(49 days)
The product is intended for use in the preparation of human sperm for intrauterine insemination (IUI).
The product is a colloidal suspension of silica particles which have been covalently modified with hydrophilic silane. The colloid is formulated in a buffered physiological solution compatible with human sperm. The product is packaged in two formats. One format consists of a kit of two solutions which differ only in the concentration of the colloidal silica, and therefore in their density. The two solutions, labeled "Upper" and "Lower", are utilized to form a step-gradient in a centrifuge tube. The other product format is a single solution which can be utilized as a "stock solution" to create a different step gradient from that provided by the kit. This latter solution is identical to the "Lower" (i.e., higher density) solution.
The provided text does not contain detailed acceptance criteria with numerical targets. Instead, it describes a "substantial equivalence" study where the performance of the ISolate device was compared against predicate devices.
Here's an analysis based on the provided text, addressing as many of your points as possible:
Acceptance Criteria and Study Details for ISolate Sperm Separation Medium
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Sperm Select and Modified Ham's F-10) in sperm preparation for IUI. | "The results showed that sperm prepared with ISolate resulted in preparations which were substantially equivalent to those from the predicate devices." |
| Performance metrics for sperm preparation (e.g., recovery, motility, viability, forward progression, normal forms) comparable to predicate devices. | "The resulting purified sperm preparations were assayed for recovery, motility, viability, forward progression and normal forms." (Results explicitly stated as "substantially equivalent".) |
| Biocompatibility | Concluded to be substantially equivalent to predicate devices. |
Note on Acceptance Criteria: The document indicates that the device was deemed "substantially equivalent" to predicate devices, which is the primary criterion for 510(k) clearance in the US. Specific numerical targets for performance metrics (recovery, motility, etc.) are not provided in this summary. The "acceptance criteria" here are implied to be "no worse than" or "comparable to" the predicate devices for the specified performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact number of semen samples (fresh and cryopreserved) used in the performance study is not specified in this summary. It only states "Semen samples (fresh and cryopreserved) were processed...".
- Data Provenance: The document does not specify the country of origin of the data. It is a 510(k) submission to the US FDA, so the data would typically be expected to originate from studies conducted in a manner acceptable for US regulatory review. The study appears to be prospective in the sense that fresh and cryopreserved samples were processed "in parallel" using ISolate and predicate devices for 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 summary. The evaluation of sperm parameters (recovery, motility, viability, etc.) would typically be performed by trained lab personnel rather than "experts" in the context of ground truth establishment for diagnostic algorithms.
4. Adjudication Method for the Test Set
- This information is not applicable and therefore not provided. "Adjudication method" typically refers to resolving discrepancies in expert interpretations, which is not relevant for objective laboratory measurements of sperm parameters.
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. This type of study (MRMC for AI assistance) is not applicable to this device. ISolate is a sperm separation medium, a laboratory reagent, not an AI-powered diagnostic device or image analysis software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This concept is not applicable to this device. ISolate is a medium used in a laboratory procedure; there is no "algorithm" in the sense of a software-based diagnostic tool. The performance evaluation was of the chemical medium itself in processing sperm samples.
7. The Type of Ground Truth Used
- The ground truth was established by objective laboratory measurements of various sperm parameters: recovery, motility, viability, forward progression, and normal forms. These metrics represent the direct, measurable outcomes of the sperm separation process.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI. It is a chemical product; its performance is based on its physical and chemical properties and how it interacts with biological samples, not on an algorithm trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" for this type of device.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.