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Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and of themselves, a method of surgery. Generally recognized indications for diagnostic hysteroscopy include:

• Abnormal bleeding
• Infertility and pregnancy wastage
• Evaluation of abnormal hysterosalpingogram
• Intrauterine foreign body
• Amenorrhea
• Pelvic pain
  Generally recognized indications for operative hysteroscopy include:
• Directed endometrial biopsy
• Polypectomy
• Submucous myomectomy
• Transection of intrauterine adhesions
• Transection of intrauterine septa
• Endometrial ablation
  Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the user to perform various diagnostic and therapeutic procedures.

The LUMINELLE DTx Hysteroscopy System previously received 510(k) clearance (K181909) in 2018 as a hysteroscopic and cystoscopic system. To provide the user with a more rigid option for the RotoSheath and Introducer, UVision360, Inc. (hereafter UVision) proposes the addition of a new component to the system, the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid in addition to the currently available flexible Rotatable Disposable Sheath option cleared during the previous submission (K181909). No changes are proposed for the previously cleared components or the principles of operation of the LUMINELLE DTx Hysteroscopy System. The proposed change includes only the addition of a new component which is a modification to the previously cleared flexible LUMINELLE DTx 360° Rotatable Disposable Sheath.

The provided text describes a 510(k) premarket notification for a medical device called the LUMINELLE DTx Hysteroscopy System. This submission is for the addition of a new component, a rigid sheath, to an already cleared system. Therefore, the focus of the documentation is on demonstrating the substantial equivalence of the modified device, particularly the new rigid sheath, to the previous cleared flexible sheath version.

Based on the provided text, a formal study demonstrating the device meets a specific set of acceptance criteria in the conventional sense (e.g., accuracy, sensitivity, specificity for an AI/diagnostic device) is not explicitly detailed. Instead, the document describes design validation testing and other engineering tests to ensure the new component performs as intended and does not raise new questions of safety or effectiveness compared to the predicate device.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the sample size for the "in vivo models" used in design validation testing.
• Data Provenance: Not specified. The study is described as "design validation testing" using "in vivo models," which typically refers to animal or cadaveric models for medical devices, but specific details are absent. No information on country of origin or retrospective/prospective nature is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of testing described. The design validation testing focuses on confirming the sheath's functional performance and user operability, rather than diagnostic accuracy against a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The testing described is functional and safety testing of a medical device component, not a diagnostic performance study requiring expert adjudication of results.

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 document describes a hysteroscopy system, which is an imaging device for direct viewing and performing procedures. It does not appear to incorporate AI or machine learning for diagnostic interpretation that would warrant an MRMC study.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" in the diagnostic sense (expert consensus, pathology, outcomes) is not applicable here. The "ground truth" for the design validation testing would be the predefined functional and user performance specifications of the device component.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

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