(283 days)
SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique.
The SpiraBrush Cx is a biopsy instrument consisting of a sampling head and a handle. The sampling head is placed directly onto the exocervical lesion or cervical area to be biopsied, and rotated to collect a tissue sample. The head is then snapped off the handle and placed in a preservative solution for laboratory processing.
This document describes the SpiraBrush Cx, a device intended for obtaining biopsies of visible exocervical lesions. The clinical trial focused on comparing its performance to a standard cervical punch biopsy.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document does not explicitly state quantitative "acceptance criteria" for the SpiraBrush Cx. Instead, the study's conclusion focuses on demonstrating substantial equivalence to a standard cervical punch biopsy. The primary performance metric reported is related to the adequacy of the biopsy and a secondary benefit regarding hemodynamics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biopsy Adequacy: Produce an adequate transepithelial cervical biopsy for meaningful clinical diagnosis. | The clinical trial supported that the SpiraBrush Cx Biopsy Instrument produced an adequate transepithelial cervical biopsy that was substantially equivalent to a standard cervical punch biopsy for producing a tissue specimen that a reviewing pathologists could utilize to arrive at a meaningful clinical diagnosis by accepted cervical classification systems. Tissue confirmation by LEEP or conization further supported safety and effectiveness. |
| Hemostasis/Patient Comfort: Less frequent need for hemostasis and less pain/bleeding for patients. | The SpiraBrush cervical biopsy also produced less pain and bleeding for patients than standard cervical punch biopsy. In clinical trials, the SpiraBrush CX biopsy instrument resulted in less frequent need for hemostasis as compared with the standard punch biopsy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 37 subjects (out of 41 enrolled, 90% completed evaluation).
- Data Provenance: The document does not explicitly state the country of origin, but it mentions "4 investigation sites," suggesting the study was conducted in a clinical setting. It is a prospective study as subjects underwent both SpiraBrush Cx biopsy and cervical punch biopsy prior to LEEP.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: The document states that a "reviewing pathologists" utilized the tissue specimens. The exact number of pathologists is not specified.
- Qualifications of Experts: The qualifications are referred to as "reviewing pathologists." No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for the test set regarding the comparison of SpiraBrush and punch biopsy results. It implies that pathologists independently reviewed specimens to arrive at a diagnosis. However, "tissue confirmation by LEEP or conization" served as an overarching confirmation of the findings for both biopsy methods. This implies LEEP/conization served as the definitive ground truth, against which the diagnostic capability of both biopsy types was assessed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving AI assistance was not mentioned. The device is a manual biopsy instrument, not an AI-powered diagnostic tool. The document focuses on the equivalence of the biopsy sample quality, not on improving human reader performance with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not performed. The SpiraBrush Cx is a physical biopsy instrument that collects tissue, which is then interpreted by a pathologist. It is not an algorithm.
7. The Type of Ground Truth Used
The ground truth for assessing the "adequacy" and "meaningful clinical diagnosis" of the biopsy samples was pathology (microscopic classification by reviewing pathologists) and outcomes data in the form of "tissue confirmation by LEEP or conization." LEEP (Loop Electrosurgical Excision Procedure) or conization is a definitive surgical procedure that typically removes the entire affected area and provides a comprehensive histological diagnosis, serving as a strong gold standard.
8. The Sample Size for the Training Set
A training set is not applicable here as the study is comparing a physical biopsy instrument to a standard biopsy instrument, not training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no algorithm training set.
§ 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.