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

The Bakri Essential Postpartum Balloon is composed of a double lumen silicone balloon catheter and a stopcock. The balloon catheter has a balloon with maximum inflation volume of 500 mL and a 24 Fr silicone shaft with an overall length of 58 cm, which includes the working length of 54 cm and proximal fittings. The shaft has two lumens, one designated for drainage, and the other for balloon inflation. The Bakri Essential is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The Bakri Essential Postpartum Balloon is packaged in a Tyvek®Polyethylene Peel-Open Pouch with five individually packaged and labeled products per marketing carton, is provided sterile, and is intended for one time use.

This document is a 510(k) premarket notification for the Bakri Essential Postpartum Balloon, a medical device. It does not describe a study involving an AI/ML device, therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific aspects cannot be extracted.

The document discusses the substantial equivalence of the Bakri Essential Postpartum Balloon to a predicate device (Bakri Postpartum Balloon, K170622). It focuses on non-clinical performance testing related to packaging modifications and the removal of a syringe from the product set, not on a study proving a device's performance against specific clinical acceptance criteria in the context of an AI/ML system.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance (in the context of an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size with AI assistance.
6. Whether standalone performance was done for an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The "Summary of Non-clinical Performance Testing" section details tests performed for the physical device's packaging and sterilization integrity, with specific acceptance criteria for those tests:

• Pouch Seal Strength Testing: Minimum seal strength shall meet or exceed 1.2N per 15mm when tested in accordance with ASTM F88-15.
• Bubble Leak Testing: Packaging shows no signs of cracks, pinholes, or imperfect seals indicated by bubbles, per ASTM F2096-11.
• Dye Penetration Testing: No packaging seal may be breached by dye per F1929-15.
• Additional distribution testing followed by functional verification: Device shows no signs of damage after sterilization and simulation distribution.

These criteria and tests relate to the physical integrity and sterility of the packaged device, not a performance study of a diagnostic or therapeutic AI/ML algorithm.

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