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510(k) Data Aggregation
(80 days)
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
Dulbecco's Phosphate Buffered Saline Solution (PBS 1X) is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, PBS 1X is intended for use as a spermprocessing medium in washing procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo.
PBS 1X is a defined mixture of salts in a physiologic buffer designed to be used as an oocyte retrieval medium, for the short term "bench-top" maintenance of oocytes prior to manipulation, and for the transport of fertilized embryos during implantation procedures.
This document describes the acceptance criteria and the study for a medical device called "PBS 1X," a Dulbecco's Phosphate Buffered Saline Solution, designed for use in assisted reproductive technology (ART) procedures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional for intended use: Support of embryonic growth (as required by predicate device and 21 CFR 886.6180) | "PBS 1X is assayed by mouse embryo assay prior to its release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth..." |
| Absence of toxic components: (as required by predicate device and 21 CFR 886.6180) | "...and that no toxic components are present in the formulation." |
| Meets criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | "The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that PBS 1X is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
| Sterility (condition of release) | "Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing." |
| Endotoxin levels (condition of release) | "Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing." |
| Historical Clinical Performance as a "standard media" (implied acceptance based on historical use and predicate) | "PBS 1X has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become one of the standard media used for the retrieval, maintenance and transport of human gametes and embryos." (This point doesn't specify a numerical acceptance criterion but rather the device's established efficacy and safety in practice, which supports the claim of meeting general requirements for reproductive media.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mouse embryo assay test set or its provenance (e.g., country of origin). It mentions "mouse embryo assay" implying a biological test, but specific numbers are not provided. The phrase "PBS 1X has been used in a variety of clinical settings... for a number of years" suggests a retrospective review of real-world clinical usage, but no specific data or sample sizes from these clinical settings are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the mouse embryo assay. It states that "mouse embryo assay" is performed, implying a standard laboratory procedure, but does not detail the personnel involved in interpreting results or establishing the "truth" of embryonic growth or toxicity. For the historical clinical data, no experts are cited as establishing a ground truth for a discrete test set; rather, it refers to the product's long-term use and acceptance within the "professional literature."
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1) for the test set. The mouse embryo assay appears to be a laboratory test with outcome measures (embryonic growth, toxicity), rather than a subjective assessment requiring multi-reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned, nor is there any discussion of human reader improvement with or without AI assistance. This device is a biological solution, not an AI or imaging diagnostic tool that would typically involve an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. PBS 1X is a biological solution, not an algorithm, and therefore does not have a standalone algorithm-only performance to assess.
7. The Type of Ground Truth Used
The primary ground truth for the device's performance relies on:
- Biological Outcome Data: The "mouse embryo assay" directly assesses the product's ability to support embryonic growth and the absence of toxic components.
- Regulatory Compliance: Meeting the criteria outlined in the "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335" serves as a regulatory ground truth.
- Historical Clinical Acceptance: The fact that it "has become one of the standard media used" and has been used in "a variety of clinical settings, for its intended use, for a number of years" implies a form of "community consensus" or established clinical efficacy and safety as a ground truth.
8. The Sample Size for the Training Set
This question is not applicable because PBS 1X is a biological product and not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above; there is no training set for this type of device.
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