(147 days)
The CrossBay™ Cervical Dilator Catheter System is intended to be used whenever cervical softening and dilation is desired. Some examples are:
- Treatment of cervical stenosis
- IUD placement and removal
- Placement of instruments for intrauterine radiotherapy
- Endometrial biopsy
- Global endometrial ablation
- Uterine tissue removal
- Uterine curettage
- Diagnostic hysteroscopy
- Operative hysteroscopy
This device is not intended for use in the induction of labor.
The CrossBay Cervical Dilator Catheter System is a sterile, single use device composed of an inflation device, dilator catheter, everting membrane, and dilator balloon which enable softening and dilation of the cervical canal. The CrossBay Cervical Dilator Catheter System contains an Inflation Device and a Dilator Catheter that accesses the cervix using a hydraulic pressure-filled everting Membrane. The Inflation Device provides the hydraulic energy with saline supplied by the user. Once placed at the exocervix, the Dilator Catheter advances through the cervix by everting the Membrane through the endocervix. A Dilator Balloon is attached to the inner tube of the device that is positioned across the cervix when the everting Membrane is fully everted. The Inflation Device is then used to further pressurize the system to split open the everting Membrane to expose the Dilating Balloon. The Inflation Device is used to pressurize the Dilator Balloon to the prescribed level. Once dilated, the Dilator Catheter is removed from the cervix and the subsequent uterine cavity procedure can commence.
The CrossBay Cervical Dilator Catheter with Dilator Balloon is provided in three sizes of 5mm, 7mm, and 9mm. The three sizes are identical except for the diameter of the Dilator Balloon when pressurized.
I am sorry, but based on the provided text, there is no information about a study proving the device meets acceptance criteria for an AI/ML powered medical device. The document pertains to a 510(k) premarket notification for a mechanical medical device (CrossBay Cervical Dilator Catheter System), not an AI/ML product.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for the test set or data provenance for an AI/ML device.
- Number of experts or their qualifications for establishing ground truth for an AI/ML device.
- Adjudication method for an AI/ML device test set.
- MRMC comparative effectiveness study or effect size for AI assistance.
- Standalone (algorithm only) performance for an AI/ML device.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set or how ground truth was established for the training set for an AI/ML device.
The document discusses non-clinical performance data for the mechanical dilator, including bench testing, biocompatibility, sterilization, package integrity, and shelf life. These are standard tests for a physical medical device to demonstrate substantial equivalence to a predicate device, not for an AI/ML model's performance.
§ 884.4260 Hygroscopic Laminaria cervical dilator.
(a)
Identification. A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.(b)
Classification. Class II (performance standards).