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Intended Use: DoubleCHEK is intended to indicate whether the tip of a naso/oro gastric tube tip is in an acidic or CO2 environment during or after initial placement. The DoubleCHEK is NOT intended to confirm the location of the naso/oro gastric tube.

Indications for Use: The DoubleCHEK is indicated for use with an in-situ naso/oro gatric tube. It is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment during or after initial placement. It is NOT intended to confirm the location of the naso/oro gastric tube. The device is intended to be used by Health Care Professionals on all patients within a health care setting. The device is intended to be used with a single patient for up to 24 hours.

The proposed device, DoubleCHEK DC-1001 is a hand-held, non-powered disposable device which consists of CO2 and pH chambers ultrasonically welded to the device upper (top) and the reservoir interface. pH and CO2 indicator papers are integrated into the design directly underneath the top so they are visible to the users next to the primary device label which contains the color scale.

There are three ports where accessories are intended to the device to enable use:

• The Syringe Port: A male ENFit connector designed per ISO 80369-3:2016.
• The NG Tube (NGT) Port: A female ENFit connector designed per ISO 80369-3:2016.
• The Reservoir Interface: A 22 mm bung style connector.

To use the proposed device, the user attaches the reservoir to the reservoir interface, the naso/orogastric tube to the NGT Port and the syringe to the Syringe Port. The user then pumps the syringe (withdraws the plunger) to aspirate either liquid (stomach contents) or gas (exhalation gas). The gaseous aspirate will traverse the sample pathway to the CO2 indicator paper, where the presence or absence of CO2 can be detected via a color change in the paper. The liquid aspirate will traverse through the sample pathway to the pH paper, which will indicate pH level via a color change in the paper.

The provided text describes the 510(k) premarket notification for the DoubleCHEK DC-1001 device, which is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not provide a formal table of acceptance criteria with specific numerical targets for performance metrics (e.g., sensitivity, specificity, accuracy) for the pH and CO2 indicators. Instead, it states that "non-clinical performance testing was conducted to demonstrate that the proposed device, the DoubleCHEK DC-1001, is substantially equivalent to the predicate device and is safe and effective for its intended use."

The performance tests conducted were primarily focused on demonstrating the device's functional capabilities and adherence to existing standards, rather than clinical efficacy against a gold standard.

Here's a summary of the non-clinical performance tests mentioned:

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

The document explicitly states: "Clinical performance testing was not required to demonstrate the performance of the DoubleCHEK DC-1001."

Therefore, there is no clinical test set, sample size for a test set, or data provenance from patient studies to report. The evaluation was based entirely on non-clinical (laboratory/bench) testing.

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)

Since no clinical performance testing was conducted, there were no patient-derived ground truth determinations by medical experts. The performance was assessed against defined physical and chemical parameters in a laboratory setting.

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

Not applicable, as no clinical test set using human subjects was utilized for performance evaluation.

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

Not applicable. The DoubleCHEK DC-1001 is a diagnostic device that provides an indication (color change for pH and CO2 presence); it is not an AI-assisted diagnostic tool that aids human readers in interpreting complex medical images.

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

This refers to the device's inherent physical and chemical detection capabilities. The "standalone" performance was effectively evaluated through the non-clinical tests described in point 1 (e.g., pH and CO2 indicator imprecision and bias studies). The device's function is to show a color change, and the accuracy of that color change in response to specific pH or CO2 levels was the subject of these non-clinical tests.

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

For the non-clinical tests, the "ground truth" was established by controlled laboratory conditions and known chemical/physical parameters. For example:

• For pH indication, the ground truth would be solutions with known pH values.
• For CO2 indication, the ground truth would be gas mixtures with known CO2 concentrations.
• For mechanical tests (e.g., leakage), the ground truth is the engineering specification for what constitutes a pass/fail.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model that requires a "training set." Its function is based on chemical indicators and mechanical design.

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

Not applicable, as there is no training set for this type of device.

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