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The Bakri Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Postpartum Balloon is designed to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted. The Bakri Postpartum Balloon is an inflatable tamponade balloon designed and proven to be affective in reducing and controlling postpartum bleeding. The construction of the Bakri Postpartum Balloon is silicone rubber. Biocompatibility testing has shown the materials to meet the test requirements. Bench testing has proven the products durability during simulated use. The Bakri Postpartum Balloon is provided sterile in peel open pouches and is intended for one time use.

The provided text describes a 510(k) premarket notification for the Bakri Postpartum Balloon. The core of this submission is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested sections (2-9 relating to study details) are not explicitly present in the provided documentation, as a different regulatory pathway was taken.

Here's a breakdown of the information that can be extracted and an explanation for the missing elements based on the nature of a 510(k) submission based on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Performance Goal: The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device, specifically the SOS Bakri Tamponade Balloon Set (K013597).

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)

This information is not provided as this submission relies on demonstrating substantial equivalence to a predicate device, not on a clinical trial with a "test set" for performance evaluation in the way requested. The "testing, gathered data, and the history of the predicate device" refer to the existing data for the already cleared predicate.

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)

This information is not provided for the same reasons as above. No specific "test set" with expert-established ground truth was part of this 510(k) for the new device.

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

This information is not provided as no specific clinical "test set" requiring adjudication for ground truth was used in this 510(k) submission.

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 device is a manual obstetric-gynecologic instrument (balloon), not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.

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 or AI.

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

The "ground truth" for the current device's safety and effectiveness is primarily established through demonstration of substantial equivalence to an already legally marketed and cleared predicate device (SOS Bakri Tamponade Balloon Set K013597). This implies that the predicate device's safety and effectiveness (likely supported by historical data, clinical experience, and potentially older, pre-market clearance studies not detailed here) serves as the basis. The current submission highlights:

• "testing, gathered data, and the history of the predicate device... proves that the Bakri Postpartum Balloon is a safe and effective device."
• Biocompatibility testing results for the specific materials.
• Bench testing for durability.

8. The sample size for the training set

This information is not provided. As this is a 510(k) submission for a physical medical device based on substantial equivalence, there is no "training set" in the context of machine learning or AI.

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

This information is not provided. No "training set" in the context of machine learning or AI was used. The "ground truth" for the device's overall claims relies on its demonstrated equivalence to the predicate and the predicate's established track record.

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