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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 PeriFuse™ regional anesthesia Catheter is indicated for use during procedures where intermittent administration of local anesthetics is indicated for control of operative, postoperative, acute or chronic pain for peripheral nerve block procedures. The duration of use should not exceed 72 hours.

The PeriFuse™ Catheter is an echogenic regional anesthesia catheter intended to enhance visibility of the catheter under ultrasound guidance. The PeriFuse™ Catheter is made of flexible nylon tubing and comes in two versions. One version is a closed end with 3 lateral eyes. The second version is an open end with a finished tip. The catheters are available as 21G (O.D. 0.83mm nominal/I.D. 0.41mm nominal) and have a nominal length of 944mm. They will be provided as sterile, single use, disposable devices. The PeriFuse™ Catheter tip is marked for ease of identification and to ensure complete catheter removal. The catheter is extruded using a patented Smiths Medical technology which leaves a surface finish that is slightly textured on both the inner diameter and outer diameter. The PeriFuse™ Catheter may be packaged in either a catheter kit or may be included in Smiths Medical regional anesthesia trays (K965017).

The provided text describes a 510(k) submission for the PeriFuse™ Catheter and explicitly states that no clinical data was required for this submission. Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

The submission focuses entirely on non-clinical data to establish substantial equivalence to predicate devices. The non-clinical testing conducted included mechanical, functional, and performance evaluations, demonstrating compliance with "stated sections of BS 6196:1989 Sterile epidural catheters and introducer needles for single use."

Since no clinical study was performed, most of the requested information regarding acceptance criteria, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable based on the provided document.

Here's an attempt to fill in the table and address the questions based solely on the information given, highlighting what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A). No clinical test set or data provenance from a clinical study is mentioned. Non-clinical testing was performed, but specific sample sizes for these tests are not provided in the summary.

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

• N/A. No ground truth established by experts for a clinical test set is mentioned.

4. Adjudication method for the test set

• N/A. No clinical test set or adjudication method is mentioned.

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

• N/A. No MRMC study performed. The device is a medical catheter, not an AI diagnostic tool involving human readers.

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

• N/A. The device is a medical catheter, not an algorithm.

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

• For the non-clinical performance evaluation, the "ground truth" was compliance with specified sections of BS 6196:1989 Sterile epidural catheters and introducer needles for single use. This standard itself would define the performance metrics and acceptable ranges.
• For substantial equivalence, the "ground truth" was the technological characteristics and indications for use of the predicate devices.

8. The sample size for the training set

• N/A. No training set for an algorithm is applicable.

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

• N/A. No training set for an algorithm is applicable.

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