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PBS(-), Phosphate Buffered Saline is intended for use in assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include oocyte retrieval from ex vivo ovarian tissues, short term oocyte maintenance, and handling of fertilized embryos prior to embryo transfer.

Phosphate Buffered Saline [PBS(-)] is a colorless isotonic buffered solution with a pH of 7.20-7.60.
PBS(-) composition:

• Sodium Chloride
• · Potassium Chloride
• Monopotassium phosphate
• Di-sodium Hydrogen Phosphate Anhydrous
  PBS(-) will be available in volumes of 100mL and 500mL. Packaging for PBS(-) consist of a PETG (Polyethylene Terephtalate Glycol-modified) bottle and HDPE (High Density Polyethylene) cap. PBS(-) has a six-month shelf-life.

This document is a 510(k) premarket notification for a reproductive media called "PBS(-), Phosphate Buffered Saline" by KITAZATO BioPharma Co., Ltd. It outlines the device's description, indications for use, and a comparison to a predicate device, along with performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Note: The document explicitly states "Non-clinical performance testing demonstrated that all product specifications were met" and "Shelf-life testing demonstrated that PBS(-) maintained all specifications at the end of the six-month shelf-life period." While specific numerical performance results matching the specifications exactly aren't provided in the table, the text confirms that the device met these criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical performance testing of a reproductive media. This type of testing typically does not involve human patient data or test sets in the same way a diagnostic or therapeutic device would.

• Sample size for the test set: Not explicitly stated for each assay, but implies sufficient samples were tested to demonstrate compliance with each specification. For cell-based assays like the 1-cell MEA, this typically involves a certain number of embryos/replicates.
• Data provenance: The testing was conducted by KITAZATO BioPharma Co., Ltd. which is located in Japan. The data is non-clinical, meaning it's laboratory-based testing of the product itself, not human clinical data. It would be considered prospective testing of manufactured batches of the product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device and study. The "ground truth" for reproductive media is established by validated laboratory analytical methods and biological assays (like the 1-cell Mouse Embryo Assay - MEA), not by human expert consensus or interpretation of images. The specifications themselves serve as the 'truth' criteria which the product must meet.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies where human interpretation or subjective assessment of outcomes is involved, especially when there are discrepancies between multiple readers. For laboratory-based performance testing of a solution like PBS, the results are typically quantitative and objective measurements from validated equipment and procedures.

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

This question is not applicable. This document describes the performance testing of a phosphate-buffered saline solution for assisted reproductive procedures. There is no mention of AI, human readers, or multi-reader multi-case studies. These types of studies are relevant for diagnostic image analysis devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This device is a consumable solution, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here. The performance described is the intrinsic physical, chemical, and biological performance of the solution itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance testing is established by:

• Analytical Specifications: Defined ranges for pH, osmolality, endotoxin levels, and qualitative characteristics like color and particle-freeness. These are objective, measurable product characteristics.
• Biological Assay Results: The 1-cell MEA (Mouse Embryo Assay) result of "≥80% developed to blastocyst at 96 hrs." This is a pass/fail biological performance criterion demonstrating the media's ability to support embryo development, which serves as a functional 'truth' about its suitability for its intended purpose.

8. The sample size for the training set

This question is not applicable. This device is a chemical solution, not an AI/ML algorithm that requires a "training set." The performance data presented refers to testing of the product batches.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

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