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Hysteroscopy: The LUMINELLE DTx System is used to permit 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 are not, in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures. 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 use for operative hysteroscopy include: Directed endometrial biopsy, Polypectomy, Submucous myomectomy, Transection of intrauterine adhesions, Transection of intrauterine septa, Endometrial ablation. Cystoscopy: The LUMINELLE DTx 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. NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

The LUMINELLE DTx System, previously known as the LUMINELLE DTx Hysteroscope System, originally received 510(k) clearance in 2018 as a hysteroscopic system (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827) and LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) (K19227). The LUMINELLE DTx System permits viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The LUMINELLE DTx System is intended for use in endoscopic access to the examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the LUMINELLE DTx System allows the user to perform various diagnostic and therapeutic procedures. The LUMINELLE DTx System is comprised of the following components: LUMINELLE DTx Scope; LUMINELLE Communication Cable; LUMINELLE Control Hub: USB cable: HDMI cable, and; power cord. UVision360, Inc. (hereafter UVision360) designed a new accessory, the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) that is compatible with the LUMINELLE DTx System that permits direct viewing of the cervical canal and uterine cavity during biopsy procedures. LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) is a single use accessory and is made of the same materials as the previously cleared sheaths (K190827, K192278). The LUMINELLE DTx Scope is reprocessed after each use, depending on the procedure. High Level Disinfection (HLD) solutions can be used to reprocess the LUMINELLE DTx Scope when used with a cystoscopy procedure. 0.6% Ortho-Phthalaldehyde (OPA), a chemical disinfectant, has been previously cleared for HLD. However, UVision360 has verified and validated an additional chemical, Steris Revital-Ox™ RESERT® High Level Disinfectant, for HLD with the LUMINELLE DTx System. Steris Revital Ox™ RESERT® High Level Disinfectant has been tested in order to determine that it identically cleans the LUMINELLE DTx Scope as 0.6% OPA and does not adversely affect the functionality of the LUMINELLE DTx System. Before a hysteroscope procedure, the LUMINELLE DTx Scope must be sterilized to be reprocessed. In the previous submissions, Ethylene Oxide, qualified by Andersen Scientific, Inc., has been used to sterilize the LUMINELLE DTx Scope. An additional sterilization method, V-PRO® Low Temperature Sterilization, qualified by Steris located in Mentor, OH, has been validated and verified as an additional sterilization method to ensure that it properly sterilizes the LUMINELLE DTx Scope.

The provided document is a 510(k) Premarket Notification from the FDA for the LUMINELLE DTx System. This type of document is a submission for a medical device to demonstrate it is substantially equivalent to a legally marketed predicate device. This typically involves performance and design testing rather than clinical study data regarding AI performance. Based on the provided text, the LUMINELLE DTx System and its new accessory (LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)) are a hysteroscopy and cystoscopy system, which are medical imaging devices for direct viewing of internal body cavities. There is no mention of Artificial Intelligence (AI) or an AI-powered component within the LUMINELLE DTx System.

Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for AI test sets, expert ground truth establishment for AI, MRMC studies, standalone AI performance) are not applicable to this device submission.

However, I can extract the general acceptance criteria and study information related to the device's performance, safety, and effectiveness as a medical device, which are based on "bench testing" (engineering tests) and compliance with relevant standards.

Here's the breakdown of the information that is available in the document:

1. Table of acceptance criteria and the reported device performance (based on the device's technical specifications and safety/performance testing):

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

• Test Sets (Bench Testing): The document describes various bench tests:
  • Performance - Bench: "useful life testing following multiple cycles of high-level cleaning and disinfection," "performance testing after accelerated aging," "durability of the reusable handle markings."
  • Design Validation: "usability testing in accordance with IEC 62366-1 and ANSVAAMI HE75 in simulated uterine and bladder models." "in vivo models" (for LUMINELLE Bx sheath).
  • Shelf-Life: "an established 100% Ethylene Oxide (EO) sterilization process in accordance with ISO 1135:2014, with a Sterility Assurance Level (SAL) of 10-6." "leak testing in accordance with ASTM F2096-11 and seal strength testing in accordance with ASTM F88-15 following accelerated aging in accordance with ASTM F1980-16." "simulated distribution testing in accordance with ASTM D4169-16, Distribution Cycle 13."
  • Reprocessing: Validation per "FDA guidance document 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'"
  • Biocompatibility: In accordance with "ISO 10993-1," "ISO 10993-10:2016," "ISO 10993-5:2009."
  • Electrical Safety/EMC: Compliant with "IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-1-2."
• Data Provenance: The studies are described as "Design verification and validation" and "Bench testing." These are laboratory-based engineering and performance tests, not clinical studies with patient data. The provenance is internal company testing to meet regulatory standards. No country of origin for patient data (as there isn't any) or retrospective/prospective status (as it's not a human study) is relevant here.
• Sample Size: Specific numerical sample sizes for these bench tests are not provided in the summary. The document states "multiple cycles," "accelerated aging," and refers to compliance with various ASTM and ISO standards, which would imply defined sample sizes within those methodologies, but the specific numbers are not disclosed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• For the "usability testing," it states "Instructions for Use were also evaluated by the physicians during the design validation testing." and "The reprocessing instructions were validated for use by Sterile Processing Department technicians."
• For the "in vivo models" with the LUMINELLE Bx sheath, it aimed to "confirm that [...] the user is able to operate the system as intended, and the sheath conforms to user needs."
• The document implies that qualified professionals (physicians, Sterile Processing Department technicians) provided input on usability and operational aspects, serving as "experts" for this kind of "ground truth" (i.e., whether the device is usable and meets user needs). However, no specific number of experts or detailed qualifications (e.g., 10 years of experience) are provided.

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

• Not applicable. This is a medical device submission based on bench and performance testing, not a study evaluating human reader performance or image interpretation requiring adjudication of discrepancies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This device is not an AI-powered diagnostic tool, and the submission does not involve comparative effectiveness studies of human readers with versus without AI assistance.

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

• No. There is no algorithm or AI component mentioned in the LUMINELLE DTx System.

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

• The "ground truth" for this device's validation is primarily based on engineering specifications, compliance with international standards (ISO, IEC, ASTM), and user/usability feedback. For biocompatibility, it's lab test results showing lack of cytotoxicity, sensitization, or irritation. For performance, it's successful operation within defined parameters, durability under testing conditions, and maintaining sterile barriers. For usability, it's feedback from physicians and technicians. There is no mention of pathology or outcomes data as "ground truth" in this 510(k) summary for the device itself.

8. The sample size for the training set:

• Not applicable. There is no AI component, so no training set.

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

• Not applicable. There is no AI component, so no training set ground truth.

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Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit 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 are not, in and of themselves, a method of surgery. When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

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 use 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 blader. When combined with accessory instruments, the user to perform various diagnostic and therapeutic procedures.

NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

The LUMINELLE DTx Hysteroscopy System originally received 510(k) clearance in 2018 as a hvsteroscopic and cvstoscopic svstem (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827).

Based on user feedback for a thinner option for the disposable sheath for only diagnostic use, UVision360, Inc. (hereafter UVision) proposes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), as part of an engineering performance change.

The LUMINELLE DTx Hysteroscopy System indications for use is identical to the previously cleared indications for use for the system. However, when the system is used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the indications for use are limited to diagnostic use only.

No changes are proposed for the previously cleared components of the LUMINELLE DTx Hysteroscopy System. The new LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) accessory is a modification of the LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid component of the previously cleared LUMINELLE DTx Hysteroscopy System (K190827) with the following main changes:

• . The new accessory has one fluid line rather than the two fluid lines of the previously cleared component.
• . The new accessory has a combined channel for the scope and the fluid line rather than the separate channels of the previously cleared component.
• The new accessory has no operative channel available unlike the previously cleared . component, due to the fact that it is for diagnostic use only.

The provided text describes a 510(k) submission for the LUMINELLE DTx Hysteroscopy System, which includes the addition of a new accessory, the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).

The study aims to demonstrate substantial equivalence to a previously cleared predicate device (LUMINELLE DTx Hysteroscopy System, K190827).

Summary of Acceptance Criteria and Device Performance:

The document primarily focuses on verifying the safety and effectiveness of the new accessory by demonstrating that the modified device remains as safe and effective as the predicate. It does not provide specific quantitative acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity for detecting specific conditions) for the new diagnostic sheath, as the intent of this 510(k) is an engineering performance change and limitation of use for the new accessory rather than a new diagnostic claim. Instead, the "acceptance criteria" are implied through the successful completion of various engineering, biocompatibility, and usability tests.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Detailed Information about the Study:

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

   • Note: The document does not specify quantitative diagnostic performance metrics because the submission is for an engineering change and a limitation of use for an accessory, not a new diagnostic claim that would require clinical performance study. The "acceptance criteria" are primarily related to safety, sterility, shelf life, and basic functionality as a medical device to ensure equivalence to the predicate.

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

   • Test Set Sample Size: The document does not explicitly state specific sample sizes for the various tests (e.g., how many sheaths were tested for accelerated aging, how many "in vivo models" were used for usability). It refers to "all samples met specifications" or "packages were confirmed."
   • Data Provenance: The information provided is retrospective in nature, as it's a summary of testing already performed for a 510(k) submission. The country of origin for the data is implied to be within the scope of UVision360 Inc.'s operations (Raleigh, NC, USA), but not explicitly stated for the testing sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of submission. The "ground truth" for these engineering, biocompatibility, and usability tests is established by adherence to recognized standards (e.g., AAMI TIR28, ASTM F1980-16, ASTM D4169-16, ASTM F88-15, ASTM F2096-11, ISO 10993-10:2016, ISO 10993-5:2009) and predefined acceptance criteria set during the device's development and validation. Experts in relevant engineering, toxicology, and quality assurance fields would have designed and overseen these tests, but their specific number and qualifications are not detailed in this regulatory summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This document describes technical device performance testing (e.g., sterility, shelf life, biocompatibility, mechanical function), not clinical diagnostic performance requiring expert adjudication of patient cases.

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 is not an AI/ML-enabled device and no MRMC study was performed or needed for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-enabled device.

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

   • The "ground truth" for the tests described is the adherence to specified technical and safety standards (e.g., ISO, ASTM standards for biocompatibility, packaging integrity, and accelerated aging) and predefined functional specifications for the device. For the usability and design validation, it implicitly relies on objective performance measures and user feedback in "in vivo models" compared against "predefined acceptance criteria."

8. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established: Not applicable.

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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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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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