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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.

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.

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