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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 subject of this submission is the Jada System kit, which includes 1) the Jada System, 2) a commercially available pre-sterilized vacuum tubing, and 3) a commercially available pre-sterilized luer lock syringe.

The Jada System is a 41 cm long intrauterine device made of silicone. 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 the vacuum tubing. 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 luer lock syringe to the seal valve. The intrauterine loop consists of a loop tube with 21 vacuum pores oriented toward the inside diameter of the intrauterine loop. On the outer surface of the intrauterine loop is a shield which overhangs the vacuum pores to protect tissue from vacuum and to prevent the vacuum pores from plugging with tissue and blood clots.

Before placing the Jada System device inside the uterus, the intrauterine loop is compressed. The compressed loop is inserted into the uterus transvaginally. The cervical seal is placed within the vagina, at the external cervical os, and inflated and filled with 60-120 mL of sterile fluid. The vacuum tubing is attached to the vacuum connector on the Jada System and vacuum is then applied to a maximum value of 90 mmHg until bleeding is controlled. The Jada System should be fixed to the thigh along the tube.

The provided text describes a 510(k) submission for the Jada System, a device intended for the control and treatment of abnormal postpartum uterine bleeding or hemorrhage. The submission argues for substantial equivalence to a predicate device (also the Jada System) based on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes various mechanical, packaging, biocompatibility, and sterilization tests performed, and states that these tests demonstrate "substantial equivalence" and that the device is "as safe and effective as the predicate device." The "performance" column below is derived from the descriptions of the tests and implies that the device met the implicit acceptance criteria for each test.

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

The document does not specify the sample sizes used for the mechanical, packaging, biocompatibility, or sterilization tests. It only states that these tests were performed to support substantial equivalence.

The data provenance is from non-clinical testing (laboratory/bench testing) performed by Alydia Health. There is no mention of clinical data, human subjects, or any specific country of origin for test data, as it appears to be primarily laboratory-based engineering and material testing.

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 provided document. The studies described are non-clinical (bench testing) and do not involve human subject data requiring expert interpretation to establish a ground truth. The "ground truth" for these tests would be the specific pass/fail criteria defined by engineering and material standards.

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

This information is not applicable to the provided document, as it concerns non-clinical testing, not interpretation of clinical data where adjudication among experts would be necessary.

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. The device is an obstetric-gynecologic specialized manual instrument (Jada System) and not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

This information is not applicable. The Jada System is a physical medical device, not an algorithm, and its performance relies on human-in-the-loop operation for placement and activation.

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

For the non-clinical tests described:

• Mechanical Testing: The "ground truth" is defined by established engineering specifications, dimensional tolerances, force requirements, flow rates, and integrity standards (e.g., ability to withstand pressure, maintain dimensions, not leak, etc.).
• Packaging Testing: The "ground truth" is adherence to ASTM standards for transportation, leak detection, and seal strength.
• Biocompatibility Testing: The "ground truth" is the absence of adverse biological reactions as defined by ISO 10993-1 and specific test methodologies (e.g., no cytotoxicity, no sensitization, etc.).
• Sterilization and Shelf-Life Testing: The "ground truth" is achieving a Sterility Assurance Level (SAL) of 10^-6 and maintaining performance for the stated shelf-life as per ISO standards.

8. The sample size for the training set

This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model, so there is no "training set."

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

This information is not applicable for the same reason as point 8.

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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

• Cervical seal withstands 180 mmHg vacuum.
• Evacuates 400 mL simulated blood in ≤ 1 minute.
• Maintains 70mm diameter for 48 hours. | All mechanical tests performed and verified. (Specific quantitative results for each test are not provided in the summary but were affirmed as met during the review process.) |
  | Biocompatibility Testing | Compliance with ISO 10993-1, including Cytotoxicity, Maximization Sensitization, Vaginal Irritation, Systemic Toxicity, and Material Mediated Pyrogenicity. | All specified biocompatibility tests were conducted. (Results were deemed acceptable, allowing for substantial equivalence determination.) |
  | Sterilization & Shelf-Life Testing | Sterilized to SAL = 10-6 (ISO 11137-2:2013).
  Shelf-life of 4 years. | Sterilized using gamma radiation to a SAL = 10-6.
  A shelf-life of 4 years has been established based on real-time aging. |

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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