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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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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 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:

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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

• 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

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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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The Soft-Pass™ Embryo Mock Transfer Catheter Sets are used for mock (simulated) embryo transfer procedures to and in verifying catheter access and positioning in advance of an embryo transfer procedure.

The Soft-Pass Embryo Mock Transfer Catheter Sets are used to aid in verifying access and positioning of embryo transfer catheters prior to placing transfer catheters containing embryos into the uterine cavity. These devices consist of a polyethylene guide catheter that is 6.8 Fr in diameter and either 12 or 17.3 cm long, and a polyethylene mock transfer catheter that is 4.4 Fr in diameter and 19.7 or 24.7 cm long. The tip of the mock transfer catheter is closed. The echogenic tip versions of the device also include an echogenic stainless steel band on the distal tip of the mock transfer catheter to aid in tip visualization when using ultrasound. The echogenic tip versions also include a supporting stainless steel cannula in the proximal portion of the mock transfer catheter. Depth markers are also included on both the guide and mock transfer catheters to aid in placement of the device during a mock procedure. These devices are sterilized by ethylene oxide, single-use only, and have a three-year shelf-life.

This device submission (K191015) for the Soft-Pass™ Embryo Mock Transfer Catheter Sets does not include a new study to demonstrate acceptance criteria.

Instead, the submission states that the subject device is identical to the predicate device cleared under K173103, and the changes made in the current submission are solely to clarify the Indications for Use. Therefore, the device relies on the performance data submitted for its predicate device (K173103). The provided document does not contain the details of the study submitted for K173103.

Due to the lack of a new study in this specific document, most of the requested information cannot be extracted. However, based on the provided text, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or device performance data for this submission (K191015) because it relies on the predicate device's data. It asserts that the subject device is identical to the predicate device in terms of material specifications, physical characteristics, and manufacturing features.

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

• Not provided in this document. This information would have been part of the K173103 submission.

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

• Not provided in this document. This information would have been part of the K173103 submission. The nature of the device (a physical catheter) suggests that performance testing would likely involve engineering and clinical use validation rather than expert image interpretation, but without the K173103 details, this is speculative.

4. Adjudication method for the test set:

• Not provided in this document.

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 instrument (catheter), not an AI/software device that would typically undergo MRMC studies relating to human reader performance or AI assistance.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• Not provided in this document. For a medical device like a catheter, "ground truth" would generally refer to successful mechanical function, material integrity, biocompatibility, and sterility, verified through various physical, chemical, and biological tests, rather than a clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. This device is a physical instrument, not an AI/machine learning model that requires a training set.

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

• Not applicable. This device is a physical instrument, not an AI/machine learning model.

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Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, and Soft -Trans Malleable Obturator:

Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity.

GuardiaTM ETS Embryo-Tested Syringe:

For use with catheters indicated for intrauterine insemination and embryo transfer.

Flushing Catheter:

The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.

This 510(k) covers eight devices from five of COOK's device families. These devices, as outlined in the table below, are sold separately.

The polyurethane obturators are designed to fit dimensionally compatible embryo transfer guide catheters. Some of these devices are designed to be adjustable in length.

The flushing catheter is a 20 cm tube measuring 14.9 Fr at the proximal end and tapering to 3.5 Fr at the distal end. It features a depth indicator and directional side port with an ink mark aligned with the position of the side port. This device is identical to the Insemi-Cath IUI catheter cleared under K172321.

The Guardia Embryo-Tested Syringe is two-part syringe with a polypropylene barrel and a highdensity polyethylene plunger. This device undergoes Mouse Embryo Assay (MEA) and endotoxin testing (LAL) before lot release.

All subject devices are supplied sterile and intended for one-time use. The Guardia Embryo-Tested Syringe has a shelf-life of five years, whereas the remaining subject devices have a shelflife of three years.

The Cook Incorporated K180302 submission describes several devices, including Obturators, an Embryo-Tested Syringe, and a Flushing Catheter. The acceptance criteria and supporting studies are primarily focused on the physical and biological characteristics of these devices rather than a comparative performance study with human readers or AI.

1. Acceptance Criteria and Reported Device Performance

The provided document lists acceptance criteria and reported performance for several non-clinical tests.

2. Sample Size for Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of devices tested for tensile strength or leak tests). The studies are laboratory-based and conducted by the manufacturer, Cook Incorporated, in the United States. They appear to be prospective in nature, as they involve testing newly manufactured devices against established criteria.

3. Number of Experts and Qualifications for Ground Truth

This type of device (assisted reproduction catheters and obturators) does not typically involve human expert interpretation of images or data for establishing ground truth in the same way an AI diagnostic device would. The "ground truth" here is defined by physical performance characteristics, biological safety, and adherence to engineering specifications and international standards. Therefore, information about the number or qualifications of experts for establishing ground truth in this context is not applicable and not provided in the document.

4. Adjudication Method for Test Set

Given that the tests are primarily objective measurements of physical and biological properties against predefined specifications and standards, an adjudication method (like 2+1 or 3+1 used in clinical studies with subjective interpretations) is not applicable. The results are typically pass/fail based on direct measurement or observation.

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

No MRMC comparative effectiveness study was done. The device is a physical medical instrument, not a diagnostic AI device that assists human readers. Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not relevant or measured.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop) is not applicable here as the device is not an algorithm or an AI system. The performance studies described are essentially "standalone" in that they test the device's physical and biological properties directly.

7. Type of Ground Truth Used

The ground truth for these tests is based on:

• Engineering Specifications: Device input requirements for dimensions, material properties, and functional performance (e.g., leak resistance, tensile strength, securement).
• International Standards: e.g., ISO 11135-1:2007 for sterilization, ISO 10993-5/10 for biocompatibility, AAMI/ANSI ST72:2011 for endotoxin, ASTM D4169-05 for transportation, ASTM F2096-04 and F88-09 for package integrity, ISO 11070:1999 for fracture testing.
• Biological Activity: The Mouse Embryo Assay (MEA) uses the development of embryos to the blastocyst stage as an objective biological measure of non-toxicity.

8. Sample Size for the Training Set

"Training set" is not applicable as this is not an AI/machine learning device.

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

Not applicable, as there is no training set mentioned for this device.

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The Towako Transmyometrial Embryo Transfer Set is indicated for transfering IVF embryo(s) into the endometrial cavity through the myometrium for patients undergoing Assisted Reproductive Procedures.

The Towako Transmyometrial Embryo Transfer Set is comprised of an echo tipped stainless steel 19 Gauge needle, matching stainless steel stylet and a 2 Fr polyethylene transfer catheter. The stylet fits into the needle with both bevels flush, and is inserted with the stylet in-situ to prevent blockage of the needle lumen and provide stiffness to the needle during insertion. When the needle is positioned correctly, the stylet is removed and the transfer catheter with the embryos loaded is inserted to allow embryo transfer. The device is used when difficulty is experienced in transferring embryos into the uterine cavity using a standard trans-cervical route. The Towako Transmyometrial Embryo Transfer Set is a sterile and single-use device.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Towako Transmyometrial Embryo Transfer Set." It describes the device, its intended use, comparison to a predicate device, and performance data.

However, the document does not contain information about a study involving an AI/Machine Learning device and its performance against acceptance criteria. The listed performance data pertains to traditional medical device testing such as biocompatibility, mouse embryo assay, endotoxin testing, mechanical performance testing, and stability testing. There is no mention of a test set, ground truth, expert readers, or any other elements related to the evaluation of an AI algorithm as requested in your prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The text describes the regulatory clearance process for a physical medical device, not a software or AI medical device.

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