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The SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (consisting of Camera Control Unit and Camera Head) is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process signals transmitted from a fiberoptic endoscope that is connected to the Camera Head.

This product may be used on all patients requiring endoscopic examination using SCHOELLY Laparoscopes and FUJIFILM's light source BL-7000X together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging) and LCI (Linked Color Imaging) are adjunctive tools which can be used to supplement white light endoscopy. BLI and LCI are not intended to replace histopathological sampling as a means of diagnosis.

The SCHOELLY OSI Camera System is further intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in pattents at risk for ischemic states. The prospective clinical value of measurements made with OSI has not been demonstrated in disease states.

The proposed SCHOELLY Oxygen Saturation Imaging (OSI) Camera System is comprised of the SCHOELLY OSI Camera Control Unit (CCU) and the SCHOELLY OSI Camera Head (CH). It is intended for real-time endoscopic imaging and may be used on all patients requiring endoscopic examination.

The proposed device is for use with SCHOELLY Laparoscopes - mounted to the SCHOELLY OSI CH, or a videoscope connected to the SCHOELLY OSI CCU, an endoscopic light source and light guide and optional further light guide accessories. Further optional accessories to complete the endoscopic system include a monitor, an image recorder and further peripheral input devices (keyboard, mouse, foot pedal, etc.).

The proposed SCHOELLY OSI Camera System is suitable for real-time endoscopic visible imaging (white light imaging, WLI) as well as for real-time visualization of tissue oxygen saturation (StO2) levels during minimally invasive surgery (oxygen saturation imaging, OSI).

The document provided does not contain a study proving the device meets specific acceptance criteria based on human-in-the-loop performance, nor does it detail a multi-reader multi-case (MRMC) study or standalone algorithm performance with clearly defined acceptance criteria and adjudicated ground truth as typically found in AI/ML device submissions.

Instead, the document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the SCHOELLY Oxygen Saturation Imaging (OSI) Camera System. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling pre-defined performance acceptance criteria for an AI/ML algorithm.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, and effect sizes in MRMC studies, are not explicitly present in the provided text in the context of an AI/ML performance study.

However, I can extract information related to the device's technical and non-clinical performance and substantial equivalence:

Acceptance Criteria and Reported Device Performance (based on Non-Clinical Performance Testing):

The document details non-clinical performance testing and a comparison to a predicate device. While not presented as a formal "acceptance criteria table" for an AI/ML model, the comparison to the predicate device and the successful completion of specified tests serve as the basis for demonstrating equivalence.

• Sterilization: Successfully passed sterilization validations according to instructions in the user manual, compliant with ANSI/AAMI ST98:2022 and ISO 14937:2009. |
  | Software Documentation | - Software documentation provided for a Basic Documentation Level per FDA Guidance (June 2023).
• Software lifecycle, documentation, and validation managed in accordance with IEC 62304:2006 + A1:2016. |
  | Electrical Safety and EMC Testing | - Assessed for conformity and complied with IEC 60601-1:2005+AM1:2012, IEC 60601-1-2:2014, IEC 60601-1-2:2020, and IEC 60601-2-18:2009. |
  | Imaging Mode Performance (WLI, BLI, LCI) | - Accurately reproduced reference artifacts for image sharpness, depth of field, signal-to-noise ratio, temporal noise, color reproduction, dynamic range, and distortion.
• Produced images with similar intensity, color, and contrast compared to the primary predicate device in in-vivo animal and human oral cavity/hand testing. |
  | OSI Performance (Oxygen Saturation Imaging) | - Accuracy: Measurements of oxygen saturation were similar to those produced by the primary predicate device when compared to a reference device (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) on a tissue phantom with controlled oxygen levels.
• Effect of Variables: OSI testing included measurements regarding the effect of distance, angle, orientation, temperature, and duration.
• 2D Variation: Measurement of two-dimensional StO2 variation was performed.
• Image Similarity: Produced similar images of tissue oxygenation compared to the primary predicate device in human oral cavity/hand and in-vivo animal (intestines and stomach) testing. |

Regarding the other specific requirements for AI/ML performance studies:

1. Sample size used for the test set and the data provenance:

   • The document mentions "images of the human oral cavity and hand" and "intestines and stomach images from an in-vivo animal study."
   • It does not specify the exact number of images, patients, or animals used for these comparative tests.
   • The provenance is implied to be both human (oral cavity and hand) and animal (intestines and stomach), likely from a clinical or laboratory setting for in-vivo testing, but the country of origin is not specified, nor is whether the data was retrospective or prospective.

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

   • The document does not mention the use of experts to establish "ground truth" for the imaging comparisons in the sense of independent clinical review. The comparisons are stated as being directly between the SCHOELLY device's output and the predicate device's output, and against reference artifacts/tissue phantoms for quantitative measures.
   • For the oxygen saturation accuracy, the "reference device" (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) serves as a quantitative reference for the tissue phantom, but this is a device-to-device comparison, not expert-adjudicated ground truth.

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

   • Not applicable as no expert adjudication process is described for establishing ground truth for an AI/ML model's output. The performance relies on instrumental comparisons and visual similarity to a predicate.

4. 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 is mentioned. The device's primary function is imaging and visualization, including adjunctive oxygen saturation monitoring, not necessarily an AI-driven diagnostic aid for human readers. Therefore, an MRMC study demonstrating human reader improvement with AI assistance is not described.

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

   • The document implies a "standalone" technical performance evaluation for the imaging capabilities and oxygen saturation measurements, where the device's output is compared directly to reference standards or the predicate device. However, this is for the device's imaging capabilities (hardware and embedded algorithms for image processing), not an independent AI algorithm producing a standalone diagnostic output.

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

   • For imaging characteristics (sharpness, color reproduction, etc.), "reference artifacts" were used.
   • For oxygen saturation accuracy, a "tissue phantom with controlled oxygen levels" and a "reference device" (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) were used.
   • For visual comparisons (intensity, color, contrast, tissue oxygenation), the predicate device's output and in-vivo human/animal images served as the comparison basis, not a an independent "ground truth" established by expert consensus, histology, or outcomes. The substantial equivalence relies on the similarity to the predicate device's output.

7. The sample size for the training set:

   • Not applicable. This is a 510(k) submission for an imaging system, not explicitly an AI/ML device that requires a distinct "training set" for model development as typically understood in AI/ML validation studies. The "algorithms" mentioned are for image processing (BLI, LCI, OSI modes) and are inherent to the camera system, not necessarily a separate AI/ML model trained on a large dataset.

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

   • Not applicable for the same reason as above. If the device incorporates learned algorithms, the details of their training and validation are not provided in this 510(k) summary, which focuses on demonstrating substantial equivalence rather than detailing AI/ML model development.

In summary: The provided text is a 510(k) summary demonstrating substantial equivalence for an endoscopic camera system. It highlights non-clinical performance testing comparing the device's output to a predicate device and established technical standards, rather than an AI/ML performance study with a distinct test set, ground truth experts, and reader studies.

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Camera System: The Camera System is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ endoscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

NIR FI Light Source: The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

The individual components of the subject device, SCHOELL Y's NIR FI System, form a system to provide real-time endoscopic visible imaging (wight light imaging, WLI) and near-infrared (NIR) illumination and imaging (fluorescence imaging, FI) using indocyanine green (ICG):

• Camera System suitable for processing and recordings visible light images as well as NIR images. The Camera System consists of a Camera Control Unit (CCU) and a Camera Head for connection to a fiberoptic scope;
• . Light Source and Light Guide for use with a fiberoptic scope for emitting light within the visible spectrum as well as in the NIR spectrum to cause fluorescence;
• . Fiberoptic Laparoscope suitable for visible light and NIR light illumination and imaging;

The imaging agent (ICG) is not provided by SCHOELLY as part of the subject system.

The submitted information does not contain a study that proves the device meets the acceptance criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It describes general performance testing conducted, but not in the context of specific acceptance criteria and detailed study results as typically found in clinical trials or dedicated performance studies for AI/ML devices.

However, based on the provided text, I can extract information related to the device and the types of testing performed to support its regulatory clearance.

Here's an attempt to structure the available information, noting where specific details (like acceptance criteria, sample sizes, ground truth establishment, or expert involvement for performance scores) are not explicitly present in the provided document:

Device Name: Near-Infrared (NIR) Fluorescence Imaging (FI) System: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific sensitivity, specificity, accuracy targets). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of evaluating a dataset for AI performance. The performance data mentioned refers to engineering and quality system validation tests. No information is provided regarding the origin (country, retrospective/prospective) of specific data sets used for validating imaging performance beyond general statements about "non-clinical performance test data."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable based on the provided text. The document does not describe a study involving expert readers establishing ground truth for a test set to assess AI performance. The focus is on the device's technical specifications and safety/effectiveness in a comparative context to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. As no human expert evaluation of a test set for AI performance is described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and compliance with standards, rather than a study comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only) Performance Study Was Done

The device described is a medical imaging system (hardware and integrated functionality for visible and NIR fluorescence imaging), not a standalone AI algorithm. Therefore, a standalone algorithm performance study as typically understood for AI/ML software is not applicable here. The "Non-Clinical Performance Testing" refers to the system as a whole.

7. The Type of Ground Truth Used

For the "Non-Clinical Performance Testing," the "ground truth" implicitly refers to the expected performance characteristics based on an existing predicate device and the design input requirements for endoscopic white light and near-infrared fluorescence imaging. The document does not specify an external "ground truth" like pathology, expert consensus on images, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of an AI algorithm with a training set. The device is an imaging system, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no mention of a training set or AI algorithm training, the establishment of ground truth for such a set is not discussed.

Summary of Non-Inclusion:

The provided document is a 510(k) summary for a medical device (an imaging system) seeking clearance based on substantial equivalence. It is not a report on a clinical or performance study evaluating an AI/ML algorithm against specific performance metrics with independent test sets and expert ground truth. Therefore, many of the requested details, particularly those related to AI/ML study design (sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies), are not present in the given text. The "Performance Data" section details compliance with recognized safety, software, and reprocessing standards, and general non-clinical performance demonstrations for substantial equivalence.

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The TipVision™ 0°/30° Videoscopes and EleVision™ HD 2 CCU are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic procedures.

The Tip Vision™ Videoscope System, consisting of the Tip Vision 0° / 30° Videoscope and the EleVision™ HD 2 Camera Control Unit (CCU), is used for 2D visualization of anatomical structures of the human body during endoscopic surgery including general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic surgical procedures. The TipVision™ Videoscope can only be used with the EleVision™ HD 2 CCU; this combination of videoscope and camera controller results in a camera based on complementary metal-oxide-semiconductor (CMOS) technology with LED illumination. When used with a compatible monitor, the camera delivers a native full HD image resolution using progressive scanning (1080p). All parameters that can be adjusted through the user interface of the CCU (magnification, illumination brightness, saturation, selective color enhancement, color shift, image storage, etc.) can also be controlled by the buttons on the TipVision™ Videoscope.

The Tip Vision™ Videoscope is connected to the Ele Vision™ HD 2 CCU by means of a cable attached to the scope handpiece. The user has the ability to adjust videoscope imaging parameters using the buttons on the videoscope handle, or via the CCU. The EleVision™ HD 2 CCU is available in two configurations: image recording only, or image and video recording.

The provided text is a 510(k) summary for the TipVision Videoscope System. It describes the device, its indications for use, comparison to predicate devices, and a summary of non-clinical performance testing. However, it does not contain information about acceptance criteria and a study that proves an AI/ML device meets those criteria.

The document details testing related to:

• Reprocessing: Cleaning and sterilization validations per FDA guidance and AAMI/ISO standards.
• Biocompatibility: Evaluation and testing according to ISO 10993 series and USP .
• Performance Testing (Optical and Mechanical): Optical characteristics (field of view, resolution, color, etc.), photobiological safety, thermal safety, usability, noise/dynamic range, and tip rotation per ISO and IEC standards.
• Software Documentation: Adherence to FDA guidance for Moderate Level of Concern devices and IEC 62304.
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601 series.

All these tests are for the physical and software aspects of a traditional medical device (a videoscope system), not for an AI/ML-driven device that would have "acceptance criteria" related to its algorithm's performance (e.g., accuracy, sensitivity, specificity, AUC) and requiring a "test set" with "ground truth" established by experts.

Therefore, I cannot fulfill the request for a table of acceptance criteria and the study proving an AI/ML device meets them, as the provided text does not describe an AI/ML device or its associated performance studies. The request specifically asks for details related to "AI vs without AI assistance," "standalone (algorithm only) performance," and "ground truth" establishment, which are concepts relevant to AI/ML device validation and are entirely absent from this 510(k) summary.

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The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories with additional Optical Grasping Forceps (51-0575a) and Optical Scissor (51-0576a) are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

The Schoelly Cystoscope/Hysteroscope and Accessories comprise several models of rigid endoscopes as well as rigid endoscopic sheaths, obturators, and instrument bridges; the currently marketed system also includes a flexible grasping forceps. This Premarket Notification adds two rigid cystoscope/hysteroscope accessories (optical scissors and optical grasping forceps), both of which have been designed and are intended for use with the currently marketed Schoelly 4mm rigid cystoscope/hysteroscope and 20Fr sheath cleared in K150158. There are no changes to any of the other system components or accessories, nor are there any changes to the Schoelly Cystoscope/Hysteroscope and Accessories indications for use. The optical scissors and optical grasping forceps accessories both consist of a rigid shaft with an inner lumen that accommodates the 4mm Schoelly Cystoscope/Hysteroscope. The outer diameter and the working length of both accessories are 4.6mm and 266mm, respectively. During application, the scissor or the forceps can be attached to the cystoscope via a simple mechanical locking located at the very proximal portion of the devices. The scissor or grasper is then inserted through a 20Fr Schoelly Cystoscope/Hysteroscope Sheath while being connected to the Schoelly Cystoscope/Hysteroscope. Another mechanical locking mechanism allows the user to lock all three coaxial components (scope, scissor/grasper accessory, and sheath) together. The scissor and grasper accessories incorporate a control handle. Operation of the control handle actuates the distal tip double action jaws via a pull wire mechanism. The optical scissor and grasper accessories are made entirely of stainless steel. The accessories are reusable instruments that are supplied nonsterile.

The provided text is a 510(k) premarket notification for a medical device. It describes the acceptance criteria for a new device and its accessories (optical grasping forceps and optical scissors) and states that testing was performed to confirm substantial equivalence to a predicate device. However, it does not provide the detailed results of a study to prove the device meets those acceptance criteria in the format requested, particularly for AI/machine learning aspects.

The document discusses non-clinical performance testing. It indicates that the device has met "pre-determined acceptance criteria" but does not define these criteria numerically or provide the raw or summarized performance data against them. There is no mention of AI or machine learning in this submission.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's what can be extracted and what cannot:

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

The document mentions that "Design verification and validation activities included the following: Physical/functional/bench testing (cutting performance, gripping performance, ease of movement, visibility in the endoscope image)..." and later concludes that the device "meet all the pre-determined acceptance criteria of the testing performed to confirm substantial equivalence." However, the specific acceptance criteria (e.g., "cutting performance must be >= X cycles," or "grip strength must be >= Y N") and the actual measured device performance against these criteria are not provided in this document.

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

This information is not provided in the document. The document refers to "testing performed" but does not elaborate on the sample sizes for physical/functional/bench testing, biocompatibility, or reprocessing validation.

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 as the document describes a physical medical device (cystoscopes/hysteroscopes and accessories) and refers to non-clinical performance testing, not studies involving human interpretation or AI using ground truth established by experts.

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

This is not applicable as the document describes a physical medical device and non-clinical performance testing, not studies involving human interpretation or AI.

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

This is not applicable. The document describes a physical medical device; there is no mention of AI or human readers.

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

This is not applicable. The document describes a physical medical device; there is no mention of an algorithm or AI.

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

This is not applicable. The document describes non-clinical performance testing of a physical medical device. The "ground truth" would be the engineering specifications and test standards for physical attributes like cutting force, grip strength, material properties, and reprocessing efficacy.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device and non-clinical testing, not an AI or machine learning model that requires a training set.

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

This is not applicable. See point 8.

Summary of available information from the document:

Here's a table based on the limited information that can be inferred regarding performance criteria and the claim of meeting them, acknowledging the absence of specific numerical acceptance criteria and performance data:

Conclusion: The provided document is a 510(k) summary for a traditional medical device (cystoscopes/hysteroscopes and accessories) and details the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. It explicitly states that the device "meet all the pre-determined acceptance criteria" but does not provide the specific numerical acceptance criteria or the study results/data that would allow for a detailed fulfillment of your request regarding device performance against acceptance criteria. Crucially, it does not involve AI/machine learning, human readers, or structured ground truth beyond standard engineering/biocompatibility testing.

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The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.

The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.

The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set".

Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges.

The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.

The provided document describes the Schoelly Nephroscope Set and Schoelly Ultra-Mini Nephroscope Set and claims substantial equivalence to predicate devices. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy in humans.

Instead, the performance data section focuses on engineering and biocompatibility testing to demonstrate the device's safety and functionality in a technical sense, aligning with established medical device standards.

Here's an analysis based on the information provided:

1. Table of acceptance criteria and reported device performance:

   Performance Metric (Acceptance Criteria Implicitly Met)	Reported Device Performance (as per testing)
   Temperature (specified in IEC 60601-2-18)	Measured surface temperatures at various locations using different light sources reached steady state and met requirements specified in IEC 60601-2-18.
   Optical Parameters (specified in ISO 8600)	Tested for all relevant optical parameters (e.g., field of view and direction of view accuracy) and met requirements specified in ISO 8600.
   Biocompatibility (according to ISO 10993)	A series of biocompatibility tests (cytotoxicity, sensitization, acute systemic toxicity) demonstrated that patient-contacting components are biocompatible.
   Reprocessing - Cleaning (AAMI TIR12:2010, AAMI	Reprocessing validations completed, including manual and automated cleaning. These studies were performed in accordance with AAMI TIR12:2010, AAMI TIR30:2011, and ANSI/AAMI ST15883-1:2009.
   Reprocessing - Sterilization (ISO 14937:2009,	Reprocessing validations completed, including steam sterilization. These studies were performed in accordance with ISO 14937:2009, ANSI/AAMI ST81:2004, ISO 17664:2004, and ANSI/AAMI/ISO 17665-1:2006.
   Electrical Safety (IEC 60601-2-18)	The device is stated to be IEC 60601-2-18 compliant, indicating it meets electrical safety standards.

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

   • Test Set Sample Size: Not applicable in the context of clinical studies. The document describes device testing (temperature, optical, biocompatibility, reprocessing) which involves physical samples of the device components, not a patient test set. No patient data is involved in these reported performance tests.
   • Data Provenance: The tests conducted are laboratory-based engineering and biological compatibility tests. They are not derived from patient data or clinical settings. The document implies these tests were conducted by the manufacturer (Schoelly Fiberoptic, GmbH) as part of their submission to the FDA.

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

   • Not applicable. These are engineering and safety tests against predefined standards (e.g., IEC, ISO, AAMI TIR), not clinical studies requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

   • Not applicable. This concept applies to clinical studies where expert consensus might be needed for diagnosis or outcome measurement. The reported tests are objective measurements against specified technical standards.

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 or AI-related study was done or is mentioned. The device is a traditional endoscope (nephroscope) and its accessories, not an AI-powered diagnostic tool.

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

   • Not applicable. The device is a surgical instrument, not an algorithm.

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

   • The "ground truth" for the reported performance evaluations is defined by international and national standards for medical device safety, performance, and reprocessing (e.g., IEC 60601-2-18, ISO 8600, ISO 10993, AAMI TIR, ISO 17664). The device's performance is compared against the technical specifications and requirements outlined in these standards.

8. The sample size for the training set:

   • Not applicable. The device is a physical instrument, not an AI algorithm that requires a training set.

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

   • Not applicable, as there is no training set mentioned or implied for this type of device submission.

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The Schoelly Cystoscopes Hysteroscopes and Accessories are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

The proposed Schoelly Cystoscopes/Hysteroscopes and Accessories comprise several models of rigid endoscopes as well as endoscopic sheaths, obturators, instrument bridges and grasping forceps. The devices are indicated to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples for the use of the devices include the visualization and manipulation of anatomy as the surgeon deems appropriate. The Schoelly Cystoscopes/Hysteroscopes and Accessories are intended to be used in general urological and gynecological surgery through a minimally invasive approach by utilizing natural orifices to access the surgical site.

Endoscopes (Cystoscopes/Hysteroscopes):
The endoscopes described in this submission are rigid reusable endoscopes for visualization of the operating site during cvstoscopic and hysteroscopic minimally invasive procedures in conjunction with a commercially available light source, video camera, monitor, and printer.

Light that is created by an external light source is transmitted from the endoscope's light guide connector through the endoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid lens system.

Technical parameters of the Schoelly Cystoscopes/Hysteroscopes that characterize the optical view are the Direction of View (0°-70°) and the Field of View (70°-85°). The image can be displayed by a camera/monitor system which can be connected to the endoscope eyepiece. Models of the Schoelly Cystoscopes/Hysteroscopes differ in diameter and length of the insertion tube (2.9mm; 4mm / 300mm - 365mm). None of the endoscope models have a working channel.

Like other currently marketed rigid cystoscopes and hysteroscopes, all endoscope models have outer surfaces mainly made from metal (Phynox cobalt-nickelchromium stainless steel alloy, 304 stainless steel) and incorporate fiber optics for light transmission and rigid lenses for image transmission.

Some Schoelly endoscope models have already been cleared for marketing by FDA (K060899) for the same general intended use but with a different material of the insertion tube and a different bonding material used for the fixation of the plan glass at the endoscope's distal end. Accessories do not have a prior 510(k) clearance.

Sheath:
The endoscopic sheaths included in this submission are rigid reusable instruments with an inner lumen and mainly made from stainless steel; the sheath serves as the most outer part of the whole device setup in cystoscopic or hysteroscopic procedures. The proximal end of the endoscopic sheath has two irrigation ports with integral stopcocks for the introduction and the egress of irrigation media. The distal end of the sheath is cut away in a fenestration to permit the use of working instruments and endoscopes with a Direction of View of more than 0°. Opposite to the fenestration, the sheath is bevelled to facilitate its introduction into natural body orifices (transurethral/transvaginal). The outer diameter of the sheaths in this submission ranges from 17Fr - 25Fr, which are standard sizes used in cystoscopic or hysteroscopic procedures in adults. The sheaths can be used with all endoscopes models, obturators and bridges that are included in this submission.

Obturator:
The obturators included in this submission are rigid reusable instruments with (visual obturators) or without (blind obturators) an inner lumen and mainly made from stainless steel. During application, the obturator can be attached to the endoscopic sheath; it fills the space inside the sheath to provide a smooth surface. The visual obturator has an inner channel that accommodates the endoscope and allows the sheath to be introduced under direct vision. The overall length of the obturator used in conjunction with the sheath complies with the working length of the endoscope.

Bridges:
This submission includes standard endoscope bridges, which are rigid reusable instruments with an inner lumen and mainly made from stainless steel. The evaluation bridges without any accessory port allow the connection of the endoscope to the endoscopic sheath; the single horn bridges include an accessory port with stopcock to allow the insertion of instruments through the inner lumen of the sheath. Both types of bridges are available in a range of lengths for use with the full range of endoscope working lengths.

Grasping forceps:
As with standard endoscopic grasping forceps, the one described in this submission is a flexible forceps solely made from stainless steel and designed for grasping tissue and/or retrieving foreign bodies under endoscopic visualization. It consists of a flexible shaft and a manual proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws. The outer diameter and the working length of the grasping forceps comprised in this submission are 7Fr and 400 mm, respectively. The grasping forceps can be introduced into the instrument bridge and moved forward through the inner lumen of the sheath towards the tip.

The Schoelly Cystoscopes/Hysteroscopes and Accessories are delivered in a nonsterile condition and will have CE mark.

The provided document describes Schoelly Cystoscopes/Hysteroscopes and Accessories, which are medical devices intended for endoscopic diagnostic and therapeutic surgical procedures. The document focuses on establishing substantial equivalence to legally marketed predicate devices through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance:

The document states that the "Performance data demonstrated that the Schoelly Cystoscopes/Hysteroscopes and Accessories have met pre-determined acceptance criteria and are substantially equivalent to predicate devices. The devices are as safe, as effective, and perform as well as or better than the predicate devices."

The specific acceptance criteria are not explicitly detailed in a pass/fail format within the provided text. Instead, the document lists various performance tests and implies that meeting the standards referenced is the acceptance criteria. The reported device performance is that it met these criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in terms of patient data or images. The testing described is non-clinical performance testing on the device itself.

• Sample Size for Test Set: Not applicable in the context of patient data. The number of physical devices or components subjected to each non-clinical test is not specified, but it's implied that sufficient samples were used to meet the requirements of the listed standards.
• Data Provenance: Not applicable in the context of patient data. All testing is non-clinical, likely conducted in a laboratory setting. The manufacturer, Schoelly Fiberoptic GmbH, is based in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the described testing is non-clinical performance and not an assessment of diagnostic performance against a ground truth established by medical experts for patient data.

4. Adjudication Method for the Test Set:

This information is not applicable as the described testing is non-clinical performance and not an assessment of diagnostic performance against a ground truth established by medical experts for patient data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing of the device's physical and optical characteristics, sterilization, and biocompatibility, not its effectiveness in a clinical diagnostic setting with human readers.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable. The device is a rigid endoscope and accessories, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used:

This information is not applicable as the described testing is non-clinical performance (e.g., optical properties, reprocessing efficacy, material biocompatibility), which uses established engineering and biological standards as the "ground truth" for performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical instrument, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as the device is a physical medical instrument, not a machine learning algorithm.

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The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscopic diagnosis within the nasal lumens and airway and is intended to provide visualization via a video monitor.

The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation.

The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU.

The endoscope further incorporates a ventilation system to protect the shaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.

The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition.

This document is a 510(k) summary for a Special 510(k) submission, meaning the changes described are limited to a modification of an already cleared device. In this specific case, the only change is an update to the Instructions for Use to add a validated method for high-level disinfection.

Therefore, the "device performance" described is specifically the performance of the High-Level Disinfection (HLD) process, not the overall performance of the nasopharyngoscope system for its intended diagnostic use. The study proves the HLD process meets the acceptance criteria for disinfection efficacy.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for HLD Efficacy Test: "In total, five results for microbial reduction by HLD and three inoculation control results were obtained as part of the efficacy study." This refers to the number of test devices and control devices used in the disinfection validation.
• Data Provenance: The devices used for validation had "previously been in clinical use to ensure 'real life' conditions." This suggests the data provenance is retrospective clinical use, but the validation itself was a prospective laboratory study performed on these used devices. The country of origin for the data is not explicitly stated, but the manufacturer is based in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this specific study. The "ground truth" for the HLD efficacy study was established through laboratory methods (culturing viable indicator organisms to determine log reduction), not through expert clinical consensus or interpretation of images.

4. Adjudication Method for the Test Set

This is not applicable. The HLD efficacy test involved quantitative microbiological culturing and functional/material testing, not human interpretation that would require adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases with and without AI assistance and is relevant for evaluating diagnostic accuracy, which is not the focus of this specific 510(k) submission (which only concerns HLD validation).

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

This concept is not applicable. There is no "algorithm" or AI in the context of high-level disinfection validation. The study evaluated the mechanical and chemical process of disinfection.

7. The type of ground truth used

The ground truth used for the HLD efficacy study was laboratory-derived quantitative microbiological counts. Specifically, the number of viable indicator organisms (Mycobacterium terrae) remaining after disinfection, determined by culturing.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of validating a high-level disinfection process. This is a laboratory validation, not a machine learning model.

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

This is not applicable for the reasons stated above.

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The Schoelly Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including thinology, and endoscopic plastic and reconstructive surgery.

The Schoelly Sinuscope is a rigid reusable endoscope for visualization during Otolaryngology-Head and Neck surgery in conjunction with a commercially available and approved light guide, light source, video camera, monitor, and printer. Light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

Schoelly Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view). Several models of the Schoelly Sinuscope have already been cleared for marketing by FDA (K133682) for the visualization during arthroscopic procedures.

Like other currently marketed sinuscopes, Schoelly Sinuscopes have outer surfaces mainly made from metal (Phynox cobalt-nickel-chromium alloy, 304 stainless steel) and further comprise fiber optics for light transmission and rigid rod-lenses for image transmission.

The Schoelly Sinuscope is delivered in a non-sterile condition and is already CE marked.

The Schoelly Sinuscope is a rigid reusable endoscope intended for visualization during Otolaryngology-Head and Neck surgery. The device's performance was evaluated through non-clinical testing, including temperature, optical parameter, biocompatibility, and performance testing, demonstrating its substantial equivalence to the predicate device, SHARPSITE Ac (K965233).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "sample size" for a test set in the traditional sense of a clinical study with patient data. The testing described is primarily non-clinical, involving laboratory-based evaluations of the device's physical and material properties.

• Test Set: Not applicable in the context of patient data. The "test sets" refer to the Schoelly Sinuscope devices themselves that were subjected to the various physical and chemical tests (e.g., specific units for temperature testing, optical testing, biocompatibility testing, reprocessing validation). The exact number of devices used for each specific test is not detailed.
• Data Provenance: The studies are non-clinical, laboratory-based tests of the device. There is no mention of geographical provenance (e.g., country of origin) or retrospective/prospective classification as it relates to human subject data. The testing was conducted by or on behalf of Schoelly Fiberoptic GmbH, located in Denzlingen, Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for the non-clinical tests (e.g., temperature, optical parameters, biocompatibility, bonding strength, reprocessing effectiveness) is established by adherence to recognized international standards (e.g., IEC, ISO, AAMI) and internal specifications, rather than expert consensus on medical images or clinical outcomes. The "ground truth" is defined by the objective physical or chemical properties of the device and its demonstrated ability to meet the quantitative and qualitative requirements of these standards.

4. Adjudication Method for the Test Set

Not applicable. As the testing is non-clinical and objective (e.g., measurements against a standard), there is no need for adjudication by multiple human observers to establish a ground truth.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed to evaluate the diagnostic accuracy or effectiveness of an AI system or diagnostic device when interpreted by multiple human readers, often comparing performance with and without AI assistance. The Schoelly Sinuscope is a physical medical device (an endoscope) for direct visualization, not an AI-powered diagnostic tool, and its evaluation did not involve human reader interpretation of data for diagnostic purposes in an MRMC setting.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Schoelly Sinuscope is a physical medical device, not an algorithm or AI system. Therefore, a standalone performance study without human-in-the-loop is not relevant.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is derived from:

• International Standards and Regulations: e.g., IEC 60601-2-18, IEC 60601-1 (for temperature), ISO 8600 series (for optical parameters), ISO 10993 (for biocompatibility), AAMI TIRs, ANSI/AAMI STs, and ISO 14937, ISO 17664, ANSI/AAMI/ISO 17665-1 (for reprocessing).
• Internal Specifications: These specifications set the minimum requirements for the device's optical parameters.
• Predicate Device Performance: For performance testing (e.g., bonding strength), the "ground truth" or acceptance criterion was defined by comparison to the established performance of the legally marketed predicate device, SHARPSITE Ac (K965233).

8. Sample Size for the Training Set

Not applicable. Since the Schoelly Sinuscope is a physical medical device and not an AI/machine learning system, there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set as this is not an AI/machine learning device.

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The Schoelly Laparoscope is indicated for examination of body cavities, hollow organs, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The Schoelly Laparoscope is a rigid reusable endoscope for visualization of body cavities used in conjunction with a commercially available and approved light guide, light source, video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

Light that is created by an external light source is transmitted from the laparoscope light guide connector through the laparoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid rod lens system.

Schoelly Laparoscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view).

Like other currently marketed laparoscopes, the proposed device has outer surfaces mainly made from metal (304 stainless steel) and further comprise fiber optics for light transmission and rigid rod-lenses for image transmission.

The Schoelly Laparoscope is delivered in a non-sterile condition and is already CE marked.

This document does not contain the information required to populate the fields of the request. The document describes a 510(k) premarket notification for a medical device (Schoelly Laparoscope) and focuses on demonstrating substantial equivalence to a predicate device.

The provided text details:

• The device's intended use and design.
• That changes were limited to material and dimensional configurations.
• That performance testing involved biocompatibility in accordance with ISO 10993-1.
• A conclusion that the modified device met predetermined acceptance criteria and does not introduce new risks, therefore being substantially equivalent.

However, the document does not provide:

1. A table of acceptance criteria and reported device performance for clinical effectiveness studies. The "acceptance criteria" mentioned refer to engineering and biocompatibility tests, not clinical performance metrics like sensitivity, specificity, accuracy, or AUC.
2. Details about a study that assesses clinical performance against specific acceptance criteria. The document focuses on regulatory equivalence based on design and biocompatibility, not on a clinical performance study with human subjects or a large dataset.
3. Information about sample sizes for test sets, training sets, or data provenance in the context of clinical AI/ML model evaluation.
4. Details about ground truth establishment, expert involvement, or adjudication methods.
5. Information regarding multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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The Schoelly CMOS Video Nasopharyngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhinoflaryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.

The Schoelly CMOS Video Nasopharyngoscope System consists of a flexible and steerable endoscope and a camera control unit (CCU) for regulation of light intensity and connection to a monitor, PC, medical video recorder or printer for image display or image documentation.

The endoscope has outer surfaces mainly made from plastic. The endoscope handle incorporates a control lever to bend the distal tip and an integrated LED light source. Light is transmitted through fiberoptic bundles illuminating the anatomy under investigation. The video signal is captured by a CMOS imaging sensor located at the tip of the endoscope shaft and transferred to the CCU.

The endoscope further incorporates a ventilation system to protect the shaft. The exhaust valve at the endoscope handle can further be used for leakage testing. For this purpose the system is accompanied by a leakage tester and accessories.

The Schoelly CMOS Video Nasopharyngoscope System is delivered in a non-sterile condition and is already CE marked.

The provided document K132009 for the Schoelly CMOS Video Nasopharyngoscope System is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on studies involving clinical outcomes or diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, the document does not contain the information requested regarding acceptance criteria related to diagnostic performance or image interpretation, nor does it describe a study assessing such performance (like a standalone study or MRMC study).

The "acceptance criteria" mentioned in the document refer to general safety and performance standards for a medical device of its type, confirmed through non-clinical testing, rather than criteria for diagnostic accuracy or human reader improvement.

Here's a breakdown of why each requested point cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "Performance data demonstrated that the Schoelly CMOS Video Nasopharyngoscope System has met pre-determined acceptance criteria and is substantially equivalent to the predicate devices." However, these acceptance criteria are related to engineering, safety (IEC standards), biocompatibility (ISO 10993), and reprocessing validation, not image interpretation performance or diagnostic accuracy.

2. Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic "test set" described as the submission is for a device for visualization, not for an AI/CAD system or a diagnostic tool requiring such a test set. The non-clinical tests involved physical device testing, reprocessing validation, and electrical safety, not the analysis of medical images or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment experts are mentioned because there's no diagnostic test set being evaluated.

4. Adjudication method: Not applicable. No adjudication is mentioned for diagnostic 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 type of study is for evaluating AI-assisted diagnostic tools. The Schoelly CMOS Video Nasopharyngoscope System is a visualization device, not an AI or CAD system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm that would have standalone performance.

7. The type of ground truth used: Not applicable. No diagnostic ground truth is established or used for performance evaluation in this 510(k). The evaluation is around the physical and functional aspects of the endoscope itself.

8. The sample size for the training set: Not applicable. There is no AI component, and thus no training set.

9. How the ground truth for the training set was established: Not applicable. There is no AI component, and thus no training set or ground truth establishment for it.

In summary, the provided 510(k) document for the Schoelly CMOS Video Nasopharyngoscope System is a regulatory submission for a medical device (endoscope) that emphasizes substantial equivalence to predicate devices based on non-clinical engineering, safety, and reprocessing performance, rather than clinical diagnostic performance metrics and studies involving image interpretation by human experts or AI.

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