirm safety (e.g., absence of thrombosis, tissue damage).

8. The sample size for the training set

This question is not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

This question is not applicable as there is no AI/ML training set for this device.

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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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SWEDEN & MARTINA SURGICAL TRAY (Model "ZSHORTY-INT") is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets.

The tray is to be enclosed in an FDA cleared steam sterilization validation was completed by: - Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 ℃ (273 ℃) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes.

The validated load weight is 230 grams.

Not Found

The provided text is related to an FDA 510(k) clearance for a surgical tray. It discusses regulatory matters, product classification, and indications for use. It does not contain any information regarding acceptance criteria or a study that proves a device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a medical device (a surgical tray) and not on the performance evaluation of an AI-powered or diagnostic device that would typically have acceptance criteria and associated study details as outlined in your prompt.

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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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PRAMA White Implant Systems are intended for both one- and two-stage surgical procedures. PRAMA White Implant Systems, endosseous implant and abutments, are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. PRAMA White Implant Systems are intended to be used in fully edentulous or partially edentulous maxillary and/or mandibular arches.

Not Found

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a dental implant system (PRAMA White Implant Systems), which primarily details the regulatory approval of the device and its intended use.

Therefore, I cannot provide the requested information.

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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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