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pH™-100 is intended to be used as a visual indicator for CO»/pHcontrol in the culture dish or incubator. It is not intended for the preparation or culture of cells.
For visual CO2/pH control. Not for culture.

pH™100 is a bicarbonate-buffered pH-indicator containing Phenol Red. It is used as a visual CO2/pH indicator in the culture dish or incubator. Readyto-use after equilibrium at +37 °C and 5% CO2. pH™-100 includes Penicillin-G as a preservative.

The provided document describes the pH™-100, a bicarbonate-buffered pH-indicator for visual CO2/pH control in culture dishes or incubators. The information focuses on its regulatory classification and equivalence to existing devices, rather than detailed performance studies with acceptance criteria in the context of typical AI/ML device evaluations.

Here's an analysis based on the provided text, addressing your questions to the best of my ability given the nature of the device and the document:

Device Type: This is not an AI/ML device. It's a chemical indicator used in assisted reproduction. Therefore, many of the questions regarding AI/ML specific studies (like MRMC studies, standalone algorithm performance, training set details) are not applicable. The "study" described is primarily about demonstrating its safety and long-standing use, not a performance study as would be conducted for a diagnostic device.

Acceptance Criteria and Device Performance

Given that this is a chemical indicator and not a diagnostic device with specific performance metrics like sensitivity or specificity, the "acceptance criteria" are implied by its intended use and chemical properties rather than quantitative thresholds for diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Mouse Embryo Assay: Not performed on pH™-100 because its composition is neither intended for nor compatible with embryo development (thus, not relevant for this safety aspect given its intended use). |
| Functionality (Intended Use) | Effectively functions as a visual CO2/pH indicator. | Clinical Experience (Historical): "pH™-100 has been used for CO2/pH control during culture for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use." |
| Technological Equivalence | Identical to other legally marketed media for its category. | "The technological characteristics of pH™-100 are identical to other legally marketed media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements." This implies that its chemical formulation and mechanism of action are consistent with established, safe, and effective indicators. |
| Sterility/Preservation | Contains preservative for stability (and potentially sterility). | "pH™-100 includes Penicillin-G as a preservative." (While specific criteria for preservative efficacy aren't stated, its inclusion is a characteristic relevant to product integrity). |

Study Details (as applicable to a non-AI/ML device)

2. Sample size used for the test set and the data provenance:

• LAL Assay: The document states that "each lot of pHTM-100 is assayed." This implies 100% inspection for manufactured lots. The "sample" here would be representative aliquots from each production batch. The provenance is internal manufacturing quality control.
• Clinical Experience: No specific "test set" sample size is mentioned for the clinical experience. The document refers to "many years at many different assisted reproduction facilities," which is a general statement about real-world usage and not a controlled study. This would be considered retrospective observational data gathered over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This concept is not applicable in the context of this device. The "ground truth" for the LAL assay is a quantitative measurement of endotoxin levels, interpreted against a standard. The "ground truth" for pH indication is the actual pH of the solution. The clinical experience relies on the judgment of the IVF facility staff over many years regarding the successful use of the indicator. There's no panel of experts adjudicating a "test set" in the way one would for diagnostic imaging.

4. Adjudication method for the test set:

• Not applicable. There is no "adjudication method" described for a test set in the traditional sense. Quality control (LAL assay) follows established laboratory protocols. Clinical effectiveness is based on the long-term, widespread acceptance and absence of reported issues in IVF settings.

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:

• No. This is not an AI device, so an MRMC study comparing human readers with and without AI assistance is entirely irrelevant.

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

• No. This is not an AI device, so there is no algorithm or standalone performance to evaluate. The device itself is a visual indicator that provides a direct, observable output.

7. The type of ground truth used:

• LAL Assay: The ground truth is objective quantitative measurement of endotoxin levels against defined thresholds (standards for bacterial endotoxins).
• Clinical Experience: The "ground truth" for effectiveness is established by the observed utility and absence of negative impact in real-world clinical use over many years, by practitioners in assisted reproduction facilities. This relies on real-world outcomes and expert consensus-in-practice over time regarding the indicator's performance.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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