(303 days)
ProInsert™ is used during preparation of human sperm from a semen sample using density gradient separation during assisted reproductive procedures. ProInsert™ facilitates density gradient preparation and pellet retrieval following density gradient separation.
ProInsert™ is packaged in a sterile pouch, is single-use only, and includes the following components: Two 15 mL Conical Centrifuge tubes (one for the density gradient preparation and one for washing) 2 Pellet Retrieval Pipettes 1 ProInsert™
Here's a breakdown of the acceptance criteria and the study information for the ProInsert™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Specifications: | |
| Shelf life | 1 year |
| Endotoxin level | Less than 1.0 EU/device |
| Sterility | Gamma irradiated - SAL 10⁻⁶ |
| Human Sperm Survival Assay (HSSA) | Greater than 80% motility following 24h exposure to device materials |
| Functionality Testing: | |
| Gradient separation effectiveness | Tested using the ProInsert as compared to conventional separation procedures. (Implication: met standards for effectiveness, though specific numerical results are not provided in this summary.) |
| Endotoxin testing | Performed (Implied compliance with the 80% motility, matching the device specification) |
Study Proving Device Meets Acceptance Criteria:
The document describes "Performance testing: functionality testing" and "Lot Release Tests" as the studies conducted.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify a separate sample size for a "test set" in the context of clinical or comparative studies. The testing described appears to be a series of laboratory-based performance and safety evaluations.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of the tests (e.g., endotoxin, sterility, HSSA), they are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of testing described for the ProInsert™. The "ground truth" for the performance criteria (e.g., endotoxin levels, sterility, sperm motility percentage) would be established by validated laboratory assays and measurement standards, not by expert consensus in this context.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods are typically used in clinical studies where individual assessments or interpretations are involved (e.g., image reading). The tests described are objective laboratory measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI Assistance:
No, an MRMC comparative effectiveness study was not done. The ProInsert™ is a physical labware device, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
No, a standalone study (in the context of an algorithm) was not done. The ProInsert™ is a physical medical device; there is no AI algorithm involved in its primary function.
7. The Type of Ground Truth Used:
The ground truth for the device's performance relies on objective laboratory measurements and validated assay results.
- Endotoxin: Measured against a quantitative limit (less than 1.0 EU/device).
- Sterility: Measured against a quantifiable sterility assurance level (SAL 10⁻⁶).
- Human Sperm Survival Assay (HSSA): Measured as a percentage of sperm motility.
- Functionality (gradient separation effectiveness): Compared to conventional separation procedures, implying successful implementation of the intended function.
8. The Sample Size for the Training Set:
This information is not applicable. There is no AI algorithm being trained for this device. The "training set" concept is typically used in machine learning or AI development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no training set for an AI algorithm.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.