(56 days)
The Cervex-Brush Combi is intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD). The Cervex-Brush Combi is not intended for use in pregnant women.
This device consists of handle with a multi-bristled, soft plastic brush mounted on it. The bristles are intended to collect cervical cells for testing and evaluation. For the middle part of the Cervex-Brush Combi the cell-collecting ability of the device is comprised of substantially eccentrically placed parallel plastic bristles, forming a brush head that is connected to the handle. The eccentrically placed bristles are positioned on opposite sides of a square base. The top of the brush is rounded. Digital rotation with gentle pressure by way of the handle causes to scrape and remove cytological material simultaneously from the ectocervix and the endocervix. Because the bristles are plastic, wet or humid cells are not absorbed so that the cytological material can easily be transferred to a glass slide or a preservative fluid and sent to the laboratory for evaluation. The device is offered sterile and nonsterile. The Cervex-Brush Combi head is composed of polyethylene, the same material that is used for the Cervex- Brush.
The provided document is a 510(k) summary for the Cervex-Brush Combi, a medical device for collecting cervical cells. This type of submission focuses on demonstrating substantial equivalence to pre-existing devices, rather than presenting a performance study with acceptance criteria in the manner requested for AI/algorithm-based devices.
Therefore, the requested information outlining acceptance criteria and a study proving the device meets those criteria cannot be fully provided from this document. The document specifically states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This indicates that the approval is based on equivalence, not on a new performance study against specific acceptance criteria for a novel device.
However, I can extract information related to the device's characteristics and its equivalence claim, which serves as its "proof" of meeting regulatory requirements in this context.
Here's a breakdown of what can be inferred and what cannot:
What can be extracted/inferred from the document:
- Device Performance: The document claims the device is "substantially equivalent in terms of intended use, design, manufacturing processes, physical properties, and principles of operation" to its predicate devices (Cervex-Brush® and EndoCervex-Brush). This equivalence is the basis for its market entry, implying it performs comparably to already approved devices.
- Intended Use/Acceptance: The device is "intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD)." The device meets this intended use by being substantially equivalent to devices already accepted for this purpose.
What cannot be extracted from this document (as it's not a study report for a novel AI device):
- A table of explicit acceptance criteria (e.g., sensitivity, specificity thresholds) and reported device performance against those criteria.
- Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth used for such studies, or training set details. These are typically part of a de novo approval or a PMA for a novel device, especially AI/ML.
Based on the provided document, here's a best-effort response, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from Equivalence) | Reported Device Performance (Inferred from Equivalence) |
|---|---|
| Intended Use: Collection of cervical cells for Pap smear and/or STD detection. | Substantially equivalent to predicate devices (Cervex-Brush® and EndoCervex-Brush) for this intended use. |
| Design: Multi-bristled, soft plastic brush. | Design is substantially equivalent to predicate devices. |
| Manufacturing Processes: Standard medical device manufacturing. | Manufacturing processes are substantially equivalent to predicate devices. |
| Physical Properties: Material (polyethylene), cell collection ability (scraping and removing cytological material). | Physical properties are substantially equivalent to predicate devices. |
| Principles of Operation: Digital rotation with gentle pressure to collect cells. | Principles of operation are substantially equivalent to predicate devices. |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets its "acceptance criteria" (which are defined implicitly by the characteristics of the predicate devices) is the 510(k) Substantial Equivalence Determination. The FDA concluded that the Cervex-Brush Combi is "substantially equivalent" to the predicate devices (Cervex-Brush® and EndoCervex-Brush) manufactured by Rovers Medical Devices BV, based on its intended use, design, manufacturing processes, physical properties, and principles of operation.
Key Information from the Document:
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document is a 510(k) summary for a physical medical device (a cervical cell scraper), not an AI/software device. The approval is based on demonstrating substantial equivalence to predicate devices, not on a performance study with a test set of data in the context of an AI algorithm. Therefore, details about a "test set" in that sense are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method for the test set:
- Not Applicable. See point 2.
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. See point 2. This device is a cell collection instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 2 and 5.
7. The type of ground truth used:
- Implied Ground Truth/Standard: The "ground truth" for this type of submission is the established performance and safety profile of the predicate devices (Cervex-Brush® and EndoCervex-Brush). The Cervex-Brush Combi is assessed against these already legally marketed and accepted devices.
8. The sample size for the training set:
- Not Applicable. See point 2. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. See point 2 and 8.
§ 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.