(218 days)
To obtain endocervical cells for Pap smear cytology test
The Puritan Histobrush consists of nylon bristles secured by stainless steel to a plastic handle. The device is used to obtain endocervical samples for Pap smear cytology. The device is for single use only and is non-sterile.
The provided text is a 510(k) summary for a medical device called "Histobrush Model 2188," a cervical cytology brush. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, rather than proving performance against specific acceptance criteria through a standalone clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and human expert involvement is not applicable or not provided in this document.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal "acceptance criteria" in the way a performance claim for an AI/diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. The "reported device performance" is essentially the equivalence shown through these tests and comparisons.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Non-Clinical Test Results) |
|---|---|
| Biocompatibility | Demonstrates substantial equivalence to predicate cervical cytology brushes.** |
| Tensile strength of brush fibers | Demonstrates substantial equivalence to predicate cervical cytology brushes.** |
| Force to remove fibers from wire | Demonstrates substantial equivalence to predicate cervical cytology brushes.** |
| Force to remove wire from handle | Demonstrates substantial equivalence to predicate cervical cytology brushes.** |
| Note: The document explicitly states: "The results of the testing demonstrate substantial equivalence to predicate cervical cytology brushes." |
2. Sample size used for the test set and the data provenance
For the non-clinical tests (biocompatibility, tensile strength, fiber removal force, wire removal force), the sample sizes are not specified in this document.
The data provenance is not specified regarding country of origin or whether it's retrospective/prospective, as no clinical study on human subjects is described. The tests are non-clinical (laboratory-based).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This document describes non-clinical engineering and materials testing, not a study requiring human experts to establish ground truth for a diagnostic outcome.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. As there's no diagnostic test set or human expert review, there's no adjudication method 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. This device is a manual medical instrument (cervical cytology brush), not an AI or imaging diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests would be the established engineering and material standards for the specific tests conducted (e.g., specific force thresholds for tensile strength, biocompatibility standards). These are implied standards relevant to the predicate devices, as the comparison is one of substantial equivalence. No pathology or outcomes data is referenced.
8. The sample size for the training set
Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. As above, no training set for an algorithm is relevant here.
In summary:
This 510(k) submission for the Histobrush Model 2188 demonstrates substantial equivalence by comparing its technological characteristics and non-clinical test results (biocompatibility, mechanical strength) to previously cleared predicate devices. It does not involve clinical studies with human participants, AI algorithms, or the establishment of diagnostic ground truth by experts from patient data. The "study" referenced is a series of non-clinical, laboratory-based tests to ensure the new device performs similarly and safely to existing products.
§ 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.