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The products are used to store medical devices before, during, and after sterilization.

The products are intended to enable sterilization of the enclosed medical devices but are not intended to maintain sterility on their own; instead, they are used in conjunction with an FDA-approved sterilization wrap that is legally available on the market.

The products have no medical indications. Sterilization cycle times are as follow: Exposure time: 3 min Temperature: 132 ℃ Drying time: 20 min

The maximum validated load weight for all devices listed below is 4.5 kg (approx. 9.92 lbs).

All measurements are in millimeter and are coded as follows [WidthxHeightxLength].

UNIVERSAL PERFORATED BASKET 1 (33001); 732x117x282) UNIVERSAL PERFORATED BASKET 2 (33002); (743x200x282) UNIVERSAL PERFORATED BASKET 3 (33003); (538x117x250) UNIVERSAL PERFORATED BASKET 4 (33004); (538x117x250) UNIVERSAL PERFORATED BASKET 5 (33005); (549x200x250) PERFORATED BASKET FOR SMALL PARTS (33006); (128x40x121) PERF. BASKET – KNEE ARTHROSC. BASIC SET (33007); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 1 (33008); (549x150x250) PERF. BASKET - KNEE ARTHROSC. ACL/PCL 2 (33009); (549x150x250) PERF. BASKET FOR KNEE ARTHROSC. PREP TAB (33010); (549x150x250) PERF. BASKET FOR VERTEBRIS LUMBAR (33011); (549x150x250) PERF. BASKET FOR SHOULDER ARTHROSCOPY (33012); (538x117x250) PERF. BASKET FOR VERTEBRIS FORAMINOTOMY (33013); (525x65x255) PERF. BASKET FOR VERTEBRIS STENOSIS (33015); (549x150x250) PERFORATED BASKET FOR CAMERA HEAD (38002); (448x73x200) PERFORATED BASKET, UPPER URINARY TRACT 1 (38003); (635x75x132) PERF. BASKET FOR CYSTOSCOPE/TELESCOPE (38004); (467x75x132) PERFORATED BASKET FOR DISCOSCOPE (38005); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 1 (38006); (467x75x132) PERF. BASKET FOR VIDEO MEDIASTINOSCOPE (38007); (256x85x250) PERFORATED BASKET FOR TELESCOPE (38008); (467x75x132) PERFORATED BASKET FOR HYSTEROSCOPE 2 (38009); (467x90x132) PERFORATED BASKET FOR STEREO TELESCOPE (38010); (477x139x196) PERFORATED BASKET FOR NEPHROSCOPE (38011); (467x75x172) PERFORATED BASKET FOR MORCESCOPE (38012); (467x75x172) PERFORATED BASKET FOR CYSTO-URETHROSCOPE (38013); (451x64x80) PERFORATED BASKET FOR 3D TELESCOPE (38014); (583x80x200) PERF. BASKET FOR STANDARD TELESCOPE 1 (38015); (297x54x59) PERF. BASKET FOR STANDARD TELESCOPE 2 (38016); (481x54x59) PERF. BASKET FOR STANDARD TELESCOPE 3 (38017); (619x54x59) PERFORATED BASKET FOR PAIN THERAPY (33014); (525x95x255)

The PERFORATED BASKETS all have the same basic configuration, a metal basket base and a basket lid, with optional product specific instrument carriers (for multiple levels) or adapters and an additional basket for small parts. The base part and the lid of the PERFORATED BASKET are connected by a locking mechanism, which assures a tight connection of both parts.

The provided text describes the acceptance criteria and study proving the performance of "Perforated Baskets" for sterilization.

Here's the breakdown of the requested information:

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)

The document does not explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). It mentions "For each device it was evaluated whether specific testing was necessary" and lists "all devices" in relation to the maximum validated load weight, implying that all listed "Perforated Baskets" were part of the evaluation for performance testing.

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 information is not provided in the document. The ground truth for cleaning and sterilization effectiveness is based on scientific standards and quantitative measurements (e.g., protein, hemoglobin levels, SAL), which do not typically require expert consensus in the same way as, for example, image interpretation.

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

The document does not mention any adjudication method. The tests conducted are objective, quantitative measurements against established standards.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (perforated baskets for sterilization), not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

A standalone performance evaluation was conducted for the device's ability to facilitate cleaning and steam sterilization. This device does not involve an algorithm or AI.

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

The ground truth used for performance evaluation is based on established scientific and industry standards for cleaning effectiveness (AAMI TIR 30: 2011, ANSI/ AAMI ST98: 2022) and sterilization assurance (EN ISO 14937, Annex D). These standards define quantitative thresholds and methodologies for determining success.

8. The sample size for the training set

This information is not applicable and not provided. The "Perforated Baskets" are not an AI/ML device that requires a training set.

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

This information is not applicable. The "Perforated Baskets" are not an AI/ML device that requires a training set.

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The product is used for generating high frequency electrical current for cutting and coagulating tissue electrosurgically.

The HF SURGERY GENERATOR 400KHZ is used for electrosurgical cutting and coagulation of living human tissue. For this purpose, electrical energy from the power supply network is transformed into high frequency current which allows this surgical property. The device offers a multitude of different profiled current forms which are optimized for the different surgical requirements. It is equipped for monopolar and bipolar cutting and coagulation in micro- and macrosurgical operations.

Here's a breakdown of the acceptance criteria and the study information for the HF SURGERY GENERATOR 400KHZ, based on the provided FDA 510(k) summary.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, it primarily reports on comparative testing and compliance with standards rather than detailed acceptance criteria and specific performance metrics of a novel algorithm or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria in numerical terms (e.g., minimum accuracy, sensitivity, or specificity) nor does it provide a numerical "performance" for such criteria. Instead, the acceptance criteria are largely implied by compliance with safety and performance standards, and comparison to the predicate device.

The "reported device performance" is primarily that the device meets relevant standards and is substantially equivalent to the predicate.

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

This document does not describe a clinical study with a "test set" in the context of AI or diagnostic device performance based on patient data. The performance testing conducted for the HF SURGERY GENERATOR 400KHZ is primarily bench testing and animal testing.

• Sample Size for Test Set: Not applicable in the context of patient data for AI. For bench and animal testing, specific sample sizes are not detailed in this summary.
• Data Provenance: Not applicable for patient data. The testing involves engineering verification and validation.
  • One test mentioned is "Validation of the performance on tissue (Section 19 Performing Testing Animal)". This suggests animal models were used, but details on the number of animals or specific data are not provided in this summary.

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

Not applicable. This device is an electrosurgical generator, which is a therapeutic device, not a diagnostic device that requires expert interpretation for a "ground truth" to evaluate an algorithm's performance.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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 an electrosurgical generator, not an AI-assisted diagnostic tool for human readers.

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

The device contains software classified as a "Major Level of Concern." While "Software Verification and Validation" was performed, the document does not describe a standalone algorithm-only performance study in the way this question typically refers to AI performance (e.g., classifying images without human input). The software's role is in controlling the electrosurgical generator's functions, not performing diagnostic interpretations.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the "Validation of the performance on tissue (Section 19 Performing Testing Animal)" and "Validation of the performance based on waveform comparison," the "ground truth" would be established through:

• Bench Test Results: Measured electrical outputs (power, voltage, frequency, crest factor) compared against engineering specifications and predicate device characteristics.
• Animal Tissue Response: Observation and potentially histological analysis of tissue effects (cutting, coagulation) in animal models, likely assessed against expected outcomes for electrosurgery.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML-driven diagnostic or image analysis device that requires a training set of data. The software is likely rule-based or control-loop based, validated against specifications.

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

Not applicable. No training set is described for this type of device.

In summary, the provided FDA 510(k) substantial equivalence summary for the HF SURGERY GENERATOR 400KHZ focuses on demonstrating that the device is safe and effective by:

1. Compliance with recognized electrical safety and EMC standards.
2. Comparison of technological characteristics to a legally marketed predicate device.
3. Performance testing: This includes bench testing of electrical outputs, waveform comparison, animal tissue testing, software verification/validation, and transportation validation.

It is crucial to understand that the questions posed are typically relevant to AI/ML-enabled diagnostic medical devices, which this electrosurgical generator is not.

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Upon intravenous administration of TRADENAME (ICG drug product), System green is used with TRADENAME (ICG drug product) to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.

System green is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. System green enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with System green is intended for use with standard of care white light, and when indicated, intraoperative cholangiography.

The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration of TRADENAME (ICG drug product), System green is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes

System green combines the camera head, the rigid endoscope, the light source including light cables and a foot switch and the camera controller. The camera head is connected via a standard camera cable while the connection between the camera controller and light source is possible via a LAN (Ethernet) connection cable. This is the precondition for the video in fluorescence mode.

The camera head is further connected to the rigid endoscope via a snap-on locking mechanism. The rigid endoscope is further coupled via the fiber light source, which can also be connected to an optional foot switch.

System green allows for fluorescence imaging by exciting indocyanine green (ICG), a dye (FDA approved drug, not included in this submission) that is applied intravenously or interstitially in the body. Fluorescence imaging and white light imaging is possible with the same system setup at the same time. The NIR images can only be displayed as overlay pictures with the NIR information added to the white light image. The white light image can also be displayed on its own.

The provided text is a 510(k) summary for the "System green" endoscopic fluorescence imaging system. It details the device's indications for use and a summary of performance testing. However, it does not contain the specific information required to describe acceptance criteria for an AI/ML-based device or a detailed study proving the device meets those criteria in human clinical trials.

The performance testing section (5.10 Summary of Performance Testing) primarily focuses on non-clinical performance (e.g., Electromagnetic Compatibility and Electrical Safety, Photobiological safety, Temperature safety, Tightness, Transport simulation) and animal testing. There is no mention of a human clinical study, an AI component, specific acceptance criteria for AI model performance (like sensitivity, specificity, AUC), or details about ground truth establishment, expert adjudication, or MRMC studies.

Therefore, most of the requested information cannot be extracted from this document. The device in question is an imaging system that enables fluorescence imaging by exciting indocyanine green (ICG), a dye, and displaying NIR images as overlays. It is not an AI/ML diagnostic or prognostic device that has specific performance metrics in terms of classification, detection, or segmentation, which would typically be evaluated in the manner requested.

Unable to Fulfill Request with Provided Information:

The provided document describes a medical device clearance submission (K212808) for "System green," an endoscopic fluorescence imaging system. The performance testing detailed in the document (Section 5.10) focuses on non-clinical tests (electromagnetic compatibility, electrical safety, photobiological safety, temperature safety, tightness, transport simulation) and animal testing.

There is no mention of any AI or machine learning component within the "System green" device, nor is there any description of a clinical study, acceptance criteria, or performance metrics typically associated with AI/ML device validation (e.g., sensitivity, specificity, AUC, human reader improvement).

Therefore, I cannot populate the requested table or answer the specific questions related to AI acceptance criteria, ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies based on the provided text. The document indicates that the device met "all specified acceptance criteria set out for the animal testing," but these are not the detailed AI/ML specific criteria requested.

Information that can be extracted, but does not directly address the AI/ML acceptance criteria or study details:

• Device Name: System green (includes Logic HD camera head green, Light Source LED Green, Fiber Light Cable, Logic HD Camera Controller, Logic 4K Camera Controller, PANOVIEW ULTRA Telescopes).
• Study Type (closest fit): Animal Testing (pre-clinical model).
• Device Performance (from animal testing): "The test results show that the subject device met all specified acceptance criteria set out for the animal testing, and that the performance of the device with respect to the risk of incorrect fluorescence has been confirmed. Animal testing verified the effectiveness as described in the indications for use."
• Ground Truth (for animal testing): Implied to be derived from the animal model itself, confirming effectiveness and risk of incorrect fluorescence.

All other requested information regarding AI acceptance criteria, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for the training set, is not present in the provided text.

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The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.

The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories. The subject device is used in combination with sensor endoscopes and a monitor for visualization. In this context, the D Camera Controller is the control unit, its primary performance characteristics are signal processing of the image data and image recording. No further light source is required for the intervention. The D Camera Controller supplies the distal LED of the endoscope with light. The electrical signals provided by the sensor endoscope are processed and adequately converted to render a visible image of the endoscopic scene on a connected display device for the user.

This document is a 510(k) Summary for the Richard Wolf D Camera Controller (K211332), filed with the FDA. It declares substantial equivalence to a predicate device, the LOGIC HD LITE CAMERA CONTROLLER (K200617). The core argument for equivalence primarily rests on non-clinical performance testing and software verification.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This device, the "D Camera Controller," is a hardware component (a camera controller) for endoscopy, not an AI or imaging diagnostic device in the traditional sense. Therefore, many of the typical acceptance criteria and study types associated with AI/ML diagnostic tools (like those involving image classification, human reader performance, ground truth establishment by expert consensus, etc.) are not applicable or described in this document. The focus here is on the functional safety and effectiveness of the device as a video endoscopy component.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML diagnostic device, the acceptance criteria are largely related to functional performance, electrical safety, electromagnetic compatibility, and software validation. The document describes that the device met these criteria rather than providing a quantitative table of thresholds vs. observed performance in a diagnostic context.

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

• Sample Size: The document does not specify a "test set" sample size in terms of clinical cases or patient data. The testing described is primarily bench testing (performance, electrical safety, EMC) and software testing, not a clinical study involving a dataset of medical images or patient outcomes.
• Data Provenance: Not applicable in the context of clinical image data. The testing is described as internal verification and validation of the device's engineering performance.

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

• Not applicable. The "ground truth" for this device is its adherence to engineering specifications, electrical safety standards, electromagnetic compatibility, and software functionality, as verified through standard testing procedures. It is not an AI diagnostic device where expert interpretation of clinical data constitutes "ground truth."

4. Adjudication Method for the Test Set

• Not applicable. As the performance testing is against technical specifications and standards, there is no need for expert adjudication of medical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

• No. An MRMC study is relevant for AI image analysis tools where human reader performance (with and without AI assistance) is being evaluated. This device is a camera controller, not such an AI tool.

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

• Not applicable. This device is a hardware component with integrated software for image acquisition and processing. Its "standalone" performance is its ability to meet specified technical and functional requirements, which are detailed implicitly through the various compliance tests mentioned (EMC, electrical safety, software V&V, functional tests). It's not a standalone diagnostic algorithm that produces a finding independent of human interaction.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is:
  • Engineering Specifications: The device must meet its design requirements for signal processing, image recording, user interface functions, etc.
  • Regulatory Standards: Compliance with electrical safety (e.g., EN/IEC 60601-1), electromagnetic compatibility (e.g., IEC 60601-1-2), and software development/validation standards (e.g., IEC 62304).
  • Predicate Device Equivalence: The ultimate "ground truth" sought by the 510(k) pathway is demonstrating that the device is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness. This is achieved by showing that any differences do not raise new questions of safety or effectiveness.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI models that require a "training set" of data in the common sense. Its software performs fixed algorithms for image processing and control, not adaptively learning from data.

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

• Not applicable. (See point 8).

In Summary:

The provided document describes the regulatory submission for a medical device (a camera controller for endoscopy) that is primarily a hardware component with integrated software. The "acceptance criteria" and "study" proving it meets them are focused on engineering and regulatory compliance (e.g., electrical safety, EMC, software validation) rather than the clinical performance metrics often associated with AI/ML diagnostic tools (like sensitivity, specificity, or human reader study endpoints). The substantial equivalence claim is built on non-clinical performance testing and software verification, demonstrating that any technological differences from the predicate device do not raise new questions of safety or effectiveness. No clinical or image-based diagnostic performance studies are mentioned or required for this type of device.

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The products are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.

The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.

The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes which are used in invasive surgery or via natural orifices for diagnosis and therapy and serve to visualize the inside of the body.

The products are used for interventions in different medical disciplines, such as surgery and laparoscopic interventions e.g. in urology and gynecology.

The submitted devices can be grouped by working length (WL) and direction of view.

The PANOVIEW Ultra telescopes (common name: telescopes) are rigid endoscopes with a fixed eyepiece, integrated light guide, optical system, cold light connector, with screw-on adapter for fiber light cables and with color coding ring for direction of view.

The telescopes are constructed of a cladding tube, which is surrounded by a rigid sheath, a fixed eyepiece and an eyecup at the proximal end.

Within the cladding tube, images are transferred via a rod lens system to the fixed eyepiece. Illumination is provided via light guide bundles connected to a light source. Visualization can directly be performed via the fixed eyepiece (direct visualization method) or alternatively via a monitor and user interface (indirect visualization method). For the second option, a camera must be attached to the fixed eyepiece and must be connected to a monitor.

The provided document, K203226, is a 510(k) Premarket Notification for rigid endoscopes (Telescopes) manufactured by Richard Wolf Medical Instruments Corporation. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results that would typically be associated with AI/ML devices or new diagnostic tests.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, AI improvement effect size, training set details) are not applicable (N/A) because this submission pertains to a physical medical device (endoscope) and its manufacturing and performance validation, not a software-driven or AI-based diagnostic tool.

The document describes non-clinical performance testing (bench testing) to demonstrate the safety and effectiveness of the device, primarily by comparing its characteristics and performance to a legally marketed predicate device.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance for Rigid Endoscopes (K203226)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantifiable acceptance criteria with corresponding performance metrics in a way commonly seen for software or AI/ML device clearances. Instead, the acceptance criteria are implicitly or explicitly stated through the validation of various engineering and functional aspects, and performance is demonstrated by meeting these and showing equivalence to the predicate.

• Automated cleaning process: Must pass all acceptance criteria.
• Sterilization (moist heat/steam): Must achieve a Sterility Assurance Level (SAL) of 10⁻⁶ (according to AAMI TIR12, Annex B). | - Manual cleaning process: "passed all acceptance criteria."
• Automated cleaning process: "passed all acceptance criteria."
• Sterilization: SAL of 10⁻⁶ "was achieved" (sterility ensured). |
  | Biocompatibility | - Biological risk assessment performed according to ISO 10993-1:2018 and FDA guidance.
• Biological testing and chemical characterization to demonstrate safety (for materials with direct patient contact: optical glass, stainless steel, glue, soft solder, classified as external communicating device with contact to tissue, bone, and dentin for ≤24h). | - Biological testing and chemical characterization "proved that the PANOVIEW Ultra telescopes are as safe as the predicate devices." |
  | Performance Testing (Bench) | - Optical performance validation (according to ISO 8600-1/-3/-5 for parameters like spectral range, working lengths, working distance).
• Optical performance validation after simulation of aging.
• Performance testing addressing differences from predicate: different working length, shaft thickness, new material of light guide bundle, focal length, distortion.
• Functionality: ability to visualize inside the body, image transfer via rod lens system, illumination via light guide bundles.
• Packaging validation (specifically for 434 mm working length).
• Stability testing.
• Temperature testing (according to IEC 60601-2-18).
• Overall design, basic safety, and essential performance requirements and specifications met. | - Optical performance validated; parameters compared to predicate devices "to prove equivalence."
• Optical performance after aging validated.
• Confirmed that changed characteristics (e.g., working length) "do not question safety and effectiveness."
• Function as described (e.g., "images are transferred via a rod lens system," "illumination is provided via light guide bundles").
• Packaging validated for the 434mm subset.
• Stability testing performed.
• Temperature testing performed.
• "Testing confirms that the products meet all the requirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met." |
  | Equivalence to Predicate | Functional and safety equivalence to the predicate device (Endoscope 0°/30°/50° Ø 10MM, K993103). | - "the submitted devices are as safe and as effective as the predicate devices."
• "submitted devices function as safe as effective as the predicate device"
• "deemed to be substantially equivalent to the legally marketed devices." |

2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a physical device, not an AI/ML diagnostic. The testing involved various bench tests on the device units themselves. The number of physical units tested for each validation (reprocessing, biocompatibility, optical performance, etc.) is not specified in this summary.
* Data Provenance: Not applicable in the context of patient data (e.g., retrospective/prospective, country of origin). The data comes from internal laboratory/bench testing of the physical medical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* N/A. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not applicable here. The "truth" for this device's performance is established by objective engineering measurements against established standards (e.g., ISO, IEC) and manufacturer specifications in a laboratory setting. No medical experts were described as establishing a "ground truth" for the test set.

4. Adjudication Method for the Test Set:
* N/A. Given that this is bench testing of a physical device against engineering standards, an "adjudication method" involving human experts is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
* N/A. This device is an endoscope, not an AI/ML-assisted diagnostic tool or software. No MRMC study was performed as it is not relevant to the clearance of this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Performance was Done:
* N/A. This applies to algorithms. The device itself is a standalone physical instrument used by a human operator for visualization. Its "standalone performance" refers to its optical and mechanical integrity, which was evaluated through bench testing.

7. The Type of Ground Truth Used:
* The "ground truth" for this device's performance is based on adherence to engineering specifications, international standards (e.g., ISO 8600-1/-3/-5 for optical performance, AAMI TIR12 for sterilization, ISO 10993-1 for biocompatibility, IEC 60601-2-18 for temperature testing), and validation against the characteristics of a predicate device. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense for this type of device clearance.

8. The Sample Size for the Training Set:
* N/A. This document describes a physical medical device, not a software or AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:
* N/A. As there is no training set mentioned or implied for this physical device, the concept of establishing ground truth for it is not applicable.

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Sensor-Ureterorenoscopes are used within the scope of therapeutic interventions. The products are active, sterile and for single-use. They are used for visualizing body cavities via natural passages and for the insertion of auxiliary instruments through the working channel as well as the supply of irrigation fluid.

The Sensor-Ureterorenoscope is used in Urology for examination, diagnostics and/or therapy of the upper urinary tract.

ADAPTER FOR CONTROLLER 5525

The products are used for operating a sensor endoscope in conjunction with an ENDOCAM Logic 5525 Camera Controller, for the mechanical connection to the sensor endoscope as well as for controlling the signals generated.

The Sensor-Ureterorenoscope features a semi-rigid instrument sheath and a flexible and actively deflectable tip. It is equipped with two separate working channels for applications with laser fibers and/or flexible auxiliary instruments. The two working channels have different diameters, allowing the insertion of the laser fiber via working channel (2) and a stone-extraction basket or flexible auxiliary instruments via working channel (1)

Irrigation is effected via working channel (1) and is connected via the luer connector marked in blue on the housing.

A third channel integrated in the instrument sheath allows the return flow via distal holes on the instrument head. The drain is effected via the lower luer connector marked in gray.

The flexible deflectable tip can be controlled in both directions (upward and downward) +/-300° via the control wheel on the handle. Thanks to the high torsional stiffness of the semi-rigid instrument sheath the sheath movements are transmitted directly in radial and axial directions. The working channel (2) permits the insertion of laser fibers up to a diameter of 272 µm.

For visualization the Sensor-Ureterorenoscope is connected to an endoscopy camera controller. The Sensor-Ureterorenoscope is sterile and for single-use.

The ADAPTER FOR CONTROLLER 5525 is an accessory to the RIWO D-URS, which serves as an interface to connect the RIWO D-URS to an ENDOCAM Logic 5525 Camera Controller (not part of this submission).

This FDA 510(k) summary describes a new medical device, the SENSOR-URETERORENOSCOPE 9 FR WL 600 MM and its ADAPTER FOR CONTROLLER 5525, and compares it to a predicate device. The document focuses on demonstrating substantial equivalence, primarily through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly presented in a clear, quantitative, pass/fail table format common for AI/Software as a Medical Device (SaMD) clearances. Instead, the document discusses various types of non-clinical testing performed to demonstrate safety and effectiveness and compare the subject device to the predicate. The "reported device performance" is framed in terms of successful completion of tests and compliance with standards, rather than specific performance metrics (e.g., accuracy, sensitivity, specificity).

The document states that the testing "proved that the RIWO D-URS is as safe as the predicate device" and "can be deemed substantially equivalent."

Here's an attempt to extract the closest equivalents to acceptance criteria and reported performance:

Detailed Study Information (Based on provided text):

1. A table of acceptance criteria and the reported device performance:
(Provided above)

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

• Sample Size: The document does not specify exact numerical sample sizes for most of the engineering or non-clinical tests (e.g., how many units were tested for sterility, biocompatibility, or functional performance). It refers to "several tests" or "bench testing."
• Data Provenance: Not explicitly stated. These are non-clinical (laboratory/bench) tests conducted by the manufacturer to demonstrate compliance with standards and equivalence. No patient data or geographical origin is mentioned as it's a device clearance, not an AI/SaMD clearance. The manufacturer is Richard Wolf GmbH, located in Germany, so it's likely testing was conducted there or at partner labs.
• Retrospective/Prospective: Not applicable in the context of these non-clinical device tests.

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 an AI/SaMD study involving human expert review for ground truth establishment. The "ground truth" for these tests is defined by compliance with established engineering standards (e.g., ISO, ASTM, IEC).
• For the usability study, while not explicitly stating "experts establishing ground truth," it involved assessing the ease and safety of operation by "medically qualified and adequately instructed persons" (as per the "User" statement in the Indications for Use), who implicitly serve as the evaluators in a usability context. The number or qualifications of these users are not detailed.

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

• Not Applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical image reads). Test outcomes are determined by adherence to predefined technical specifications and standards.

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

• No. An MRMC study was not conducted as this is a traditional medical device (urorenoscope) and not an AI/SaMD requiring assessment of human reader performance with or without AI assistance.
• A usability study was performed to compare the operational aspects of the subject device to the predicate device, implying a comparison of human interaction/performance, but this is distinct from an MRMC study for diagnostic accuracy.

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

• Not Applicable. The device (ureterorenoscope) does not contain a standalone algorithm. The device itself is the "standalone" component being tested for its physical and functional performance characteristics.

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

• Ground Truth: For this type of device, the "ground truth" is defined by adherence to engineering specifications, national/international standards (e.g., ISO, ASTM, IEC), and the ability to perform its stated function (visualization, instrument insertion, fluid irrigation) effectively and safely as confirmed by non-clinical bench testing. It's not a diagnostic device where pathology or outcome data would be the ground truth.

8. The sample size for the training set:

• Not Applicable. This is not an AI/Machine Learning device that requires a training set.

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

• Not Applicable. As no training set is used, no ground truth for a training set was established.

Summary of the Study Approach:

The study presented in this 510(k) summary is a series of non-clinical, benchtop, and laboratory tests designed to demonstrate that the new ureterorenoscope and its adapter are as safe and effective as a previously cleared predicate device. The primary method for proving "substantial equivalence" is through demonstrating compliance with recognized safety and performance standards (e.g., for sterilization, biocompatibility, EMC, and functional performance) and by conducting a usability study comparing the subject device's operation to the predicate. No clinical trials or AI/ML-specific performance studies with human readers or large datasets were conducted or required for this device type.

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ENDOCAM Logic 5525 Camera Controller:

LOGIC HD CAMERA CONTROLLER / LOGIC 4K CAMERA CONTROLLER:
The Logic HD Camera Controller and the Logic 4K Camera Controller have been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.

LOGIC HD LITE CAMERA CONTROLLER:
The Logic HD lite Camera Controller has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.

The ENDOCAM Logic 5525 Camera Controller describes all Richard Wolf ENDOCAM Logic Camera Controllers, by name LOGIC 4K CAMERA CONTROLLER, LOGIC HD CAMERA CONTROLLER and LOGIC HD Lite CAMERA CONTROLLER.

The main purpose of the ENDOCAM Logic 5525 Camera Controller is identifying the applied part(s) and configuring the data stream, managing the interaction and providing an access point for the user.

The ENDOCAM Logic 5525 Camera Controller contains software which is classified as a minor Level of Concern. The main features of the software are configuration of the image processing, archiving and providing different views and a user interface to the user.

The ENDOCAM Logic 5525 Camera Controller is not intended to contact the patient directly or indirectly.

The ENDOCAM Logic 5525 Camera Controller is delivered non-sterile. The devices are reusable and do require cleaning and reprocessing during their use-life, i.e. users are required to clean and disinfect the device before every application and before returning for repairs. Methods of cleaning and reprocessing are detailed in the Instruction for Use.

The provided text describes a 510(k) premarket notification for the ENDOCAM Logic 5525 Camera Controller. This submission focuses on demonstrating substantial equivalence to a predicate device, specifically the LOGIC 4K CAMERA CONTROLLER (K180583), rather than presenting a novel device that requires extensive clinical studies or a new set of acceptance criteria with detailed performance metrics.

Therefore, many of the requested points regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not applicable or explicitly stated in the provided document. The document primarily focuses on verifying that an updated software version and the subject devices maintain the same performance and safety characteristics as the predicate device.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the updated device continues to meet the safety and performance standards established for the predicate device. The general "acceptance criteria" are implied to be compliance with relevant standards and demonstration of equivalent performance to the predicate.

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

• Test Set Sample Size: Not specified. The studies cited are "verification and validation testing" and "functional testing" which are typically internal engineering tests performed on the device itself, rather than testing with a "test set" of clinical data.
• Data Provenance: Not applicable in the context of clinical data. The testing described is non-clinical (engineering and software verification/validation).

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

• Number of Experts & Qualifications: Not applicable. This type of information would be relevant for studies involving the interpretation of results (e.g., image analysis by radiologists). The described testing focuses on the camera's technical performance and safety compliance.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no evidence of a "test set" that requires adjudication by human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done.
• The device is an endoscopic camera controller, not an AI diagnostic aid. Therefore, this type of study is not relevant to its regulatory submission as described.

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

• Not applicable. The device is a camera controller, an imaging component, not a standalone algorithm. Its function is to process and manage video streams for human operators.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not applicable in the clinical sense. For the non-clinical testing, the "ground truth" would be established engineering specifications, performance standards (e.g., signal-to-noise ratio, resolution, color accuracy), and regulatory compliance requirements.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The device relies on embedded software/firmware for camera control and image processing, not on machine learning or deep learning models that require a "training set" of data in the AI sense.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no "training set" in the context of this device.

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The Flexible Sensor-Ureterorenoscopes BOA Vision EF and Flexible Sensor-Ureterorenoscopes COBRA Vision EF are used for visualizing body cavities and organs via natural and surgically created passages.

These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

For examination, diagnostics and/or therapy in conjunction with endoscopic accessories. The product is used in the following disciplines: Urology:

• Urogenital tract

• Nephroscopy

The Flexible Sensor-Ureterorenoscope BOA VISION EF (short name: BOA) and Flexible Sensor-Ureterorenoscopes COBRA VISION EF (short name: COBRA) are flexible video endoscopes used for visualizing body cavities and organs via natural and surgically created passages.

The Flexible Sensor-Ureterorenoscopes compromise a handle and a flexible shaft connected to the handle with an active controlled deflection section at the endoscope tip.

The video image of the Flexible Sensor-Ureterorenoscopes is produced by a CMOS imaging sensor located at the tip of the insertion shaft together with the objective lens. The imaging sensor with the electronics in the handle generates a signal that is transferred to the designated camera controller ENDOCAM Flex HD (cleared with K161204), which processes the signals to display them on a monitor (not part of this submission).

The Flexible Sensor-Ureterorenoscopes use integrated LED lights for illumination.

The Flexible Sensor-Ureterorenoscopes provide a working channel with 1.2 mm diameter and a working length of 680 mm length. A Luer sealing cap may be used to seal the provided Luer connectors if not used.

The Flexible Sensor-Ureterorenoscope COBRA VISION EF has a second separate channel with 0.8 mm diameter for laser fibers or continuous irrigation. The laser fiber channel is equipped with a laser adjustment unit for housing, clamping and aligning the laser fiber, which support to move the clamped laser fiber sensitively by turning an adjustment ring for contacting the stone.

Parts of the Flexible Sensor-Ureterorenoscopes have direct patient contact. When used as intended, the duration of tissue contact is limited (up to 24 hours). The used raw material with direct or indirect patient consist of Stainless steel, optical glass, Polyurethane, Perfluoroalkoxy (PFA) and adhesives (epoxy).

I am sorry, but the provided text does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of device performance metrics like accuracy, sensitivity, or specificity.

The document is a 510(k) premarket notification for Flexible Sensor-Ureterorenoscopes. It outlines the device's indications for use, comparison to a predicate device, and various performance tests conducted to demonstrate substantial equivalence, such as biocompatibility, cleaning and sterilization validation, electrical safety, photobiological safety, and some mechanical and optical performance.

However, it does not include:

• A table of acceptance criteria and reported device performance for metrics like accuracy, sensitivity, or specificity.
• Details about sample size, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human readers with AI assistance.
• Specifics about standalone algorithm performance.
• The type of ground truth used (beyond general performance testing).
• Sample size for a training set or how its ground truth was established, as the device doesn't contain software and therefore wouldn't have a "training set" in the AI/ML context.

The document primarily focuses on demonstrating the new device's safety and effectiveness compared to a predicate device through adherence to various international and FDA standards, which are general engineering and medical device safety standards, not performance metrics for an AI/ML-based device.

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LOGIC 4K CAMERA CONTROLLER: The ENDOCAM® Logic 4K Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic 4K Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.

LOGIC 4K CAMERA HEAD: Logic 4K Camera Head 85525942 is used for applications in conjunction with the Logic 4K Camera Controller 5525301 for diagnostic and therapeutic interventions. This product is exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical doctors.

Richard Wolf's ENDOCAM® Logic 4K Camera System 5525 consists of the Logic 4K Camera Controller and Logic 4K Camera Head. The Logic 4K Camera System has been designed for highdefinition video endoscopy and is used in conjunction with other video equipment and endoscopic accessories.

The Logic 4K Camera Controller is the control center of the system, its primary performance characteristics are signal processing of the image data and image recording. The Logic 4K Camera Controller is equipped with various outputs (e.g. HDMI 4K and HDMI HD) and can process a 2K / HD or 4K resolution. The Logic 4K Camera Controller device parameters are controlled and set via the touchscreen, access to all control elements / parameters is possible in OSD via the PC keyboard the handheld remote control or via core.nova.

The Logic 4K Camera Controller housing is made of of powder-coated stainless steel measuring 300mm x 120mm x 416mm; the front foil consists of Polyester AUTOPEX.

The Logic 4K Camera Head is used in conjunction with the Logic 4K Camera Controller, its primary performance characteristic is to receive and transfer an optical image from a variety of endoscopes (rigid, semi-rigid, and flexible endoscopes).

The Logic 4K Camera Head housing is made of stainless steel measuring approximately 40mm x 47mm x 102mm. The camera head cable is securely attached and is 3.0m in length.

The LOGIC 4K Camera Controller and LOGIC 4K Camera Head are not intended to contact the patient directly or indirectly.

The LOGIC 4K Camera Controller and Logic 4K Camera Head are delivered non-sterile. The devices are reusable and do require processing during their use-life. Users are required to process the device for initial use and after each use. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use.

This document, a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA), describes the "LOGIC 4K CAMERA CONTROLLER LOGIC 4K CAMERA HEAD" (K180583) and its substantial equivalence to a predicate device. It primarily focuses on technical specifications, safety, and performance testing rather than a study designed to meet specific clinical acceptance criteria in the way one might evaluate an AI/CAD product.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a camera system and not an AI or diagnostic tool with typical performance metrics like sensitivity/specificity, the "acceptance criteria" are related to technical standards and functional performance.

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

• Sample Size for Test Set: This document does not describe a "test set" in the context of clinical data or imaging studies. The performance evaluation was primarily through bench testing and compliance with recognized electrical safety and EMC standards. Therefore, the "sample size" would refer to the number of devices tested in engineering labs rather than patient data. Specific numbers of units tested are not provided in this summary.
• Data Provenance: Not applicable in the context of patient data. The provenance of the engineering test data would be from internal testing labs of Richard Wolf Medical Instruments Corporation (USA) and Richard Wolf GmbH (Germany), as well as potentially external accredited testing facilities for standard compliance. The data is prospective in the sense that the testing was performed on the device itself to verify its performance against predefined standards.

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

• This information is not applicable as the document does not describe a clinical study involving experts to establish ground truth for a diagnostic outcome. The evaluation is focused on the device's technical functionality and safety compliance.

4. Adjudication method for the test set

• This information is not applicable as the document does not describe a clinical study requiring adjudication of expert 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, an MRMC comparative effectiveness study was not done. This device is a 4K camera system, an imaging component, not an AI or CAD system. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

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

• No, a standalone algorithm performance study was not done. This device is a camera system, not an algorithm.

7. The type of ground truth used

• This is not applicable in the context of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this device's evaluation was engineering specifications, international safety standards (electrical, EMC, usability), and functional requirements for an endoscopic video imaging system.

8. The sample size for the training set

• This information is not applicable. There is no mention of a "training set" as this device is a hardware camera system, not an AI or machine learning model.

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

• This information is not applicable. As there is no training set for a machine learning model, there is no ground truth relevant to a training set to be established.

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The RF instruments are used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopically performed or supported surgery intended are:

• • Endoscopic procedures
• • Orthopedic coagulation
• • Neurosurgical coagulation
    The products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.

The TipControl RF (Radio Frequency) Instruments, bipo are disposable single-use, sterile packaged electrosurgical devices, used for tissue and vessel coagulation (hemostasis) by means of radio-frequency current. The products are intended for use in endoscopic performed or supported surgeries. The types of surgery intended are: Endoscopic procedures, orthopedic coagulation, and neurosurgical coagulation. These products are exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical personnel.
The TipControl RF Instrument, bipo consists of a handle, a sheath tube, the TipControl RF electrode and a connection cable with an US 2-PIN device connector. The just mentioned components comprise a complete unit for disposable use and cannot be dismantled. They are currently available in a working length of 280 mm or 350 mm.
The TipControl RF Instruments, bipo are designed to be used in conjunction with the electrosurgical bipolar radiofrequency generators Surgitron and Surgi-Max Plus up to 4 MHz and endoscopic accessories. The RF generator provides power and delivers electrical current to the distal tips of the RF instruments.

This document is a 510(k) premarket notification for the "TipControl RF Instrument bipo Ø 2.5mm WL 280mm" and "TipControl RF Instrument bipo Ø 2.5mm WL 350mm". The device is an electrosurgical cutting and coagulation device and accessories. The filing seeks to establish substantial equivalence to a predicate device, the "Trigger Flex™ Bipolar Electrode (K003126)".

Here's an analysis of the acceptance criteria and study data based on the provided text:

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)

The document does not specify a distinct "test set" in the context of an AI/algorithm-based device, as this is a traditional medical device (electrosurgical instrument). The tests performed are laboratory-based and conducted on samples of the device itself.

• Sample Size: Not explicitly stated for specific tests (e.g., how many devices were tested for biocompatibility or bench testing). These are generally conducted with a sufficient number of samples to ensure statistical validity for the relevant standard.
• Data Provenance: The device manufacturer (Richard Wolf GmbH) is located in Germany. It can be inferred that the testing and data originate from within the company's quality assurance and R&D processes, likely conducted in Germany or by certified contract laboratories. The document does not specify if data is retrospective or prospective, but as it pertains to device design verification and validation, it would be prospective for the evaluated device.

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

This is not applicable as the document describes a physical electrosurgical device, not an AI/diagnostic algorithm that requires ground truth established by experts. The "ground truth" for this type of device is established through compliance with recognized standards and successful performance in defined laboratory tests (e.g., measuring electrical parameters, biological responses).

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

Not applicable. This device does not involve expert adjudication as it is not a diagnostic device requiring interpretation of data by multiple experts.

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 does not incorporate AI, therefore no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device does not have an algorithm component.

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

As mentioned in point 3, the concept of "ground truth" as it applies to AI/image analysis is not directly relevant here. For this electrosurgical device, the "ground truth" is defined by:

• Compliance with recognized international standards: e.g., ISO 11135, ISO 10993 series, IEC 60601 series.
• Successful performance in bench tests: Meeting predefined specifications for electrical performance, mechanical integrity, and functional capabilities as outlined in relevant FDA guidances.
• Biocompatibility testing results: Demonstrating non-cytotoxicity, non-hemolysis, non-irritation, non-sensitization, and non-toxicity based on established biological evaluation protocols.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

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

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