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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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