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The OSTOM-i™ Alert is intended to be used as an accessory to any ostomy bag by monitoring the filling of the bag which information is sent via Bluetooth to a tablet computer to warn healthcare personnel when a patient's bag is close to being full. The Tablet computer automatically captures the data as to the volume and timing of output for each patient.

The OSTOM-i™ Alert is indicated for all patient populations.

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn patient when ostomy bag is close to being full. The sensor-based OSTOM-i™ Alert is intended to be used by the hospital environment.

The OSTOM-i™ Alert is indicated for all patient populations.

The sensor-based OSTOM-i™ Alert attaches to any ostomy bag and is able to send messages via Bluetooth to a mobile app to warn the health care provider when their patients' bags are close to being full, or to the patient in the post-hospital setting.

The flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag. This information is relayed to the tablet generating an additional report on bag status versus the visual one now available.

The provided document describes the Ostom-i™ Alert, an accessory for ostomy bags. The device monitors the filling of the bag and sends an alert via Bluetooth to a tablet computer when the bag is close to being full. The document focuses on demonstrating the device's substantial equivalence to a predicate device (Hollister, Inc.'s Two Piece Ostomy System, K813269) rather than presenting a traditional clinical study with acceptance criteria and statistical performance metrics for diagnostic accuracy.

Here's an attempt to extract and synthesize the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or provide specific diagnostic accuracy metrics (like sensitivity, specificity, accuracy) for the Ostom-i™ Alert. Instead, it focuses on qualitative performance and safety aspects as part of demonstrating substantial equivalence. The "performance" reported is primarily about its function and usability, not diagnostic accuracy against a ground truth.

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

The document does not specify a numerical sample size for the "test set" in the traditional sense of a diagnostic performance study.

• For the "Usability and Label Comprehension Study by Intended User," it mentions "nurses who would use this in a hospital setting" but does not give a number of participants.
• For "Patient Usability Testing," it refers to "Patients" but does not specify how many patients or simulations were involved.

The data provenance is not explicitly stated in terms of country of origin, nor is it clearly categorized as retrospective or prospective for a clinical study. The usability and performance testing described appear to be prospective tests conducted as part of the device development and submission process.

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

This information is not provided. Since the device's function is to alert based on physical fill rather than interpret complex imagery or physiological signals, the "ground truth" for the fill level would likely be objective (e.g., measured volume, physical observation of a full bag). The "experts" involved were primarily "nurses" for the usability study, but their role was to evaluate usability, not to establish ground truth for a diagnostic task.

4. Adjudication Method

No adjudication method is mentioned for establishing ground truth, as the studies described are not focused on diagnostic accuracy requiring expert consensus.

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

No MRMC study is mentioned. The document does not describe a study comparing human readers (with vs. without AI assistance) or quantifying an effect size of improvement. The device acts as a direct monitor and alert system, not an AI to assist human interpretation.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted, though it's not a "standalone algorithm performance" in the typical sense of a diagnostic AI. The "Performance Testing" section describes various tests (patient usability, environmental robustness, biocompatibility, EMC, wireless coexistence) that evaluate the device's function and safety independently. The device's core function is to detect and report bag fullness, which was tested by simulating an alert condition.

7. Type of Ground Truth Used

The ground truth implicitly used for the device's primary function (alerting when the bag is full) is physical observation/simulation of a full bag. This is supported by:

• "An alert was simulated by curving the bag to the filling of the bag thereby creating the alarm condition."
• The "flex sensor changes its resistance according to curvature and converts resistance into mls, thereby detecting the progressive filling of the bag."

For usability studies, the ground truth is subjective user feedback and observation of task completion.

8. Sample Size for the Training Set

This information is not applicable or provided. The Ostom-i™ Alert appears to be a sensor-based device that directly measures and converts physical changes (flex/curvature) to volume, rather than an "algorithm" in the machine learning sense that requires a training set of data.

9. How Ground Truth for the Training Set Was Established

This information is not applicable or provided, as there is no mention of a training set for a machine learning algorithm.

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