(35 days)
Indication for Use: To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.
The Vag O Speculum is a non-metal hand-held device used to expose the interior of the vagina.
1. Acceptance Criteria and Reported Device Performance:
The provided document describes a vaginal speculum, a non-AI/ML device. Therefore, the concept of "acceptance criteria" based on performance metrics like sensitivity, specificity, or AUC, as typically applied to AI/ML diagnostic devices, does not directly apply here. Instead, acceptance for this type of device is usually based on demonstrating substantial equivalence to a legally marketed predicate device.
The "acceptance criteria" implicit in this 510(k) submission are that the Vag O Speculum is substantially equivalent to the predicate device, the Kleenspec (Welch Allyn Vaginal Speculum), in terms of intended use, technological characteristics (being a non-metal, hand-held device to expose the interior of the vagina), and safety and effectiveness.
The reported device performance, in this context, is that the FDA reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
2. Sample size used for the test set and the data provenance:
This is not applicable as the submission is for a physical medical device (vaginal speculum), not an AI/ML diagnostic or predictive algorithm that would require a test set of data. The "test" here refers to demonstrating substantial equivalence, likely through design comparisons, material specifications, and potentially some limited performance testing (e.g., strength, fit) which are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of expert consensus, is irrelevant for a physical device like a vaginal speculum. Substantial equivalence is assessed by the FDA against existing regulatory standards and predicate devices.
4. Adjudication method for the test set:
Not applicable. There is no "test set" in the AI/ML sense, and thus no adjudication method for it.
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. This is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used:
For a physical device like a vaginal speculum, the "ground truth" to determine marketability is primarily based on:
- Predicate device comparison: The device must be demonstrated to be as safe and effective as a legally marketed predicate device.
- Regulatory compliance: Adherence to general controls provisions of the Federal Food, Drug, and Cosmetic Act (e.g., annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
- Design and manufacturing specifications: The device's design, materials, and manufacturing processes must ensure safety and functionality for its intended use.
8. The sample size for the training set:
Not applicable. There is no "training set" for a physical device like this.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" for a physical 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.