(59 days)
The Global Healthcare's Vaginal Speculum is intended to be used for general vaginal operation in which it is inserted into the vagina to expose the cervix.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a Global Healthcare Vaginal Speculum, issued on January 17, 2002. This type of document confirms substantial equivalence to a legally marketed predicate device.
It is important to note that this document is for a medical device (vaginal speculum), not an AI/ML-powered or software-based medical device. Therefore, the detailed acceptance criteria and study information requested (e.g., sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to the traditional medical device approval process reflected here.
The FDA's decision for this device is based on substantial equivalence to existing predicate devices, implying that its safety and effectiveness are similar. The letter does not describe specific performance studies in the way one would for an AI/ML product.
Therefore, I cannot provide a detailed response for the requested sections relevant to AI/ML device studies because the provided document does not contain that information.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance:
Since this is a traditional medical device demonstrating substantial equivalence, there isn't a table of quantitative acceptance criteria and reported device performance in the same way an AI/ML product would have (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on:
| Acceptance Criterion | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Intended Use | "The Global Healthcare's Vaginal Speculum is intended to be used for general gynecological examination and vaginal operation. It is inserted into the vagina to expose the cervix." |
| Safety | Considered comparable to legally marketed predicate devices. |
| Effectiveness | Considered comparable to legally marketed predicate devices in performing its intended function. |
| Basic Design & Materials | Similar enough to predicate devices to not raise new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The approval is not based on a clinical trial with a "test set" in the context of an AI/ML model. It relies on a comparison to existing predicate 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 Applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data. This is not how traditional medical devices are evaluated for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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 a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For this traditional device, the "ground truth" is its established function and safety record compared to existing, legally marketed devices.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for a physical medical device.
9. How the ground truth for the training set was established:
- Not Applicable.
§ 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.