Search Results

SSS-NX is intended for use in assisted reproductive technology (ART) procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for ART media.

SSS-NX (Serum Substitute Supplement-NX) is an assisted reproduction media supplement consisting of a combination of human serum proteins (approximate protein content 50 mg/mL, 5% w/v) in a saline solution. Of this, ≥83% is albumin and ≤17% is globulins. The product is supplied as a ready to use liquid in 10 mL containers distributed in a twelve (12) x 10 mL kit and a 100 mL liquid packaged in a 125 mL container.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SSS-NX (Serum Substitute Supplement-NX)
Device Type: Assisted reproduction media supplement
Predicate Device: Serum Substitute Supplement (SSS)
510(k) Number: K233764

1. Table of Acceptance Criteria and Reported Device Performance

Note: While the "Indications for Use" statement differs between the subject and predicate devices, the "Intended Use" is considered the same: for manipulation of gametes and embryos and for culture use. The differences in device materials do not raise different questions of safety and effectiveness. The subject device has a more stringent endotoxin limit than the predicate, which is considered an improvement and does not raise different safety and effectiveness concerns. The shorter shelf life for the subject device is noted but not presented as a failure of acceptance criteria, as it was supported by testing.

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

The provided document describes testing for a reproductive media supplement, not a diagnostic or AI-powered device. Therefore, the concept of a "test set" in the context of imaging or algorithm performance is not applicable here.

• Sample Size: The document does not specify the exact sample size for each test (e.g., how many batches for sterility, how many embryos for MEA). It implies that testing was performed on sufficient samples to meet the specified criteria.
• Data Provenance: Not applicable in the traditional sense for this type of product. The data is generated through laboratory testing of the manufactured product (SSS-NX). There is no mention of country of origin of data or retrospective/prospective clinical data for human subjects because it is a manufacturing component, not a device directly used in a patient.

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

Not applicable. As this is a reproductive media supplement, the "ground truth" is established through standardized laboratory assays and physical/chemical property measurements, not clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for this product is determined by objective laboratory tests and adherence to specified ranges (e.g., pH, osmolality, sterility) and biological performance (MEA). There would be no expert adjudication in the manner of diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for AI-assisted diagnostic devices involving human readers interpreting medical images or data. SSS-NX is a laboratory reagent.

6. Standalone Performance Study (Algorithm Only)

Not applicable. SSS-NX is a physical product (a liquid supplement), not an algorithm or software. Its performance is measured directly by laboratory tests.

7. Type of Ground Truth Used

The ground truth for this device is based on:

• Laboratory Assay Results:
  • Sterility (absence of microbial growth per USP )
  • Endotoxin levels (per USP )
  • pH (per USP )
  • Osmolality (per USP )
  • Mouse Embryo Assay (MEA) performance (percentage of 1-cell embryos developing to expanded blastocyst at 96 hours). This is a biological performance test to ensure the media supports embryo development.
• Physical/Chemical Properties: Clarity and Color.
• Standards Adherence: ISO 13408-1:2008, ISO 13408-2:2018, ASTM F1980-21, ASTM D4169-22.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this product.

Ask a specific question about this device