(91 days)
The Umbilical Cord Clamp is indicated for use following a live birth. It provides a means of constricting the umbilical cord in order to prevent loss of blood as the cord dries and shrinks after birth. It is used immediately following delivery of the infant and prior to the separation of umbilical cord between mother and infant.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an Umbilical Cord Clamp. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of an AI or diagnostic device against specific acceptance criteria.
Therefore, almost all of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance is not present in this document.
Here's what can be inferred or directly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Not present. This document does not establish specific performance criteria like sensitivity, specificity, or accuracy. It's a regulatory clearance based on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. There is no mention of a test set, sample size, or data provenance as this is not a performance study as typically understood for AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not present. No experts are mentioned in the context of establishing ground truth for a test set. The clearance is based on comparison to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present. No test set or adjudication method is described.
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:
- Not applicable/Not present. This is a physical medical device (umbilical cord clamp), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. As above, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not present in the context of a performance study. The "ground truth" for this regulatory approval is the legally marketed predicate device to which the new device is compared for "substantial equivalence."
8. The sample size for the training set:
- Not applicable/Not present. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/Not present. No training set ground truth to establish.
In summary, the provided document (an FDA 510(k) clearance letter) is about regulatory approval for a physical medical device (Umbilical Cord Clamp) based on substantial equivalence. It does not contain information about the performance evaluation of an AI or diagnostic device against specific acceptance criteria. Therefore, most of the requested details are not applicable or not present in this type of document.
§ 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.