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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.

Regarding the specific questions asked for an AI/ML device:

1. A table of acceptance criteria and the reported device performance: Provided above for the non-clinical tests described.
2. Sample sized used for the test set and the data provenance: Not applicable. These were non-clinical, benchtop, and laboratory tests. No "test set" in the context of patient data or clinical images is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical/chemical tests is established by laboratory standards and measurements, not expert human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, ground truth was derived from standardized testing methods, material specifications, and validated laboratory procedures (e.g., spectrophotometry for cytotoxicity, bacterial growth for endotoxin, visual inspection, dimensional measurements, mechanical testing).
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.

In conclusion, the provided FDA clearance letter pertains to a conventional medical device (Embryo Transfer Catheter) and not an AI/ML artificial intelligence medical device. Therefore, the detailed requirements for AI/ML device testing (e.g., data sets, expert review, MRMC studies) are not found in this document. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the rigorous non-clinical, laboratory, and benchtop performance testing that ensured the device's safety and effectiveness compared to a legally marketed predicate device.

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VitaVitro Embryo Transfer Catheter is used to place in vitro fertilized (IVF) embryos into the uterine cavity

The VitaVitro Embryo Transfer Catheters are sterile (ethylene oxide), single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. They have a three-year shelf-life.

The device includes five catheter models that are composed of a transfer catheter and a guide catheter (some with obturator).

The 172 mm length Guide catheters have OD 2.4 mm for straight (Models ET-SI and ET-S) and OD 2.2 mm for the curved version type (Model ET-A).

The curved version type (Model ET-A) has an additional adjustable positioner which aids in positioning the device to the targeted depth within the uterine cavity during a procedure. Both types have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.

The 240 mm transfer catheter with an OD 0.95 mm is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) is connected to the connector of the transfer catheter and is used to deliver the embryos into the uterine cavity.

The 200 mm obturator with OD 1.3 mm is an optional accessory for the device. It has a rounded/blunt closed tip. The obturator is used to provide additional support (increase rigidity) during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.

The provided text describes the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) and its substantial equivalence to a predicate device. However, this document does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance as initially requested in the prompt.

The document details the non-clinical performance data for a medical device (a catheter), not a software or AI-driven diagnostic device. Therefore, the specific questions related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training/test set sample sizes are not applicable to the information provided.

The "acceptance criteria" discussed in the document are related to the physical and biological performance of the catheter, such as sterilization, biocompatibility, and functional integrity.

Here's an attempt to answer the questions based only on the provided text, recognizing that it does not align with the implied context of AI/algorithm performance:

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

Regarding the other questions, the provided text does not contain the requested information as it pertains to an embryo transfer catheter and not an AI-powered device:

2. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned are lab tests on physical device properties and biological interaction (MEA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on established laboratory standards and measurements, not expert human interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the listed tests is based on scientific and engineering standards (e.g., ISO for biocompatibility and sterilization, ASTM for mechanical properties, USP for endotoxin), and biological assay results (MEA).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The twoplus Applicator is indicated for over-the-counter home use by individuals who choose not to conceive through intercourse. The twoplus Applicator kit allows for semen collection and the vaginal canal. The twoplus Applicator should be used during the ovulatory phase of the menstrual cycle.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or any study details that prove the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "twoplus™ Applicator". It primarily discusses regulatory compliance and general information regarding the device's classification and marketing.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method.
5. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. Whether standalone performance was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The PherDal® At-Home Insemination Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or have chosen not to conceive through intercourse, for semen collection and the delivery of semen to the vaginal canal. The PherDal® At-Home Insemination Kit should be used during the ovulatory phase of the menstrual cycle.

The PherDal® At-Home Insemination Kit is a sterile, over-the-counter (OTC) medical device intended for intravaginal insemination (IVI) at home. It consists of three sets of sterile, single-use, plastic syringes and semen collection cups, and Instructions for Use. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally.

The provided text details the 510(k) submission for the PherDal® At-Home Insemination Kit and includes non-clinical and clinical performance data. However, it does not describe an AI/algorithm-based medical device. Therefore, the questions related to AI device performance metrics, algorithm-specific ground truth establishment, MRMC studies, and effect sizes are not applicable to this document. The document focuses on the physical device's performance, user comprehension, and biocompatibility.

I will provide information based on the available text relevant to the device's acceptance criteria and the studies performed.

Here's an analysis of the acceptance criteria and study information provided for the PherDal® At-Home Insemination Kit:

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

The document provides acceptance criteria for various non-clinical tests and a target threshold for clinical (user comprehension) studies.

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

• Self-Selection Study:
  • Sample Size: 87 biological female participants (47 contraindicated, 40 non-contraindicated).
  • Data Provenance: The participants were stated to be "representative of the U.S. demographic." The study appears to be a prospective design, as participants actively determined utility based on provided labeling.
• Labeling Comprehension Study:
  • Sample Size: 164 biological female participants.
  • Data Provenance: The participants were stated to be "representative of the U.S. demographic." The study appears to be a prospective design, as participants actively answered questions based on reviewing the labeling.

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

This information is not applicable as the studies described (Self-Selection and Labeling Comprehension) do not involve expert-established ground truth in the context of diagnostic interpretation (e.g., radiology). Instead, the "ground truth" for these studies is the correct understanding or appropriate self-selection based on the device's labeling and intended use, which is assessed directly from user responses in a controlled study environment.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in image interpretation studies where multiple readers assess cases and disagreements need to be resolved to establish a robust ground truth. The studies here are user comprehension and self-selection studies, where participant responses are directly evaluated against predefined correct answers based on the device's instruction for use.

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 information is not applicable. The device is an at-home insemination kit, not an AI-assisted diagnostic tool or system designed to improve human reader performance. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.

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

This information is not applicable. As previously stated, this is a physical medical device and not an AI algorithm.

7. The type of ground truth used

For the clinical studies (Self-Selection and Labeling Comprehension), the "ground truth" was established by the correct answers based on the official Instructions for Use and device labeling. For instance, a correct understanding of a warning or an accurate self-determination of whether the kit is indicated for them. This is a form of definitive outcome based on regulatory and instructional content, not a medical "pathology" or "outcome data" in the traditional sense.

For the non-clinical tests (biocompatibility, sterilization, functional testing, HSSA), the "ground truth" or standard of success was adherence to established international and FDA-recognized standards and predefined specifications (e.g., ISO, ASTM standards, specified motility percentages).

8. The sample size for the training set

This information is not applicable. "Training set" refers to data used to train an AI algorithm. This device is not an AI algorithm.

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

This information is not applicable. This device is not an AI algorithm.

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The Mosie Baby Kit is indicated for over-the-counter home use, by individuals who have been unable to conceive through intercourse or choose not to conceive through intercourse, for semen collection and the delivery of semen or donor sperm to the vaginal canal. The Mosie Baby Kit should be used during the ovulatory phase of the menstrual cycle.

The Mosie Baby Kit is an over-the-counter (OTC) device intended for intravaginal insemination (IVI) at home. The Mosie Baby Kit includes the following components:

• Two Mosie syringes
• Two Mosie collection cups
• Instructions for Use.
  Each component is single-use only and supplied non-sterile. The collection cup is used to hold and contain the sperm and work in conjunction with the syringe when it is time to transfer the sperm into the syringe. The syringe is used to withdraw the semen from the collection cup and deploy the semen intravaginally. The syringe features a rounded front end with a slotted tip opening. The syringe has a rounded stopper that fits within the rounded end of the syringe to aid in sperm delivery from the syringe to the vagina. The syringe also contains flanges designed to aid in device handling during use.

The provided text describes the regulatory clearance of the Mosie Baby Kit and includes summaries of non-clinical and clinical performance testing. However, it does not describe an AI/ML-driven medical device and therefore does not contain information related to multi-reader multi-case (MRMC) studies, ground truth establishment by experts, or the effect size of AI assistance.

The document primarily focuses on the physical and functional characteristics of a medical device (a home insemination kit) and regulatory requirements for its approval for over-the-counter use.

Based on the provided document, here's an attempt to answer the questions, highlighting where the information is not applicable to AI/ML devices:

Acceptance Criteria and Device Performance (Based on Mosie Baby Kit Document)

Since this is not an AI/ML device, the acceptance criteria are not in terms of AI model performance metrics like sensitivity, specificity, or AUC. Instead, they relate to the physical and functional properties of the device, as well as user comprehension and self-selection for an over-the-counter product.

Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (Addressing AI/ML-specific questions where applicable, or stating N/A)

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

   • See the table above.

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

   • Shelf-Life, Bioburden, HSSA, Functional Testing: Test articles were subjected to accelerated aging conditions. Specific sample sizes for each test are not explicitly stated, but are implied to be sufficient for the tests mentioned (e.g., "samples" for HSSA, "test articles" for bioburden).
   • Biocompatibility Testing: Not specified as a "test set" in the context of an AI model, but rather as individual tests performed on device materials. Specific sample sizes for cytotoxicity, sensitization, and irritation tests are not provided.
   • Clinical Performance Testing (User Studies):
     • Self-Selection Study: 32 participants (15 contraindicated female participants and 17 non-contraindicated female participants).
     • Human Factors Validation Study: 30 participants (15 self-administered, 15 administered to a female recipient).
   • Data Provenance: The document states that participants in the clinical performance studies were "representative of the intended user in the United States." The studies appear to be prospective user studies conducted to evaluate the device's usability and label comprehension.

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

   • N/A for this device. This device is not an AI/ML diagnostic tool that requires expert-established ground truth for image/data interpretation. Ground truth for the user studies was based on the defined indications for use, contraindications, and correct understanding/performance of tasks as defined by the manufacturer and assessed by the study design.

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

   • N/A for this device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in expert-based review of medical images/data, which is not relevant here. The user studies' "ground truth" was based on whether participants correctly understood instructions or performed tasks as intended, as assessed by study protocols.

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, an MRMC study was not done. This is not an AI/ML diagnostic device, so a study comparing human reader performance with and without AI assistance is not applicable.

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

   • N/A for this device. This device is a physical product (insemination kit), not an algorithm.

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

   • For the physical tests (bioburden, HSSA, biocompatibility, functional), the "ground truth" was defined by established laboratory testing standards (e.g., USP, ISO, ASTM) and manufacturer specifications.
   • For the user studies (self-selection, human factors), the "ground truth" was based on predefined correct answers for comprehension questions and successful completion of tasks as outlined in the Instructions for Use (IFU) and verified by study observers. Essentially, it's a task-based performance and comprehension ground truth as defined by the device's labeling and intended use.

8. The sample size for the training set:

   • N/A. This is not an AI/ML device that requires a training set. The data presented are from verification and validation studies of the physical device and user interaction.

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

   • N/A. As there is no training set for an AI/ML model, this question is not applicable.

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The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance

The FemaSeed Intratubal Insemination consists of polymer curved transfer catheter with balloon, polymer guide catheter and separate balloon inflation syringe. The balloon inflation syringe is a 3 mL syringe fitted with clips that allow for the piston to lock in place to maintain balloon inflation. When the clips are pinched, the piston releases, deflating the balloon. The device is intended to deliver washed sperm or in vitro fertilized embryos into the uterine ostium via ultrasound guidance by a licensed healthcare provider specifically trained in women's health.

Prior to insertion, the slider is moved back until the curved transfer catheter is fully retracted and contained within guide catheter. The preassembled guide catheter is then passed transvaginally through the cervix to the fundus, under ultrasound guidance. Once in position, the preloaded transfer catheter is advanced approximately 2 cm into the uterine ostium and the balloon is inflated with the provided syringe. The balloon location in the uterine ostium is confirmed using ultrasound. The samples are then instilled into the uterine ostium of the fallopian tube, followed by deflating the balloon and discarding the device. The recommended volume for loading washed sperm should not exceed 1 mL and 50-100 µL when loading embryos.

The provided text describes the FemaSeed Intratubal Insemination device and its comparison to a predicate device, along with a summary of non-clinical performance data. However, it does not include detailed acceptance criteria or a study proving the device meets them in the format requested. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It lists various tests performed and their general outcomes (e.g., "all predetermined acceptance criteria were met"), but it doesn't quantify those criteria or the specific performance metrics for each, nor does it describe specific studies with sample sizes, expert involvement, or ground truth establishment for a device performance acceptance criteria table as requested.

Therefore, the following response will extract the available information and highlight the missing details based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantified acceptance criteria and reported device performance are generally not detailed. The document often states that "predetermined acceptance criteria were met" without specifying what those criteria were. However, some specific acceptance criteria and performance are mentioned:

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

The document describes non-clinical performance studies (e.g., sterilization, package integrity, biocompatibility, bench testing). However, it does not specify the sample sizes used for these tests. For instance, for mechanical tests or HSSA/MEA, the number of devices or biological samples tested is not provided. The data provenance is implied to be from laboratory testing performed by or for the device manufacturer (Femasys, Inc.), which is typically considered prospective data generation for regulatory submission. There is no mention of country of origin for any data beyond the general context of U.S. FDA submission.

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

This information is not provided in the document. The studies mentioned are non-clinical, benchtop, and biological compatibility tests, which typically do not involve human "experts" establishing a ground truth in the way described (e.g., radiologists interpreting images). The "ground truth" for these tests would be the established scientific and engineering standards and methods against which the device performance is measured (e.g., acceptable cytotoxicity levels, sperm motility percentages, embryo development rates).

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers/evaluators where there might be inter-observer variability in assessment. The non-clinical tests described do not involve such a process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. The studies described are non-clinical hardware performance and biological compatibility tests, not clinical or reader performance studies.

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

No, a "standalone" study in the context of an algorithm or AI without human intervention was not done or mentioned. The device is a physical medical instrument (catheter) used by a healthcare provider.

7. The type of Ground Truth Used

For the biological tests:

• Mouse Embryo Assay (MEA): The ground truth is the biological standard of embryo development (≥ 80% embryos developed to expanded blastocyst at 72 hours).
• Human Sperm Survival Assay (HSSA): The ground truth is the biological standard of sperm motility (≥80% of control motility).
• Endotoxin: The ground truth is the chemical standard of acceptable endotoxin levels (< 20 EU/device).

For mechanical/physical tests:

• The "ground truth" or reference is the predetermined acceptance criteria based on engineering standards, design specifications, and regulatory requirements, ensuring functionality, safety, and compatibility.

For sterilization, package integrity, and biocompatibility:

• The "ground truth" is adherence to recognized international standards and FDA guidance documents (e.g., ISO 11135-1:2014, ASTM F2096-11, ISO 10993 series).

8. The Sample Size for the Training Set

This information is not provided and is not applicable as the device is a physical catheter, not an AI/ML algorithm that requires a training set.

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

This information is not provided and is not applicable for the same reason as point 8.

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Daylily Single Use Sterile Embryo Transfer Catheters are used to place in vitro fertilized (IVF) embryos into the uterine cavity.

Daylily Single Use Sterile Embryo Transfer Catheters are sterile single use catheters used to deliver in vitro fertilized embryos to the uterine cavity. All models of the Daylily Single Use Sterile Embryo Transfer Catheters consist of a transfer catheter and a guide catheter. Some device models (Type II and Type IV) also include a trial catheter.

The guide catheter is composed of a catheter shaft, connector, and a positioning ring (for certain Type III and IV variants). Guide catheters for some Type III and Type IV variants are also provided pre-curved. Guide catheters have a rounded/blunt tip and marker bands at the distal tip to aid in catheter placement. The guide catheter is delivered through the cervix first and is used to guide the insertion of the transfer catheter holding the embryos into the uterine cavity.

The transfer catheter is composed of a catheter shaft, connector, and a stainless-steel sleeve (for Type III and IV models). Transfer catheters have a rounded/blunt tip and marker bands at the proximal end of the catheter to aid in catheter placement. The transfer catheter is loaded with embryos prior to delivery through the guide catheter and into the uterine cavity. A syringe (not provided with catheters) connected to the connector of the transfer catheter is used to deliver the embryos into the uterine cavity.

The trial catheter is an optional accessory for specific models (Types II and IV), composed of a catheter shaft, connector, and a polymer-coated stainless-steel core. Trial catheters have a rounded/blunt closed tip. The trial catheter is used to provide additional support during guide catheter placement and to assess the placement of the device prior to conducting an actual embryo transfer procedure.

The provided text describes the Daylily Single Use Sterile Embryo Transfer Catheters and reports on the non-clinical performance data to support its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

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

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

The document does not explicitly state the numerical sample sizes for each test set (e.g., number of catheters tested for dimensional analysis, number of mice/embryos for MEA). It only mentions that "all predetermined acceptance criteria were met in the following tests."

The data provenance (e.g., country of origin, retrospective/prospective) is not provided. The manufacturer is Shanghai Horizon Medical Technology Co., Ltd. from China, suggesting the testing likely occurred in or was overseen by a facility associated with the manufacturer.

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 device is an embryo transfer catheter and the studies performed are non-clinical, primarily bench performance and biocompatibility tests. Therefore, it does not involve establishing ground truth from expert clinical interpretation (like in imaging AI devices). The "ground truth" for these tests are the defined acceptance criteria and standardized test procedures (e.g., ISO, ASTM standards, FDA guidance).

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

Not applicable. This is not a clinical study involving human interpretation of data requiring adjudication. The tests are objective measurements against predefined specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device (embryo transfer catheter), not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical performance studies are the predetermined acceptance criteria based on established industry standards and regulatory guidance. For example:

• Biocompatibility: ISO 10993 series standards define acceptable biological responses.
• Endotoxin: USP <85> and AAMI/ANSI ST72:2019 define acceptable endotoxin levels.
• Mouse Embryo Assay (MEA): The 2021 FDA guidance "Mouse Embryo Assay for Assisted Reproduction Technology Devices" sets the specification for embryo development.
• Other Bench Tests: Conformity to physical and functional specifications.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. Since there is no training set, this question is not relevant.

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Allwin Embryo Transfer Catheters are used to introduce in vitro fertilized (IVF) embryos into the uterine cavity. Allwin Embryo Transfer Catheters (Pro Embryo Trans, Pro Echo Trans, Twinkle Pro Embryo Trans, and Bulb Trans Star ETC) include stylets or soft obturators intended to assist in uterine access of the guide catheter during an embryo transfer procedure.

Allwin Stylets and Soft Obturators are intended to be used with Allwin Embryo Transfer Catheters to assist in uterine access of the guide catheter during an embryo transfer procedure.

Allwin ETC include the following models: Embryo Trans, Twinkle Embryo Trans, Bulb Trans Ultra, Bulb Trans Star, Pro Embryo Trans, and Twinkle Pro Embryo Trans Embryo Transfer Catheter.

Allwin ETC Stylets and Soft Obturators include the following models: Stylet For Embryo Trans / Twinkle Embryo Trans, Stylet For Pro Embryo Trans / Pro Echo Trans / Twinkle Pro Embryo Trans, Stylet for Bulb Trans Ultra / Bulb Trans Star, Soft Obturator For Pro Embryo Trans / Twinkle Pro Embryo Trans Embryo Transfer Catheter.

This FDA 510(k) clearance letter pertains to Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets, and Soft Obturators. It is a clearance for a medical device, not an AI/ML algorithm. Therefore, the provided text does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, a study proving its performance, sample sizes, expert involvement, or ground truth establishment.

The document discusses the regulatory process for medical devices and confirms that the Allwin devices are substantially equivalent to legally marketed predicate devices. It outlines the "Indications for Use" for these physical medical devices, but there is no mention of any AI or software component requiring performance evaluation as described in the prompt.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, or details about experts and ground truth as these are not relevant to the content of this specific FDA letter.

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Kitazato ET Catheters are intended for ultrasound guided introduction of embryos into the uterine cavity following in vitro fertilization.

Kitazato ET Catheters are sterile, single-use catheters for use in embryo transfer procedures. The catheter is used to hold and deliver embryos to the uterine cavity during a procedure. Catheters are available in 3Fr and 4Fr sizes, both of which are provided in lengths of 220 mm and 250 mm, as well as one version that is 3Fr and 400 mm length that has the same uterine insertion depth as the other device versions, but allows the user to be positioned further from the patient during a procedure. Devices also include versions with and without an echo reflective chip in the tip of the catheter. The echo reflective chip aids in visualization of the catheter during a transfer procedure; all transfer procedures are to be done under ultrasound guidance. Both the Type 2 devices also include a stainless steel or polyimide core to provide additional rigidity to the catheter. The guide is used to navigate the pathway through the cervical canal to allow for easier catheter insertion Guides are provided with a 30° pre-curved distal shaft and are available in lengths of 170 mm and 200 mm. Guides also include a styrene elastomer stopper to aid in positioning the targeted uterine insertion depth. The guides are also available with a straight or bulb tip design, and with and without an echo reflective chip in the tip of the guide. An obturator with a length of 170 mm or 200 mm is provided with the Type 2 versions of the device to prevent ingress of fluid into the guide lumen during guide insertion. The Stylet is an optional accessory used when additional rigidity is needed during insertion of the guide through the cervix, and is provided in two lengths, 170 mm and 200 mm. The stainless steel core of the Stylet can be shaped to aid in guide delivery through the cervix.

This document describes a 510(k) premarket notification for the Kitazato ET Catheters. The focus of the provided text is on demonstrating the substantial equivalence of the Kitazato ET Catheters to a legally marketed predicate device (Guardia™ Access Embryo Transfer Catheter Sets). As such, the information provided is geared towards comparing the new device to an existing one, rather than establishing the performance of a novel AI/software medical device against defined acceptance criteria in the way a traditional clinical study would for an AI-powered diagnostic.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI medical device (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size and ground truth establishment) is largely not applicable to this submission.

This submission is for a physical medical device (catheters) and relies on bench testing and biocompatibility studies to show substantial equivalence, not a clinical study involving human readers and AI performance.

However, I can extract information related to relevant non-clinical performance and "acceptance criteria" where applicable to this physical device, as described in the document.

Acceptance Criteria and Device Performance for Kitazato ET Catheters (Physical Device)

This submission focuses on demonstrating substantial equivalence of a physical medical device (embryo transfer catheters) to a predicate device, primarily through non-clinical performance data. Therefore, the "acceptance criteria" are related to established norms for medical device safety and performance rather than AI-specific metrics like AUC, sensitivity, or specificity in a diagnostic context.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable in the traditional sense of an AI/ML test set. The "tests" here are non-clinical bench and lab experiments on the physical device components and assembled units (e.g., sterilization validation, biocompatibility, mechanical testing, Mouse Embryo Assay).
• Data Provenance: The studies are described as "performed to support substantial equivalence." The source of the materials and specific lab locations are not specified beyond the manufacturer (Kitazato Corporation) and their correspondent (Emergo Global Consulting, LLC) being based in Japan and the USA respectively. These are prospective tests of the manufactured device.

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

• Not Applicable. Ground truth, in the context of expert consensus for image or data interpretation, is not relevant here as this is a physical device submission. The "ground truth" for these tests comes from established international standards (ISO, ASTM, AAMI/ANSI, USP) and verified laboratory procedures.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations (e.g., in MRMC studies for AI). Here, the tests follow defined protocols with measurable outcomes.

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

• No. An MRMC study is not relevant for this type of physical medical device submission.

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

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• For this physical device, the "ground truth" is derived from:
  • Established Industry Standards: Compliance with ISO, ASTM, AAMI/ANSI, and USP standards.
  • Laboratory Measurements and Biological Assays: Objective measurements (e.g., dimensions, tensile strength) and biological assays (e.g., Mouse Embryo Assay, cytotoxicity testing) with predefined acceptance limits.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm.

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

• Not Applicable. See point 8.

Summary for this specific FDA Submission (K192540):

The FDA 510(k) clearance for the Kitazato ET Catheters is based on demonstrating substantial equivalence to an existing legally marketed predicate device. This is achieved through a comprehensive set of non-clinical performance tests, including sterilization validation, biocompatibility studies, endotoxin testing, packaging and transportation simulation, and specific bench performance tests (dimensional verification, appearance, tensile strength, Luer taper inspection, colorfastness, echo test). Additionally, a Mouse Embryo Assay (MEA) is performed to confirm the device's compatibility with embryos. The "acceptance criteria" are the successful completion of these tests in accordance with relevant international and national standards, with all predetermined criteria reported as met. The study design is not a clinical AI performance study, but a series of laboratory and bench tests on the physical device.

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Allwin Intra Uterine Insemination Catheters are intended for the introduction of washed spermatozoa into the uterine cavity.

Not Found

The provided text is a 510(k) clearance letter from the FDA for Allwin Intra Uterine Insemination Catheters. It establishes that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on regulatory clearance based on substantial equivalence and general controls, rather than outlining performance metrics or the results of a specific performance study.

Therefore, I cannot provide the requested information.

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