(268 days)
The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.
The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only. The wee Bell is designed to assist in the performance of a circumferential crushing of the foreskin (prepuce) by tightening the ligature around the bell portion of the device. The remaining foreskin is then removed.
The wee Bell is comprised of two components: a transparent plastic bell and a ligature. It is available in six (6) sizes to accommodate anatomy variation in the size of newborn and infant glands. The device is EtO sterilized and is a single-use device.
The provided text is a 510(k) summary for the "wee BELL Circumcision Device" and describes its characteristics, intended use, and comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving performance against such criteria for a medical device that would involve a test set, ground truth, expert opinions, or MRMC studies.
The document states:
- "Nonclinical functional performance testing was performed on the subject device and included functional testing (visual inspection, tensile testing and smoothness testing), packaging testing per ASTM F88-21, ASTM D4169-22 and ISO 11607, sterilization per ISO 11135:2014 and biocompatibility according to ISO 10993-1 for a surface device in prolonged contact with intact skin. Additionally, material mediated pyrogenicity was conducted."
This indicates engineering and material-based tests were performed to ensure the device's physical properties, sterility, and biocompatibility, but not clinical performance benchmarks in terms of diagnostic accuracy or effectiveness measured against a ground truth developed by experts. The device is a "manual instrument," not an AI/ML-driven diagnostic device, which is typically what the questions (sample size for test set, ground truth, experts, MRMC, etc.) pertain to.
Therefore, I cannot provide the requested table and information based on the provided text, as the type of evaluation described is foundational for a medical device's physical integrity and safety, rather than a clinical performance study with statistical endpoints related to diagnostic accuracy or efficacy improvement with human-in-the-loop.
§ 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.