(151 days)
The disposable vaginal speculum is a non-sterile product and is to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.
The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.
This is a 510(k) summary for a Disposable Vaginal Speculum, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, sample sizes, and expert qualifications for AI/ML performance is not applicable.
The document describes a traditional medical device and its substantial equivalence to a predicate device based on material, intended use, and mechanical/biocompatibility safety testing.
Here's a breakdown of the relevant information provided for this device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Safety | Complies with standard YY0336-2002, Disposable Vaginal Speculum. |
| Environmental Safety | Complies with standard YY0336-2002, Disposable Vaginal Speculum. |
| Biocompatibility (Cytotoxicity) | Complies with ISO 10993-5, Biological Evaluation for Medical Devices, tests for Cytotoxicity. |
| Biocompatibility (Irritation) | Complies with ISO 10993-10, Biological Evaluation for Medical Devices, tests for irritation and delayed type hypersensitivity. |
| Biocompatibility (Hypersensitivity) | Complies with ISO 10993-10, Biological Evaluation for Medical Devices, tests for irritation and delayed type hypersensitivity. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This is a physical medical device, and the evaluation relies on compliance with established consensus standards for mechanical properties and biocompatibility, rather than a "test set" of data in the context of AI/ML.
- The document implies that the tests were performed by, or on behalf of, Kunshan Deyi Plastic Co., Ltd., which is a manufacturer in China.
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 AI/ML sense is not relevant for this type of device submission. The "ground truth" here is compliance with material, design, and performance standards as determined through laboratory testing.
4. Adjudication method for the test set:
- Not applicable. There is no "adjudication method" described as would be for an AI/ML system's output. Compliance is determined by the results of the specified tests against the criteria in the standards.
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-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- For mechanical and environmental safety: Compliance with the specified performance requirements within the standard YY0336-2002 (Disposable Vaginal Speculum).
- For biocompatibility: Absence of cytotoxicity, irritation, or delayed type hypersensitivity reactions as determined by the methods and criteria in ISO 10993-5 and ISO 10993-10.
8. The sample size for the training set:
- Not applicable. There is no training set for a physical, non-AI 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.