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The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments.

The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

The G210 InviCell Plus with SignipHy™ pH Monitoring System is an assisted reproduction incubator that includes an accessory pH monitoring feature. The incubator component of this device (G210 Invicell) is regulated under 21 CFR 884.6120, product code PBH (exempt). The incubator includes 10 incubation chambers and one larger preparation chamber that is used for the equilibration of plates/oil before use. The tri-gas incubator provides a controlled environment (temperature, CO2/O2/N2) for gametes and embryos in the incubation chambers.

The pH monitoring feature of the G210 InviCell Plus with SignipHy™ pH Monitoring System is controlled separately and does not impact the operation or incubator functions of the device. The SignipHy™ pH Monitoring System consists of the following components:

• . SignipHy™ TrakPod – An LED-based, optical pH measurement instrument. The SignipHy TrakPod is physically supported within the chassis of the incubator and allows monitoring of one incubator chamber. It is a USB connected fluorescent measurement device with a fiber optic cable and fixture that connects to the SignipHy sv2 Sensor inside an incubator chamber. The SignipHy TrakPod and SignipHy sv² Sensor together detect the pH of a liquid sample.
• . SignipHy™ sv2 Sensor – The SignipHy sv2 Sensor is a single-use, polystyrene, ethylene oxide sterilized vessel that is loaded with a sample of bicarbonate-buffered assisted reproduction technology (ART) media with a pH between 6.8 and 7.2 for pH tracking. The bottom of the sensor includes a membrane that is impregnated with a dye that is affected by the pH of the media sample. The sensor fits into the SignipHy TrakPod fiber optic fixture located in an incubation chamber. SignipHy sv2 Sensors can be used for measuring pH at one-minute intervals for three days or 30-minute intervals for seven days.
• . SignipHy™TrakStation – A tablet computer running proprietary software that initiates pH readings, displays results, and stores pH measurement data over time. Up to eight SignipHy TrakPods can be connected to a single SignipHy TrakStation.
• SignipHy™ qc² Alignment Tool - A fluorescent reference device for use in system alignment and quality control.

To make a pH measurement, the SignipHy TrakPod sends green light flashes (peak 518 nm) through the fiber optic fixture. The dye in the membrane reacts by sending back flashes of light at a different wavelength (peak 600 nm). The SignipHy TrakPod reads this result and calculates the pH of the media sample that is then displayed on and stored in the SignipHy™TrakStation.

Here's a breakdown of the acceptance criteria and the studies performed for the G210 InviCell Plus with SignipHy™ pH Monitoring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific quantitative values for "all specifications" for pH monitoring, or the exact numerical results for linearity, stability, precision, accuracy, and interfering substances, are not detailed in the provided text. The document states they "met all specifications."

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

The document does not explicitly state the sample sizes used for the test sets in the "Non-Clinical Performance Testing" section. It describes the types of tests conducted:

• Shelf-Life of SignipHy™ sv2 Sensors: Tested "real-time aged samples after shipping/distribution." The number of samples is not specified.
• Mouse Embryo Assay (MEA): Tested under "worst-case conditions (samples taken every minute for 96h)." The number of embryo samples is not specified.
• pH Monitoring Validation Testing: Tested various parameters, but the number of samples for each is not provided.

The data provenance is not explicitly mentioned (e.g., country of origin). Based on the context of an FDA submission for a US company (CooperSurgical Inc., Trumbull, CT), it is highly likely the studies were conducted in the US or in compliance with US regulatory standards. The studies appear to be prospective in nature, as they involve testing the device's performance under specified conditions.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the specific performance tests mentioned.

• In the Shelf-Life of SignipHy™ sv2 Sensors performance testing, the ground truth for pH measurement was established by comparison to a "gold standard (blood gas analyzer)." This implies the use of a validated, established method as the reference truth, rather than expert consensus on subjective interpretation.
• For the Mouse Embryo Assay (MEA), the acceptance specification uses a clear biological endpoint ("≥90% blastocysts at 96h"), which would be objectively assessed rather than requiring expert consensus to establish ground truth for each case.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods (e.g., 2+1, 3+1) for the test sets. The tests performed are objective performance measurements against established standards or gold standards (like a blood gas analyzer), which typically do not involve subjective expert adjudication.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is an incubator with a pH monitoring system, not an imaging or diagnostic device that requires human interpretation of outputs. Therefore, a study comparing human readers with and without AI assistance is not applicable to this device.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance studies were done for the pH monitoring system. The "pH Monitoring Validation Testing" directly assesses the device's ability to measure pH against specifications for linearity, stability, precision, accuracy, and interfering substances, without human intervention in the pH measurement process itself. Similarly, the "Shelf-Life" testing on the SignipHy™ sv2 Sensor performance compared subject device pH measurements to a "gold standard (blood gas analyzer)." The MEA also assessed the device's impact directly.

7. Type of Ground Truth Used

The ground truth methods used in the performance studies include:

• Comparison to a Gold Standard: For pH measurement accuracy and performance at end of shelf-life, the device's pH measurements were compared to a "gold standard (blood gas analyzer)."
• Objective Biological Endpoint: For the Mouse Embryo Assay (MEA), the ground truth was the objective biological outcome of embryo development ("≥90% blastocysts at 96h").
• Established Industry Standards and Specifications: Many tests adhere to ISO, AAMI, ASTM, and IEC standards, where the ground truth is compliance with the defined parameters and limits of those standards (e.g., seal strength, electrical safety, EMC).

8. Sample Size for the Training Set

The document does not provide details on the sample size for any training set. The device appears to be a hardware-based system with proprietary software for measurement and display, rather than a machine learning/AI diagnostic system that typically requires large training datasets. The software documentation mentioned (minor level of concern) also suggests it's not primarily a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Since no training set details are provided or implied for a learning algorithm, there is no information on how its ground truth might have been established. The documented testing focuses on validating the device's physical and functional performance against established benchmarks and specifications.

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