(30 days)
Procedure trays containing components intended for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes (i.e. Hysterosalpingography or Hysterosonography).
The H/S Procedure Tray, Elliptosphere Procedure Tray and Multi-Purpose Tray contain components that can be used for conducting either Hysterosalpinography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and falopian tubes using ultrasound sonography). All components are provided sterile for single use only.
The provided document describes a 510(k) premarket notification for "H/S Catheter Procedure Tray," "H/S Elliptosphere Procedure Tray," and "Multipurpose Procedure Tray." This submission is for medical devices, specifically procedure trays used for hysterosalpingography or hysterosonography.
Based on the content, this document does not contain the information required to answer your request. The request asks for details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, and MRMC studies, which are typically part of a comprehensive clinical validation report or performance study.
Here's why the provided text is insufficient:
- Type of Submission: This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo performance against specific acceptance criteria through a new study.
- Focus on Equivalence: The "Technological Characteristics" section explicitly states: "The expanded tray has the same technological characteristics as the predicate device. The intended use, operating principle, incorporate the same product designs incorporate the same materials and are packaged and sterilized using the same materials and processes." This indicates that the claim for acceptance is based on similarity to an already approved device, rather than new, independent performance testing against defined metrics.
- Lack of Study Details: There is no mention of a specific study, clinical trial, or performance data beyond the assertion of equivalence. All points in your request (sample sizes, experts, adjudication, MRMC, standalone performance, ground truth types and establishment) are absent because they are not typically required for a 510(k) pathway that relies solely on substantial equivalence without new clinical performance claims.
- Device Type: Procedure trays are collections of components. The performance claims for such devices usually relate to sterility, material compatibility, and the ability of the components to facilitate the intended procedure, not complex diagnostic accuracy metrics that would require algorithms or AI. The FDA letter even highlights that the drug components (povidone-iodine) are regulated separately.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The document serves its purpose for a 510(k) by establishing substantial equivalence to a predicate device (Ackrad H/S Procedure Tray K881680) rather than presenting new performance data.
§ 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.