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The ebb Complete Tamponade System is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The ebb Complete Tamponade System should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

The ebb Complete Tamponade System is a disposable, multiple lumen catheter attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The device consists of two inflatable balloons: The upper uterine balloon is inflated inside the uterus and the lower vaginal balloon is inflated inside the vagina. Inflation is accomplished with isotonic intravenous fluid such as normal saline or Ringers Lactate. The uterine balloon catheter has separate lumens to enable inflation/deflation, irrigation and drainage. The vaginal balloon catheter has a lumen to enable inflation/deflation. The uterine and vaginal balloons are permanently assembled and are not to be separated. The device may be retained in position for up to 24 hours in the post-operative mode of treatment. The ebb Complete Tamponade System is supplied sterile in peel open pouches for one time use to a single patient.

This document describes a Special 510(k) notice for a modified medical device, the ebb Complete Tamponade System. It's a re-submission for a device that already has a predicate (K150573). The modification is specifically the addition of a UV Band around the proximal and distal ends of the vaginal and uterine balloons.

The information provided focuses on demonstrating that the modified device is substantially equivalent to its predicate, meaning the changes do not introduce new questions of safety or effectiveness. As such, the study described is a performance test to validate the modification, not a clinical trial to establish initial efficacy or performance against a broader set of acceptance criteria in a clinical setting.

Therefore, many of your requested points regarding clinical study design, ground truth, expert opinions, and comparative effectiveness are not applicable to this type of submission. The document primarily reports on bench testing to ensure the modified component maintains or improves strength.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance

• Sample size: Not explicitly stated. The document mentions "the modified devices" and "none of the modified devices failed," implying multiple units were tested.
• Data provenance: Bench testing (laboratory environment), not country of origin of clinical data or retrospective/prospective human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. This was a bench test focused on the mechanical strength of the device, not a diagnostic or treatment device requiring expert clinical ground truth. The "ground truth" was the physical performance of the device under stress.

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

Not Applicable. As this was a bench test, there was no clinical adjudication process involving human reviewers. Performance was measured by defined physical parameters (e.g., failure under stress).

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

Not Applicable. This is not an AI-assisted diagnostic or therapeutic device requiring human reader improvement studies. It is a physical medical device.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this performance study was determined by physical stress testing where the operational limits and failure points of the device were observed and measured under controlled laboratory conditions, particularly focusing on cyclic physiologic pressures.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not a machine learning/AI device.

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

Not Applicable. There is no "training set" as this is not a machine learning/AI device.

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The ebb Complete Tamponade System is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The ebb Complete Tamponade System should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

Both devices are disposable, multiple lumen catheters attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The devices consist of two inflatable balloons: The upper uterine balloon is inflated inside the uterus and the lower vaginal balloon is inflated inside the vagina. Inflation is accomplished with isotonic intravenous fluid such as normal saline or Ringers Lactate. The uterine balloon catheter has separate lumens to enable inflation/deflation, irrigation and drainage. The vaginal balloon catheter has a lumen to enable inflation. The uterine and vaginal balloons are permanently assembled and are not to be separated. The devices may be retained in position for up to 24 hours in the post-operative mode of treatment, and are supplied sterile in peel open pouches for one time use to a single patient. There are no differences in the material, chemical composition or energy source of the subject and predicate devices. The change in design of the subject device is limited to the modification to the bond of the distal end of the uterine balloon from a heat bond to a UV bond, to increase the bond strength.

This document, a 510(k) summary for the ebb Complete Tamponade System, describes modifications made to a previously cleared device (K091958 Belfort-Dildy Obstetric Tamponade System). The key modification is changing the bond at the distal end of the uterine balloon from a heat bond to a UV bond to minimize potential leaks and increase bond strength.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document mentions "none of the modified devices failed" and "we subjected the modified devices," implying a test set was used, but the exact number of devices tested is not provided.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer, Clinical Innovations, LLC, to support the device modification. There's no indication of clinical data or patient data being used for this specific performance testing.

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

• Not Applicable. This study is focused on the mechanical performance of the device (bond strength, leakage under pressure) rather than diagnostic accuracy or clinical outcomes that would require expert-established ground truth. The "ground truth" here is the physical failure or non-failure of the device under specific test conditions.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a mechanical performance study, there's no "adjudication method" in the typical sense of expert review for medical imaging or clinical diagnosis. The outcome (failure/non-failure) is objectively measurable based on the test protocol.

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

• No. This is a mechanical performance study of a physical medical device (uterine tamponade system), not a diagnostic algorithm or imaging system that would typically involve an MRMC study.

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

• Not Applicable. This device is a physical medical device, not an algorithm. Therefore, the concept of "standalone algorithm performance" does not apply. The performance described is the standalone function of the device itself.

7. The Type of Ground Truth Used:

• Engineering/Mechanical Performance Data: The "ground truth" for this study is derived from controlled laboratory testing measuring physical properties such as bond strength and resistance to leakage under pressure. This is objective experimental data rather than expert consensus, pathology, or outcomes data typically associated with diagnostic device ground truth.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning study that would involve a "training set." The testing performed is to verify a physical modification to a medical device.

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

• Not Applicable. There is no training set involved in this mechanical performance study.

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