(116 days)
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
| Acceptance Criteria (Endpoint) | Performance Goal / Description | Reported Device Performance |
|---|---|---|
| Primary Effectiveness Endpoint | Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada® System per the Instructions for Use. | |
| (Performance goal was 82.0% success rate, based on a meta-analysis of Bakri Postpartum Balloon literature data). | ITT Cohort: 94.3% (100/106), with a lower bound 95% confidence limit of 88.1%. | |
| mITT Cohort: 96.2% (100/104; 95% CI: 90.4%, 98.9%). | ||
| PP Cohort: 99% (96/97; 95% CI: 94.4% to 100%). | ||
| (All reported success rates exceed the performance goal of 82.0%.) | ||
| Primary Safety Endpoint | Incidence, severity, and seriousness of device-related adverse events. | No adverse events judged definitely related to the device or procedure. |
| Low rate of possibly related adverse events, all anticipated. | ||
| Five possibly device-related adverse events rated "mild". | ||
| Three possibly device-related adverse events rated "moderate" (endometritis). | ||
| No "severe" events. | ||
| Mechanical Testing | Verification of various physical and functional attributes (e.g., dimensions, integrity, vacuum performance, flow rate, bond strength). Examples: |
- 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.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.