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Sperm Washing Medium and Modified Sperm Washing Medium are intended for sperm processing procedures prior to intrauterine or in vitro fertilization procedures.
Sperm Washing Medium and Modified Sperm Washing Medium are intended for assisted reproduction procedures that require the processing or manipulation of human sperm prior to insemination or in vitro fertilization.

Sperm Washing Medium and Modified Sperm Washing Medium are synthetic, defined media composed of a mixture of salts and other physiologically compatible substances. The two products differ only in their protein supplementation. Sperm Washing Medium contains 5 mg/mL of human serum albumin, while Modified Sperm Washing Medium contains the same concentration of bovine serum albumin.

Here's a breakdown of the acceptance criteria and the study information for Irvine Scientific's Sperm Washing Medium and Modified Sperm Washing Medium, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it refers to regulatory compliance and historical use as indicators of suitability.

Study Information

The provided text describes a submission for a 510(k) premarket notification, which largely relies on demonstrating substantial equivalence to a predicate device and established safety/effectiveness through existing data and product history. It does not detail a formal, prospective clinical study designed to "prove" the device meets specific, novel acceptance criteria in the way a new drug or high-risk device might.

Here's what information can be extracted regarding the "study" aspects:

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

   • Test Set Sample Size: Not explicitly stated as a separate "test set" for a new study. The primary "testing" referenced is:
     • Mouse embryo assay: This is a quality control test for each lot, not a clinical study test set. The number of embryos per assay is not specified.
     • "Variety of clinical settings": The products "have been used in a variety of clinical settings, for their original, intended use, for a number of years." This implies a large, cumulative, retrospective dataset from actual clinical practice. No specific numbers of patients or procedures are given.
   • Data Provenance: Not specified, but given Irvine Scientific's US location, it's likely primarily US-based clinical use, though this is an inference. Predominantly retrospective.

2. 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):

   • This is not applicable in the context of the information provided. The "ground truth" for the performance claims relies on the historical clinical outcomes from using these media and the biological assays (mouse embryo assay, endotoxin, sterility). There isn't a "ground truth" established by human experts reviewing test data in the way a diagnostic imaging study might.

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

   • Not applicable. There's no human adjudication of a novel test set performance. The "adjudication" of the device's suitability fundamentally comes from regulatory bodies (FDA) based on the provided evidence of equivalence and historical safety/effectiveness.

4. 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 applicable. This device is a biological medium, not an AI-powered diagnostic tool, and no MRMC study was conducted or mentioned.

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

   • Not applicable. This is not an algorithm or AI device. The mouse embryo assay could be considered a "standalone" test of product quality, but it's a product quality control, not a standalone performance study in the AI context.

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

   • The primary "ground truth" for the device's effectiveness relies on outcomes data (successful insemination/fertilization outcomes from actual clinical use) and biological assay results (absence of toxicity from mouse embryo assay, sterility, endotoxin levels). The success in assisted reproductive procedures when these media were used over "a number of years" serves as strong evidence.

7. The sample size for the training set:

   • Not applicable in the conventional sense. This is not a machine learning or AI device. The term "training set" doesn't apply to the development or validation of these media in the provided context. The general "history of satisfactory use" could be thought of as a vast, non-quantified "experience set" that informed both the current product and its predicate.

8. How the ground truth for the training set was established:

   • Not applicable, as there's no training set in the AI sense. The "ground truth" of the product's quality and suitability for its intended use stems from established biological testing methodologies (mouse embryo assay, endotoxin, sterility) and long-term clinical experience with the product and its predicate, indicating successful outcomes in assisted reproductive procedures.

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