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The ELLAVI UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The ELLAVI UBT is an 18 cm long intrauterine balloon tamponade device primarily comprised of thermoplastic elastomer. The balloon and internal tubing are made of thermoplastic elastomer, while the exterior tubing is made of polyvinyl chloride. A supply bag is the filled, connected, and hung at a pre-determined height based on the patient's systolic blood pressure. The device consists of a balloon that is inserted into the uterus transvaginally into the postpartum uterus after delivery and removal of the placenta. A valve is then opened, and this allows the fluid to inflate the balloon and apply pressure to achieve a hemostatic effect.

The ELLAVI UBT device, intended for temporary control or reduction of postpartum uterine bleeding, underwent a series of non-clinical performance tests to demonstrate substantial equivalence to its predicate device, the Bakri Postpartum Balloon. The provided documentation primarily focuses on mechanical, biocompatibility, sterilization, and shelf-life testing. No clinical study data is provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document details non-clinical performance data (mechanical, biocompatibility, sterilization, and shelf-life testing). It does not describe a "test set" in the context of clinical or image-based studies with human subjects. Therefore, information about sample size, country of origin, or retrospective/prospective nature of such a test set is not applicable from this document. The tests performed are laboratory-based evaluations of the device's physical and material properties.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document describes non-clinical engineering and material science tests. "Ground truth" in the context of expert consensus for clinical diagnosis is not relevant to these types of tests.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical or diagnostic performance that would require an adjudication method. The reported performance is based on direct measurements and observations from laboratory testing.

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

No MRMC comparative effectiveness study was mentioned or conducted, as this documentation pertains to non-clinical testing for substantial equivalence of a medical device.

6. Standalone Performance Study

The documented studies are standalone in the sense that they evaluate the device itself (its mechanical properties, biocompatibility, etc.) without human interaction as part of the performance evaluation. However, this is not a "standalone performance" in the context of algorithm-only performance for a diagnostic device, as the ELLAVI UBT is a physical medical instrument.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described is based on engineering specifications, material science standards, and established laboratory testing protocols. For instance:

• Mechanical Testing: Physical measurements against design specifications, established parameters (e.g., pressure ranges, fill volumes, time limits).
• Biocompatibility Testing: Compliance with ISO 10993 series standards, where reactivity or toxicity is evaluated against established biological models.
• Sterilization and Shelf-Life: Compliance with ISO 11135 and ASTM standards for sterility assurance levels, aging profiles, and package integrity.

8. Sample Size for the Training Set

Not applicable. The ELLAVI UBT is a physical medical device. It does not involve machine learning algorithms or a "training set" in the context of artificial intelligence.

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

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

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