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The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition.

Origin™ is an inline biosensor system that is integrated between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics. Origin™ system continuously monitors the pH of wound drainage. Origin™ App is a mobile application for displaying and analyzing data from the Origin™ inline device. Origin™ App is pre-installed on an Android mobile device supplied by FluidAI. The Origin™ inline device connects to Origin™ App via Bluetooth.

The provided FDA 510(k) clearance letter and summary document for the Origin™ system primarily focus on the non-clinical performance of the device, particularly its analytical performance in measuring pH. It does not describe a study involving human readers or multi-reader multi-case (MRMC) comparative effectiveness. Therefore, some of the requested information, particularly related to clinical studies, human expert involvement in ground truth establishment for a test set, and MRMC studies, is not present in the provided text.

However, based on the analytical performance studies described, we can extract the following information:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through the results presented. The "Overall" pH range for linearity, for example, is 0.1446 pH units from 5 to 9, and 0.1 pH units from 4-10 using buffer solutions. For precision, the "Within-Laboratory" precision (total) is 0.0922 SD (1.46% CV) for sample A (pH ~6.3) and 0.1650 SD (2.10% CV) for sample B (pH ~7.85).

Since the document presents the results of studies conducted to demonstrate that the device meets some internal performance goals, we can infer that the reported values met their pre-specified acceptance criteria for analytical performance. However, the specific numerical acceptance thresholds (e.g., "Max Deviation from Linearity must be <= X") are not explicitly stated as separate criteria but are implied by the reported results indicating successful testing.

Table of Acceptance Criteria (Implied by Reported Performance) and Reported Device Performance

Note: The acceptance criteria are "implied" because the document states "Performance testing demonstrates equivalence" and presents these results. It is assumed that these reported values either met or fell within the pre-defined acceptance limits set by the manufacturer for non-clinical analytical performance. The document doesn't explicitly state the thresholds for acceptance, but rather the results that were found acceptable for clearance.

Study Proof of Device Meeting Acceptance Criteria (Non-Clinical Analytical Performance)

The device demonstrates it meets its non-clinical analytical requirements through several studies:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Precision Study:

  • Sample Size: 16 devices x 5 days x 3 runs x 12 replicates = 2880 measurements (total for each pH level, so 5760 samples for both pH levels combined).
  • Data Provenance: Single site study, using buffered and spiked donor human peritoneal drainage fluid. Origin of fluid (e.g., country) is not specified, nor is whether it's retrospective or prospective collection (though likely prospective for a controlled lab study).

• Linearity Study (Peritoneal Drain Fluid):

  • Sample Size: Not explicitly stated as a single number, but mentions "peritoneal drain fluid samples collected in the Method Comparison study".
  • Data Provenance: Donor human peritoneal drain fluid samples. Origin not specified.

• Linearity Study (NIST Traceable pH Buffer Solutions):

  • Sample Size: Not explicitly stated.
  • Data Provenance: NIST traceable pH buffer solutions.

• Interference Study:

  • Sample Size: 2 pH levels x 16 paired observations per pH level = 32 paired observations per interferent. Number of interferents is 16. Total observations are 32 * 16 = 512.
  • Data Provenance: Simulated peritoneal fluids.

• Comparison Studies (Method Comparison):

  • Sample Size: 60 donor human peritoneal drain fluid samples.
  • Data Provenance: Donor human peritoneal drain fluid samples by a "glass pH probe" as the comparator. Origin not specified.

All these studies appear to be retrospective lab-based analytical studies on collected samples rather than prospective human clinical trials.

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

• This information is not applicable/not provided in the context of the described non-clinical analytical performance studies. The "ground truth" for pH measurements in these studies was established by:
  • Known concentrations of buffered solutions.
  • Measurements from a reference method (e.g., "glass pH probe" as a comparator in the method comparison study).
  • Spiked samples with known concentrations of interferents.
  • For the linearity study using NIST traceable pH buffer solutions, the NIST standard itself serves as the ground truth.

4. Adjudication Method for the Test Set:

• This information is not applicable/not provided. Adjudication by human experts is typically performed in clinical studies involving interpretation (e.g., imaging diagnostics). For analytical performance, the ground truth is established by the reference method or known properties of the samples, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. The provided document describes non-clinical analytical performance studies, not studies involving human readers or comparative effectiveness with or without AI assistance. The device is a "blood gases (PCO2, PO2) and blood pH test system" that measures pH, not an AI-based diagnostic tool for interpretation.

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

• Yes, in essence, the described "Analytical Performance" studies evaluate the device's standalone performance. The Origin™ system (device and app) independently measures pH. The precision, linearity, interference, and method comparison studies assess its direct measurement capabilities without human interpretation or intervention in the measurement process itself, beyond standard laboratory handling. It's a continuous pH monitoring device, and its accuracy is evaluated against known values or reference methods.

7. The Type of Ground Truth Used:

• Analytical/Reference Ground Truth:
  • For precision and linearity studies using buffered solutions: Known pH values of the buffers, or measurements by a calibrated reference instrument (like the "glass pH probe" mentioned).
  • For linearity using NIST traceable pH buffer solutions: The certified pH values of the NIST traceable buffers.
  • For interference study: Known concentrations of spiked interferents in simulated peritoneal fluids.
  • For method comparison: Measurements obtained from a "glass pH probe" on donor human peritoneal drain fluid samples served as the comparator/reference.

8. The Sample Size for the Training Set:

• The document does not explicitly describe a "training set" in the context of machine learning or deep learning models for an AI device. The Origin™ system measures pH using a "potentiometric measurement pH" principle with an "Ion-sensitive field-effect transistor (ISFET) electrode". This suggests a sensor-based measurement rather than a machine learning algorithm that requires a "training set" in the typical sense.
• The closest concept would be the data used for the internal development and calibration of the device's measurement algorithm, but this is not detailed in terms of a specific "training set size" in this submission.

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

• As above, the concept of a "training set" ground truth is not applicable to the type of device described. The device is a direct pH measurement system, not an AI-interpretive device trained on labeled data. Its "ground truth" for functionality and calibration during development would be established through standard analytical chemistry principles, using reference buffers and comparison to established methods or instruments.

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