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The ESM-UBT device is intended to provide temporary control of postpartum uterine bleeding when conservative management is warranted.

The Every Second Matters - Uterine Balloon Tamponade ("ESM-UBT") device is a single use product that consists of the kitting of 510(k)-cleared or off-the-shelf ("OTS") class I exempt components. The kit also contains an antiseptic prep pad that is marketed under an OTC monograph and is intended for use as an accessory with and during the assembly of the class I medical device components of the ESM-UBT device:

• Urinary catheter
• Luer lock valve
• Condom
• Syringe
• Elastic O-ring
• Catheter holder
• Antiseptic (povidone iodine) prep pad

The components will not be modified from their packaged state, and the entire kit will be re-labeled as the ESM-UBT device. The device is assembled in an ISO certified clean room using the Foley urinary catheter, Luer lock valve, condom, and a green elastic O-ring. The assembled condom-catheter is inserted into the bleeding uterus through the cervical opening. Upon placement within the uterine cavity, the balloon on the Foley catheter is inflated first with 15 mL of saline. This small balloon helps secure the catheter inside the uterus. One port on the Foley catheter is used for the syringe to inject saline into the small balloon, whereas the other port is used to inflate the condom balloon with saline. This condom balloon should be inflated until tamponade occurs as evidenced by bleeding cessation. The maximum fill volume of 500 mL was verified in bench tests. The device should be fixed to the thigh at the end using the catheter holder.

The provided text is a 510(k) summary for the Every Second Matters-Uterine Balloon Tamponade ("ESM-UBT") device. It describes the device, its intended use, and comparative information with a predicate device. However, it does not explicitly define acceptance criteria in a quantitative manner as typically expected for device performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and positive clinical outcomes from peer-reviewed publications.

Here's an analysis based on the provided information, addressing your questions as best as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria are not presented in a traditional tabular format within this document. The device performance is largely established through a combination of non-clinical (mechanical, biocompatibility) testing and clinical evidence from publications demonstrating safety and effectiveness compared to the predicate and in the intended population.

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

The document references "peer-reviewed publications" for clinical data.

• Sample Size: Over 900 devices have been used based on the collective data from these publications.
• Data Provenance: Retrospective, derived from devices used in India, Tanzania, Kenya, Senegal, Sierra Leone, and Nepal. This suggests a multi-national and real-world setting.

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

The document states: "Ujenzi assessed the severity, expectedness, and relatedness of each reported death and provided this information to an independent committee for review."

• Number of Experts: An "independent committee" was used. The exact number of experts in this committee is not specified.
• Qualifications of Experts: Not explicitly stated beyond being an "independent committee."

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

For reported deaths, the adjudication involved an "independent committee for review." The specific adjudication method (e.g., how disagreements were resolved) is not detailed. For the broader clinical effectiveness, the peer-reviewed nature of the publications implies some level of expert review, but a formal adjudication method for a test set (like for a diagnostic device) is not described because this is a therapeutic device.

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 was not done. This device is a physical therapeutic device (uterine balloon tamponade), not an AI-assisted diagnostic or imaging device that would typically involve "human readers" or AI assistance in that context. The "effect size" mentioned would be irrelevant here.

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

• No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm or AI program.

7. The Type of Ground Truth Used

For the clinical data, the ground truth was outcomes data (survival rates, complication rates, bleeding cessation) observed in real-world clinical practice, as reported in peer-reviewed publications. The severity and relatedness of deaths were also adjudicated by an independent committee.

8. The Sample Size for the Training Set

No specific "training set" is mentioned as this device is a physical medical device, not a machine learning algorithm. The clinical data cited from "over 900 devices" used across multiple countries served as supporting evidence for its safety and effectiveness.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The clinical evidence was gathered from real-world usage and documented in peer-reviewed publications.

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