(87 days)
Demarcation of the cervical/vaginal junction during laparoscopy, laparoscopic-assisted vaginal hysterectomy, laparoscopic bladder surgery and other laparoscopic procedures where delineation of the junction is desired.
The Colpo cup is an accessory to the ClearView Uterine Manipulator that is used to demarcate the cervical/vaginal junction during laparoscopy. This product is a sterile, single patient use device.
Here's a breakdown of the acceptance criteria and study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Mechanical Integrity (no parts loose) | Laboratory testing and basic design assure no parts will come loose. |
| Biocompatibility (safe material) | Independent lab testing shows material is safe. |
| Clinical Safety | Clinical evaluation verified safe nature. |
| Effectiveness: | |
| Ease of Use (compared to predicate) | Clinical trials showed it was as effective as the predicate. |
| Device Retention (compared to predicate) | Clinical trials showed it was as effective as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "clinical evaluation" and "clinical trials" but does not explicitly mention the sample size or the country of origin for these clinical studies. It also doesn't specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The document refers to "clinical evaluation" and "clinical trials" but does not detail how the ground truth for these evaluations was established, nor does it mention the number or qualifications of experts involved.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document describes clinical trials comparing the Colpo Cup to a predicate device, focusing on "ease of use" and "device retention," but not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone algorithm-only study was not performed. The Colpo Cup is a mechanical medical device, not an AI or algorithm-based product.
7. The Type of Ground Truth Used
The ground truth for the effectiveness claims ("ease of use" and "device retention") appears to be based on clinical evaluation/observation during "clinical trials," comparing the device's performance directly to the predicate device. For safety, it was based on laboratory testing and clinical evaluation.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Colpo Cup is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this type of device.
§ 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.