(90 days)
Biopsy to obtain a sample for histologic evaluation of the endometrium (uterine mucosal lining) or sample extraction of the uterine menstrual content for:
- Evaluation of infertility conditions, menstrual disorders, postmenopausal bleeding, abnormal cytology suggesting endometrial origin, hormonal replacement therapy (HRT);
- Detection of endometrial carcinoma (Please note: The most reliable method for the detection of endometrial carcinoma is dilation of the cervix and uterine curettage performed under general anesthesia);
- Evaluation of luteal defect (Evaluation of luteal defect is visually determined histologically from endometrial tissue obtained only during the secretory [progestational] phase of the menstrual cycle);
- Endometrial dating;
- Microscopic examination;
- and, this device is useful for patients presenting a narrow cervix or cervical canal and in postmenopausal women whose cervix might be narrower However, because of its smaller with any of the indications listed above. diameter, it should be recognized that the amount (quantity) of sample obtained with this device will be reduced.
The SelectCells Mini, like the Pipelle, comprises a long clear, flexible, polypropylene sheath and a rod made of acetal copolymer onto which a piston is molded.
The sheath of the SelectCells Mini is a one part tube whose distal half has a smaller diameter than its proximal half. The sheath of the Pipelle is a one part tube with the same diameter throughout.
The device opening, by which the specimen is to be aspirated, is located at 2.5 mm distance (3 mm for Pipelle®) from the extreme distal tip of the sheath. The extreme distal end of the sheath is rounded and closed.
A piston is molded on the rod at almost its half length point (piston located at the distal end of the rod for Pipelle). This rod can be moved forward and backward within the proximal half length of the sheath lumen. The piston and rod are prevented from being totally withdrawn from the sheath during manipulation by the tapered proximal lumen end of the sheath (for Pipelle, by an identation in the sheath located at its proximal end).
The new device has an ergonomic 2.5 cm long finger grip which is molded onto the rod that protrudes the proximal end of the sheath. The Pipelle has a cylindrical 2.4 cm long knob which is glued to the rod that protrudes the proximal end of the sheath. This finger grip (Knob, for Pipelle) is used to move the rod within the sheath.
The SelectCells™Mini bears seven (7) coloured graduation marks with figures that are placed at 4. 5. 6. 7. 8. 9. and 10 cm distance from the extreme distal tip of the sheath. The predicate device bears four (4) coloured graduation marks with figures and three (3) marks in the form of a line that are placed at 4, 5, 6, 7, 8, 9 and 10 cm distance from the extreme distal tip of the sheath. The new and predicate devices bear an arrow on their sheaths indicating the location of the device opening. The graduation marks on the sheath serve as a guide for insertion depth of the device into the uterine cavity.
The provided document describes the SelectCells™ Mini, an endometrial sampling device, and compares it to a predicate device, the Pipelle®. The study aims to demonstrate substantial equivalence to the predicate device.
Here's an analysis of the acceptance criteria and study details:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Metric | Predicate Device Performance (Pipelle®) | New Device Performance (SelectCells™ Mini) | Acceptance Criteria/Conclusion |
|---|---|---|---|---|
| Non-clinical Performance | Negative Pressure Generated (Endometrial Suction) | Average of 19.3 mm of water | Average of 20.1 mm of water | The new device generates slightly more negative pressure, indicating it can suction an endometrial specimen as well as the predicate device. Conclusion: Substantially equivalent. |
| Tensile Force | Average of 13.9 lbs | Average of 13.7 lbs | Tensile force results are equivalent as both devices are made of the same material. Conclusion: Safe and efficacious, substantially equivalent. | |
| Tensile Strength | Average of 4010 PSI | Average of 3940 PSI | Varies by less than 2% and is statistically insignificant. Conclusion: Safe and efficacious, substantially equivalent. | |
| Elongation at Break | Average of 605% | Average of 364% | The new device has one-half the elongation of the predicate device. All breaks in the new device occurred at the region proximal to the change in diameter. Note: Neither device is subjected to these forces during use, so this difference is deemed acceptable. Conclusion: Substantially equivalent. | |
| Clinical Performance | Concordance of Pathology Reports (Diagnosis) | N/A (within-patient comparison) | N/A (within-patient comparison) | In all 10 successful samplings, pathology reports were concordant as to the diagnosis obtained with either device. Conclusion: Efficacious, substantially equivalent. |
| Preservation of Histologic Detail | N/A (within-patient comparison) | N/A (within-patient comparison) | Comparable from both devices. Conclusion: Efficacious, substantially equivalent. | |
| Histologic Grade Results | N/A (within-patient comparison) | N/A (within-patient comparison) | Histologic grade results favor the predicate device but not more than by one and one half grades. These differences do not affect efficacy as diagnoses were concordant. Conclusion: Efficacious, substantially equivalent. | |
| Sample Size (Quantity) | N/A (within-patient comparison) | N/A (within-patient comparison) | The predicate device produced a larger sample size than the new device. Note: This is expected due to the new device's smaller diameter, and is deemed acceptable as diagnostic concordance was maintained. Conclusion: Efficacious, substantially equivalent. | |
| Patient Comfort (Cramping, Bleeding, Pain) | N/A (within-patient comparison) | N/A (within-patient comparison) | The new device provided greater patient comfort, producing less cramping, cervical bleeding, cervical, and uterine pain. Conclusion: Safer and more comfortable. | |
| Adverse Events/Complications | None reported | None reported | No Protocol deviations, adverse events or complications occurred with either device. Conclusion: Safe, substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Sample Size: 10 patients (after excluding 2, from an initial recruitment of 12). Each patient underwent two samplings, one with the new device and one with the predicate device, for a total of 20 endometrial samplings.
- Data Provenance: The document does not explicitly state the country of origin. The study was a prospective, randomized clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states: "the pathology reports were concordant as to the diagnosis obtained with either sampling device." This implies the "ground truth" (pathological diagnosis) was established by pathologists reviewing the collected specimens.
- Number of experts: Not specified (implied to be one or more pathologists per sample).
- Qualifications of experts: Not specified, but generally, pathologists are medical doctors with specialized training and certification in diagnosing diseases by examining tissues and bodily fluids.
4. Adjudication method for the test set
The document does not detail an adjudication method beyond stating that "the pathology reports were concordant as to the diagnosis." This suggests that the diagnoses from each device for a given patient were independently assessed and matched, or possibly that a single pathologist reviewed both samples from a patient and provided a single diagnostic outcome for each. There is no mention of a majority vote or formal adjudication process if there were discrepancies.
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
There was no MRMC comparative effectiveness study done, and this study does not involve AI assistance. It is a comparison between two physical medical devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical endometrial sampling tool, not an algorithm or AI system.
7. The type of ground truth used
The primary ground truth used for efficacy was pathology reports/histological biopsy for diagnostic concordance and preservation of histologic detail.
8. The sample size for the training set
This is not applicable as the device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 884.1175 Endometrial suction curette and accessories.
(a)
Identification. An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.(b)
Classification. Class II (performance standards).