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The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations, but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable and a single-use Sensor Receptacle. The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The IPM contains an optical system that generates visible and near-infrared light signals that are sent through the optical sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the optical sensor cable from the patient's skin. Measured changes between the emitted and reflected signal are processed by ivWatch signal processing algorithms to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the peripheral IV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

Based on the provided FDA 510(k) summary for the ivWatch Model 400 (K222212), this submission primarily concerns a change in the sterilization method for the Sensor Receptacle component of the device. Therefore, the "study" proving the device meets acceptance criteria is specifically focused on demonstrating the equivalence of the new sterilization method to the previous one and showing that the device, with this new sterilization, still meets relevant standards for sterility and biocompatibility.

Here's an breakdown of the information requested, drawing from the provided text:

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

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 does not explicitly state the sample size for the sterilization validation test set. Sterilization validation typically involves a statistically determined number of units. However, it mentions "half-cycle overkill approach" which is a common method for EO sterilization validation, implying a robust testing protocol.

The data provenance is not specified beyond being generated for this 510(k) submission, likely from ivWatch, LLC (Newport News, Virginia, USA). The study is prospective in the sense that it was conducted for regulatory submission for a change to an existing device.

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

This type of submission (focused on sterilization) does not typically involve expert review for "ground truth" in the way a clinical study for diagnostic accuracy would. The "ground truth" here is the adherence to established international standards for sterilization and biocompatibility. The "experts" would be the metrology and microbiology professionals who conducted and validated the sterilization process and testing, though their specific number and qualifications are not detailed in this summary.

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

Adjudication methods like 2+1 or 3+1 are used in clinical image interpretation studies. This document concerns a physical device modification and sterilization validation, not diagnostic accuracy requiring human interpretation. Therefore, none is applicable in this context. The results are based on quantitative measurements against established chemical and biological limits.

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. An MRMC comparative effectiveness study is not relevant to this 510(k) submission. The ivWatch Model 400 is hardware with signal processing algorithms to detect infiltrations. It is an "adjunctive device" to clinical evaluation, not an AI intended to improve human interpretation of images or data in a comparative reading study. The submission focuses on the safety and performance of the device itself, particularly after a manufacturing change (sterilization method).

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

The ivWatch Model 400 functions as a standalone device in its detection capability. It continuously monitors tissue optical properties and autonomously signals an alert if an infiltration is detected. The "study" mentioned here is about the sterilization of a component, not the performance of its detection algorithm. However, the device's core functionality (the algorithm processing optical signals) is designed to operate autonomously to detect changes. The overall summary states: "Measured changes between the emitted and reflected signal are processed by ivWatch signal processing algorithms to determine if an infiltration event may have occurred." This implies standalone performance of the algorithm for detection. The current submission proves that this device, with a modified sterilization, maintains its performance.

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

For this particular 510(k) which is focused on sterilization, the "ground truth" is adherence to validated international standards for sterilization (ISO 14937:2009 for sterility assurance, ISO 10993-7:2008 for EO/ECH residuals). The acceptance criteria are scientifically established limits defined by these standards.

8. The sample size for the training set

This is not applicable. The ivWatch Model 400 is not described as an AI/ML device that requires a "training set" in the context of this 510(k) summary. While it uses "signal processing algorithms," these are likely deterministic or rule-based, or if they involve ML, the training data for the original algorithm would have been part of the predicate device's (K162478) submission, not detailed here for a sterilization change.

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

Not applicable, as this submission does not describe an AI/ML model that requires a training set. The "ground truth" for the device's functional performance (detection of infiltration) would have been established through clinical studies for the original device, likely involving induced infiltrations in human subjects or animal models, confirmed by visual inspection or other clinical signs. However, this information is not part of the provided 510(k) summary for this submission (K222212), which is focused on a change in manufacturing process for a component.

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