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The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.

The UNIDRIVE S III ENT is a motorized surgical device system used for the excision, ablation, removal or transection of bones/tissues during head, neck, ENT, or otoneurological surgical procedures. The system components include a control unit used in conjunction with the High-Speed Micro Motor that houses the high-speed handpieces and DrillCut-X® II Shaver handpieces. The modifications made to the UNIDRIVE® S III ENT system is the addition of the DrillCut-X® II-35 and DrillCut-X® II-35 N Shaver handpieces. Additional accessories used with the UNIDRIVE S III ENT system include the shaver blades, sinus burrs and the sinus burr 35k.

The provided text describes a 510(k) premarket notification for the UNIDRIVE S III ENT system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study for a new AI/CAD device. Therefore, many of the requested criteria related to AI/CAD system performance, such as human reader improvement with AI assistance, sample sizes for AI training/test sets, expert qualifications for ground truth, and adjudication methods, are not applicable or findable in this document.

However, I can extract the information relevant to the device's technical performance and the non-clinical testing performed to demonstrate its acceptance criteria.

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

The document doesn't present acceptance criteria in a quantitative table with specific performance metrics for the device itself (like accuracy, sensitivity, specificity for an AI system). Instead, its acceptance appears to be based on adherence to recognized consensus standards and successful completion of specific non-clinical tests to demonstrate safety and effectiveness, and substantial equivalence to a predicate device.

Here's a summary of the non-clinical performance data provided, which serves as the "acceptance criteria" through compliance:

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

Not applicable. This device is a surgical drill system, not an AI/CAD system evaluated on patient data. The "test set" here refers to the device itself undergoing various engineering and biological safety tests. No patient data or associated provenance is mentioned.

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. Ground truth in the context of AI/CAD systems usually refers to verified diagnoses or findings from medical images. For this surgical device, "ground truth" would be established by engineering standards, material science, and biological safety standards, which are inherent to the testing methodologies used. The document does not specify the number or qualifications of experts involved in the direct testing of the device, beyond implying qualified personnel conducting the tests and regulatory bodies reviewing the submissions.

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

Not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations for establishing ground truth in AI/CAD image analysis studies. This document discusses mechanical, electrical, and biological testing of a surgical device.

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. An MRMC study is relevant for AI/CAD systems that assist human interpretation of medical images. This document describes a surgical drill system.

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

Not applicable. This device is a surgical hardware system, not an AI algorithm. Its performance is inherent to its mechanical and electrical function.

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

The "ground truth" for this device's acceptance is established by engineering standards, material science, and biological safety standards, as demonstrated through the various non-clinical tests (electrical safety, EMC, cleaning/sterilization validity, rotation speed/torque inspection, biological evaluation) and compliance with national and international standards (IEC, ISO, ANSI/AAMI).

8. The sample size for the training set

Not applicable. This document describes a hardware device, not an AI algorithm that requires a training set.

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

Not applicable. As noted above, this is not an AI/CAD algorithm.

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The Image 1 S is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures.

The Image 1 S 4U camera head is intended to the Image1 S Camera Control Unit (CCU) and compatible endoscope for visualization, image recording and documentation during general endoscopic and microscopic procedure.

The Image1 S camera control unit is a medical device which consists of the Image1 S Connect (TC200US), Image1 S Connect II (TC201US) modules and the link modules. The link modules are Image1 S H3-Link (TC300US), Image1 S X-Link (TC301US), Image1 S D3-Link (TC302US) and Image1 S 4U-Link (TC304US).

The Image1 S Connect (TC200US) and the Image1 S Connect II (TC201US) modules can be connected to a minimum of one and a maximum of three links modules. The modularity enables customers to customize their Image1 S system to their specific current and future video needs.

The Image1 S includes, but not limited to, the following features:
• Brightness control
• Enhancement Control
• Automatic Light Source Control
• Shutter Control
• Image/Video Capture

When the Image1 S Connect II module is used with the 4U-Link and the Image1 S 4U camera head, it can output a 4K image to the monitor and also offers 7 increments of zoom ranging from 1x to 2.5x.

The software version of the Image1 S camera control is upgraded to version 4.0. Software version 4.0 introduces the KS HIVE, an Ethernet based interface that allows for communication between the Image 1 S camera control unit and certain KARL STORZ devices.

This is a premarket notification (510(k)) for an endoscopic video imaging system, the Image1 S CCU and Image1 S 4U Camera Head. The primary purpose of this 510(k) is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device (Image1 S, K160044). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the testing and analysis performed to demonstrate this substantial equivalence, rather than a clinical outcome-based performance study typically associated with AI/ML devices.

Here's the breakdown of the information requested, based on the provided text:

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

Since this is a substantial equivalence submission for an imaging system rather than an AI/ML diagnostic or prognostic device, the "acceptance criteria" are related to safety, effectiveness, and technological characteristics compared to the predicate device. The "reported device performance" are the results of the non-clinical tests demonstrating these aspects.

2. Sample sizes 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: The document does not specify a "test set" in the context of clinical images or patient data that would typically be used for AI/ML performance evaluation. The testing primarily involved non-clinical bench testing, software verification/validation, and compliance with standards. Therefore, the "sample size" would refer to the various components and systems tested, but no numerical count is provided for this.
• Data Provenance: Not applicable as no clinical patient data was used for performance evaluation in this 510(k). The testing is primarily engineering and regulatory compliance based.

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)

• Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of clinical annotations by experts for AI/ML performance, was not established as this is not an AI/ML diagnostic device with a clinical performance study. The "ground truth" here is compliance with engineering standards, design specifications, and the functionality of the device as tested by engineers and technicians.

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

• Adjudication Method: Not applicable. There was no clinical ground truth established requiring expert adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an endoscopic video imaging system, not an AI/ML diagnostic assistant, so such a study is not relevant to this submission. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."

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

• Standalone Performance: Not applicable. This is not an AI/ML algorithm. The "standalone performance" refers to the device's functional operation (imaging, brightness control, zoom, etc.) as detailed in the non-clinical performance data and bench testing, which was indeed performed without human-in-the-loop diagnostic interpretations.

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

• Type of Ground Truth: For this device, the "ground truth" used is primarily engineering specifications, compliance with recognized international standards (e.g., IEC 60601 series, ANSI/AAMI reprocessing standards), and the functional design requirements of the imaging system. It's not clinical ground truth like pathology or expert consensus on disease.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not involve an AI/ML algorithm that would require a "training set" of clinical data.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no AI/ML training set.

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The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 11301CE1/20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

The provided information is a 510(k) summary for the KARL STORZ Flexible HD Cysto-Urethroscope System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on AI performance or clinical efficacy. The changes submitted in this 510(k) are related to adding new sterilization methods (Sterilization V PRO-60 and High Level Disinfection).

Therefore, the document does not contain the kind of information requested regarding acceptance criteria and performance studies for an AI/ML driven device, specifically:

• A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for a diagnostic or AI-driven device, but rather refers to reprocessing validation and biocompatibility.
• Sample size used for the test set and the data provenance: Not applicable as there's no mention of a test set for AI performance. The studies mentioned are non-clinical (biocompatibility and reprocessing validation).
• Number of experts used to establish the ground truth...: Not applicable as there's no AI component or ground truth establishment for diagnostic performance.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document explicitly states "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This means no MRMC study was performed.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device.
• The type of ground truth used: 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 Device Performance and Acceptance Criteria from the Provided Document:

The acceptance criteria and performance data in this 510(k) summary are related to the safety and functionality of the endoscope itself, particularly regarding its reprocessing and biocompatibility, as opposed to diagnostic performance of an AI component.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify sample sizes for the biocompatibility or reprocessing validation tests. These tests are typically performed on a limited number of device samples or representative materials.
• Data provenance is not specified beyond being "non-clinical bench testing." There's no mention of country of origin or retrospective/prospective nature as this applies to clinical study data, which was explicitly not required.

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

• Not applicable. Ground truth establishment by experts pertains to diagnostic or clinical performance evaluations, which were not part of this 510(k) submission.

4. Adjudication method 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:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This device is an endoscope system, not an AI-driven diagnostic tool.

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

• Not applicable. This is not an algorithm or AI-driven device.

7. The type of ground truth used:

• Not applicable in the context of diagnostic performance. For biocompatibility and reprocessing, the "ground truth" is adherence to established international standards and FDA guidance for these types of non-clinical tests.

8. The sample size for the training set:

• Not applicable. 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.

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The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.

The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 091011-20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US). The Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)) is a reusable, flexible video scope with an insertion shaft OD of 5.5 mm and length of 37 cm, a working channel OD of 2.3 mm, and a suction channel. Users can choose to attach either a LUER port with stopcocks (Part Number: 11014L) or a double LUER port (Part Number: 11014LU) to the working channel port. In terms of optics, it has direction of view of 0 degrees and field of view of 100 degrees.

The provided document does not describe the acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it focuses on the substantial equivalence of the Flexible HD Cysto-Urethroscope System to predicate devices based on non-clinical performance data, primarily concerning electrical safety, EMC, biocompatibility, and reprocessing validation.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific performance metrics like sensitivity, specificity, or image quality scores that would typically be associated with acceptance criteria for diagnostic devices. Instead, the "performance" is demonstrated through compliance with various safety and technical standards for medical devices.

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

No sample size for a "test set" in the context of diagnostic performance (e.g., patient data, image dataset) is mentioned. The studies performed were non-clinical bench testing to evaluate electrical safety, EMC, biocompatibility, and reprocessing. These tests involve laboratory procedures on device components or the entire device, not on human subjects or patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in this context.

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

Not applicable. Since the studies were non-clinical bench tests (e.g., electrical measurements, material testing, sterilization efficacy), there was no "ground truth" to be established by experts in the diagnostic sense. The results of these tests are typically evaluated against established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as above. There was no need for expert adjudication for non-clinical bench testing.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This indicates that there was no human reader study, and therefore, no effect size of AI assistance could be determined.

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

No, a standalone algorithm performance study was not done. This device is a physical endoscope system, not an AI algorithm.

7. The Type of Ground Truth Used:

As noted, there was no "ground truth" in the diagnostic context. For the non-clinical tests, the "ground truth" implicitly refers to the established scientific and regulatory standards (e.g., specific voltage limits for electrical safety, acceptable cytotoxicity levels for biocompatibility, sterility assurance levels for reprocessing).

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reason as above.

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The CMOS Video-Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.

The CMOS Video-Rhino-Laryngoscope System includes two main components: (1) the CMOS Video-Rhino-Laryngoscope (11102CM) and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatible with two KARL STORZ CCUs: C-HUB and C-MAC.

The document provided is a 510(k) Summary for the KARL STORZ CMOS Video-Rhino-Laryngoscope System (K182186). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving specific clinical performance or to meet acceptance criteria through a clinical study in the way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and multi-reader multi-case studies is not applicable in this context.

This document focuses on comparing the new device's technical specifications and non-clinical performance data (electrical safety, EMC, bench testing, biocompatibility, reprocessing validation) against recognized standards and its predicate device to show that it is substantially equivalent and does not raise new questions of safety or effectiveness.

Here's a summary of the provided information, addressing the spirit of your request where possible, but highlighting the absence of specific clinical performance acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

This type of request for an AI/ML device would typically involve metrics like sensitivity, specificity, AUC, F1-score, etc., with predefined thresholds. For this traditional medical device, the "acceptance criteria" are compliance with established medical device standards and demonstrating substantial equivalence to a predicate device.

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

• Not Applicable. This document does not describe a clinical study with a "test set" in the context of an AI/ML algorithm evaluation. The assessments are based on engineering bench tests, biocompatibility tests, and reprocessing validations rather than clinical data sets.

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

• Not Applicable. Ground truth, in the AI/ML sense, is not established for this type of device submission.

4. Adjudication method 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. This device is a visualization tool, not an AI-assisted diagnostic or interpretive system. Clinical studies comparing human reader performance are not described.

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

• Not Applicable. This is a physical endoscope system, not an algorithm.

7. The type of ground truth used:

• Not Applicable. The "truth" in this context is defined by adherence to engineering specifications, safety standards, and performance characteristics as verified through non-clinical testing.

8. The sample size for the training set:

• Not Applicable. This device does not involve a "training set" as it is not an AI/ML system.

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

• Not Applicable.

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The Flex-THOR System is indicated for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.

The Flex-THOR System includes two main components: (1) the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR), and (2) the Camera Control Unit (CCU). The insertion shaft of the Flex-THOR Scope (Part Number: 11292VS(U)A-THOR) has an outer diameter of 2.9 mm and a working length of 675 mm with 8.5 Fr elliptical shaped distal tip (major diameter of 3.2 mm and minor diameter of 2.4 mm). Users can access the 1.2 mm working channel through the Luer ports.

This FDA 510(k) summary for the KARL STORZ Flex-THOR System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness.

Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (electrical safety, EMC, and reprocessing validation) and a comparison of technological characteristics.

Therefore, I cannot fulfill the request to provide details about acceptance criteria and a study that proves the device meets them in the context of clinical performance or diagnostic accuracy.

Here's what can be extracted from the provided text:

Acceptance Criteria and Device Performance (Not applicable for clinical performance/diagnostic accuracy)

As mentioned, there are no specific acceptance criteria for clinical performance or diagnostic accuracy provided in this document. The focus for this 510(k) submission is on demonstrating safety and effectiveness through substantial equivalence, primarily via non-clinical testing.

The document does report performance against safety and reprocessing standards:

Study Information (Primarily Non-Clinical)

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

   • Test Set Sample Size: Not applicable. The document discusses non-clinical bench testing for electrical safety, EMC, and reprocessing. These types of tests typically involve devices/prototypes and simulated conditions, not a "test set" of patient data in the sense of clinical performance or diagnostic accuracy.
   • Data Provenance: Not specified, but generally, bench testing is performed in a controlled laboratory environment. It is not patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of clinical expert consensus is not part of this 510(k) submission for this device. The non-clinical tests rely on established engineering and microbiological methodologies.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for expert review of images or data, which is not described here.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study was done, as this device (an endoscope) does not involve AI or image interpretation for diagnostic assistance that would require such a study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests:

   • Electrical Safety & EMC: Compliance with international standards.
   • Reprocessing: Verification based on microbiological testing (reduction of microbial load) and visual inspection against established reprocessing protocols outlined in the standards.

7. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm.

Summary of what the document does provide:

• Clinical Performance Data: The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
• Purpose of Non-Clinical Data: The non-clinical data covered electrical safety, electromagnetic compatibility (EMC), and reprocessing validation, all to demonstrate the device is as safe and effective as the predicate device.
• Conclusion: The submission concludes that based on non-clinical performance data and comparison of device characteristics, the Flex-THOR System is substantially equivalent to the predicate device, and the differences do not raise new questions of safety and effectiveness.

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KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.

The KARL STORZ New Generation Trocars provide a port of entry during endoscopic and laparoscopic procedures in pediatric and adult patients. The New Generation Trocars are available in diameters 2.5mm to 13.5mm and consist of a cannula, trocar, and a valve seal. The trocars combine single-use and reusable components since the valve seal is single use while the cannula and trocar are reusable components. The trocars are color coded by size and are available with pyramidal, conical, or conical-blunt tips. Reducers can be used to reduce the size of the trocar to accommodate a smaller instrument without losing pneumoperitoneum.

The KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each bench test performed. It generally states that "Bench verification performance testing has been performed" for the listed parameters.

• Data Provenance: The studies were bench tests performed by the manufacturer, KARL STORZ Endoscopy-America, Inc. There is no information about the country of origin of the data beyond the manufacturer's location in El Segundo, CA. All testing appears to be retrospective in the sense that it was completed prior to the 510(k) submission.

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

Not applicable. The "ground truth" for the performance tests was established through direct measurement against pre-defined engineering and regulatory standards (e.g., ISO standards, specific force/leakage thresholds set by the manufacturer for functional performance). There is no mention of human experts establishing ground truth for these objective bench tests.

4. Adjudication Method for the Test Set

Not applicable. For objective bench tests, results are typically determined by measurement against specified criteria, not by human adjudication.

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 mechanical surgical instrument (trocar), not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance. No MRMC study was performed.

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

Not applicable. This device is a mechanical surgical instrument; it does not involve algorithms or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the bench tests was based on engineering specifications and established regulatory standards (e.g., ISO standards). For example, for biocompatibility, the ground truth was compliance with ISO 10993. For sterility, the ground truth was validation against ISO 11135 and ISO 11737. For mechanical tests, the ground truth would be the defined acceptable ranges for forces, leakage, etc.

For the expansion of indications to include a pediatric population, the "ground truth" was established through medical literature review (real-world evidence) from various peer-reviewed publications covering pediatric minimally invasive surgery.

8. The Sample Size for the Training Set

Not applicable. This device does not use an algorithm that requires a training set. The term "training set" is typically associated with machine learning or AI models.

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

Not applicable. As there is no algorithm or AI, there is no training set or ground truth associated with it.

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The KARL STORZ Slim Nasopharyngoscope System is indicated to provide visualization and access of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic and therapeutic procedures in adult and pediatric patients.

The KARL STORZ Slim Nasopharyngolaryngoscope (Model Number: 11161V) is a reusable, flexible videoscope used for examination of the nasal lumens and airway anatomy. The KARL STORZ Slim Nasopharyngolaryngoscope System is identical to the KARL STORZ Flexible Video-Neuro-Endoscope System, which is currently distributed under K161112.

This document pertains to the 510(k) premarket notification for the KARL STORZ Slim Nasopharyngolaryngoscope System (K171402). This device is a flexible videoscope used for visualization during ENT diagnostic and therapeutic procedures.

Important Note: This submission is for a device that is identical in design and performance to a previously cleared device (KARL STORZ Flexible Video-Neuro-Endoscope System, K161112), with the exception of an additional High-Level Disinfection (HLD) method being supported. Therefore, the majority of the acceptance criteria and study data relate to demonstrating this equivalence and validating the new HLD method, rather than a de novo clinical performance study of the device's efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a device largely identical to a predicate, the "acceptance criteria" here primarily refer to demonstrating equivalence to the predicate and compliance with relevant standards. No performance metrics like sensitivity, specificity, or accuracy (typical for AI/Algorithm-driven devices) are applicable here, as this is an endoscopic visualization device, not an AI diagnostic tool.

The "acceptance criteria" are thus implicitly met by demonstrating that the device is identical in design and performance to the predicate (K161112), and that the new HLD method is validated.

Specific Study Information (as applicable to this type of device submission):

For this 510(k) submission, the primary "study" is demonstrating substantial equivalence to the predicate and validating the new HLD method. Clinical performance data was not required because non-clinical bench testing was deemed sufficient to establish substantial equivalence. This is not an AI/Algorithm device, so many of the requested points do not apply.

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

   • Test Set (for HLD validation): The document states an "HLD validation study was performed using a representative device." It does not specify the exact sample size (number of devices or test cycles) but implies rigorous testing in compliance with the listed standards (e.g., AAMI TIR12, ISO 15883-5).
   • Data Provenance: Not explicitly stated, but typically such validation studies are done in a controlled laboratory environment by the manufacturer or a contracted lab. The document implies it's a prospective validation study to support the new HLD method for this specific device. Country of origin for the HLD study data is not provided.

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

   • Not applicable. For this type of device and submission, "ground truth" as it relates to clinical diagnosis or imagery (like in AI/Algorithm studies) is not established by expert readers. The "ground truth" for HLD validation is established through microbiological testing (e.g., absence of viable microorganisms after disinfection) and material compatibility testing, which are performed by qualified lab personnel following validated protocols, not clinical experts.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical image interpretation studies, typically for AI where there's a need to reconcile discordant expert reads against a reference standard. Here, the "test set" is for HLD validation, not for image interpretation.

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

   • Not applicable. This device is an endoscope for direct human visualization, not an AI-assisted diagnostic tool. No MRMC study was performed or required.

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

   • Not applicable. This device is a manual endoscopic instrument; it does not have a standalone algorithm component.

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

   • For the HLD validation, the "ground truth" for efficacy is the microbiological sterility or reduction level achieved, as determined by validated laboratory methods (e.g., culture, spore count reduction). For material compatibility, the "ground truth" is the absence of degradation or adverse effects on device components after repeated HLD cycles.

7. The sample size for the training set:

   • Not applicable. This device does not have a "training set" in the context of an AI/machine learning algorithm. The design of the existing predicate device (K161112) served as the "base" or "trained" design, and this submission focuses on demonstrating equivalence and validating a new cleaning process.

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

   • Not applicable. (Same reasoning as above).

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The AUTOCON III 400 is intended for use by qualified surgeons to provide a high frequency electrical current for monopolar and bipolar cutting and coagulation of tissue structures during surgical operations.

The AUTOCON III 400 is an electrosurgical unit (ESU) that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. AUTOCON III 400 offers a total of 37 different modes that can be divided into 4 main categories: Monopolar cutting (13 modes), monopolar coagulation (11 modes), bipolar cutting (4 modes), and bipolar coagulation (9 modes). The various modes in each category represent different settings that provide controlled cutting and coagulation. Each mode can be defined by the waveform type, power, crest factor, and duty cycle which correspond to different tissue effects. AUTOCON III 400 consists of a generator, a foot switch, and a power cord. A touchscreen user interface displays the connection status of accessories and peripherals and allows the user to select modes, power settings, effect, and various other settings. AUTOCON III 400 has a bipolar socket, a monopolar socket, and neutral electrode socket for the instruments and accessories with which the generator is compatible. Contact quality indicators are displayed to indicate if the neutral electrodes are correctly connected or not.

The KARL STORZ Endoscopy-America, Inc. AUTOCON III 400 is an electrosurgical generator designed for monopolar and bipolar cutting and coagulation of tissue during surgical operations. The submission focuses on non-clinical performance data to demonstrate substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format for direct comparison of numerical thresholds. Instead, it details the type of non-clinical tests performed and concludes that the device performed comparably to its predicate devices. The study aimed to demonstrate substantial equivalence, meaning the AUTOCON III 400 performs as safely and effectively as the predicate devices. The reported performance is an affirmation of compliance with recognized standards and comparable results in bench testing.

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

The document describes bench-top testing and does not specify a numerical sample size for the "test set" in terms of patient data or clinical cases. The testing was focused on the device itself and its interaction with proxy materials (e.g., tissue samples like liver, kidney, muscle).

• Data Provenance: The data is based on non-clinical, bench-top testing performed by the manufacturer, KARL STORZ Endoscopy-America, Inc. The document does not specify the country of origin of the data beyond the manufacturer's location in El Segundo, CA, USA, and the regulatory body (FDA) in the USA.

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

Not applicable. This was a non-clinical, bench-top study evaluating the technical performance and safety of an electrosurgical unit against regulatory standards and predicate devices, not a study requiring expert clinical ground truth on patient outcomes or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable. Since there was no clinical data or assessment by human readers/experts for a diagnostic or treatment outcome, no adjudication method was used. The evaluation was based on objective measurements and comparison to recognized standards and predicate device performance.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The AUTOCON III 400 is an electrosurgical generator, and its evaluation focused on electrical safety, electromagnetic compatibility, and bench-top performance, not on interpretation by human readers.

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

Yes, a standalone study was performed in the sense that the device's performance was evaluated based on its technical specifications and physical effects, without direct human intervention in the "performance" during the tests outside of operating the device for the bench tests. The tests assessed the device's output, waveform, power, and thermal effects on tissue, which are intrinsic properties of the algorithm/hardware. This was a "device-only" performance assessment in a controlled bench setting.

7. Type of Ground Truth Used:

The "ground truth" for this study was established through:

• Compliance with recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• Comparison to the performance of legally marketed predicate devices (AUTOCON II 400 and ERBE VIO 300D) as defined by the FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery."
• Objective measurements of technical specifications (e.g., output waveform, power output, thermal effects on tissue) to demonstrate "comparable tissue effects and electrical waveforms" to the predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is an electrosurgical generator, not an AI/ML-based device that typically requires a training set of data. The "design" and "settings" of the device are based on engineering principles and intended surgical effects, not on learning from a large dataset.

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

Not applicable, as no training set was used for this type of medical device.

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The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures such as shunt placement, tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration in pediatrics and adult population.

The components subject of this submission are: (1) the KARL STORZ ShuntScope (Model Number: 28164SSA), (2) the examination sheath (Model Number: 11577KA) and (3) operating sheath (Model Number: 11577KE)

The KARL STORZ ShuntScope is indicated to provide visualization and access during cranial diagnostic and therapeutic procedures. This response pertains to the non-clinical performance data for the device. Clinical studies were not required or performed to demonstrate substantial equivalence to predicate devices, as non-clinical bench testing was deemed sufficient.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size (number of ShuntScope units) used for each bench test. The term "bench testing" refers to in-vitro testing, suggesting the tests were performed on manufactured devices. The provenance of the data is from KARL STORZ Endoscopy-America, Inc., and these tests are inherently prospective as they are performed to verify the design of the new device.

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

Not applicable. This is a non-clinical bench testing study assessing physical and optical characteristics of a device, not a diagnostic or clinical performance study requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" here is adherence to manufacturing specifications and design requirements.

4. Adjudication Method for the Test Set:

Not applicable. As this is non-clinical bench testing, there is no adjudication method in the context of clinical interpretation or diagnosis. The "Pass" results indicate that the device met its pre-defined engineering and performance specifications.

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

No. An MRMC comparative effectiveness study was not done. This study focuses on the technical performance of the device itself (e.g., its physical dimensions, optical properties) rather than its effectiveness in a clinical setting with human readers.

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

Not applicable. This device is a neurological endoscope, which is a physical instrument for visualization and access, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for these bench tests consisted of pre-defined technical specifications and engineering requirements. For instance, the "Maximum insertion portion width" has a ground truth of "not larger than 1 mm," and the "Direction of view" has a ground truth of "0° ± 10°." These are objective, measurable criteria established during the device's design and manufacturing process.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of this performance evaluation.

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

Not applicable, as there is no training set for this type of device.

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