(82 days)
The LeeSpec™ Disposable Vaginal Speculum is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during gynecological or obstetrical procedures.
The LeeSpec™ Disposable Vaginal Speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.
This K021017 document is a 510(k) summary for a medical device called the LeeSpec™ Disposable Vaginal Speculum. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics.
Therefore, the "acceptance criteria" for this device are primarily based on its substantial equivalence to the predicate device. The "study that proves the device meets the acceptance criteria" is the comparison analysis presented in the 510(k) summary itself, which highlights the similarities to the predicate device.
Here's an analysis of the provided information relative to your requested categories:
1. A table of acceptance criteria and the reported device performance
For a 510(k) of this nature, the "acceptance criteria" are not performance metrics in the way one might think of a diagnostic test (e.g., sensitivity, specificity). Instead, they are the criteria for substantial equivalence to the predicate device. The "reported device performance" is the statement that the characteristics of the new device match those criteria.
| Feature (Acceptance Criteria) | ITL LeeSpec™ Disposable Vaginal Speculum (Reported Device Performance) |
|---|---|
| Intended Use: Instrument used by a medical professional to expose the interior of the vagina for gynecological or obstetrical procedures. | Instrument used by a medical professional to expose the interior of the vagina for gynecological or obstetrical procedures. (Meets) |
| Materials of construction: Polystyrene | Polystyrene (Meets) |
| Hand held and manually operated? Yes | Yes (Meets) |
| Design: Dual, biparting blades | Dual, biparting blades (Meets) |
| Single use? Yes | Yes (Meets) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This 510(k) summary does not describe an analytical or clinical study with a "test set" in the traditional sense of evaluating performance metrics. It's a comparison to a predicate device.
- Therefore, there is no sample size for a test set, no data provenance, and no retrospective or prospective study mentioned in this document. The "data" here is the descriptive information of the device and its comparison to the predicate.
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)
- As there is no traditional "test set" or clinical study, there are no experts mentioned in this document as being used to establish ground truth. The "ground truth" for substantial equivalence is derived from the characteristics of the predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- None mentioned, as there was no formal "test set" requiring adjudication.
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
- No MRMC study was done. This device is a physical speculum and does not involve AI or human readers in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a manual medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device and 510(k) submission, the "ground truth" for performance is the established safety and effectiveness of the legally marketed predicate device (Medisul Disposable Vaginal Speculum K000414), which serves as the benchmark against which the new device is compared. The expectation is that because the new device is substantially equivalent in its design, materials, and intended use, it will have similar performance characteristics to the predicate.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an algorithm being developed or a clinical trial in the sense of patient enrollment for a new treatment.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.