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The Spirotome Endo is a family of large core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue.

The Spirotome Endo is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities of the internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.

The Spirotome Endo is a core biopsy device. It consists of a stainless steel receiving needle with a helical shape, stainless steel cutting cannula, and a polypropylene releasing element. The receiving needle is inserted though the cutting cannula prior to advancing to the biopsy site. The receiving needle is rotated clockwise into the tissue using the plastic hub on the proximal end. The cutting cannula is then rotated clockwise to separate the biopsy sample from the surrounding tissue. Following retraction from the biopsy site, the releasing element is used to remove the tissue sample from the receiving needle. The receiving needle is rotated counter-clockwise to release the tissue. The Spirotome Endo is operated manually.

The Spirotome Endo has four variants: one 8 gauge, and two 14 gauge needles. The receiving needle is 375 mm in length and the cutting cannula is 325 mm long. The helical needle is 18 mm long in all the variants except one 14 gauge variant, where it is 10 mm long. The device is provided sterile and is for single-use only.

A. Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document for the Spirotome Endo device itself. The document focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, based on shared design principles, materials, manufacturing, and clinical literature. Specific performance metrics related to biopsy sample quality or diagnostic accuracy are not detailed.

B. Sample Size and Data Provenance

The document refers to leveraging "functional testing" from prior devices (Spirotome SU K060384 and Spirotome Cervicore K080095) for the Spirotome Endo. However, it does not specify the sample sizes used for these functional tests.

For the claim of "safe and effective use of the subject device for internal female reproductive organs," the document cites "clinical use of the Spirotome Endo for gynecological tissues... reported in peer reviewed journals." The number of patients or samples in these literature reports is not provided, nor is the country of origin explicitly stated, though "clinical use" suggests prospective patient data. The provenance of this data is retrospective, as it refers to existing peer-reviewed publications.

C. Number and Qualifications of Experts for Ground Truth

The document does not describe the establishment of ground truth by experts for a specific test set. Instead, it relies on clinical literature to support safety and effectiveness. Therefore, the number and qualifications of experts for ground truth are not applicable in the context of a specific study described here. The "histological and biomolecular detection and confirmation" mentioned in the Indications for Use imply the involvement of pathologists or other specialists in clinical practice, but not for a dedicated ground truth study within this submission.

D. Adjudication Method

No adjudication method is described, as there isn't a stated ground truth study involving expert review for a test set within this document.

E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on demonstrating substantial equivalence through non-clinical bench testing and existing clinical literature, rather than comparing human reader performance with and without AI assistance.

F. Standalone (Algorithm Only) Performance Study

This device is a physical biopsy instrument, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted.

G. Type of Ground Truth Used

The ground truth implicitly relied upon for demonstrating the device's utility in providing adequate tissue samples for diagnosis is histology and biomolecular detection and confirmation as performed in routine clinical practice based on the collected tissue. This is inferred from the device's "Indications for Use" which state it is intended "to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities." However, this is not a ground truth established for a specific study within this submission but rather the expected clinical outcome.

H. Sample Size for Training Set

No training set is mentioned as this is a physical medical device, not an AI/ML algorithm.

I. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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