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Pre-Seed™ Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

Pre-Seed™ Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.

The provided document is a 510(k) summary for the Pre-Seed™ Fertility Lubricant. It details the device's characteristics, indications for use, comparison with a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical performance testing. It does not refer to a "test set" in the context of clinical trials with human subjects or a defined set of "cases." Instead, the testing involves laboratory-based assessments of the lubricant's physical, chemical, and biological properties.

• Sample Size:

  • Human Sperm Survival Assay (HSSA): Not explicitly stated, but typically involves multiple replicates and control groups for in vitro testing.
  • Biocompatibility: Not explicitly stated, but ISO standards typically define sample sizes for in vitro and in vivo (e.g., animal) tests.
  • Condom Compatibility: Not explicitly stated, but ASTM D7661-10 specifies the number of condoms and lubricant applications for testing.
  • Shelf-Life, Appearance/Color, Odor, pH, Osmolality, Viscosity, Microbial Count, Endotoxin, Antimicrobial Effectiveness: These are typically performed on multiple batches of the product at various time points during stability studies. The exact number of samples tested is not quantified in the summary.

• Data Provenance: The studies are non-clinical, laboratory-based tests. The country of origin of the data is not specified, but the testing was conducted according to international standards (e.g., ISO, USP, ASTM). The data is prospective in the sense that the tests were designed and executed to evaluate the specific product.

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

Not applicable. This is a non-clinical device, not an AI/diagnostic device that typically requires expert-established ground truth for a test set. The "ground truth" here is objective laboratory measurements against predefined specifications and validated assay methods.

4. Adjudication Method for the Test Set:

Not applicable, as this is non-clinical performance testing against objective criteria, not a diagnostic or AI study requiring adjudication of expert interpretations.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation by human readers. The Pre-Seed™ Fertility Lubricant is a personal lubricant, not a diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not applicable. This is a physical and chemical product, not an algorithm or AI system. Its performance is inherent in its formulation and physical properties, tested in a standalone manner (the lubricant itself against criteria).

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is based on:

• Objective laboratory measurements: Directly measured physical and chemical properties (pH, osmolality, viscosity, appearance, odor, endotoxin levels, microbial counts).
• Validated assay outcomes: Results from standardized biological assays like the Human Sperm Survival Assay (HSSA), which measures sperm motility against a control.
• Compliance with international standards: Biocompatibility testing according to ISO 10993 series and condom compatibility testing per ASTM D7661-10. These standards define the procedures and acceptance criteria.
• Stability data: Measuring the maintenance of all specifications over time to establish shelf-life.

8. The Sample Size for the Training Set:

Not applicable. There is no concept of a "training set" for this type of non-clinical device performance testing. The lubricant's formulation and manufacturing processes are developed to meet the desired specifications, and then the final product is tested against those specifications.

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

Not applicable, as there is no training set mentioned or implied for this non-clinical device.

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