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510(k) Data Aggregation
(259 days)
The SperSort™ Sperm Sorting Chip is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
The SperSort™ Sperm Sorting Chip is used to prepare motile sperm for assisted reproductive technology (ART) procedures. The device separates motile sperm from the semen based on the mobility (i.e., swim-up nature) of motile sperm. The SperSort™ Sperm Sorting Chip consists of an upper collection chamber and a lower semen sample chamber. The chambers are separated by porous filter which allow motile sperm to pass from the lower chamber to the upper chamber. Both the semen sample injection port and sperm collection port are located on the upper cover. The semen sample injection port directly connects to the lower chamber, while the sperm collection port is connected to the upper chamber. The SperSort™ Sperm Sorting Chip accommodates a 1.9 mL semen sample. Liquefied semen is added to the lower chamber and cleared sperm washing medium (1.5 mL) is added to the upper chamber. Following incubation for 30 minutes at 37°C, the isolated sperm are gathered from the collection port. The SperSort™ Sperm Sorting Chip is a radiation-sterilized device with a sterility assurance level (SAL) of 10-9. They are individually packaged and for single use only.
The FDA 510(k) summary for the SperSort™ Sperm Sorting Chip (IPG02) provides information on its acceptance criteria and non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a single table, but can be inferred from the performance testing section and comparison with the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (SperSort™ Sperm Sorting Chip) |
|---|---|---|
| Sterility Assurance Level (SAL) | 10⁻⁶ (as per predicate device and FDA guidance) | 10⁻⁶ |
| Package Integrity | Maintain sterile barrier after simulated transport and aging | Passed (Can withstand shipping, sterile barrier maintained) |
| Shelf-Life Performance (HSSA) | ≥ 80% of the control motility at 24 hours after exposure for 30 minutes | Maintained performance after two years accelerated aging and passed HSSA (≥ 80% control motility) |
| Endotoxin | ≤ 20 EU/device (device specific) | < 20 EU/device |
| % Motile Sperm (after separation) | Significantly increased compared to input (demonstrating efficacy) | 95.89% (from 57.50% before separation) |
| % Progressive Motile Sperm Cells (PMSC) (after separation) | Significantly increased compared to input (demonstrating efficacy) | 92.97% (from 47.07% before separation) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used in the performance testing.
The data provenance is not specified. It is unclear if the data is from a particular country or if it's retrospective or prospective. The study is described as "Performance Testing" using "donor semen samples," implying a prospective study, but details are lacking.
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 performance testing primarily focuses on device output measurements (% motile sperm, % progressive motile sperm) rather than expert-adjudicated ground truth for a diagnostic interpretation.
4. Adjudication Method for the Test Set
This information is not provided as the testing described focuses on quantitative measurements of sperm characteristics rather than qualitative assessments requiring 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
The SperSort™ Sperm Sorting Chip is a physical device for processing semen samples, not an AI software/algorithm for interpretation. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers assisting AI or vice-versa is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The SperSort™ Sperm Sorting Chip is a physical device, not an algorithm or AI. Therefore, a standalone algorithm performance study is not applicable and was not performed. The "standalone" performance in this context refers to the device's ability to separate sperm effectively on its own, which is what the performance testing describes.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" for the effectiveness of sperm separation was established through quantitative measurement of sperm parameters (percentage of total motile sperm and progressively motile sperm cells) in both the input (before separation) and output (after separation) samples. These measurements serve as an objective ground truth for the device's performance in improving sperm quality.
8. The Sample Size for the Training Set
The document describes a physical medical device, not an AI or machine learning algorithm that requires a "training set." Therefore, information about a training set size is not applicable and not provided.
9. How the Ground Truth for the Training Set was Established
As this is a physical device and not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it is not applicable.
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