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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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The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavily for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.

The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavity for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use. The materials used in the construction of the Cook® Sonohysterography Biopsy Device are well known in the medical field. Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective. Literary articles prove the usefulness of this type of device to the clinician and patient population.

The provided text is a 510(k) summary for the Cook® Sonohysterography Biopsy Catheter, submitted in 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the document does not contain this information.

The document details:

• Device Description: The Cook® Sonohysterography Biopsy Catheter is designed for saline infusion sonohysterography and, if indicated, endometrial biopsy using the same device. It is supplied sterile for one-time use.
• Substantial Equivalence: The submission asserts that the device is substantially equivalent to existing predicate devices based on its indications for use, materials, physical construction, manufacturing process controls, quality assurance, packaging, and sterilization procedures.
• Predicate Devices: Several predicate devices are listed for both the sonohysterography function (e.g., Tampa Catheter, EZ-HSG Catheter, Cook Hysterocath™, Goldstein Sonohysterography Catheter) and the biopsy function (e.g., Probet, Uterine Explora Model I, Wallace Suresample, Pipelle de Cornier®, Aspiracath™).
• Testing Mentioned: The document briefly states, "Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective." However, it does not elaborate on these "test requirements," specific acceptance criteria, or the results of these tests in detail. It also mentions "Literary articles prove the usefulness of this type of device," implying reliance on existing scientific literature rather than a new, specific performance study for this device.

None of the requested specific information about acceptance criteria, a formal study demonstrating performance against these criteria, sample sizes, ground truth establishment, or expert involvement is present in the provided text. The 510(k) process for this type of device often relies on demonstrating similarity to already marketed devices, and detailed performance studies with explicit acceptance criteria might not be fully presented in the public summary.

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The EchoSampler™ is a single-use, sterile, disposable curette for:

• Detection of abnormalities of the uterus and endometrium using real-time sonography during injection of sterile saline into the uterine cavity
• Obtaining histological biopsy of the glandular epithelium and superficial uterine endometrial wall or sample extraction of uterine menstrual content for any of the following:
• a) Routine screening for early detection of endometrial carcinoma or other precancerous conditions which could make estrogen therapy inadvisable,
• b) Evaluation of endometrial tissue response in patients receiving estrogen replacement therapy for menopausal symptoms
• c) Endometrial dating and evaluation of uterine pathology associated with infertility, luteal insufficiency, or functional metrorrhagia
• d) Identification of specific uterine pathogens by bacterial culturing of uterine samples
• e) Inadequate imaging of the endometrium by endovaginal sonography
• f) Further evaluation of suspected abnormalities as seen on endovaginal sonography, including focal or diffuse endometrial thickening or debris,
• q) Preoperative and postoperative evaluation of the uterine cavity especially with regard to uterine polyps, myomas and cysts
• h) Congenital abnormalities and/or anatomic variants of the uterine cavity
• i) Infertility and habitual abortion

The EchoSampler™ is a single-use, sterile, disposable curette.

This is an FDA Premarket Notification (510(k)) K041237 for the EchoSampler, an endometrial aspirator. This document is a regulatory clearance letter, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning that the FDA has determined it is as safe and effective as a similar device already on the market. This determination is typically based on comparing the new device's design, materials, and technological characteristics to those of the predicate device, rather than requiring new clinical studies with established acceptance criteria and performance metrics described in detail in the 510(k) summary provided to the FDA.

Therefore, I cannot provide the requested information from the provided text.

Specifically, I cannot extract:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Results from a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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