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Telescopes for adults
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults.

Telescopes for adults and pediatrics
KARL STORZ HOPKINS Telescopes for Urology when used with sheaths, obturators, accessories, and instruments are intended to provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics.

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems, which provide visualization and operative access during urological procedures in adults and pediatrics. Urological devices consist of sheaths, obturators, accessories, and instruments, which are combined into a cystoscope system for diagnostic or therapeutic procedures in the lower urinary tract such as prostate, bladder, and urethra. The sheath provides a working channel for therapeutic instruments, as well as ports for irrigation and aspiration. The obturator is inserted through the sheath for atraumatic insertion to the surgical site, then removed after placement. The telescope is inserted through the sheath for visualization of the surgical site. All instruments subject to this submission are optical instruments, and compatible with telescopes; the optical instruments are only compatible with adult systems. Compact telescopes are all-in-one cystoscopes with built-in sheaths, obturators, and optics, they do not require device compilation for use.

The provided text is an FDA 510(k) clearance letter and its accompanying summary for the KARL STORZ HOPKINS Telescopes for Urology. This document details the regulatory pathway for a medical device, specifically rigid endoscopes, not an AI software or system. Therefore, most of the questions regarding acceptance criteria and study design for AI performance are not applicable.

Here's an analysis of the provided information:

Analysis of Acceptance Criteria and Study for a Medical Device (Endoscope):

Given that this is a medical device (endoscope), the "acceptance criteria" are typically related to meeting established performance standards for such devices. The "study" refers to non-clinical bench testing to demonstrate compliance with these standards and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with specific numerical performance targets and reported values in the way you might see for an AI algorithm's accuracy or sensitivity/specificity. Instead, the acceptance criteria are implicit in the adherence to international and national standards for medical devices, particularly endoscopes. The reported device performance is that it complies with these standards.

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

• Sample Size: Not applicable in the context of an endoscope's non-clinical bench testing. The "test set" here refers to the actual device prototypes or representative samples tested in a laboratory setting to verify compliance with engineering and safety standards. The number of units tested isn't specified but typically involves a sufficient number to ensure reproducibility and meet statistical requirements for the specific test (e.g., several samples for biocompatibility, multiple cycles for reprocessing).
• Data Provenance: The testing is non-clinical bench testing, meaning it does not involve human subjects or real-world patient data. It is performed in a controlled laboratory environment by the manufacturer (KARL STORZ SE & Co. KG), likely in Germany given their address.

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

• Experts for Ground Truth: Not applicable. For a rigid endoscope, "ground truth" is defined by established engineering specifications and compliance with recognized national and international standards. The "truth" is whether the device performs according to these measurable standards, not a subjective interpretation by experts.
• Qualifications of Experts: Not applicable. The "experts" involved are likely engineers, quality assurance personnel, and regulatory specialists within Karl Storz and external testing laboratories who are qualified to conduct and interpret the specified tests according to the standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image diagnosis). For physical device testing, the results are typically quantitative measurements that either pass or fail against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No. MRMC studies are used to evaluate the impact of a new diagnostic aid (like an AI system) on human reader performance across multiple readers and cases. This is not relevant for a rigid endoscope, which is a physical visualization and access tool.

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

• Standalone Performance: Not applicable. This device is a physical endoscope, not an AI algorithm. Its function is to provide visualization, which inherently involves a human user (the clinician) in the loop.

7. The type of ground truth used:

• Type of Ground Truth: The "ground truth" is adherence to established engineering specifications, safety standards (e.g., thermal safety), optical performance metrics (e.g., field of view, resolution), biocompatibility requirements, and validated reprocessing protocols as defined by the numerous ISO, IEC, AAMI, ASTM, and ANSI standards listed. It is a technical and regulatory compliance "ground truth."

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.

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

• Training Set Ground Truth: Not applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set."

In summary, the provided document is a regulatory submission for a physical medical device (an endoscope) and not for an AI/software device. Therefore, the specific questions related to AI performance metrics, sample sizes for AI training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" are demonstrated through non-clinical bench testing proving compliance with relevant industry standards and substantial equivalence to a predicate device.

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This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.

The device is suitable for professional healthcare facility environments such as hospitals and clinics.

This product shall not be used for other purposes.

The Single-Use Video Flexible Cysto-Nephroscope mainly consist of insertion portion, handle and connector section which include a detachable video cable which connect the endoscope to the Endoscopic Video Image Processor.

The provided FDA 510(k) clearance letter and summary describe a physical medical device (Single-Use Video Flexible Cysto-Nephroscope), not an AI/ML-driven software device. Therefore, the information requested about acceptance criteria and studies (especially those related to AI performance, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of the new device to a predicate device based on non-clinical performance testing of the physical properties and functionality of the endoscope itself. There is no mention of any AI component or software that processes images or provides diagnostic assistance.

Here's a breakdown of what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The proposed device has met the testing acceptance criteria in accordance with internal requirements and applicable standards to support substantial equivalence of the proposed device." However, it does not provide a specific table listing detailed acceptance criteria and the corresponding reported performance values for each physical test. It only lists the types of tests performed.

• Sterilization Validation:
  • Acceptance Criteria: Determined by ISO 11135:2014 half-cycle method to establish routine control and monitoring parameters.
  • Reported Performance: Method validated. (Specific parameters not provided).
• Shelf Life and Simulated Transportation Distribution followed by Sterile Packaging Integrity Test:
  • Acceptance Criteria: Validated according to ASTM F1980-21, ISO11607-1:2019, ISO11607-2:2019, ASTM F1929-23, ASTM F88/F88M-23, ASTM F1886/F1886M-16, ASTM D4169-23.
  • Reported Performance: Validated. (Specific results not provided).
• Performance Testing (using methods and acceptance criteria from K241500):
  • Surface and Edges:
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.
  • Deflection system and Fatigue test of Rocker and Bending Section: (Note: Downward deflection angle changed from 135° to 225° for all models).
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.

Information Not Applicable to this Device/Document (for AI/ML products):

The following points are typically relevant for AI/ML device submissions but are not found in this document because it pertains to a physical, non-AI medical instrument.

• Sample sized used for the test set and the data provenance: Not applicable. Evaluation was based on physical device testing, not a dataset.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI algorithm.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Study Type:

The study described is a non-clinical performance testing study for a physical medical device (endoscope), designed to demonstrate substantial equivalence to a previously cleared predicate device. It involves component and system-level testing of physical characteristics, sterilization, packaging integrity, and functionality based on established industry standards and previous submission's methodologies. There is no AI or software performance evaluation in this clearance.

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Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures.

Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The cystoscopes/hysteroscopes described herein are rigid endoscopes for visualizing the urethra, the urinary bladder or uterus, fallopian tube ostium and the cervical canal during the performance of endoscopic procedures in urology or gynecology.

A rigid endoscope consists of a fiber optic cable and sensitive image transmission system with eyepiece. The fiber optic cable is used to illuminate the site inside the body. The connector for connecting the light guide to the light source is situated at the proximal end of the endoscope. The adapters required to connect the light guide are included in the scope of delivery.

The distal end of the endoscope features an objective lens that captures the image from inside the body. The image is sent through the image transmission system to the eyepiece.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Strauss Surgical Cystoscopes & Hysteroscopes." This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the newly cleared device itself.

Crucially, the document explicitly states under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section that:

"The subject and predicate devices have identical technological characteristics. Therefore, no performance testing was necessary to demonstrate that the subject device is equivalent to the predicate device in terms of safety and performance."

This means that a study proving the device meets individual acceptance criteria, as typically understood for new device performance validation, was not performed or not deemed necessary by the FDA for this 510(k) clearance due to the identical technological characteristics with a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding specific acceptance criteria and the study that proves the device meets them because the document clearly states such testing was not performed for this clearance.

However, I can still address some of your points based on the information provided, even if it's to state the absence of the requested detail:

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

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

• Sample Size for Test Set: Not applicable, as no performance testing was conducted.
• Data Provenance: Not applicable, as no performance testing was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable, as no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

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 device is a rigid endoscope for visualization, not an AI-powered diagnostic tool. Furthermore, no performance testing was conducted.

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

• Not applicable. This device is a rigid endoscope, not an algorithm. Furthermore, no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

8. The sample size for the training set

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

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

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

Summary of Document's Key Information regarding Performance:

The FDA clearance for the Strauss Surgical Cystoscopes & Hysteroscopes (K251652) was based on substantial equivalence to existing predicate devices (K150158 Schoelly Cystoscopes/Hysteroscopes and accessories). The manufacturer asserted, and the FDA accepted, that the subject device and the predicate device have identical technological characteristics. Therefore, no new performance testing (non-clinical or clinical) was deemed necessary or performed to demonstrate safety and effectiveness for this specific 510(k) submission. The clearance relies on the established safety and performance of the predicate device.

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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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The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.

The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The devices are for use in professional Healthcare Facility Environment.

The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.

The provided document, a 510(k) summary for the Hunan Vathin Medical Instrument Co. Ltd's Single-use Flexible Cystoscope and Digital Video Monitor, describes non-clinical performance testing for device acceptance and claims substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets acceptance criteria through clinical performance metrics, multi-reader multi-case (MRMC) studies, or AI-assisted diagnostic improvements. The document focuses on bench testing, biocompatibility, electrical safety, sterilization, software validation, and cybersecurity.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established. This information is typically found in clinical validation studies, which are not detailed in this 510(k) summary.

The document primarily addresses the safety and fundamental performance of the device itself (e.g., optical properties, mechanical bending, material biocompatibility) rather than its diagnostic accuracy or impact on human reader performance, especially in relation to AI assistance.

Despite the lack of information to fully address your request, here's what can be extracted from the document regarding acceptance criteria for non-clinical performance:

1. A table of acceptance criteria and the reported device performance (based on non-clinical tests):

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The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.

This Special 510(k) discloses the modifications to the steps to carry out surface disinfection of the model 4500 handle that was reviewed and cleared in K232837. The Uro-G HD Flexible Cystoscope is a handheld, battery- operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. When fully assembled, the Uro-G HD Flexible Cystoscope- cannula and handle-has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.

This document describes a Special 510(k) submission for the Uro-G HD Flexible Cystoscope, focusing on a minor modification to its surface disinfection process. There is NO mention of an AI/ML device or algorithm. Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of AI/ML.

The provided text only discusses the equivalence of the modified device to its predicate, based on unchanged intended use, indications for use, and technological characteristics, except for the disinfection process.

Here's what I can extract regarding the device performance and the "study" mentioned, which is not an AI/ML study but rather microbiology testing for disinfection:

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

Since the document focuses on a change in the disinfection process and asserts that other performance characteristics remain unchanged from the predicate, and does not provide specific acceptance criteria values for the disinfection, I cannot create a table with specific numbers. Instead, I can describe the nature of the change and the demonstrated outcome.

Regarding the study that proves the device meets the acceptance criteria:

The study referenced is a microbiology testing study conducted to evaluate the effectiveness of the revised surface disinfection process for the reusable handle of the Uro-G HD Flexible Cystoscope.

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

• Sample size: Not specified in the provided text. The document refers to "testing" that "found" specific results for log reductions.
• Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This is not applicable to a microbiology disinfection study. The "ground truth" would be established by the standardized protocols and results of the microbiological tests themselves, rather than expert consensus on interpretation.

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

• Not applicable to a microbiology disinfection study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/ML device, and no MRMC study was performed or mentioned.

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

• Not applicable. This is not an AI/ML device.

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

• For the disinfection efficacy, the "ground truth" was established through microbiology testing results demonstrating "log reductions of ≥ 3 and ≥ 6 of tested pathogens." This is a quantitative measure of antimicrobial effectiveness.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device; there is no training set mentioned.

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

• Not applicable. This is not an AI/ML device.

In summary, the provided document describes a regulatory submission for a medical device (a cystoscope) focusing on a change in its disinfection instructions. The "study" mentioned is a microbiology test to validate the effectiveness of the new disinfection protocol. There is no information related to AI/ML or an algorithm in the provided text.

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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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The LiNA CystoVu HD is intended for use in visualization via LiNA displaying unit of adult male and female urethra and bladder cavity during diagnostic and therapeutic cystoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

The LiNA ScopeVu is intended for visualization from compatible LiNA endoscopes for female and male patients of all ages during diagnostic and therapeutic endoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

The LiNA CystoVu™ HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by LiNA Scope Vu™ full HD display and light source. The LiNA Cysto Vu™ HD is intended to be used with a reusable LiNA ScopeVu™ to visualize the urethra and the bladder. The LiNA CystoVu™ HD can be operated by the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.

The provided text describes the LiNA CystoVu HD and LiNA ScopeVu, single-use flexible cystoscopes, and their substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria with detailed device performance metrics, MRMC comparative effectiveness studies, standalone algorithm performance, or training set details as requested in your prompt.

The document focuses on demonstrating substantial equivalence to a predicate device (Ambu aScope 4 Cysto) through non-clinical performance testing.

Here's a breakdown of what can be extracted from the provided text based on your request, and what is missing:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The text states: "Non-clinical performance testing was conducted in order to demonstrate that the LiNA CystoVu HD and LiNA ScopeVu perform according to their requirements and specifications." It then lists the types of tests conducted:

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

This information is not provided. The non-clinical performance testing description does not specify sample sizes for individual tests or the provenance of any data used for these tests.

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

This information is not provided. The testing described is primarily non-clinical and technical performance testing, not involving expert interpretation of medical images or diagnoses. Human factors testing included "Test participants representing the intended users," but their qualifications for establishing ground truth (in the diagnostic sense) are not relevant or mentioned.

4. Adjudication method for the test set

This information is not provided. Given the nature of the non-clinical performance tests conducted, an adjudication method as typically understood for clinical or image interpretation studies is not applicable or described.

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 information is not provided. The document makes no mention of AI or an MRMC study. It describes a medical device (endoscope components) and its direct performance, not an AI-assisted diagnostic tool.

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

This information is not provided. There is no mention of an algorithm or standalone performance testing for AI components.

7. The type of ground truth used

For the technical and performance tests, the "ground truth" would be the engineering specifications, relevant ISO/IEC standards, and expected functional outcomes. For biocompatibility, it's the established safety profiles within ISO 10993. For sterilization, it's the validated SAL (Sterility Assurance Level).
The document explicitly states: "Clinical data was not used to support substantial equivalence of the subject device to the predicate device." This means there was no ground truth derived from pathology, expert consensus on clinical cases, or outcomes data in a clinical setting for substantial equivalence.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.

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

This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.

In summary: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a medical device (endoscope components) to a predicate device through non-clinical performance testing and technological comparison. It does not involve AI, clinical data for determining substantial equivalence, or detailed studies with the specific metrics the prompt is asking for related to AI performance, expert ground truth, or training sets.

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