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The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.

Based on the provided FDA 510(k) clearance letter for the KARL STORZ Cysto-Urethro-Fiberscope, it's clear that no clinical performance data was provided or required for this 510(k) submission. The submission relies entirely on non-clinical (bench) performance data.

Therefore, many of the requested elements pertaining to acceptance criteria and clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for clinical data) are not applicable to this particular device clearance.

The 510(k) summary explicitly states:

Clinical Performance Data Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to support substantial equivalence.

Given this, I will describe the acceptance criteria as implied by the non-clinical tests conducted and the proof that the device met these criteria based on the information provided.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for KARL STORZ Cysto-Urethro-Fiberscope

As per the submitted 510(k) summary (K244001), the substantial equivalence of the KARL STORZ Cysto-Urethro-Fiberscope was established through non-clinical performance data only. No clinical studies were conducted or required for this clearance.

Therefore, the "acceptance criteria" are derived from the successful completion of various bench tests and compliance with recognized standards designed to ensure the safety and effectiveness of the device. The "study" proving the device meets these criteria refers to the non-clinical (bench) performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to the successful completion and passing results of the tests conducted in accordance with the listed standards and internal design specifications. The performance is reported as meeting these standards.

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

• Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" in this context refers to the physical units of the device subjected to bench testing. The specific number of units tested for each non-clinical performance test is not detailed in the 510(k) summary, but it would have been sufficient to meet the requirements of the cited standards and internal quality procedures.
• Data Provenance: Not applicable for a clinical study. The non-clinical testing was conducted by KARL STORZ SE & CO. KG, which is based in Tuttlingen, Germany. The data is from laboratory (bench) testing, not patient data.

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

Not applicable. No clinical test set requiring expert ground truth establishment was used. Bench testing relies on objective measurement against predefined specifications and standard requirements, not subjective expert assessment of clinical data.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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

No. An MRMC study was not conducted as no clinical performance study was performed or required.

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

Not applicable. This device is a medical instrument (fiberscope), not an AI algorithm. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the bench tests is the objective, measurable performance of the device against established engineering specifications, safety standards (e.g., IEC, ISO, ANSI/AAMI), and the functional capabilities of the predicate device. This is determined through physical measurements, chemical analyses, and standardized test protocols.

8. The Sample Size for the Training Set

Not applicable. No clinical training set was used as this is a physical medical device (fiberscope), not an AI/ML algorithm requiring data-driven training.

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

Not applicable. No clinical training set was used.

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The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11274BCU1) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The provided text is a 510(k) Summary for the KARL STORZ Pediatric Cysto-Urethro-Fiberscope. It outlines the characteristics of the device and establishes its substantial equivalence to a predicate device. However, it does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy.

The document details non-clinical performance data, primarily focusing on compliance with various international standards for biocompatibility, reprocessing validation, and bench performance testing for mechanical, optical, and thermal/photobiological safety.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML.
2. Sample size and data provenance for a test set (as no such test set for diagnostic performance is described).
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth (as no ground truth for diagnostic performance is mentioned).
8. Sample size for the training set.
9. Ground truth establishment for the training set.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device." This confirms that there was no study conducted to assess the device's diagnostic performance against specific acceptance criteria using patient data, which is what your questions are geared towards.

The "Non-Clinical Performance Data" section lists various standards the device complies with, but these are related to the physical and functional safety of the endoscope itself, for example:

• Biocompatibility Testing: ISO 10993 series for biological evaluation of medical devices.
• Reprocessing Validation: Standards like ISO 14937, ISO 17665-1, AAMI ST98 for cleaning and sterilization.
• Bench Performance Testing: IEC 60601-2-18, IEC 62471, ISO 8600-3, ISO 8600-5 for mechanical, optical, and thermal/photobiological performance.

These are not acceptance criteria or performance metrics related to diagnostic accuracy or the performance of an AI/ML component. The device is a flexible fiber endoscope, and the regulatory filing focuses on its substantial equivalence to another endoscope based on engineering specifications and safety standards, rather than any AI-driven diagnostic capabilities.

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The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.

The Flexible CMOS-Video-Cysto-Urethroscope system consists of an endoscope and a monitor. The endoscope is a single device and can be said to be made up of an instrument handle, a shaft and a video connector cable. The handle has three camera control buttons, a deflection control lever and a luer connector to the working channel. An LED located in the handle and is use to provide the illumination for visualization of the anatomy under examination. The light is transmitted from the LED to the distal tip via glass fiber light bundles, where it is used to illuminate the body cavity under examination. The CMOS imaging sensor is located at the distaltip of the endoscope shaft captures the reflected light and converts it to a standard NTSC video signal. The luer connector and working channel are used as an introduction port for irrigation fluid and endoscopic instruments. The 8402ZX monitor provides visualization of the image being captured by the CMOS chip in the endoscope. During the procedure, the physician can use the control buttons on the monitor to perform functions, such as video and single image capture.

The KARL STORZ Flexible CMOS-Video-Cysto-Urethroscope is a medical device designed for visualizing and providing operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract, including the bladder and urethra. The submission does not explicitly list acceptance criteria in a table format with performance metrics. However, it states that "Testing demonstrated that the device is as safe & effective and performs as well as or better than the predicate devices." The predicates are KARL STORZ Video-Urethro-Cystoscope System (K062918) and KARL STORZ Flexible Fiber Optic Cystoscope (K945185).

Therefore, the implicit acceptance criteria are that the device meets or exceeds the safety and effectiveness of these predicate devices. The study conducted to prove this involves various non-clinical performance and safety tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not provided in a quantifiable table, the table below reflects the comparison to predicate devices, which serves as the basis for substantial equivalence.

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

The provided document describes bench testing (non-clinical) and does not mention human subject testing or specific data sets in terms of images or patient cases. Therefore, there is no information on a "test set" in the context of image analysis or algorithm performance, nor is there information on data provenance (country of origin, retrospective/prospective). The testing focused on physical, electrical, and material performance of the device itself.

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

Not applicable. The study is based on bench testing of the device's physical and functional properties against engineering standards and comparison to predicate devices, not on interpretation of outputs by human experts to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no human expert adjudication of a test set is described.

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

Not applicable. The submission does not describe a MRMC study or any study comparing human readers with AI assistance versus without. The device itself is an endoscope, not an AI-powered diagnostic tool requiring human-in-the-loop analysis.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is an endoscope, which is a tool for visualization and access, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Conformance to recognized international standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 8600-1, ISO 8600-3, ISO 8600-4.
• Results from bench testing for mechanical, optical, and illumination performance.
• Successful validation studies for cleaning, disinfection, and sterilization protocols.
• Biocompatibility testing per ISO 10993-1:2009.
• Software verification testing.
• The intended use and technological characteristics being substantially equivalent to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is an endoscope, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

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The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories are intended used for by a physican in thevisual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories includes a flexible endoscope and accessory items designed for treatment of urological endoscopic procedures. The Karl Storz Pediatric Flexible Cysto-Urethnel Fiberscope is a Class II device under 21CFR876.1500, Endoscope and accessories.

This looks like a 510(k) premarket notification for a medical device (Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories). However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

• Identification of the applicant and device.
• Device description and intended use.
• Claim of substantial equivalence to a predicate device.
• FDA's letter of clearance for marketing the device.

For medical devices that clear via substantial equivalence to a predicate, extensive primary studies demonstrating performance and adherence to acceptance criteria are often not required to be submitted in the 510(k) itself, particularly for devices with well-established technologies and similar specifications to existing devices. The FDA clearance letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This means the device's safety and effectiveness are inferred from its similarity to an already approved device, rather than requiring new, detailed performance studies to meet specific acceptance criteria.

Therefore, I cannot provide the requested information. The document as provided does not contain the data to fill out your table or answer your specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies.

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The Anchorage™ Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications:

Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology

The Anchorage™ Scope is a flexible fiber optic endoscope provided as a sterile single use device. The endoscope is used to visualize body cavities, organs, canals, and tissues. The Anchorage Scope is introduced through natural body cavities or surgical incisions through introducers or trocars, catheters, sheaths or other devices of with lumens having an inside diameter greater than the outside diameter of the endoscope.

Here's an analysis of the provided text regarding the Epitek Anchorage™ Scope, focusing on the acceptance criteria and supporting study data:

The provided 510(k) summary for the Epitek Anchorage™ Scope does not contain the specific acceptance criteria or a detailed study description that proves the device meets those criteria, as one would typically find for a medical imaging AI device.

Instead, this document describes a traditional medical device (an endoscope) and focuses on demonstrating substantial equivalence to a predicate device based on in-vitro testing, biocompatibility testing, and conformance to consensus and voluntary standards.

Therefore, I cannot populate the requested table or provide answers to most of the specific questions about AI/software performance studies. The information provided is for a hardware device, not an AI or software-based medical device.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not specified. The document refers to "in-vitro testing" but does not give specific sample sizes for particular tests.
• Data Provenance: Not applicable in the context of clinical data for AI. The testing appears to be laboratory-based (in-vitro) and compliance-based.

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

• Not applicable. This is not a study requiring expert ground truth for image interpretation or diagnosis.

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

• Not applicable. This is not a clinical study involving adjudication of interpretations.

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 is not an AI device, and therefore no MRMC study with human readers and AI assistance was conducted or reported.

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

• No. This is not an AI algorithm.

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

• Not applicable in the context of clinical ground truth. For the hardware device, the "ground truth" for its performance would be its adherence to engineering specifications, safety standards (e.g., biocompatibility standards), and functional requirements observed during in-vitro testing.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable.

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The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.

The KARL STORZ Flexible Video-Urethro-Cystoscope System is use of the Video-Urethro-Cystoscope with Karl Storz CCU and Karl Storz Light source. The body contact portions of the Video-Urethro-Cystoscope are composed of materials used in other Karl Storz devices which have a long history of biocompatibility for human use and are commonly used in medical devices for a wide range of applications.

The provided text is a 510(k) summary and FDA clearance letter for a medical device called the "Karl Storz Flexible Video-Urethro-Cystoscope System." This document aims to establish substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria in the way an AI/ML device would. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable or available in this type of submission.

Here's a breakdown based on the provided text, indicating where information is not present:

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

   • Not applicable / Not provided. This document is a 510(k) summary for substantial equivalence, not a performance study report with specific acceptance criteria and performance metrics. The submission asserts that "The minor differences between the Karl Storz Video-Urethro-Cystoscope System and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This statement implies that performance is considered equivalent to the predicate, but no specific performance criteria or data are presented.

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

   • Not applicable / Not provided. No test set or associated data are mentioned for this type of submission.

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 / Not provided. No ground truth establishment is described as this is not a study assessing diagnostic performance against a gold standard.

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

   • Not applicable / Not provided. No test set or adjudication process is 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

   • Not applicable / Not provided. This is a hardware device (an endoscope system), not an AI/ML diagnostic aid, so an MRMC study related to AI assistance is not relevant.

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

   • Not applicable / Not provided. This is a hardware device, not an algorithm.

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

   • Not applicable / Not provided. No ground truth is established for this type of submission. The device's "ground truth" is its functional equivalence to a predicate device for visual examination and therapeutic access in urological procedures.

8. The sample size for the training set

   • Not applicable / Not provided. No training set is relevant as this is a hardware device, not an AI/ML model.

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

   • Not applicable / Not provided. No training set or associated ground truth establishment is mentioned.

Summary based on the provided text:

The submission confirms the device's intended use and describes its components, noting that body contact portions are made of materials with a "long history of biocompatibility for human use." The core of the submission is the claim of "Substantial Equivalence" to predicate devices, meaning it is considered equally safe and effective without raising new questions of safety or effectiveness. There is no performance study described with acceptance criteria in the traditional sense for an AI/ML or diagnostic performance claim. The FDA's clearance is based on this claim of substantial equivalence.

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The Laserscope GDD Cystourethroscope Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological surgery through minimally invasive approach by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra and cold slitting strictures Trans-urethral incision, vaporization, and resection of the prostrate Trans-urethral removal of bladder tumors

The 24 Fr GDD Cystourethroscope is designed with a continuous flow outer sheath, a separate inner sheath/bridge, and an obturator. The outer sheath has the inflow and outflow Stopcocks attached to it. The inner sheath/bridge has one integral accessory port and can accommodate one accessory up to 9 Fr in size. The obturator is designed to allow atromatic introduction of the outer sheath in a natural orfice. The true continuous flow design washes away blood and small tissue particles to ensure a clear operative field. The working length is 23.2 cm to allow access to the entire lower urinary tract. The dedicated operative channel stabilizes accessories including laser fibers. The Continuous Flow Laser Cystourethroscope is designed to be used with low viscosity fluids, including normal saline, Glycine, Sorbitol, or Ringer's Lactate, and standard surgical accessories.

The provided document is a 510(k) summary for the Laserscope Guided Delivery Device (GDD) Cystourethroscope & Accessories. It explicitly states in section "K. Clinical Data" that "No clinical tests were performed." This means that the submission for this device did not include any studies proving the device meets specific acceptance criteria based on clinical performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found within this document.

The manufacturer, Laserscope, based their rationale for substantial equivalence and safety on the device sharing "the same Indications For Use, similar design, materials, component features, and functional features" with the predicate device, the Stryker Urology and Gynecology Hardware System. They concluded that "There are no new issues raised regarding the safety or effectiveness of the device."

In summary, the document does not contain the information needed to answer your questions because no clinical studies were conducted for this 510(k) submission.

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The Cysto-Urethroscopes 'E-Line' and Accessories are used to visualize and manipulate the bladder, urethra and ureter via natural passages.

The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage.

The obturator/vlewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed.

The inserts are used to guide and angle flexible auxiliary instruments.

The attachments (adapters) serve to connect endoscope and sheath.

The forceps/optical forceps and scissors are used for endoscopically controlled grasping, manipulating, cutting, dissecting and removal of tissue, bladder stones and foreign bodies via natural and surgically created passages.

Optical forceps with unipolar HF connections are used for coagulation by means of high frequency currents to treat minor hemorrhages.

The Cysto-Urethroscopes "E-Line" submission consists of Sheaths, Obturators, Inserts, Adapters and Optical Forceps.

The provided document is a 510(k) premarket notification summary for the Cysto-Urethroscope "E-Line" and Accessories device. It states that no clinical tests were performed (Section 6.0 of the 510(k) Summary of Safety and Effectiveness). Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, cannot be extracted from this document because no clinical performance data is presented. The submission relies on substantial equivalence to predicate devices and conformance with the Medical Device Directive 93/42/EEC, rather than on new clinical performance data.

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Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for use in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

The Images Cystourethroscopes and accessories transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a series of optical lenses and prisms. Sheathes and obturators are offered to allow access to the surgical site.

The provided documents are a 510(k) summary and clearance letter for the Smith & Nephew Images Cystourethroscope and accessories. This submission focuses on establishing substantial equivalence to a predicate device rather than providing a performance study with detailed acceptance criteria and testing results against those criteria.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in these documents. The primary "acceptance criterion" in a 510(k) process like this is demonstrating substantial equivalence.

Here's an analysis based on the provided information, noting where data is absent:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criterion (Implicit)	Reported Device Performance
   Substantial Equivalence to Predicate Device (Karl Storz Endoscopy Cystourethroscopes and accessories) in design, materials, and intended use.	The Smith & Nephew, Inc. Images Cystourethroscopes and accessories are deemed "substantially equivalent in design, materials, and intended use" to the Karl Storz Endoscopy Cystourethroscopes and accessories. This determination implies that the Smith & Nephew device meets the safety and effectiveness standards of the predicate device and does not raise new safety or effectiveness concerns. No specific quantitative performance metrics are provided in these documents.
   No new safety or effectiveness concerns.	The submission states the device "present no new safety or effectiveness concerns." This is a qualitative assessment made by the manufacturer and accepted by the FDA for substantial equivalence. No specific risk analysis or performance data demonstrating this is included in these documents.

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

   • Not applicable / Not provided. A formal performance study with a distinct "test set" as typically understood for AI/software devices is not described. The substantial equivalence determination relies on comparison to an existing predicate device rather than new clinical trials with quantifiable performance data.

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 / Not provided. Ground truth establishment, in the context of a performance study, is not described in these documents as no such study is detailed.

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

   • Not applicable / Not provided. Adjudication methods are not relevant as no formal test set evaluation is outlined.

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 is a hardware device (cystourethroscope) for direct visualization, not an AI or software-assisted device that would involve human "readers" or an "effect size" of improvement with AI.

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

   • No. This device is a manual medical instrument for direct human use, not an algorithm.

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

   • Not applicable / Not provided. As no formal performance study is detailed, no ground truth type is specified. The "ground truth" for a 510(k) in this context is essentially the established safety and efficacy profile of the predicate device.

8. The sample size for the training set:

   • Not applicable / Not provided. No training set is mentioned as this is not an AI/ML device.

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

   • Not applicable / Not provided. No training set or ground truth for it is relevant to this 510(k) submission.

Summary of what the document does provide:

• Device Name: Smith & Nephew Images Cystourethroscope and accessories
• Intended Use: Examination of the bladder, urethra, and distal ureter; and performing various diagnostic and therapeutic procedures with additional accessories.
• Predicate Device: Karl Storz Endoscopy Cystourethroscopes and accessories.
• Basis for Clearance: Substantial equivalence to the predicate device in design, materials, and intended use, with no new safety or effectiveness concerns.
• Function: Transfers light to the surgical site via glass fiber optics and allows visualization through optical lenses and prisms. Sheaths and obturators provide access.
• Regulatory Class: II
• Product Codes: 78 FBO, 78 KOA

Conclusion: The provided 510(k) documents are for a traditional medical device demonstrating substantial equivalence, not a software or AI device requiring detailed performance studies against specific acceptance criteria using test and training sets with established ground truths. Therefore, most of the requested points are not applicable to this type of regulatory submission.

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The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue endoscopically.

The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed for grasping tissue and/or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.

This 510(k) summary (K962474) describes a medical device, the Olympus FG Grasping Forceps, intended for grasping and retrieving tissue and foreign bodies during endoscopic procedures. It is a premarket notification for a new version of an existing device and does not contain any information about acceptance criteria, device performance studies, or AI/software validation.

Therefore, I cannot provide the requested information in the format given. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing performance evaluation data typically found for diagnostic AI devices.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria or Performance Data: The 510(k) summary does not mention any specific performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) or acceptance criteria for those metrics. It only describes the intended use and physical characteristics of the device.
• No AI/Software Component: The device is a physical grasping forceps, not an AI or software-driven diagnostic or therapeutic tool. Therefore, concepts like "test set," "training set," "ground truth," "MRMC study," "stand-alone performance," or "human reader improvement with AI" are not applicable.
• No Study Described: The document is a regulatory submission summary, not a study report. It states that the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar, but it does not present new study data to prove this equivalence in terms of specific performance metrics.

In summary, the provided document is not relevant to the questions posed, as it describes a mechanical medical device and lacks any data or discussion regarding performance acceptance criteria or a study demonstrating such performance, especially concerning AI or software validation.

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