(52 days)
The RI MOS. s.r.l. Cuscovag, Specuvag and Specuvag AS devices are used to expose the interior of the vagina. The Cuscovag is indicated as an aid for routine examination in adolescent and geriatric women, the Specuvag as an aid for routine examination and the Specuvag AS as an aid for routine examination and procedures where smoke must be evacuated from the vaginal canal.
The RI. MOS. s.r.l. speculae line are sterile, single-use, disposable devices.
This document describes a 510(k) submission for gynecological specula (GINRAM® Cuscovag, Specuvag, and Specuvag AS). The submission aims to demonstrate substantial equivalence to a predicate device, the KleenSpec® Specula marketed by Welch Allyn (K941272).
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of acceptance criteria or specific device performance metrics in the way one would expect for an AI/CADe device. This submission is for a physical medical device (specula), not a software-based diagnostic tool. The "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and safety testing.
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Substantial Equivalence | "substantially equivalent to KleenSpec® Specula marketed by Welch Allyn, K941272." |
| "The technological characteristics are the same or similar to those found with the marketed predicate devices." | |
| Intended Use | "aid in routine gynecological examinations, including a smoke evacuator model for procedures where such is required." |
| "Cuscovag is indicated as an aid for routine examination in adolescent and geriatric women, the Specuvag as an aid for routine examination and the Specuvag AS as an aid for routine examination and procedures where smoke must be evacuated from the vaginal canal." | |
| Sterility/Single-Use | "sterile, single-use, disposable devices." |
| Biocompatibility/Safety | "Safety tests were conducted and passed in accordance with the relevant sections of ISO 10993." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable or not provided in the context of this 510(k) summary for a physical medical device. There is no "test set" of patient data in the typical sense for evaluating an AI algorithm's diagnostic performance. The evaluation is focused on the device's physical and material properties and its intended use.
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)
This information is not applicable or not provided. Since there's no diagnostic AI algorithm being described, there's no "ground truth" derived from expert consensus on medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. No "adjudication method" for a test set is mentioned because there's no diagnostic performance being evaluated in this manner.
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
This information is not applicable. The device is a speculum, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance would be relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. No "ground truth" for diagnostic purposes is discussed or needed for a speculum 510(k) submission. The "truth" here relates to the device meeting safety standards and performing its intended mechanical function.
8. The sample size for the training set
This information is not applicable. There is no "training set" for a physical medical device like a speculum.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth establishment for it.
In summary: The provided document is a 510(k) summary for a physical medical device (gynecological specula). It focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with safety standards (ISO 10993). The questions you've posed are primarily relevant to the evaluation of AI/CADe (Computer-Aided Detection/Diagnosis) systems, which process and interpret data, and therefore, most of the answers are "not applicable" in this context.
§ 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.