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The RI MSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI).

The Research Instruments Migration Sedimentation Chamber (RI MSC) is sterile, non-pyrogenic proven by Limulus Amebocyte Lysate and non-toxic to sperm proven by Human Sperm Survival Assay (HSSA). The RI MSC is disposable and labelled for single use, individually packaged in medical pouches and sold in boxes of twenty (x20) units. The RI MSC is manufactured from medical grade polystyrene and its surfaces are untreated. It is injection moulded as a completed unit, housing a central well with a surrounding gallery. The cylinder is 74 mm in height with a top OD of 16.5 mm and fluid capacity of 6 ml (approx) if completely filled; however, during recommended procedures it accommodates 1-2 ml of culture medium. The RI MSC facilitates the migration sedimentation technique. The migration sedimentation technique utilizes the innate 'swimming' ability of sperm to separate vigorous, A-motile sperm from non-motile or abnormal sperm and ejaculate debris.

The provided 510(k) summary for the Research Instruments Migration Sedimentation Chamber (RI MSC) details non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It primarily focuses on material safety and performance for sperm compatibility.

Here's an analysis of the acceptance criteria and study information:

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 explicitly state the sample sizes used for the HSSA, LAL, or shelf-life testing. It only mentions "batch tested" for HSSA and LAL, implying that samples from manufacturing batches were used.
• Data Provenance: The document does not specify the country of origin for the HSSA or LAL data. It describes the testing as "non-clinical testing" and does not indicate if it was retrospective or prospective in terms of data collection for specific human subjects. For the HSSA, human sperm is involved, but the document does not elaborate on ethical considerations or donor selection.

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

This information is not applicable to the studies conducted. The document describes non-clinical testing (HSSA, LAL, sterility, shelf life) which relies on laboratory methods and established biological or chemical assays, not expert consensus or interpretation for "ground truth." The acceptance criteria for these tests are quantitative thresholds (e.g., motility percentage, endotoxin levels).

4. Adjudication Method for the Test Set

This is not applicable as the studies are laboratory-based and rely on direct measurements against pre-defined quantitative thresholds, not subjective expert 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

This is not applicable. The device is a physical labware item (Migration Sedimentation Chamber) for sperm preparation, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by:

• Validated laboratory assays:
  • HSSA: Measures sperm motility against a predefined physiological threshold.
  • LAL: Measures endotoxin levels against a predefined safety threshold.
  • Sterility testing: Confirms absence of microbial growth to meet SAL.
  • Shelf-life testing: Assesses material integrity and performance over time, often using accelerated aging methods correlated with real-time stability studies.

8. The Sample Size for the Training Set

This is not applicable. The device is a manufactured medical labware, not a machine learning model, so there is no training set in the AI sense.

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

This is not applicable for the same reason as above.

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