(181 days)
DRG SoftRelease is intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). DRG SoftRelease is not intended for use in pregnant women.
The DRG SoftRelease is a single use, disposable, manual gynecological device intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD). The device consists of a handle with a release mechanism, a spatula disc, and a brush. The common handle / release combination allows the attachment of a brush attachment for use in cervical or vaginal wall cell collection. The attachment of either the spatula or the brush allows for the release of the cell collector attachments from the device handle.
The brush is composed of bristles joined to a wire shaft. For collecting cervical cells, the brush is inserted into the cervix until only the last row of bristles are visible, rotated once via the handle, and removed from the site for transfer of the cytological material.
The spatula is made of plastic and is curve-shaped, similar to the widely used Ayre spatula. For collecting cervical cells, the spatula's blunt edge is placed against the cervix, rotated with gentle pressure on the handle, and removed from the site for transfer of the cytological material.
The provided document is a 510(k) Premarket Notification for the "DRG SoftRelease" device, a cervical cell scraper/sampler. This document is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria, sample sizes, and expert adjudication as would be found in a study report for a new AI/diagnostic device.
Therefore, the requested information regarding acceptance criteria, reported performance against those criteria, detailed study design, sample sizes, ground truth establishment, and MRMC studies is not present in this document. This type of information is typically found in clinical trial reports or performance studies, which are not included in a 510(k) summary focused on substantial equivalence for a manual device.
However, I can extract the information that is present and explain why other requested information is not available:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. This document is a 510(k) summary for a manual device (cervical cell scraper), not a diagnostic algorithm or AI device. It does not contain acceptance criteria for performance metrics (like sensitivity, specificity, or F1-score) or reported device performance against such criteria. The device's "performance" is implicitly tied to its ability to collect cervical cells, which is assumed to be equivalent to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document does not describe a clinical study with a test set of data. Its purpose is to demonstrate substantial equivalence to existing devices based on "indications for use, design, materials, and principles of operation." There is no mention of a test set, data provenance, or study type (retrospective/prospective).
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)
- Not applicable / Not provided. As no test set or clinical study is described, there is no information about experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set is described.
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 / Not provided. This device is a manual cervical cell collection instrument, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a manual medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. As no clinical study or performance evaluation against a ground truth is described, this information is not available. The "ground truth" for this type of device is simply the successful collection of representative cervical cells for subsequent lab analysis by pathologists, which is outside the scope of this 510(k) document.
8. The sample size for the training set
- Not applicable / Not provided. This is a physical, manual device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. Not an AI/ML device.
§ 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.