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Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for the central control of integrated medical devices and accessories in one central location within the operating room. In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp, OR-camera, ORtable, insufflator, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The connected devices (Richard Wolf or third party) can be control terminals (with touch screen), or the control mechanism on actual device.

The core nova (complete operating room endoscopy nova) by Richard Wolf is a networkbased integrated operating room accessory that provides central control to various Richard Wolf devices and third party devices. This control allows the user to control device settings from the sterile area. Richard Wolf's core nova is comprised of core.browser, core.connect with driver, IR Transceiver, an optional core.media, and an optional server core.portal.

The provided document is a 510(k) premarket notification for the "core nova Complete Operating Room Endoscopy" system by Richard Wolf. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might expect for a diagnostic or therapeutic algorithm.

Therefore, the requested information, particularly regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance related to diagnostic or therapeutic effectiveness, is not present in this document. The device in question, an endoscopic central control unit, is a system for managing and controlling other medical devices in an operating room, rather than a device that directly yields a diagnostic output or performs a direct therapeutic action that would typically require such performance studies.

However, I can extract information related to the device's validation based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't provide acceptance criteria and performance in the typical sense for a diagnostic device (e.g., sensitivity, specificity). The "performance" described here relates to compliance with regulatory standards for medical electrical equipment and software.

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

• Sample size: Not applicable/Not provided. The validation described is compliance with electrical and software standards, not performance on a dataset of patient data.
• Data provenance: Not applicable.

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

• Not applicable. The "ground truth" here is compliance with established engineering and software safety standards, assessed through testing, not expert interpretation of medical data.

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 MRMC study was done. This device is not an AI-assisted diagnostic tool.

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

• Not applicable. This device is an operating room control system, not a standalone diagnostic or therapeutic algorithm.

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

• The "ground truth" in this context is the adherence of the device to established international and national electrical safety and electromagnetic compatibility (EMC) standards and compliance with FDA software validation guidelines. This is verified through engineering tests and software verification documentation, not medical ground truth like pathology.

8. The sample size for the training set:

• Not applicable. This device is not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

• Not applicable.

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

The Richard Wolf ENDOCAMB Logic HD Camera System 5525 is an endoscopic camera system for rigid and flexible endoscopes (e.g. Arthroscopes, Bronchoscopes, Hosteroscopes. Laparoscopes, Ureteroscopes, etc.). The Richard Wolf ENDOCAM® Logic HD Camera System 5525 allows the doctor to visualize the image of natural and artificial cavities through the endoscope by projecting images to a monitor for visual display and data storage during endoscopic diagnostic and therapeutic surgical procedures.

The Richard Wolf ENDOCAM® Logic HD Camera System 5525 consists of:

• ENDOCAM® Logic HD Controller(s)
• ENDOCAM & Logic HD Camera Head(s), and
• Objective Lens (Coupler).

Devices are used in conjunction with other ancillary equipment such as endoscopes, light source, monitors, printers, recorders, required cabling, etc.

The Richard Wolf ENDOCAM® Logic HD Camera Head(s) use ICCD or 3CCD imaging systems to provide high definition (HD) visualization and quality images. The Richard Wolf ENDOCAM® Logic HD Camera Head cable connects to the ENDOCAM® Logic HD Controller, the ENDOCAM® Logic HD Controller relays the image from the endoscope with/without the use of an objective lens (coupler) to a video monitor; projection can be either analog or digital at the user's preference.

The Richard Wolf ENDOCAM® Logic HD Controller(s) is equipped with pre-programmed presets which can be selected via touch-screen, remote control, and/or keyboard. Self-made adjustments can be stored and individually named by user. Patient data and endoscopic images can be printed or stored directly onto USB flash drive.

The Richard Wolf ENDOCAM® Logic HD Camera System 5525 is compatible and can be integrated with the Richard Wolf RiwoNet / Core operating room system.

Devices included in the Richard Wolf ENDOCAM® Logic HD Camera System 5525 are reusable and do not require sterilization before use because there is no direct patient contact. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use Manual: these instructions were developed by Richard Wolf using standards outlined in ANSI / AAMI ST:2004/(R) 2010 and FDA's Guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. Office of Device Evaluation April 1996.

This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

Here's a breakdown of the acceptance criteria and study information for the Richard Wolf ENDOCAM® Logic HD Camera System 5525, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

The document does not specify separate "test sets" or discuss data provenance in terms of country of origin or retrospective/prospective data for a clinical study with patients. The performance data is based on design verification testing, which typically involves laboratory and engineering testing of the device itself.

3. Number of Experts and Qualifications for Ground Truth

The document explicitly states: "No clinical tests performed." Therefore, there were no experts used to establish ground truth for a clinical test set from patient data. The "ground truth" for the device's performance was established through engineering and safety standard compliance testing.

4. Adjudication Method

Not applicable, as no clinical tests were performed, and thus no patient data required adjudication.

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

• No MRMC study was done. The document states, "No clinical tests performed."

6. Standalone Performance

The design verification testing and conformity to safety standards (IEC 60601-1 and IEC 60601-1-2) represent the standalone performance of the algorithm/device. The device's performance was assessed in isolation through these engineering and compliance tests.

7. Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

• Compliance with recognized safety standards (IEC 60601-1 and IEC 60601-1-2).
• Design verification testing to ensure the device functions as intended and does not raise new safety or effectiveness concerns.

8. Sample Size for the Training Set

Not applicable. This device is a hardware system (endoscopic camera system), not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "design" and "engineering" of the device are analogous to its development process, but not a data-driven training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of medical device functionality. The "ground truth" for its design and operation would be based on engineering principles, material science, optical performance standards, and the intended use requirements for an endoscopic video camera system.

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The ENDOLIGHT LED Light Source Projector is intended to illuminate the surgical site during minimally invasive surgical procedures by producing light that is transmitted from the light source through fiber optic cable and a scope.

The ENDOLIGHT LED Light Source is a fiber optic light source utilizing a single, solid state, high power, white light emitting diode (LED) to produce visible light that used to illuminate surgical sites during minimally invasive surgical procedures. The light from the ENDOLIGHT LED Light Source is transmitted through an optical cable and a scope. ENDOLIGHT LED 1.1 and 1.2 are comprised of light source and power supply cord. The units consist of aforementioned LED, cooling fan, light port, and protective housing. ENDOLIGHT LED 1.1 and 1.2 are portable and are very similar in design, format, and functionality to other LED light sources including the predicate devices. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

The provided text describes a 510(k) premarket notification for the ENDOLIGHT LED Light Source. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study that proves the device meets specific performance thresholds in a clinical or AI-assisted context.

Therefore, many of the requested categories cannot be answered from the provided document. This document describes a medical device rather than an AI/ML powered device.

Here's an analysis based on the information available:

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

The document does not present a table of specific quantitative acceptance criteria alongside reported performance data. Instead, it states that "Design verification testing demonstrates that the devices function as intended" and lists adherence to voluntary safety and performance standards.

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

Not applicable. The document describes a traditional medical device (LED light source), not an AI/ML-powered device that would typically involve test sets of data for performance evaluation. The "testing" mentioned refers to design verification and adherence to electrical safety standards.

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

Not applicable. Ground truth and expert consensus are relevant for AI/ML-powered diagnostic or interpretive devices, which this is not. The "ground truth" for this device would be its physical properties and adherence to engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication method as it relates to evaluating data for an AI/ML-powered device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI/ML algorithm. The device stands alone as a light source.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for its performance is established by engineering specifications, international safety standards (e.g., IEC standards for medical electrical equipment), and functional design verification tests. The document explicitly states "Design verification testing demonstrates that the devices function as intended" and lists conformity to specific IEC safety standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML-powered device, so there is no "training set."

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

Not applicable.

In summary: The provided document is for a traditional medical device (an LED light source) and outlines its substantial equivalence to predicate devices based on technological characteristics and adherence to established safety standards. It does not involve AI/ML technology, and therefore, many of the requested categories related to AI/ML performance evaluation (such as test sets, ground truth establishment by experts, adjudication, and clinical effectiveness studies with AI) are not applicable.

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The KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).

The KeyPort AR System is a reusable device used for creating and maintaining an artificial access port to body cavities including the necessary pneumoperitoneum. The KeyPort AR System allows multiple instruments and /or camera access during minimally invasive procedures, which include anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision). This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons. The KeyPort AR System is comprised of KeyPort silicone sealing insert (1), KeyPort AR trocar sleeve (2), and KeyPort trocar (3). The KeyPort AR System is used in conjunction with CO2 insufflator, Pump for smoke gas evacuation, and required instruments which are selected in accordance with the indications as well as the surgeon's requirements. Unless otherwise specified, all components of the KeyPort AR System are reusable and require sterilization before use. Methods of cleaning, disinfection, and sterilization are detailed in Instruction Manual GA-B 253-2 USA.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the KeyPort AR System:

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

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

• Sterilization validation: The sample size is not explicitly stated, but the results indicate that "All acceptance criteria were met."
• Gas-tight seal testing: The sample size is not explicitly stated.
• Preclinical test (incision size): The sample size is not explicitly stated, but it was conducted using "pigs."
• Data Provenance: The document does not specify the country of origin for the sterilization and gas-tight seal tests. The preclinical test used "pigs," implying an animal model study, which is typically prospective.

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

This information is not provided in the document. The tests performed (sterilization, gas-tight seal, preclinical incision size) do not typically involve human expert ground truth for their evaluation.

4. Adjudication method for the test set:

This information is not provided as the types of tests described do not involve adjudication by multiple experts in the same way clinical studies or image-based AI studies would.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and 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 a surgical access system, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used:

• Sterilization validation: The ground truth would be established by specific performance standards for sterilization effectiveness (e.g., sterility assurance level), likely measured through microbiological assays.
• Gas-tight seal testing: The ground truth would be established by quantifiable pressure measurements and leakage rates against predefined thresholds.
• Preclinical test (incision size): The ground truth would be a direct observation of the surgical outcome (sufficiency of the incision) in the animal model.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, there is no training set for a physical medical device.

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The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic, and colonscopic) procedures, breaking up stones, cutting (i.e. structures), ablation, vaporization, excision, incision, and coagulation of tissue in the specialties as: Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery.

The Richard Wolf Medical Instruments Corporation MegaPulse Laser System is comprised of a Holmium YAG laser base unit with integrated cooling unit and system specific laser fibers. The laser system base contains the switching elements and interfaces, the display unit, the fiber connection point, components inside the laser system, and software. For a safe operation, essential functions and components are monitored automatically. The MegaPulse Laser system is designed with automated fiber recognition to ensure only permissible parameters are used. A warning message appears on the touch screen monitor and is accompanied by a signal should a fault or error occur. The MegaPulse Laser Fibers are intended to be used in with MegaPulse Laser System to deliver laser energy. The laser fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to provide access to the surgical procedure site. The laser fiber works on the principle of internal reflection. Laser energy is focused into the fiber at the proximal end and it travels the length of the fiber by means of total reflection. The fiber contains the laser beam and channels the laser energy from the proximal end of the fiber to its distal end. The laser fibers are single-use sterile packaged. They are similar if not equivalent in design and performance to other legally marketed laser fibers with an integrated fiber identification system designed to work only with the MegaPulse laser system base.

This device is a MegaPulse Laser System and its associated MegaPulse Laser Fibers, intended for various surgical procedures.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or numerical performance metrics in the way one might expect for a diagnostic or AI-based device. Instead, the "acceptance criteria" are implied to be the general safety and effectiveness standards met by the predicate devices and validated through bench testing.

2. Sample Size for the Test Set and Data Provenance

• Test set sample size: Not applicable. This submission relies on bench testing and comparison to predicate devices, not on a clinical test set.
• Data provenance: Not applicable. The "study" is a bench validation of specifications.

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

• Number of experts: Not applicable. Ground truth for a clinical test set was not established as there was no clinical study. The device's performance was evaluated against engineering specifications and comparison to predicate devices.
• Qualifications of experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

• MRMC study: No, an MRMC comparative effectiveness study was not done. This being a laser surgical instrument, such a study is not typically relevant for its 510(k) clearance process without a specific AI component for interpretation or diagnosis.
• Effect size: Not applicable.

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

• Standalone study: Not applicable. The device is a surgical instrument. "Algorithm-only" performance is not relevant in the context of this device without specific AI features for diagnosis or entirely autonomous operation, which are not described. The software validation mentioned focuses on control and operation of the laser system, not on diagnostic or interpretive algorithms.

7. The Type of Ground Truth Used

• Type of ground truth: The "ground truth" for this submission is implicitly based on engineering specifications, regulatory standards, and the established safety and effectiveness profiles of the predicate devices. For example, the laser's power output or wavelength accuracy would be verified against its design specifications, and its overall performance would be considered "acceptable" if it mirrored the safe and effective operation of already-approved predicate devices.

8. Sample Size for the Training Set

• Training set sample size: Not applicable. This device is a traditional medical device (laser system) and not an AI/ML product developed using a training set in the typical sense.

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

• Ground truth for training set: Not applicable. As an AI/ML training set was not used, there was no ground truth to establish for such a set.

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Intended use: In conjunction with a motorized handle (c.g. Power Stick M5/3), the POWER DRIVE ART1 2304 serves as a drive unit for Richard Wolf rotary blades/abraders for the removal of tissue during endoscopic intervention. Simultaneous evacuation (suction) allows continuous removal of the ablated tissue. In conjunction with Power Drill M1, bones can be severed or machined.
Indications and field of use: The product is used in conjunction with endoscopic accessories for the following purposes:

• . In arthroscopy, e.g. resection of the meniscus, for removing soft tissue as well as intraarticular severing or abrasion of bone tissue (e.g. ACL or shoulder applications).
• In theracte surgery, e.g. for the removal of hematomas. .
• In sinus surgery, e.g. for the removal of polyps.
• . In spinal surgery (arthroscopic microdiskectomy (AMD) for removing degenerated tissue.

The POWER DRIVE ART1 2304 is an enhanced version of our POWER CONTROL 2303, cleared in K030082. The new device has new electronics, new software, additional motor handles, tools and tool holders such as rotary blades/ abraders, saws, sagittal and reciprocal saw attachments, drill chucks, drills and surgical wires.
The POWER DRIVE ART1 2304, consisting of: generator, motor handles, tools (such as rotary blades/ abraders, sagittal and reciprocal saws, drills and surgical wires) and tool holders (such as sagittal and reciprocal saw attachments and drill chucks).
Additional features are new motor handles, some with integrated keypad as well as automatic tool recognition with the new rotary blades and abraders (via RFID technology) and a touch screen for user control.
Multiple use devices are not provided sterile; they must be startlized per their instruction before each use. Single use devices are provided sterife and designed for only one use on or in-a single patient.
Via the integrated CAN-BUS interface, the POWER CONTROL 2304 can be integrated into the R. Wolf RIWO NET SYSTEM with remote control, speech control, and touch-screen monitor.

The provided document is a 510(k) premarket notification for a medical device called "POWER DRIVE ART1 2304 with motor handles, tools and Accessories".

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria (e.g., numerical thresholds for performance metrics) or report device performance in a quantitative manner.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices. The core argument is that:

• The new device has same indications, equivalent design, functions, and materials as previous devices.
• New technological characteristics (electronics, software, additional handles, automatic tool recognition, touch screen) have not diminished safety or effectiveness.
• The device is designed and tested to guarantee safety and effectiveness when used according to instructions.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text as none were provided.

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

• Sample Size for Test Set: Not applicable. No clinical tests or performance studies with a specific test set are mentioned in the document. The submission states, "No clinical tests performed."
• Data Provenance: Not applicable. As no clinical tests were performed, there is no associated data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable. Since no clinical tests were performed and no ground truth determination process is described, this information is not available.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical tests or ground truth adjudication methods are mentioned.

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

• No. The document explicitly states "No clinical tests performed." Therefore, no MRMC study was conducted or reported.

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

• No. This device is a surgical instrument (drive unit for rotary blades/abraders, drills, etc.) and not an AI algorithm. Its performance is intrinsically tied to human operation. Therefore, a standalone performance study in the context of an algorithm is not relevant or reported.

7. Type of Ground Truth Used:

• Not applicable. As no clinical tests were performed, no ground truth was established or used in the context of device performance evaluation as would be seen in an AI/diagnostic device submission. The substantial equivalence argument relies on the inherent safety and effectiveness established for the predicate devices and the manufacturing/design process of the new device.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical instrument, not an AI model or software requiring a training set in the conventional sense.

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

• Not applicable. (See point 8 above).

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Intended Use: The 3 CCD HD ENDOCAM 5550 has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. In conjunction with video recorders, video printers and other video devices it can be used for recording and storing video images.

Indications and field of Use: The 3 CCD Endocam is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, gynecologic, laparoscopic, urologic, sinuscopic, plastic, and as an accessory for microscopic surgery.

The 3 CCD HD Endocam 5550 consists of a camera control unit and a connectable camera head. The camera head connects to an endoscope for High Definition visualization during minimally invasive surgical procedures.

The camera controller provides outputs for video monitoring, video recording, and connecting to the RWMIC-NET Operating Room Control System.

The provided text describes the Richard Wolf 3 CCD HD Endocam 5550, an endoscopic video camera system. It highlights its intended use, technological characteristics, and claims of substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, performance metrics, or details of a study proving the device meets acceptance criteria in the format typically used for evaluating the performance of AI/ML-driven medical devices.

The text only mentions that "Bench testing of specifications were verified / validated and software validation was performed to assure safe and effective operation / control of the software functions." It also explicitly states, "No clinical data was required to confirm safety and effectiveness."

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided document.

The document discusses the regulatory clearance process for a traditional medical device (an HD endoscopic camera system) based on substantial equivalence to existing predicate devices, rather than a novel AI/ML algorithm requiring rigorous performance evaluation against specific clinical or quantitative acceptance criteria through detailed studies.

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The "The View MD Office System" is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures

The View MD Office System is a 50 watt light source, 1 CCD camera, and LCD Monitor with image capture combined into a compact unit.

This device application is for the "View MD Office System," a light source, camera, and monitor combination. The provided documentation does not include information about AI/ML algorithm performance, acceptance criteria for such algorithms, or studies related to AI/ML.

Therefore, I cannot provide the detailed information requested in the prompt using the provided text. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with electrical safety and electromagnetic compatibility standards.

Based on the provided text, here's what can be inferred/stated regarding the performance and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable for AI/ML performance. The device is a hardware system. The "test set" here refers to the device itself undergoing electrical and EMC testing.

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

• Not applicable for AI/ML performance. Ground truth, in the context of this submission, relates to the established standards (IEC 60601-1, IEC 61000 series) and the test methodologies specified within those standards. Testing would be performed by qualified engineers or test laboratories.

4. Adjudication method for the test set:

• Not applicable for AI/ML performance. Adjudication is not mentioned as the testing refers to standard compliance.

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 such study was performed or mentioned. The device is a hardware tool for image acquisition and display, not an AI-powered diagnostic aid.

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

• No such study was performed or mentioned. There is no indication of an AI algorithm in this submission.

7. The type of ground truth used:

• For the performance data mentioned (IEC standards), the "ground truth" is adherence to the technical specifications and safety requirements defined by these international standards.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set for an AI/ML algorithm.

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

• Not applicable. There is no mention of a training set for an AI/ML algorithm.

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S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

For Urology:
Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.
Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract.

For Gynecology:
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

The bipolar S-line Resectoscopes with electrodes have a design similar to the traditional monopolar resectoscopes, but with an additional pin for the neutral pole at the working element. The HF bipolar connection cables have a standard resectoscope connector and in addition a neutral connection to the neutral pin at the neutral pin at the S-line working element and on unit side plugs for connection to bipolar generators.

The provided 510(k) summary for the "S-line" Saline Bipolar Resectoscope does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a diagnostic AI/ML device submission would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and states that no performance standards are known and no clinical tests were performed for this specific submission.

However, based on the information provided, we can infer the overarching "acceptance criteria" through the lens of safety and effectiveness, and how the submitter "proved" this through substantial equivalence.

Here's an analysis based on your requested categories:

Acceptance Criteria and Device Performance

Since no specific quantitative performance metrics are provided (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" are implied to be that the device functions safely and effectively for its intended use, comparable to its predicate devices.

Study Details (or lack thereof, in an AI/ML context)

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

   • Test set size: Not applicable. No dedicated "test set" in the context of an AI/ML performance study was used. The submission relies on technical characteristics and substantial equivalence, not data from a specific test set.
   • Data provenance: Not applicable. No clinical data provided.

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

   • Not applicable. No ground truth establishment in the customary sense for evaluating a diagnostic device's performance.

3. Adjudication method for the test set:

   • Not applicable. No test set or adjudication performed.

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. This device is a surgical instrument, not an AI/ML diagnostic aid for human readers.

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

   • Not applicable. This is a surgical resectoscope, not an algorithm.

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

   • Not applicable. Ground truth for performance metrics was not established as part of this submission. The "truth" is based on the design and intended function being safe and effective, similar to predicate devices.

7. The sample size for the training set:

   • Not applicable. This device is a hardware instrument, not a learned algorithm.

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

   • Not applicable.

Summary of the "Study" provided in Ko62720:

The submission for K062720 does not describe a "study" in the typical sense of a clinical trial or performance evaluation for an AI/ML device. Instead, it follows a 510(k) pathway for medical devices which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices.

The arguments made are:

• Technological Characteristics: The device has a similar design to traditional monopolar resectoscopes but includes an additional pin for the neutral pole, enabling bipolar functionality. It highlights the benefits of using saline over Purisole/Glycine solution (minimizing TUR-syndrome) and avoids intra-operative muscle tremor due to current localization.
• Safety and Effectiveness: The conclusion states that the devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." This suggests manufacturing controls and design verification/validation (which are typically part of a Quality System) rather than a specific clinical performance study for regulatory submission.
• Predicate Devices: Substantial equivalence is claimed to several predicate devices, including resectoscopes from Richard Wolf (K980302, K042523), Olympus, ACMI (K031001, K022480), and a Gyrus system. The device's safety and effectiveness are considered to be comparable to these established devices, with the new technological characteristics not diminishing safety or effectiveness.
• No specific performance standards or clinical tests were performed for this submission.

In essence, the "proof" the device meets acceptance criteria is derived from its design, its intended function, and its demonstrated similarity (substantial equivalence) to devices already on the market where safety and effectiveness have been previously established.

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