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The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

The Jada® System is a 41 cm long intrauterine device primarily made of silicone. The vacuum connector and seal valve are made of polyvinylchloride and acrylonitrilebutadiene-styrene. The device consists of an intrauterine loop on the distal end of a translucent tube. The proximal end of the tube has a vacuum connector for connection to a vacuum tube. Proximal to the connection of the Intrauterine Loop is a donut-shaped cervical seal. The cervical seal is filled with and emptied of 60-120 mL of sterile fluid by attaching a syringe to the seal valve. The intrauterine loop has 20 vacuum pores oriented toward its inside diameter. The outer surface of the intrauterine loop is a silicone shield which overhangs the vacuum pores to protect tissue from vacuum and to prevent the vacuum pores from plugging with tissue and blood clots.

Here's a breakdown of the acceptance criteria and the study details for the Jada® System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Pivotal Study (effectiveness and safety): 107 subjects enrolled, 106 evaluable.
  • Initial pilot study: 10 women.
  • Initial phase of pivotal study: 13 women.
• Data Provenance:
  • Pivotal Study: United States (12 sites in the U.S.), prospective, multicenter, single-arm, open label.
  • Initial pilot study: Indonesia.
  • Initial phase of pivotal study: Uganda.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" in the traditional sense for the clinical endpoints.

Instead, the primary effectiveness endpoint was externally benchmarked against a meta-analysis of literature data for the Bakri Postpartum Balloon. This implies that the 'ground truth' for setting the performance goal was derived from existing peer-reviewed clinical evidence rather than a panel of experts specifically adjudicating the cases of the Jada® study.

The safety endpoint involved assessing adverse events, which would typically be evaluated by the treating physicians and potentially reviewed by an independent safety committee (DMC/DSMB), but the document does not specify the number or qualifications of such reviewers.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes within the Jada® System pivotal study.

The study was a "single-arm, open label" design, meaning outcomes were assessed by the study investigators at each site. The performance goal for effectiveness was set based on external literature from the predicate device (Bakri Postpartum Balloon), rather than an internal expert adjudication process for the Jada® study's cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The pivotal study was a single-arm study comparing the Jada® System's performance to a literature-derived performance goal of a predicate device (Bakri Postpartum Balloon). It did not involve human readers interpreting images with and without AI assistance, as would be typical for an MRMC study in an imaging context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Jada® System is a physical medical device (an intrauterine device), not an imaging AI algorithm. Therefore, the concept of "standalone algorithm performance" or "human-in-the-loop performance" in the context of AI is not applicable to this device. The clinical study assessed the device's performance when used by healthcare professionals.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Effectiveness Ground Truth (for performance goal): The performance goal for effectiveness (82.0% success rate) was established based on a meta-analysis of data from literature assessing the performance of the Bakri Postpartum Balloon. This can be considered a form of "outcomes data" derived from existing clinical evidence.
• Effectiveness Ground Truth (for Jada® study outcomes): The "control of postpartum hemorrhage" was defined by the avoidance of further non-surgical, second-line, or surgical interventions. This represents demonstrable clinical outcomes data as observed by the treating clinicians in the study.
• Safety Ground Truth: Adverse events were reported and classified in terms of incidence, severity, and seriousness, and assessed for their relatedness to the device or procedure. This is also based on clinical outcomes data and assessment by clinicians.

8. The Sample Size for the Training Set

The Jada® System is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. The clinical data serves as the basis for demonstrating safety and effectiveness.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, the concept of a training set and its associated ground truth is not applicable here because the Jada® System is not an AI algorithm.

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