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

Bakri® Postpartum Balloon with Rapid Instillation Components is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

The proposed devices are offered in two configurations, the Bakri Postpartum Balloon (henceforth referred to as Bakri) consisting of a double lumen silicone balloon catheter, a stopcock, and a 60 mL Luer-tip syringe and the Bakri Postpartum Balloon with Rapid Instillation Components (henceforth referred to as Bakri RI) configuration which additionally includes a dual check valve and polymer tubing. The tubing is fitted with a Luer lock-type connector to the dual check valve and a non-vented bag spike with a vented cap that connects to a saline bag (not included in the device).

The balloon catheter common to both configurations is designed as a dual lumen silicone shaft with 500 mL balloon. The proximal end of the catheter has a lighthouse adaptor designed to accept a drainage bag connector and a side arm which is fitted with a Luer Lock-type adaptor to which a stopcock is attached and subsequently a Luer tip syringe or a dual check valve can be connected. The distal end of the catheter has two sideports spaced 180° opposite of each other, and the tip is rounded to a smooth finish. The polymer tubing of the Bakri RI rapid instillation components is 180 cm in length. Both the Bakri and the Bakri RI is supplied sterile and intended for one time use.

This document describes the Cook Incorporated Bakri® Postpartum Balloon and Bakri® Postpartum Balloon with Rapid Instillation Components (K170622). It is a medical device intended to provide temporary control or reduction of postpartum uterine bleeding.

Here's an analysis of the provided text with respect to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document refers to a series of tests conducted to demonstrate that modifications to the balloon catheter and the addition of rapid instillation components met "applicable design and performance requirements to support a determination of substantial equivalence" to a predicate device (K062438). The document lists several specific laboratory and engineering tests (Inflated Balloon Reliability, Dimensional Evaluation, Integrity, Tensile Test of the Distal Tip, Sideport Drainage and Deflation Reliability, Radial Pressure, Balloon Inflation Testing, Simulated Use and Leak Test, Tensile Testing).

However, the provided text does not include detailed results for each test against the acceptance criteria. It broadly states that the tests were performed and the results support a determination of substantial equivalence. It does not quantify the specific performance values achieved for each test, such as the exact drainage time or the specific load withstood during tensile testing.

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

• Sample size for the test set: Not explicitly stated in the provided text for any of the performance tests.
• Data provenance: Not explicitly stated (e.g., country of origin). The tests are described as "Test Data" conducted by Cook Incorporated, implying in-house testing. The nature of these tests (e.g., mechanical, simulated use) suggests they are laboratory-based rather than involving patient data.
• Retrospective or prospective: These are laboratory/engineering tests, not clinical studies involving patients, so the terms "retrospective" or "prospective" do not directly apply in a clinical data sense. They are likely prospective tests conducted on manufactured device samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the type of tests described. The "ground truth" here is the physical and mechanical properties of the device, measured against engineering specifications and performance requirements, not diagnostic interpretations requiring expert consensus.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or similar expert-driven evaluations. The tests described are objective, quantifiable engineering and performance tests.

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:

This information is not applicable. An MRMC study is for evaluating diagnostic devices, typically involving human readers interpreting images, often with and without AI assistance. This document describes a physical medical device (a postpartum balloon) and its mechanical performance tests, not a diagnostic AI system.

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

This information is not applicable as the device is not an algorithm or an AI system. It is a physical medical device.

7. The type of ground truth used:

The ground truth for the tests described is based on engineering specifications and performance requirements, derived from the intended use of the device and comparison to a predicate device, rather than expert consensus, pathology, or outcomes data. For example, the "ground truth" for the radial pressure test is 100 mm Hg for 3 hours without leakage.

8. The sample size for the training set:

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The tests are for the physical device itself.

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

This information is not applicable as there is no "training set."

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