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The Tamponade Uterine Balloon Catheter Set is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted. The device is one time use and is supplied sterile. "Use of this device is intended to provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted."

The Tamponade Uterine Balloon Catheter Set is intended for use in reducing and controlling post-partum uterine bleeding. The materials of the Tamponade Uterine Balloon Catheter are all silicone. Biocompatability testing has shown the materials to meet the test requirements.

The provided text is a 510(k) Premarket Notification for the Tamponade Uterine Balloon Catheter Set. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and device performance metrics in the way one would describe a diagnostic AI device or a novel therapeutic.

Therefore, much of the requested information cannot be directly extracted from this document. This submission is for a physical medical device, not an AI software.

Here's the information that can be extracted or inferred, and explanations for what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) document. A 510(k) for a device like this primarily demonstrates substantial equivalence to predicate devices, focusing on materials, design, indications for use, and manufacturing processes, rather than presenting specific quantitative performance criteria and results like sensitivity, specificity, or precision. The "acceptance criteria" for a 510(k) are typically regulatory in nature (e.g., meeting biocompatibility standards, sterilization validation, etc.), not performance metrics of the device against a defined clinical outcome.

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 present. The document does not describe a clinical test set in the traditional sense. Substantial equivalence for this type of device is usually established through comparison to legally marketed predicate devices and validation of manufacturing and material properties, not a clinical trial with a defined test set of patients.

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 applicable/not present. As there is no described clinical test set with ground truth establishment, this detail is not relevant to this 510(k) submission.

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

This information is not applicable/not present.

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/not present. This is a physical uterine balloon catheter, not an AI-assisted diagnostic or therapeutic device.

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

This information is not applicable/not present.

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

This information is not applicable/not present.

8. The sample size for the training set

This information is not applicable/not present. This is a physical device, not an AI algorithm requiring a training set.

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

This information is not applicable/not present.

Summary of Extracted Information:

The 510(k) document primarily describes the device, its intended use, and its substantial equivalence to predicate devices. It states:

• Device Name: Tamponade Uterine Balloon Catheter Set
• Intended Use: To provide temporary control or reduction of post-partum uterine bleeding when conservative management is warranted.
• Predicate Devices: Mentor U-Stasis balloons and the Balloon Uterine Stent manufactured by Cook OB/GYN®.
• Basis for Substantial Equivalence: Indications for use, design, materials of construction, manufacturing process controls, Quality Assurance Program, packaging, and sterilization procedures similar to currently marketed devices. The materials are all silicone, and biocompatibility testing showed they meet requirements.

The document does not contain the specific performance "acceptance criteria" and detailed study results typical for an AI software or a novel clinical intervention requiring extensive performance validation. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.

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