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aScope 5 Cysto HD is a sterile, single-use, flexible cysto-nephroscope intended to be used for endoscopic access to and examination of the lower urinary tract and kidney.

The cysto-nephroscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.

The Ambu® aScope™ 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract and kidney via antegrade (percutaneous) access. The cysto-nephroscope is intended to be used with a compatible and reusable Ambu displaying unit (the Ambu® aBox™ 2 or the Ambu® aView™ 2 Advance) to visualise the urethra and the bladder as well as the kidney.

The cysto-nephroscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, for instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu® aScope 5 Cysto HD shall be disposed of as infected medical device with electronic components.

Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cysto-nephroscope are available: aScope 5 Cysto HD - Reverse Deflection and aScope 5 Cysto HD - Standard Deflection. Apart from the mode of deflection, the cysto-nephroscopes share the same design.

The provided FDA 510(k) Clearance Letter for the Ambu® aScope™ 5 Cysto HD (K250269) does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.

This device is a physical endoscope, and the provided document focuses on its mechanical, optical, and safety characteristics following standard medical device testing procedures. There is no mention of an AI/ML component or associated performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for AI/ML performance. The document only lists verification and optical performance tests for the physical device, and states that these tests were met.

Here's an analysis based on the information that is present in the document, acknowledging that it's not related to AI/ML performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the device "met the test specifications set" and "passed the predefined acceptance criteria" for various tests. However, it does not provide specific numerical acceptance criteria or detailed reported performance values for most of these tests. For instance, for "Resolution," it doesn't state "Resolution shall be X lines per mm, and was Y lines per mm."

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

Since this is not an AI/ML clinical study, but rather engineering and bench testing of a physical device:

• Sample Size: Not specified for most tests. For physical device verification and optical performance tests, the "sample size" would typically refer to the number of physical devices or components tested. The document does not provide these numbers.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data comes from internal testing and validation activities by the manufacturer.

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

This information is not applicable. For physical device performance, "ground truth" is defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM, IEC). It does not involve expert readers establishing a medical diagnosis "ground truth."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for AI/ML, to resolve discrepancies among human readers or validate AI outputs against human consensus. This device's testing involves objective measurements against engineering specifications.

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

No. This document pertains to the clearance of a medical device (endoscope), not an AI/ML diagnostic software. There is no mention of human readers, AI assistance, or an MRMC study.

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

No. The device is a physical endoscope. There is no AI/ML algorithm described that would have standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Engineering Specifications: Internal design requirements for the device.
• International Standards: e.g., ISO 8600-3 (for field of view, direction of view), IEC 62471 (photobiological safety), ASTM D4169 (transportation), ISO 11135 (sterilization), ASTM F1980 (stability/shelf life), ISO 10993-1 (biocompatibility), IEC 60601-1/60601-2-18 (electrical safety), IEC 60601-1-2 (EMC).
• Validated Test Methods: Procedures designed to objectively measure specific performance characteristics.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component mentioned that would require a training set.

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

Not applicable, as there is no AI/ML component or training set.

In summary: The provided FDA 510(k) clearance letter details the regulatory approval of a physical endoscope (Ambu® aScope™ 5 Cysto HD). It successfully underwent a series of non-clinical (bench) tests to demonstrate its safety and performance in line with established engineering specifications and international standards, thereby proving substantial equivalence to a predicate device. However, it does not involve any AI/ML components or studies that would address acceptance criteria related to AI/ML performance, such as diagnostic accuracy, human reader improvement, or training/validation data characteristics.

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aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Cysto HD System is a combination of an endoscope, Ambu® aScope™ 5 Cysto HD, and a compatible displaying unit, Ambu® aBox™ 2.

Ambu aScope 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract. The cystoscope is intended to be used with a compatible and reusable Ambu displaying unit to visualise the urethra and the bladder.

The cystoscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu ° a Scope 5 Cysto HD shall be disposed of as infected medical device with electronic components.

Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cystoscope are available: aScope 5 Cysto HD – Reverse Deflection and aScope 5 Cysto HD – Standard Deflection. Apart from the mode of deflection, the cystoscopes share the same design.

The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

The Ambu® aBox™ 2 has the following physical and performance characteristics:

• Can process and display live imaging data from Ambu® aScope™ 5 Cysto HD to a monitor
• Can record, store and transport image data from Ambu® aScope™ 5 Cysto HD
• Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

The provided text is a 510(k) Premarket Notification summary from the FDA for a medical device called the Ambu® aScope™ 5 Cysto HD System. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to legally marketed predicate devices.

However, the document does not contain the detailed acceptance criteria and the study results in the format requested (e.g., a table of acceptance criteria vs. device performance, sample sizes for test/training sets, expert qualifications, clear details on MRMC studies, or specific ground truth methodologies for image-based AI studies).

This 510(k) summary primarily lists the types of tests performed (e.g., bending performance, optical performance tests, biocompatibility, electrical safety) and states that the device "performed as expected and met the test specifications set" or "passed the predefined acceptance criteria." It does not provide the specific numerical acceptance criteria or the actual measured performance values for these tests. Also, there is no mention of AI/ML or image-based diagnostic assistance, so no specific information on AI model training, ground truth establishment through expert consensus, or MRMC studies is present in this document.

Therefore,Based on the provided text, I cannot provide the specific details regarding acceptance criteria and study results in the format requested. The document does not contain this level of detail.

The document states: "In all instances, the Ambu® aScope™ 5 Cysto HD System performed as expected and met the test specifications set. N/A All included bench tests, which have been designed to evaluate substantial equivalence as well as the product's conformity to established quality and performance measures, have been successfully conducted, and have passed the predefined acceptance criteria." This is a general statement of compliance, not a detailed breakdown of criteria and performance.

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only lists types of tests (e.g., Bending performance, Irrigation performance, Optical performance tests like Field of view, Sharpness and Depth of field, Resolution, Color performance, Noise performance, Dynamic range) and states they "met the test specifications set" or "passed the predefined acceptance criteria" without giving the specifics.

2. Sample sizes used for the test set and the data provenance: Not provided. The tests mentioned are primarily bench tests, electrical safety, biocompatibility, and stability tests rather than clinical study data from patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable based on the provided document. This document describes the safety and performance validation of an endoscope and its display unit, not an AI-enabled diagnostic device that would require expert-established ground truth for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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. The device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For the physical and optical performance tests, the "ground truth" would be established by validated measurement standards and engineering specifications rather than clinical ground truth as understood for diagnostic AI.

8. The sample size for the training set: Not applicable. The device is not an AI/ML model that requires training data.

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

In summary, the provided FDA 510(k) Premarket Notification summary confirms that various non-clinical performance and safety tests were conducted and successfully met predefined acceptance criteria. However, it does not offer the detailed breakdown of the acceptance criteria or reported performance values, nor does it describe AI-specific testing methodologies (like MRMC studies, training/test set details for AI, or expert ground truth). This is likely because the device cleared (endoscope and display unit) is a hardware device where the focus of the submission is on physical, optical, electrical, and biocompatibility performance, not on AI/ML diagnostic capabilities.

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Ambu® aScope™ 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract. Ambu® aScope™ 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. Ambu® aScope™ 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi.

Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aView™ 2 Advance.

The Ambu® aScope™ 5 Uretero is a sterile, digital video ureteroscope. The Ambu® aScope™ 5 Uretero can be used in retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for providing endoscopic access and visual quidance to and in the upper urinary tract.

The Ambu® aScope™ 5 Uretero is available in one size and can be operated by either left or right hand. The Ambu® aScope™ 5 Uretero can be used with endoscopic accessories. The working channel system allows the passage of endoscopic instillation/ suction of fluids. The Ambu° aScope™ 5 Uretero is intended to be used with a compatible Ambu displaying unit, Ambu° aView™ 2 Advance.

The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8″ LCD screen. The displaying unit is powered by a rechargeable lithium-ion battery and includes a power supply with region-specific power cable.

The Ambu® aView™ 2 Advance has the following physical and performance characteristics:

• · Can process and display live imaging data from Ambu® aScope™ 5 Uretero to a monitor
• · Can record, store and transport image data from Ambu® aScope™ 5 Uretero
• Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

This FDA 510(k) summary (K242108) is a clearance for an updated version of the Ambu® aScope™ 5 Uretero and Ambu® aView™ 2 Advance, primarily focusing on additional compatibility between these two devices. It does not provide a study to prove the device meets acceptance criteria in the traditional sense of a clinical or comparative effectiveness study against a human baseline. Instead, it describes non-clinical performance testing to demonstrate that the updated device combination remains safe and effective and substantially equivalent to its predicate devices.

Therefore, many of the requested categories (like MRMC study, expert ground truth, sample size for test sets/training sets in a clinical context) are not applicable or cannot be extracted from this specific document, as the summary focuses on technical performance and equivalence,
not a study of diagnostic accuracy or human performance improvement.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists various performance characteristics that were tested. The overall reported performance is that the device "performed as expected and met the test specifications set." Specific numerical acceptance criteria or performance metrics are not
provided in this summary.

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

This document describes non-clinical performance testing of the device itself (hardware and software), not a study with patient data. Therefore, the concepts of "sample size" for a test set (in a clinical context) or "data provenance" (country/retrospective/prospective) are not applicable. The testing was likely conducted in a controlled lab environment.

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

N/A. As this involved technical performance testing of the device, not a diagnostic or clinical evaluation, the concept of "experts" establishing ground truth in a clinical sense is not relevant here. Engineering and testing personnel would have verified performance against technical specifications.

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

N/A. Adjudication methods like 2+1 or 3+1 are used for clinical studies with expert reviewers. This was technical performance testing.

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. This document does not mention or describe an MRMC comparative effectiveness study. The device is a ureteroscope system, not an AI-assisted diagnostic tool for interpretation.

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

N/A. This is a medical device for direct visualization, not an algorithm being evaluated for standalone performance.

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

The "ground truth" for the non-clinical tests would be the established engineering and optical specifications/standards (e.g., specific measurable values for resolution, field of view, electrical safety limits set by IEC standards, etc.) that the device was designed to meet.

8. The sample size for the training set:

N/A. This document pertains to the clearance of a physical medical device and its compatibility, not a machine learning model that requires a training set.

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

N/A. Not applicable for the reasons stated above.

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The aScope 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract.

aScope 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel.

aScope 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi.

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aBox™ 2.

The Ambu® aScope™ 5 Uretero is a sterile, digital video ureteroscope. The Ambu® aScope™ 5 Uretero can be used in retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for providing endoscopic access and visual guidance to and in the upper urinary tract.

The Ambu® aScope™ 5 Uretero is available in one size and can be operated by either left or right hand. The Ambu® aScope™ 5 Uretero can be used with endoscopic accessories. The working channel system allows the passage instruments, instillation/ suction of fluids. The aScope 5 Uretero is intended to be used with a compatible Ambu displaying unit - Ambu® aBox™ 2.

The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

The Ambu® aBox™ 2 has the following physical and performance characteristics:

• · Can process and display live imaging data from Ambu® aScope™ 5 Uretero to a monitor
• · Can record, store and transport image data from Ambu® aScope™ 5 Uretero
• Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

The provided text pertains to a 510(k) premarket notification for the Ambu® aScope™ 5 Uretero and Ambu® aBox™ 2. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial to prove a new device meets specific performance criteria.

Therefore, the document describes verification and validation testing against predefined specifications and established standards, not a comparative clinical study with acceptance criteria in the manner requested for an AI/device performance study.

Based on the provided text, the device's performance was evaluated through a series of non-clinical (bench) tests to demonstrate that it performs as expected and meets its predefined specifications. There is no mention of an AI component requiring a study to prove improved human reader performance with AI assistance, nor is there information about ground truth established by experts, sample sizes for training or test sets in the context of an AI model.

The document explicitly states: "All included bench tests, which have been designed to evaluate substantial equivalence as well as the product's conformity to established quality and performance measures, have been successfully conducted, and have passed the predefined acceptance criteria."

Here's an attempt to answer your questions based only on the provided text, highlighting what is and is not present:

Acceptance Criteria and Study for Ambu® aScope™ 5 Uretero and Ambu® aBox™ 2

The acceptance criteria and "study" described in this 510(k) are primarily focused on non-clinical verification and validation testing to demonstrate substantial equivalence to predicate devices, rather than a clinical trial for an AI-powered device. The device in question is a flexible digital video ureteroscope and its display unit. There is no indication of an AI component in this submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists categories of tests performed and states that the device "met the test specifications set" and "passed the predefined acceptance criteria." However, it does not provide a specific table with quantitative acceptance criteria values or detailed reported performance values for each test. Instead, it offers a high-level summary of the types of tests conducted.

2. Sample Size for Test Set and Data Provenance:

The document describes bench testing, not clinical studies with patient data. Therefore, the concept of "sample size for the test set" in the context of patient data is not applicable here. The "test set" would refer to the number of devices or components tested during verification and validation. The document does not specify the number of units tested for each category. Data provenance (country of origin, retrospective/prospective) is not applicable to these bench tests.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The ground truth for this device's performance is based on engineering specifications and recognized industry standards (e.g., ISO, IEC, ASTM), not expert consensus from medical image review.

4. Adjudication Method for the Test Set:

Not applicable. This was not a study involving human interpretation of medical images or data requiring adjudication.

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

No, a MRMC comparative effectiveness study was not performed. The device is a ureteroscope and a display unit, not an AI diagnostic tool designed to assist human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device does not have an AI algorithm with standalone performance.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on engineering specifications, design requirements, and adherence to international performance and safety standards (e.g., ISO 8600-3 for optical performance, IEC 60601 for electrical safety, ISO 11135 for sterilization, ISO 10993 for biocompatibility). There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. Sample Size for the Training Set:

Not applicable. This device does not involve training an AI model, so there is no training set.

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

Not applicable. As above, there is no AI training set.

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The aScope™ Duodeno 2 is designed to be used with the aBox™2, endoscopic accessories (e.g., biopsy forceps) and other ancillary equipment (e.g., medical grade video monitor) for endoscopic surgery within the duodenum.

The aBox ™2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Duodeno 2 Endoscopy System is a combination of the duodenoscope, Ambu® aScope™ Duodeno 2 and the compatible displaying unit, Ambu® aBox™ 2.

The Ambu® aScope™ Duodeno 2, is a sterile and single-use medical device for endoscopic surgery within the duodenum.

The Ambu® aScope™ Duodeno 2 is a flexible endoscope) with side viewing optics, deflectable tip and an elevator to control the position of inserted accessories. The angulation of the endoscope tip is wheels, whereby the angulation can be locked via levers. The elevator (Albarran lever) is also controlled via a lever. Insufflation, suction and rinsing functions are activated via user controls. The product contains remote switches / programmable buttons of the connected Displaying Unit (Ambu® aBox™ 2). The Ambu® aScope™ Duodeno 2 must be connected to the Ambu® aBox™ 2 to be able to work.

The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

The Ambu® aBox™ 2 has the following physical and performance characteristics:

• · Can process and display live imaging data from Ambu® aScope™ Duodeno 2 to a monitor
• · Can record, store and transport image data from Ambu® aScope™ Duodeno 2
• Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

The provided text describes the regulatory clearance of a medical device (Ambu® aScope™ Duodeno 2 and Ambu® aBox™ 2), but it does not contain information about an AI-powered device or a study validating its performance against specific acceptance criteria for AI.

Therefore, I cannot extract the detailed information requested in your prompt (acceptance criteria table, sample size for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, etc.) because these elements are not present in the provided FDA 510(k) summary for the Ambu® aScope™ Duodeno 2 Endoscopy System.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing (e.g., geometrical characteristics, functional performance, optical performance, biocompatibility, electrical safety), not on the performance of a software algorithm against a specific clinical task with AI-defined acceptance criteria.

The information regarding acceptance criteria and performance in the document is general, stating: "In all instances, the Ambu® aScope™ Duodeno 2 Endoscopy System performed as expected and met the set test specifications." It lists types of tests performed (e.g., optical performance, image quality, electrical safety) but does not provide quantitative acceptance criteria or detailed study results for each.

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Ambu® aScope™ Gastro Large:
The endoscope is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.
The endoscope is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Gastro Large Endoscopy System is a system used for endoscopic procedures in the upper gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Gastro Large, and a displaying unit, the Ambu® aBox™ 2.

The provided text does NOT describe an AI/ML-driven device or study. It is a 510(k) summary for a medical device called the Ambu® aScope™ Gastro Large Endoscopy System. This system is an endoscope and a display unit used for examining the upper gastrointestinal anatomy.

The document discusses various performance tests relevant to a physical medical device (e.g., geometrical characteristics, functional performance of insufflation/suction, optical performance, biocompatibility, sterilization, electrical safety, etc.). It explicitly states that the device has "similar technological characteristics and principles of operation" to its predicate devices, with only "minor technological differences" that "raise no new concerns regarding safety or effectiveness."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria from an AI/ML perspective, as the provided text pertains to a traditional, non-AI medical device. The information you requested (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are specific to the evaluation of AI/ML algorithms, which are not mentioned or implied in this document.

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aScope 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.

The Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Broncho System is a combination of an endoscope, Ambu® a5cope™ 5 Broncho, and a compatible displaying unit, Ambu® aView™ 2 Advance.

Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size configurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size, the endoscopes share a similar design. The inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a working channel system within the endoscope for use with endotherapy instillation of fluids. An introducer (luer lock adaptor), which is supplied together with the endoscopes, can be attached to the working channel port during of blood, saliva, and mucus from airway is possible through the suction system. Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor.

The Ambu® aView™ 2 Advance, also referred to as a displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8" LCD screen. The device is powered through a Lithium-ion (Li-ion) battery or a separate power adapter.

Ambu® aView™ 2 Advance displaying unit has the following physical and performance characteristics:

• · Displays the image from the Ambu® aScope™ 5 Broncho endoscope on the screen.
• · Can record snapshots or video of image from Ambu® aScope™ 5 Broncho endoscope.
• · Can connect to an external monitor.
• · Reusable device.

No information regarding acceptance criteria or a study proving the device meets the acceptance criteria is provided in the document. The document is a 510(k) clearance letter from the FDA for a bronchoscope system. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical performance testing.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information. The document merely confirms that the "Ambu® aScope™ 5 Broncho System performed as expected and met the test specifications set." but does not elaborate on these specifications or the studies performed.

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Ambu® aScope™ 5 Broncho Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.

Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.

Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.

The Ambu® aScope™ 5 Broncho Sampler Set consists of:

• Ambu® aScope™ 5 Broncho endoscope .
• Two Sample Containers (Ambu® aScope BronchoSampler™ 60 SC)
• Suction Connection Tube (SCT)
• Bronchoscope Attachment Part (BAP)
• 2 Luer lock adapters (Introducers) .

Ambu® aScope™ 5 Broncho is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree (K230428).

The Ambu® aScope BronchoSampler™ 60 SC is a 510(k)-exempt device, also sold alone under the trade name Ambu® aScope BronchoSampler™ SC.

The combination of the Ambu® aScope BronchoSampler™ 60 SC, the Bronchoscope Attachment Part (BAP) and Suction Connection Tube (SCT) is collectively referred to as the BronchoSampler 60.

BronchoSampler 60 is a sterile, single-use medical component designed as an accessory to aScope™ 5 Broncho single-use endoscopes. It is used for fluid sampling in bronchoscopic procedures such as Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.

The Ambu® aScope BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure.

The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® aScope BronchoSampler™ 60 SC, where the aspirated sample is stored.

The Suction Connection Tube (SCT) facilitates connection to suction tubing.

The Ambu® aScope BronchoSampler™ 60 SC plus an additional Sample Container, BAP, SCT and two introducers will be packaged and sterilized together with Ambu® aScope™ 5 Broncho endoscope to form a self-contained set, the Ambu® aScope™ 5 Broncho Sampler Set.

Ambu® aScope™ 5 Broncho Sampler Set has the following physical and performance characteristics:

• Maneuverable Ambu® aScope™ 5 Broncho endoscope tip controlled by the user
• Flexible Ambu® aScope™ 5 Broncho endoscope insertion cord
• Camera and LED light source at the distal tip of the Ambu® aScope™ 5 Broncho endoscope
• Sterilized by Ethylene Oxide
• For single use
• Enables aspiration and sample collection in BAL and BW procedures

The provided document is a 510(k) summary for the Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance benchmarks. Therefore, many of the requested categories are "Not Applicable" or information is unavailable from this document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format requested for a software device or diagnostic tool. Instead, it lists types of bench testing performed to verify design input requirements related to safety and functionality due to the addition of sampling functionality.

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

• Sample Size for Test Set: Not specified. The document only mentions "bench testing" without detailing the number of units or tests conducted for each category.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, likely at the manufacturer's facility (Ambu A/S, Denmark) or a contracted lab. The data is prospective in the sense that the tests were designed and executed to verify the new product's performance.

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

Not applicable. This device is a medical instrument (bronchoscope and sampling set), not an AI/diagnostic software. Ground truth in this context would refer to objective physical and chemical measurements or engineering standards, not expert medical consensus on images or data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not relevant for bench testing of a physical medical device.

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

No. This is a physical medical device, not an AI software intended to assist human readers in interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm. The device, as a physical product, operates as described (e.g., provides visualization, allows instrument passing, enables aspiration), and its performance is verified through physical and functional testing.

7. The Type of Ground Truth Used

The ground truth used for bench testing typically involves:

• Engineering specifications and design input requirements.
• Industry standards (e.g., ISO for biological evaluation, sterilization).
• Physical measurements (e.g., suction pressure, flow rates, dimensions).
• Functional checks (e.g., maneuverability, connectivity).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not applicable. There is no training set for a physical medical device.

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Ambu® aScope™ Colon:
The aScope™ Colon is a sterile, single-use, flexible colonoscope intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy.
The aScope™ Colon is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
Ambu® aBox™ 2:
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ Colon Endoscopy System is a system used for endoscopic procedures in the gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Colon, and a displaying unit, the Ambu® aBox™ 2.
The Ambu® aScope™ Colon is a sterile, single-use flexible colonoscope for accessing and examining the lower gastrointestinal anatomy. The endoscope provides a working channel for use of endotherapy accessories, as well as insufflation suction, rinsing and a water jet function. Visualization is realised via an integrated camera module with bulit-in LEDs for illumination.
The Ambu® aBox™ 2 displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ Colon endoscope on the screen Can record snapshots or video of image from Ambu® aScope™ Colon endoscope Can connect to an external monitor Is a reusable device

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

The provided FDA 510(k) Summary for the Ambu® aScope™ Colon and Ambu® aBox™ 2 is for a medical device, not a software AI algorithm. Therefore, the device performance is evaluated based on bench testing of physical and functional characteristics, rather than AI performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML-based medical devices.

Consequently, many of the requested categories (e.g., effect size of human readers with AI, standalone performance, training set details, expert qualifications for ground truth, adjudication methods) are not applicable to this type of device submission. The safety and effectiveness are established through engineering and biological testing, demonstrating that the device performs as intended and is safe for its stated indications.

Acceptance Criteria and Study Details for Ambu® aScope™ Colon Endoscopy System

Due to the nature of this submission being for a physical medical device (an endoscope and its display unit) rather than an AI/ML algorithm, the concept of "acceptance criteria" and "study" differs significantly. The acceptance criteria here refer to the successful completion of various engineering, performance, safety, and biocompatibility tests. The "study" is a compilation of these various tests and validations confirming the device's adherence to established standards and specifications.

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

Overall Conclusion: "In all instances, the Ambu® aScope™ Colon Endoscopy System performed as expected and met the set test specifications."

2. Sample size used for the test set and the data provenance
This information is not provided in the summary. For a physical device, the "test set" would refer to the number of devices or components subjected to each specific test. The provenance would refer to the manufacturing site and conditions, not typically specified in such detail in a 510(k) summary. Given this is a sterile, single-use device, extensive bench testing would typically be performed on a statistically relevant sample size from manufacturing lots, although the exact numbers are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is not an AI/ML algorithm requiring expert ground truth for classification. Ground truth for a physical device is established by engineering specifications, validated test methods, and compliance with recognized standards.

4. Adjudication method for the test set
This is not applicable as the device is not an AI/ML algorithm requiring expert consensus for annotation or diagnosis. Performance is based on objective measurements against predefined specifications.

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 device is a direct visualization tool without AI assistance. Its effectiveness is based on its ability to provide clear visualization and facilitate endoscopic procedures, not on enhancing human interpretation through AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical endoscope and a display unit, not an algorithm. Its performance is inherently tied to human operation and observation.

7. The type of ground truth used
For physical device testing, the "ground truth" is established by:

• Engineering Specifications: Designed performance parameters (e.g., length, diameter, bending angles, optical characteristics).
• Validated Test Methods: Standardized procedures to objectively measure these parameters.
• Recognized Standards: Compliance with international and national standards for safety, biocompatibility, sterilization, electrical safety, and electromagnetic compatibility (e.g., IEC 62471, ISO 10993-1, ISO 11135, IEC 60601 series).

8. The sample size for the training set
This is not applicable. The device is not an AI/ML algorithm; therefore, there is no "training set" in the machine learning sense. Design and development are based on engineering principles and preclinical testing.

9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.

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