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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 System allows the user to perform various diagnostic and therapeutic procedures.

The Luminelle DTx Hysteroscopy System is comprised of four components:

1. Luminelle DTx Hysteroscope - a non-sterile, reusable flexible hysteroscope with an integrated light source, light fiber bundle and CMOS sensor.
2. The Luminelle DTx 360° Rotatable Disposable Sheath - a sterile, two-part sheath installed over the insertion tube of the Hysteroscope and comprised of the Operative Introducer and the 360° RotoSheath. The Operative Introducer contains an operative channel for inserting surgical accessories, two fluid management lines (inflow/outflow), and a channel to protect the scope insertion tube. The 360° RotoSheath allows for rotational positioning of the camera and provides rigidity to the Scope/Introducer assembly.
3. Luminelle Communication Cable - a cable that provides both the power to the hysteroscope and transmits the image.
4. Luminelle Control Hub - the main power supply, image converter and visualization connection. The Control Hub has both HDMI and USB connectors for connection to a monitor and/or a PC. USB and HDMI cables are provided in the package.

The Luminelle DTx Hysteroscope, Communication Cable, Control Hub, USB and HDMI cables and power cord are provided together in a single package. The 360° Rotatable Disposable Sheath is provided in a separate sterile package. The 360º Rotatable Disposable Sheath is required for use with the Hysteroscope, therefore it is a component of the system and not an accessory to the system.

The CMOS sensor and fiber optic illumination bundles are contained in the Hysteroscope Insertion Tube. The insertion tube length is 29.8 cm (11.73 in.) and the outside diameter is 1.95 mm (0.077 in.). The Luminelle DTx Hysteroscope is packaged in a white form fit tray with a clear slide-on cover. The tray is made of high-impact polystyrene (HIPS). The clear cover is made of polyethylene terephthalate with glycol (PETG).

The Luminelle 360° RotoSheath has a working length of 24.0 cm (9.45 in.) with an outside diameter of 5.7 mm (0.244 in.). The Luminelle Operative Introducer has an outside diameter of 4.8 mm (0.189 in.) and the inside diameter of the operative channel is 1.85 mm (0.073 in.).

Both the Luminelle 360º RotoSheath and Luminelle Operative Introducer are supplied as a single assembled unit packaged in a bottom tray with retaining lid made of polyethylene terephthalate with glycol (PETG) and sealed with Tyvek. The assembled package is sterilized using ethylene oxide (EO).

The Control Hub supplies power to the Hysteroscope via a reusable Communication Cable. The CMOS sensors have a processor that converts the visual image into data to be transferred. A processor in the Control Hub converts this image data into streaming HDMI language, takes still images when the button is pushed, and also controls the light exposure during changing light conditions.

Visualization on a video monitor is provided via a HDMI cable, and image transfer to a PC is provided via a Type A USB cable. A 12V DC, 3A power adapter is also provided. Technical specifications for these reusable components are provided in the Instructions for Use.

The provided text describes the 510(k) premarket notification for the Luminelle DTx Hysteroscopy System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, effect sizes) is not present in this document.

However, based on the provided text, I can infer and extract information related to performance testing that was conducted to support the substantial equivalence claim.

Here's the breakdown of what can be gleaned:

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

The document doesn't present a table of specific quantitative acceptance criteria with corresponding performance metrics for image quality in a way that would be typical for an AI/ML device validating diagnostic accuracy. Instead, it refers to compliance with established standards for medical devices and compares features to predicates.

2. Sample sizes used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set with patient data. The performance testing described is primarily engineering and bench testing, as well as validation of reprocessing and sterilization.
• Data Provenance: Not applicable for AI/ML validation. The testing described is hardware and system functionality testing.

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):

• Not applicable as this is not an AI/ML device requiring clinical diagnostic ground truth. The "ground truth" for the tests performed would be adherence to engineering specifications and regulatory standards.

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

• Not applicable as this is not an AI/ML device nor a clinical study involving human readers and image interpretation.

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:

• No MRMC study was performed as this is not an AI-assisted diagnostic device. It is an endoscope for direct visualization.

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

• Not applicable, as this device does not contain an AI algorithm. It is an imaging system (hysteroscope/cystoscope).

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

• The "ground truth" for this device's performance validation is adherence to established international and FDA standards for medical devices (e.g., ISO, IEC). For example, electrical safety is validated against IEC 60601-1; biocompatibility against ISO 10993; optical resolution against ISO 8600.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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