FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided text describes a 510(k) submission for the RI.MOS. s.r.l. Rampipella, an endometrial suction curette. It's important to note that this is a traditional medical device, not an AI/ML powered device, so many of the requested fields (especially those related to AI/ML specific studies, ground truth, and expert involvement) are not applicable or not detailed in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Adequate histological grade tissue collection	Results showed sufficient amount and grade of tissue collection.
No adverse events	No adverse events were reported.
Substantial equivalence to predicate device	The device is substantially equivalent to the Unimar Pipelle® and Vabra Aspirator®.
Technological characteristics are same or similar to predicate	The technological characteristics are the same or similar to those found with the marketed predicate device.

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

Sample Size: Not specified. The document only states "Comparative clinical performance evaluations were conducted."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is a clinical performance evaluation, implying prospective, but detailed information is not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not Applicable / Not Specified: The study focuses on the physical collection of tissue and safety, not on the interpretation of results by experts in a diagnostic context for an AI/ML device. The ground truth would inherently be the tissue itself, which would then be analyzed (presumably by pathologists, though not explicitly stated) to determine "histological grade tissue collection."

4. Adjudication Method for the Test Set:

Not Applicable / Not Specified: This concept typically applies to studies where human interpreters are making subjective assessments that need to be reconciled (e.g., in AI/ML validation). The reported study is a clinical performance evaluation of a physical device.

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: This is not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation would have been conducted or is applicable.

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

No: This is not an AI/ML device.

7. The Type of Ground Truth Used:

Histological Examination (Implied): The study evaluated "adequate histological grade tissue collection." This implies that the tissue samples collected by the device were subsequently examined histologically (likely by pathologists) to confirm their quality and suitability for diagnosis. The "ground truth" here is the actual quality and diagnostic utility of the collected tissue as determined by standard pathology practices.

8. The Sample Size for the Training Set:

Not Applicable: This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable: As above, there is no training set for a physical medical device.

Summary

Regulation Number and Section

§ 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).