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ISolate® is a density gradient medium designed to separate the motile fraction of sperm from seminal fluid. As a two-layer gradient system, it effectively reduces cellular contaminants such as dead sperm, white blood cells and miscellaneous debris. The resulting sample contains predominantly motile sperm. It is intended for use as a human sperm separation medium, to concentrate and purify viable sperm, prior to in vitro fertilization, and related assisted reproductive technology, procedures.

The products are a colloidal suspension of silica particles that have been covalently modified with hydrophilic silane. The colloid is formulated in a buffered physiological solution, compatible with human sperm. They are identical to the predicate device, in formulation and differ only in the intended use.

ISolate Concentrate and ISolate Stock Solution differ only from each other, and from the predicate, in the concentration of the colloidal silica in the formulation. ISolate Stock Solution, is, in fact, identical to the "lower layer" component of the two layer kits. They are provided for those laboratories that wish to use either a two-layer gradient with densities of their own choice, or a single gradient procedure. ISolate Concentrate is designed for further dilution by the user, into an appropriate density gradient. ISolate Stock Solution may be used as supplied, for those laboratories who choose to use a single density procedure, or may be diluted to densities of the laboratory's choice.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

The document describes the submission of ISolate® Concentrate and ISolate® Stock Solution for an expanded intended use to include sperm processing procedures prior to in vitro fertilization. The primary method of demonstrating substantial equivalence is by comparing these new products to a predicate device, ISolate 2-layer kits (cleared under K971809).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "ISolate Concentrate has been compared clinically to ISolate 2-layer kits, and has been found to perform comparably in sperm survival, forward progression and percent recovery of motile sperm." The "acceptance criteria" here are implied to be "comparable performance" to the predicate device in these specific metrics. For ISolate Stock Solution, the acceptance criterion is being "identical" to the "Lower Layer" component of the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size used for the clinical comparison.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is simply referred to as a "clinical comparison."

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

• This information is not provided in the document. The document describes a "clinical comparison" but does not detail the methodology for assessing sperm parameters or the experts involved in establishing ground truth for the comparison.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

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

• No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (sperm separation media), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

• No, a standalone (algorithm only) performance study was not done. This document describes a medical device (sperm separation media), not a standalone algorithm. Its performance is evaluated based on its ability to separate sperm, which is a chemical/physical process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the clinical comparison appears to be based on direct measurements of sperm parameters: "sperm survival, forward progression and percent recovery of motile sperm." These measurements would typically be performed by laboratory technicians or embryologists using established laboratory protocols, rather than expert consensus on images or pathology.

8. The Sample Size for the Training Set

• Not applicable. This device is a chemical medium, not a machine learning algorithm that requires a training set.

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

• Not applicable. As stated above, this is not an AI/machine learning device.

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