(182 days)
PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The PapCone is not intended for use in pregnant women.
The PapCone® consists of an axially symmetric polystyrene grip with a round platform carrying a foam cone (PUR Foam B 2240), which is intended to collect exfoliated epithelial cervical cells for andysis by Pap smear methods. Due to its shape, dimension and the porosity of the foam used for PapCone® it is possible to obtain cells from the endocervix and the ectocervix. The design of the foam prevents distortion of the cells during sampling and transfer. During a gynecological examination the foam cone portion of the PapCone® is inserted for $1/3 into the cervical canal and is rotated two times for collection of cervical cells are transferred to a glass slide by applying gentle pressure and rotating the PapCone® evenly against the direction of streak on the slide, this allows for a uniform distribution of cells on the slide. To ensure the adequate coverage of the periphery of the transition zone, it is generally recommended to swap the periphery additionally with a second instrument (e.g. PapCone® or a spatula). Transfer these cells to the same glass slide. The device is offered non sterile.
The PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The key performance criteria for such a device relate to its ability to effectively collect and release cells.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. However, the study aims to demonstrate substantial equivalence to predicate devices by showing comparable performance in collecting and releasing particles and comparable clinical outcomes.
| Metric | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (PapCone®) | Predicate Device 1 (Cervex-Brush®) | Predicate Device 2 (FT Modell 2197®) |
|---|---|---|---|---|
| Bench Test: Particle Release (Mean value) | Substantially equivalent to predicate devices within the same range of particle release in a viscous suspension (comparable to cervical mucus). | 273 | 241 | 205 |
| Bench Test: Particle Release (Standard Dev.) | Substantially equivalent to predicate devices. | 50 | 54 | 57 |
| Bench Test: Particle Release (Max.) | Substantially equivalent to predicate devices. | 378 | 377 | 349 |
| Bench Test: Particle Release (Min.) | Substantially equivalent to predicate devices. | 177 | 166 | 118 |
| Bench Test: Particle Release (Spread) | Substantially equivalent to predicate devices. | 4.06 | 3.89 | 4.04 |
| Clinical Performance: Handling (Sampling/Smear) | Good acceptance by medical professionals and patients, comparable to predicate devices or showing advantages. | Good acceptance | N/A (Comparison, not reported) | N/A (Comparison, not reported) |
| Clinical Performance: Time Needed for Sampling | Comparable to predicate devices or showing advantages. | Reduced time needed for sampling | N/A (Comparison, not reported) | N/A (Comparison, not reported) |
| Clinical Performance: Patient Acceptance | Good acceptance by patients, comparable to predicate devices or showing advantages. | Good acceptance, reduced iatrogenic bleeding | N/A (Comparison, not reported) | N/A (Comparison, not reported) |
| Clinical Performance: Representative Sampling | Increased representative sampling (increased number of cells) compared to predicate devices. | Increased number of cells | N/A (Comparison, not reported) | N/A (Comparison, not reported) |
| Clinical Performance: Detection Rate of Positive Cytological Findings | Equal to compared instruments. | Equal | N/A (Comparison, not reported) | N/A (Comparison, not reported) |
The study aims to demonstrate that the PapCone® is substantially equivalent to the predicate devices (Cervex-Brush® and Puritan Foam Tip Swab Model 2197) in terms of intended use, principles of operation, materials, and performance.
Study Details Proving Device Meets Acceptance Criteria
1. Sample Size Used for the Test Set and Data Provenance:
- Bench Test: The exact sample size for the bench test is not explicitly stated in terms of number of individual tests or repetitions for each device. The results are presented as "Mean value," "Standard dev.," "Max.," "Min.," and "Spread," implying multiple measurements were taken for each device.
- Data Provenance: Not specified, but likely laboratory-based bench testing.
- Clinical Performance Evaluation:
- Sample Size: 31,000 smears were taken and compared.
- Data Provenance: The study was conducted in Europe after the legal marketing of PapCone® (SANDER H. et. al: Sampling devices for cytological examinations, 2007). This indicates prospective data collection for the clinical comparison.
2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Bench Test: Not applicable as the "ground truth" for particle collection/release would be based on quantitative measurements. No human experts are mentioned for this part.
- Clinical Performance Evaluation: The text states "The statistical detection rate of positive cytological findings was equal for the compared instruments." This implies a cytological evaluation by trained professionals (e.g., cytotechnologists, pathologists). However, the specific number and qualifications of these experts are not provided.
3. Adjudication Method for the Test Set:
- Bench Test: Not applicable. Measurements are quantitative.
- Clinical Performance Evaluation: The document does not specify an adjudication method for the cytological findings. It refers to a "statistical detection rate," suggesting standard cytological diagnostic procedures were followed, but without details on how discrepancies (if any) were resolved or how ground truth was established by expert consensus.
4. 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:
- No, an MRMC comparative effectiveness study was not done.
- The clinical study compared the PapCone® to a spatula and brush combination and cotton tip. It focused on device performance in terms of sampling effectiveness, patient/physician acceptance, and detection rate, not on assessing human reader performance with or without AI assistance. The PapCone® is a physical sampling device, not an AI-powered diagnostic tool.
5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The PapCone® is a physical medical device for cell collection, not an algorithm, so a standalone algorithm performance study was not conducted.
6. The Type of Ground Truth Used:
- Bench Test: Quantitative measurements of particle release.
- Clinical Performance Evaluation: "Positive cytological findings." This implies the ground truth for diagnostic accuracy was established through standard cytopathological diagnosis (microscopic examination of Pap smears). The "increased representative sampling due to increased number of cells" refers to a biological ground truth related to cellularity.
7. The Sample Size for the Training Set:
- Not applicable. The PapCone® is a physical medical device, not an AI or machine learning model, so there is no training set in the conventional sense.
8. How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, there is no training set for this 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.