(60 days)
Vaginal Speculums are single use and shall be used to expose the interior of the vagina.
The MAI vaginal speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.
The provided text is a 510(k) summary for a vaginal speculum. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria, device performance studies, or any of the detailed study parameters requested in your prompt (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
The 510(k) summary states:
- Description of Device: The MAI vaginal speculum is a non-metal (polystyrene), hand-held device used to expose the interior of the vagina.
- Intended use of the Device: To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetric procedures.
- Technical Characteristics: The MAI vaginal speculum has the same technological characteristics as and is substantially equivalent to the Leespec Disposable Vaginal Speculum (K021017), manufactured by ITL Corporation.
The letter from the FDA (sections 1 and 2) confirms the review of the 510(k) submission and the determination of substantial equivalence. This type of FDA clearance (510(k)) for Class II devices often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with detailed performance metrics as might be seen for novel or higher-risk devices.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, and performance metrics because that information is not present in the provided text. The document focuses on establishing substantial equivalence based on technical characteristics to a predicate device, not on presenting novel performance data or clinical study results against predefined acceptance criteria.
§ 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.