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The CrossBay IVF Embryo Transfer Catheter Set is intended for ultrasound-guided introduction of embryos into the uterine cavity following in vitro fertilization.

The CrossBay IVF Embryo Transfer Catheter Set is a sterile, single use device composed of disposable components supporting the transfer of an in vitro fertilized embryo to the uterus. The CrossBay IVF Embryo Transfer Catheter Set is comprised of a Delivery Catheter with a 6 Fr Inner Catheter and everting membrane that accesses the cervix and uterine cavity; a 3cc syringe for supplying aseptically filtered media or saline to the Delivery Catheter; and a 3 Fr Embryo Transfer Catheter that is supplied in a separately sealed pouch. The Delivery Catheter contains an acorn tip for seating the distal end of the Delivery Catheter at the exocervix. The Embryo Transfer Catheter contains a stainless steel band at the distal end to provide additional echogenicity to the catheter for ultrasound guided procedures. The Embryo Transfer Catheter has markings on its proximal end at 1 cm intervals to aid in determining the depth of insertion. The Embryo Transfer Catheter can extend a maximum distance of 4 cm beyond the distal end of the fully everted membrane when completely inserted into the Delivery Catheter. The maximum insertion depth of the Embryo Transfer Catheter and fully everted membrane is 9 cm.

The provided text describes the CrossBay IVF Embryo Transfer Catheter Set and its comparison to a predicate device, the Wallace Sure View™ Embryo Replacement Catheters & Trial Transfer Catheters (K033084), to demonstrate substantial equivalence for regulatory approval.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a consolidated table of acceptance criteria for all aspects of the device in a typical format. Instead, acceptance criteria are embedded within the "Performance Data" section for specific tests.

However, based on the provided text, we can construct the following table for the criteria that are clearly stated:

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

• Sample Size (for specific tests where mentioned):
  • Mouse Embryo Assay (MEA): Three lots of product.
  • Endotoxin Testing: Three lots of product.
  • Testing for Shelf-Life/Accelerated Aging: "samples exposed to accelerated aging conditions". Specific number not defined beyond "samples".
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be retrospective bench and lab-based tests conducted on manufactured device samples. There is no mention of prospective clinical studies or human-based data.

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

This section is not applicable as the studies described are bench tests, biocompatibility tests, and sterilization validations, which do not involve expert interpretation or ground truth establishment in the traditional sense of clinical imaging or diagnostic studies. The "ground truth" for these tests is based on established scientific and engineering principles, and the measured physical/biological properties of the device.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated in point 3. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not present here.

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

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is used to assess human reader performance, often in diagnostic imaging, which is not relevant to this device's testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This section is not applicable. The device is an embryo transfer catheter set, a physical medical device. It does not involve algorithms or AI. The performance tests described evaluate the physical, chemical, and biological properties of the device itself.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is based on:

• Established engineering specifications and product design.
• Validated laboratory methods and consensus standards (e.g., ISO, ASTM, USP).
• Direct measurement and observation of physical properties.
• Biological responses (e.g., mouse embryo development for MEA, cellular reactions for biocompatibility).

For example, for MEA, the ground truth is the observable blastocyst formation rate in the mouse embryo cultures, and for endotoxin, it's the measured endotoxin level.

8. Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not a machine learning or AI model, so there is no "training set."

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

This section is not applicable for the reasons stated in point 8.

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The CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device is indicated for use to access the uterine cavity for sonohysterography and sonohysterosalpingography procedures. The SonoFlow Device can instill salineonly or a mixture of saline and air for performance of saline infusion sonohysterography and sono-hysterosalpingography (Sono-HSG), respectively, for the evaluation of the fallopian tubes and/or the uterus. The following are generally recognized clinical indications for saline infusion sonohysterography and sonohysterosalpingography procedures: suspected polyps, fibroids, adhesions, endometrial thickening, and/or the selective evaluation of fallopian tube patency.

The CrossBay Medical SonoFlow™ Device is a catheter that enables saline and air infusion of contrast media to perform sonohysterosalpingography and sonohysterography procedures. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains an aeration component that provides an alternating pattern of saline and air as a stream of contrast media into the uterus and fallopian tubes. The proximal end of the device contains a handle with an air supply opening that allows the physician to reduce or eliminate the amount of air infusion selectively by occluding the opening of the air supply. The proximal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.

This document is a 510(k) Summary for the CrossBay SonoFlow Sonohysterography and Sonohysterosalpingography Device. It outlines the device's characteristics and demonstrates its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, nor does it detail AI performance or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on demonstrating substantial equivalence through bench testing, biocompatibility, sterilization validation, and packaging/shipping validation, rather than clinical performance testing with specific acceptance criteria that would typically involve AI evaluation.

Here's what the document does provide regarding testing:

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

• Not present in the document. The document states "Bench testing confirmed that the CrossBay Medical SonoFlow Device performs according to the product specifications" and "Passing results were obtained" for various tests, but it does not specify what those product specifications or acceptance criteria were for device performance. It also doesn't provide specific performance metrics beyond "passing."

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

• Not present in the document. The document mentions that tests were conducted on "ethylene oxide sterilized units at baseline and on devices subjected to accelerated aging conditions equivalent to six (6) months." However, it does not specify the sample size for these units or the provenance of any data beyond mechanical testing. There's no mention of a "test set" in the context of diagnostic performance or clinical data.

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)

• Not present in the document. This type of information would be relevant for a study evaluating diagnostic performance, particularly with AI. This document does not describe such a study.

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

• Not present in the document. This would pertain to a diagnostic performance study, which is not described.

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 present in the document. There is no mention of AI in this submission, nor of a MRMC study.

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

• Not present in the document. There is no mention of an algorithm or AI in this submission.

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

• Not present in the document. This would be relevant for a diagnostic performance study, which is not described.

8. The sample size for the training set

• Not present in the document. No training set is mentioned as there's no AI component.

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

• Not present in the document. No training set is mentioned as there's no AI component.

Summary of available information related to performance testing:

The document primarily focuses on demonstrating the device's substantial equivalence to existing predicate devices (Femasys, Inc. - FemVue Saline-Air Device K110288 and FemVue Catheter System K083690, and CrossBay Medical Inc. - SonoSure Sonohysterography and Endometrial Sampling Device K133144).

The "Performance Data" section details the following:

• Bench Testing: Confirmed performance according to product specifications (details not provided), including functionality, bond/joint tests, and fluid/air delivery. Tests were done on new and aged units.
• Biocompatibility testing: Asserted applicability of data from the reference device (CrossBay SonoSure device K133144) due to similar materials and manufacturing. This included Cytotoxicity, Vaginal Irritation, and Sensitization.
• Sterilization Validation: Asserted applicability of data from the reference device (CrossBay SonoSure device K133144) due to equivalent components, materials, dimensions, weight, and sterilization methodology. Complied with ISO 11135-1:2007 and ISO 10993-7:2008.
• Packaging and Shipping Validation: Successfully conducted per ASTM guidelines (ASTM F1929, D642, 5276).

In conclusion, this document primarily addresses the mechanical, material, and sterility aspects of the medical device for a 510(k) submission, not the diagnostic or AI performance with associated acceptance criteria and ground truth studies that your questions suggest.

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The CrossBay SonsoSure Sonohysterography and Endometrial Sampling Device is indicated for use to access the uterine cavity for saline infusion sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device.

The CrossBay Medical SonoSure Device is a catheter that enables saline infusion sonohysterography procedures and endometrial biopsy collection within a single device. The catheter is comprised of standard polymer materials and contains a silicone acorn tip to enable a cervical seal. The distal end of the device contains a retractable nylon brush for endometrial biopsy sampling. The distal end of the device contains an empty PVC bag that can be filled with saline. The device is provided sterile and is intended for single use only.

Here's an analysis of the provided text regarding the CrossBay Medical SonoSure Sonohysterography and Endometrial Sampling Device:

Acceptance Criteria and Device Performance Study

Based on the provided 510(k) summary, the device's acceptance criteria and performance are primarily evaluated through non-clinical performance data (bench testing and biocompatibility). The document emphasizes substantial equivalence to predicate devices rather than establishing novel clinical performance metrics with specific acceptance criteria in a dedicated clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the "test set" in terms of clinical subjects. The performance data discussed is non-clinical (bench testing, biocompatibility, sterilization, packaging). For these types of tests, samples would be units of the device itself (e.g., a certain number of devices for mechanical testing, material samples for biocompatibility). Specific numbers are not provided.
• Data Provenance: The data is generated through "physical bench testing," "biocompatibility testing," and "sterilization" and "packaging and shipping validation studies." This indicates the data is from laboratory or controlled testing environments, not from clinical subjects or patient data. Therefore, "country of origin" or "retrospective/prospective" is not applicable in the typical sense for clinical studies. It's internal product development and testing data.

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

• This question is not applicable as the provided documentation describes non-clinical performance and does not involve establishing ground truth from experts on a test set (e.g., imaging diagnosis, pathology review). The "ground truth" for these tests are typically established by objective, measurable engineering and scientific standards (e.g., pass/fail criteria for mechanical strength, established limits for cytotoxicity).

4. Adjudication Method for the Test Set

• This question is not applicable as the assessment is based on non-clinical performance data against established standards and specifications, not on subjective expert interpretation 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

• No, an MRMC comparative effectiveness study was not done.
• The device is a physical medical instrument (catheter, brush), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone performance study was not done.
• The device is a physical medical instrument, not an algorithm, and does not operate "standalone" without human interaction/use.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical tests described, the "ground truth" is derived from established scientific and engineering standards and specifications. For instance:
  • Mechanical strength: Pass/fail criteria dictated by product specifications and engineering principles.
  • Biocompatibility: Conformance to ISO 10993 standards and FDA guidance.
  • Sterilization: Compliance with ISO 11135-1 and ISO 10993-7.
  • Packaging: Adherence to ASTM guidelines.
• There is no mention of expert consensus, pathology, or outcomes data being used to establish a "ground truth" for the performance evaluation presented.

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical medical instrument and does not involve machine learning or AI, thus there is no "training set."

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

• This question is not applicable as there is no training set for this device.

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