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As the Select IUI® (predicate device), TheCurve™ (new device) is a single use, sterile, disposable, flexible catheter designed to be used for intrauterine artificial insemination.

TheCurve, such as the Select IUI, comprises a long clear polyethylene tube that is tightly surrounded on three quarters of its proximal length by an outer, clear polypropylene sheath. This leaves 4.5 cm of the inner polyethylene tube exposed at the distal end of the device. The proximal inner tube and outer sheath circumferences are molded directly onto the distal end of a luer lock hub so that only the lumen of the inner tube can provide a channel for flow. This design results in a single-channel catheter with two segments each having different degrees of flexibility. The extreme distal tip of TheCurve™ is open as compared to the extreme distal tip of the Select IUI® which is closed and has two side openings. Both TheCurve and Select IUI have six (6) coloured graduation markings placed at 5, 6, 7, 8, 9, and 10 cm distance from the extreme distal tip of the catheter. The distal portion of TheCurve is curved while the distal portion of the Select IUI is straight.

The provided text describes a 510(k) submission for a medical device called "TheCurve™," an intrauterine insemination catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the "Select IUI®."

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly state "acceptance criteria" in a quantitative sense as might be found in a performance study with defined thresholds (e.g., minimum sensitivity, specificity). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, function, and intended use. The "performance" is implicitly deemed acceptable if the device is found substantially equivalent to the already approved predicate.

2. Sample Size Used for the Test Set and Data Provenance

The documents do not describe a formal "test set" or a study with human subjects (clinical trial) to evaluate the device's performance against specific acceptance criteria. This submission is a 510(k) for substantial equivalence based on device comparison and technical specifications, not a clinical performance study. Therefore, there's no sample size or data provenance in the context of a clinical test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. As no clinical study or performance evaluation with a "ground truth" was conducted or reported, no experts were involved in establishing such ground truth for a test set. The "truth" in this submission relies on the comparison of engineering specifications and intended use to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was used.

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 (an intrauterine insemination catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a manual medical instrument and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and effectiveness of the predicate device (Select IUI®). The new device, TheCurve™, is compared against the predicate's specifications and intended use.

8. The Sample Size for the Training Set

Not applicable. Since there's no algorithm involved, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. Since there's no algorithm involved, there is no "training set" or ground truth for it.

In summary:

This 510(k) submission relies on a "benchmarking" or "comparison" approach rather than a clinical performance study with a defined test set and acceptance criteria. The "acceptance criteria" are implicitly met if the FDA determines the new device is substantially equivalent to the predicate device in terms of safety and effectiveness, despite some minor physical differences that are argued to either have no impact or slightly improve usability (e.g., curved tip for easier insertion). The evidence provided is primarily a detailed technical comparison of the new device with the legally marketed predicate device.

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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

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.

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