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The Belfort-Dildy Obstetric Tamponade System (OTS) 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 OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

The Belfort-Dildy Obstetric Tamponade System (OTS) 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 Belfort-Dildy Obstetric Tamponade System (OTS) is supplied sterile in peel open pouches for one time use to a single patient.

The provided text describes a medical device, the Glenveigh™ Belfort-Dildy Obstetric Tamponade System (OTS), and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and reported device performance in the typical sense of a diagnostic or AI-driven system.

This document details the regulatory submission for the Belfort-Dildy OTS, which is a physical medical device. The "performance data" section states that "Design verification performance test results demonstrate that the Belfort-Dildy Obstetric Tamponade System performs its intended use and is equivalent to the Bakri predicate device." It also mentions "Bench testing versus the predicate Bakri device has demonstrated that the Belfort-Dildy Obstetric Tamponade System is functionally equivalent to the Bakri predicate device and that any minor differences do not affect safety or effectiveness."

Because this is not a study of an AI or diagnostic device that would typically have metrics like sensitivity, specificity, or reader accuracy, many of the requested fields are not applicable.

Here's an attempt to answer the questions based on the provided text, noting where information is not available or not applicable:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a study involving a test set of patient data, but rather bench testing and design verification of a physical medical device.

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. "Ground truth" in the context of expert consensus on data is not relevant to this type of device submission.

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

Not applicable.

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 imaging device.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for this device's performance is based on bench testing against predicate devices and design verification performance testing, demonstrating functional equivalence and performance for intended use. Biocompatibility was established through testing according to ISO 10993-1.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable.

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The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.

The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair. The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly.

The provided text describes a submission for a medical device called the Glenveigh Vaginal Repair Balloon Catheter. However, it does not include the detailed information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• Type of Device: The Glenveigh Vaginal Repair Balloon Catheter is a physical medical device (an obstetric-gynecologic specialized manual instrument). Your questions (e.g., about test sets, ground truth, experts, MRMC studies, standalone algorithm performance, training sets) are typically relevant for software-as-a-medical-device (SaMD) or devices incorporating AI/ML, which analyze data (like images) to provide diagnostic or prognostic information.
• Nature of the Submission: This document is a 510(k) summary of safety and effectiveness, seeking clearance based on substantial equivalence to a predicate device. For physical devices, substantial equivalence is often established through manufacturing specifications, material biocompatibility, and functional bench testing.
• "Performance Data" Section: The text states, "Design verification performance test results demonstrate that the Glenveigh Vaginal Repair Balloon Catheter performs its intended use and is equivalent to the predicate device." This typically refers to engineering tests (e.g., burst pressure, inflation/deflation rates, material strength, biocompatibility), not clinical studies with human readers or AI algorithms evaluating data.

Therefore, based on the provided text, I cannot answer your specific questions relating to acceptance criteria and a study as typically understood for AI/ML-driven medical devices. The document does not contain information about:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or similar metrics. The "performance data" mentioned refers to functional equivalence testing.
2. Sample sizes for test sets or data provenance. No such clinical or dataset-based testing is described.
3. Number or qualifications of experts for ground truth. Not applicable in this context.
4. Adjudication method. Not applicable.
5. MRMC comparative effectiveness study. Not conducted for this type of device according to the document.
6. Standalone algorithm performance. No algorithm is described.
7. Type of ground truth used. Not applicable.
8. Training set size. No training set is applicable.
9. How ground truth for the training set was established. Not applicable.

Summary of what is available in the text related to "performance" and "acceptance":

• Device Function: "temporarily blocks the flow of fluids to assist in episiotomy/laceration repair."
• Performance Claim: Bench testing demonstrated the device is "functionally equivalent to predicate EpiStat/V-Stat Vaginal Tamponade Balloon, and that any minor differences do not affect safety or effectiveness."
• Biocompatibility: "materials that come in direct contact with the patient have a long history of use in medical use and are biocompatible according to ISO 10993."
• Conclusion: "Based on the performance testing, it can be concluded that the Glenveigh Vaginal Repair Balloon Catheter is equivalent to the predicate EpiStat/V-Stat Vaginal Tamponade Balloon with respect to intended use and technological characteristics."

The "acceptance criteria" for this device would likely be successful completion of these functional and biocompatibility tests, demonstrating equivalence to the predicate device, rather than diagnostic accuracy metrics.

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