FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The FemSpec disposable vaginal speculum consists of a soft plastic inflatable bladder, which once inserted into the vagina is inflated to uniformly press the vaginal wall open. Once inflated the bladder generates an annular space for diagnostic procedures of the cervix.

AI/ML Overview

The provided text is a 510(k) summary for the FemSpec Disposable Vaginal Speculum. It describes the device, its intended use, and its substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information from the given text. The FDA 510(k) summary is generally a declaration of substantial equivalence, and while it references testing that would have occurred, it does not explicitly detail the acceptance criteria or study results for performance.

To answer your request, I would need a different document, such as a test report, a clinical study summary, or a more detailed performance evaluation report that specifies acceptance criteria and observed performance.

Here's what I can extract from the provided text based on your prompt, explaining why certain sections are not applicable:

A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not define specific acceptance criteria (e.g., specific thresholds for mechanical strength, inflation time, or viewing area) nor does it report detailed device performance metrics against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. The document does not describe a clinical or performance test set, sample size, or data provenance.
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. No ground truth establishment is described as there is no performance test set detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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 device is a physical medical instrument (a vaginal speculum), not an AI-powered diagnostic system. Therefore, an MRMC study or AI-related metrics are irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As noted above, this is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth is mentioned. The device's function is to provide access for diagnostic procedures, not to perform a diagnosis itself that would require ground truth comparison for its own performance.
The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning algorithm. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set or ground truth for it.

Summary

Regulation Number and Section

§ 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.