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The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.

The electrosurgical generator is intended to be used in the following medical fields:

• · Open surgery
• · Laparoscopic surgery, including single-site surgery
• · Endoscopic surgery

Only for use by a qualified physician in an adequate medical environment.

The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different high frequency monopolar and bipolar cutting and coagulation modes with a maximum output power of 320 W, as well as capability to power the existing Olympus ultrasonic THUNDERBEAT and SONICBEAT devices via a redesigned HYBRID ULTRASONIC socket and four new modes using high frequency (RF bipolar output) energy and supporting ultrasonic energy. The maximum RF output power for the THUNDERBEAT mode is 110 W.

The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of soft tissue in open surgery, laparoscopic surgery (including single-site surgery), endoscopic surgery and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments.

The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) as well as the power switch (on/off), six output sockets and one neutral electrode socket.

The touch screen GUI displays the current settings of the chosen output mode, the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the menu in order to edit settings/procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to access user-defined settings and procedures.

Here's a breakdown of the acceptance criteria and the study details for the ESG-410 (Models: WA91327U, WA91327W), based on the provided document:

This device is an electrosurgical generator, and the information provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm's performance against specific clinical endpoints. Therefore, many of the typical acceptance criteria and study details for AI/ML devices aiming to improve diagnostic accuracy are not applicable here. This submission relies heavily on demonstrating equivalent technical characteristics and safety performance to existing, cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size in terms of number of cases or patients, as this is primarily a device safety and performance equivalence submission, not a diagnostic accuracy study.
  • For Vessel Burst Pressure and Thermal Spread, studies were conducted on "vessels" which implies a quantity of biological samples (e.g., animal tissue, ex vivo human tissue) but the exact number is not provided. The comparison was to "control groups."
  • For Performance Bench Testing (tissue effects, electrical waveforms, functional performance), the testing involved various "modes, instruments and test protocols/plans." The nature of these tests is laboratory bench testing using simulation and comparison.
• Data Provenance: The studies were non-clinical bench testing and preclinical (simulated use) evaluation.
  • No information on country of origin of data or whether it was retrospective or prospective is relevant or provided, as these are not clinical studies on human subjects.

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 to this 510(k) submission. The ground truth for functional equivalence, tissue effects, thermal safety, etc., was established through objective engineering measurements, comparisons to predicate device measurements, and compliance with recognized standards, rather than expert consensus on clinical cases.

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

• This information is not applicable. Adjudication methods like 2+1 are used in clinical diagnostic studies where expert reviewers resolve discrepancies in ground truth labeling. This submission relies on objective physical measurements and engineering evaluations.

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 is not an AI-assisted diagnostic device; it is an electrosurgical generator used for cutting and coagulation. Therefore, the concept of human readers improving with AI assistance is not relevant.

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

• This is not an algorithm-only device. The device is hardware (an electrosurgical generator) with integrated software. Its performance is always "standalone" in the sense that the generator produces desired electrical outputs or ultrasonic vibrations based on its internal programming and user settings. The human operator is "in-the-loop" by controlling the device during a surgical procedure. The software validation tests mentioned (Section 2.8.5) assess the software's performance as part of the overall device.

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

• The "ground truth" for the performance claims in this submission is primarily based on:
  • Objective engineering measurements: Verifying electrical waveform outputs, power levels, and adherence to specified performance parameters.
  • Direct comparisons to predicate devices: Establishing that the new device's performance (e.g., tissue effects, thermal spread, burst pressure) is either identical, equivalent, or statistically non-inferior/superior to the legally marketed predicate devices.
  • Compliance with recognized international standards: Demonstrating that the device meets established safety and performance benchmarks (e.g., AAMI/ANSI/IEC 60601 series for electrical safety, ISO 14971 for risk management).

8. The sample size for the training set

• This information is not applicable. This is not an AI/ML device that requires a training set in the typical sense for learning models. The software development and validation followed standard engineering practices, not machine learning model training.

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

• This information is not applicable, as there is no training set for an AI/ML model.

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HF cables for electrosurgical use in laparoscopic, and open surgery in combination with compatible active accessories and compatible electrosurgical generators

The HF-cables (see Table 2.1) subject to this submission are reusable, non-sterile devices, that connect electrosurgical generators as sender to compatible active accessories as receiver for electrosurgical use in laparoscopic, endoscopic, and open surgery. The devices are used as part of a system.

The HF-cables are class II medical device accessories under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery.

There are monopolar as well as bipolar HF-cable models subject of this submission. All of the subject HF-cables are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the cables must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use.

The HF-cables are available with different cable lengths and with different plugs for the working element/instrument as well as for the electrosurgical generator side. The different plugs allow different compatibilities in accordance with their respective labeling.

Based on the provided text, the device in question is a set of HF-cables (reusable) for electrosurgical use. The document outlines the performance data and testing conducted to demonstrate the safety and effectiveness of these cables for a 510(k) premarket notification.

It's crucial to understand that this document describes the data provided for a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy from scratch like a PMA might. As such, the types of studies and acceptance criteria are focused on demonstrating that the new device performs similarly and safely compared to the predicate, and does not raise new questions of safety or effectiveness.

Here's an analysis of the acceptance criteria and study detailed in the document, keeping in mind the context of a 510(k) submission for reusable HF-cables:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct "table of acceptance criteria and reported device performance" in the typical AI/diagnostic software study format (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by successful completion of various engineering and safety tests according to recognized standards. The "performance" is the successful completion of these tests.

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

The document describes engineering bench testing and compliance with standards, not performance on a clinical test set with patient data. Therefore, the concept of "sample size used for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) is not applicable to this type of device and submission. The "samples" would be physical units of the HF-cables. The document does not specify the number of cable units tested, which is common for this type of submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the ground truth for this device is not established by expert clinical review of data (e.g., medical images). Instead, the "ground truth" is established by the successful passing of engineering and safety tests against predefined, recognized standards and internal specifications.

4. Adjudication Method for the Test Set:

This is not applicable as it's not a study involving human readers or interpretation of clinical data that would require adjudication.

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

This is not applicable. An MRMC study is relevant for AI or diagnostic imaging devices where human reader performance is being evaluated, with or without AI assistance. This submission is for electrosurgical cables.

6. Standalone (Algorithm Only) Performance:

This is not applicable. This concept applies to AI algorithms. The HF-cables are a physical accessory, not an algorithm. Their "performance" is based on their physical and electrical characteristics when used in a system.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on:

• Engineering Specifications: The design and functional requirements for the cables.
• Recognized Consensus Standards: International and national standards (e.g., IEC 60601 series, ISO 14971) that define safety, electrical performance, thermal limits, and other critical aspects for electrosurgical accessories.
• Validation of Reprocessing Methods: Verification that cleaning and sterilization procedures are effective.

It is not based on expert consensus, pathology, or outcomes data in a clinical sense as would be the case for a diagnostic device.

8. The Sample Size for the Training Set:

This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This submission is for a physical medical device (HF-cables), not an AI algorithm.

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

This is not applicable for the reasons stated in point 8.

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Transmission of light energy from the light source to an optical instrument.

The light-guide cable is used to transmit light during endoscopic procedures or for other medical illumination application when the properties and operating instructions are complied with.

The light-guide cable is designed for use with halogen, xenon or LED based light which are utilized in medical applications that involve endoscopes, medical instruments or microscopes.

The Olympus Light-Guide Cables that are subject to this submission are intended to transmit light from the light source to an optical instrument. For that purpose the Light-Guide Cable includes a bundle of optical fibers as transmission medium. The light guide adapters are intended for the mechanical connection of the Light-Guide Cables to light sources or to endoscopes.

There are two variants of Light-Guide Cables which differ according to the shaft diameter of the connected endoscope. Cable WA03300A (2.8 mm, 3 m, CF type) can be combined with endoscopes, which have a diameter ≤ 4.1mm. Endoscopes with a diameter > 4.1mm are combined with WA03310A (4.25 mm, 3 m, CF type). Otherwise the Light-Guide Cables are identical.

This document describes the FDA's 510(k) clearance for Olympus Light-Guide Cables. The core of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to provide full performance study details typical of a de novo device. Therefore, the specific information requested in the prompt, such as detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, and effect sizes for human-in-the-loop studies, is largely not present in this type of regulatory document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document states, "The Light-Guide Cables comply with all applicable requirements/standards as listed in Appendix IIIc of this submission." However, Appendix IIIc is not provided, so the specific acceptance criteria and their corresponding reported device performance values are not detailed in this text.

The document also mentions that "the design of the subject device Light-Guide Cables is identical to that of the predicate devices" with "minor design modifications." It asserts that these differences "do not negatively impact safety or effectiveness" and "do not raise different questions of safety or effectiveness."

Based on the provided text, a table of acceptance criteria and reported device performance cannot be fully constructed. The document primarily relies on the substantial equivalence to a predicate device that has been "used safely and effectively for years," and compliance with general safety standards.

The closest we get to "reported performance" is the mention of electrical safety testing and reprocessing validation.

Study Information (Based on provided text)

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

   • Sample Size: Not explicitly stated as a separate "test set" in the context of a new performance study. The document states that because the devices are substantially equivalent and the predicate has been used for years, "it was not considered necessary to re-test the performance of the Light-Guide Cables concerned." However, "complete evidence of the performance test records is included in this submission" (referenced in Appendix 12a-e, which is not provided).
   • Data Provenance: Not specified. Given the reliance on predicate device history and general standards compliance, no specific new clinical data is presented here.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new "ground truth" was established for a new clinical test set as the submission relies on substantial equivalence and existing predicate safety/effectiveness.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new clinical test set requiring adjudication for ground truth was conducted.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a passive light-guide cable, not an AI-assisted diagnostic or therapeutic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device. Physical bench testing was likely done for electrical safety and reprocessing validation, but not a "standalone algorithm" performance.

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

   • For the aspects that were tested (Electrical Safety, Reprocessing), the "ground truth" would be the established international and national standards (e.g., ANSI AAMI ES60601-1, IEC 60601-2-18) against which the device's electrical performance was measured, and validated sterilization protocols for reprocessing.
   • For the overall device, the "ground truth" for safety and effectiveness is largely based on the predicate device's established use history and compliance with general device regulations.

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

8. How the ground truth for the training set was established: Not applicable.

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Sheath with integrated stopcocks are used in conjunction with a hysteroscope to permit direct viewing of the cervical canal and the uterine cavity to perform diagnostic and surgical procedures.

The subject device is a reusable sheath (Part WA4777A) and stopcock (Part WA47778A), provided non-sterile and labeled for reprocessing via cleaning and steam sterilization. The sheath is a rigid instrument made from stainless steel. The sheath has a working length of 206.7 ± 0.15 mm. The sheath has a single lumen shaped to allow for both, insertion of one 3 mm hysteroscope as well as a 5 Fr instrument channel for the instrument and irrigation inflow. There are three ports, one for irrigation, one for instruments, and one for the hysteroscope. There is no outflow channel for the irrigation fluid; the irrigation fluid flows out between the sheath and the cervix channel. A hysteroscope can be inserted into the hysteroscope channel of the sheath from the proximal end to provide an endoscopic image during the procedure. The endoscopic image can be viewed using the ocular or by connecting a compatible camera head. Compatible surgical instruments can be inserted into the instrument channel of the sheath. The irrigation stopcock made from stainless steel and polyether ether ketone (PEEK) can be used to control the inflow of the irrigation fluid. The instrument stopcock controls the passage of the surgical instruments.

The provided text describes the 510(k) premarket notification for a "Sheath and Stopcock Accessory" and does not contain information about an AI/ML powered device, therefore the request cannot be fully answered. This document purely focuses on a traditional medical device, specifically a reusable sheath and stopcock for hysteroscopes.

However, based on the information provided regarding the "Sheath and Stopcock Accessory," here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not specify exact sample sizes for each test set. It mentions "comparative validation testing" for mechanical performance and "risk analysis" for electrical/thermal safety, and "method validation testing" for reprocessing. The provenance of the data is from internal testing conducted by Olympus Winter & Ibe GmbH. No country of origin for the data is explicitly mentioned, but the manufacturer is based in Hamburg, Germany. The studies are assumed to be prospective experiments or tests designed specifically for this regulatory submission.

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 because the device is a physical medical instrument, not an AI/ML diagnostic tool requiring human expert interpretation for ground truth. The "ground truth" for this device is established through objective physical, chemical, and electrical measurements and adherence to recognized standards.

4. Adjudication method for the test set

Not applicable, as this is not an interpretive diagnostic device requiring adjudication of human-labeled data.

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

Not applicable. This is a medical device, not an AI/ML system, so 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 is a medical device, not an AI/ML system.

7. The type of ground truth used

The ground truth for this device's performance evaluation is based on objective physical measurements, chemical analyses (for biocompatibility), and adherence to established international and national standards (ISO, AAMI/ANSI, IEC, FDA guidance documents). For example, "non-cytotoxic" is a measurable outcome, and "comparable flow" is determined by direct measurement during bench testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML powered device.

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

Not applicable. There is no "training set" as this is not an AI/ML powered device.

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The instrument tray is intended to be used to enclose and protect one Olympus semi-rigid ureteroscope, models WA2UR11A, WA2UR12A, WA2UR14A, WA2UR21A, WA2UR22A, WA2UR22A, WA2UR23A WA2UR31A, and WA2UR32A (K200369), and accessories during sterilization in a prevacuum steam sterilizer using the following parameters or cycles:

Prevacuum steam sterilization

• Exposure time at a temperature of 135 °C (275 °F:) Wrapped instruments .......................................................................................................................................................... Unwrapped non-porous instruments ................ 3 min.

• Drying time.........................................................................................................................30 min.

After steam sterilization, let the instrument tray cool down at room temperature. - Cool-down time...............................................................................................................................30 min.

The instrument tray is also intended for the enclosure of Olympus semi-rigid ureteroscopes and accessories during transport and storage within the reprocessing cycle. The instrument tray is not compatible with flexible ureteroscopes.

The instrument tray is to be used in conjunction with a FDA cleared sterilization wrap. Maintenance of sterility depends on the sterilization wrap.

Worst case load:

The instrument tray containing a ureteroscope, attachments, light-guide cable adapters, sealing caps and stopcocks must not exceed a weight of 3300 grams (7.27 lb) altogether.

The instrument tray, for semi-rigid ureteroscope is specifically designed for enclosure of Olympus ureteroscopes and accessories during sterilization and storage of Olympus ureteroscopes and accessories after sterilization, as well as enclosure during transport within the reprocessing cycle. A loaded instrument tray cannot be used for automated cleaning of the contained devices.

The Olympus instrument tray is autoclavable and delivered in non-sterile condition to the customer. It is reusable and has to be reprocessed before first and each subsequent use according to defined reprocessing methods in the Instructions for Use.

The provided text describes the acceptance criteria and study results for the "Instrument tray, for semi-rigid ureteroscope" (K203492).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test within the "Summary of Non-clinical Testing" section. It refers to "the study" or "400 sterilization cycles" for the durability test.

• Sample Size: Not explicitly stated for most tests, except for "400 sterilization cycles" for the durability test.
• Data Provenance: The studies were conducted in support of a 510(k) premarket notification for a medical device. This indicates the data is likely prospective and generated specifically for regulatory submission, rather than retrospective analysis of existing data. The manufacturer is Olympus Winter & Ibe GmbH, located in Hamburg, Germany, so the origin of the data would be associated with their testing facilities.

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 are primarily engineering and microbiology validation tests (e.g., biocompatibility, cleaning efficacy, sterilization efficacy, durability, moisture evaluation). These types of tests typically rely on standardized protocols and objective measurements rather than expert consensus on subjective interpretations.

4. Adjudication method for the test set

This information is not applicable/not provided as the tests are objective performance evaluations with defined criteria, not requiring adjudication in the context of expert review or consensus building.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any discussion of AI assistance. This device is an instrument tray for sterilization, not an AI-powered diagnostic or assistive technology.

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

This information is not applicable as the device is a physical instrument tray, not an algorithm, and does not involve AI or software performance.

7. The type of ground truth used

The ground truth for these performance tests is based on:

• Objective measurement against pre-defined thresholds: For cleaning validation (residual protein/TOC), sterilization validation (6 log reduction, no viable growth), and residual moisture (no visible condensation).
• Visual inspection and observation against criteria: For cleaning validation (visibly clean), durability (no visible degradation, no corrosion, legibility of markings).
• Standardized biological assays: For biocompatibility (non-cytotoxic).

These are all empirical and objective measures, not pathology, outcomes data, or expert consensus in the typical sense of diagnostic accuracy.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.

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

This information is not applicable as there is no training set for this device.

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Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. Specific indications: transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis), lysis of intrauterine septa, endometrial ablation.

The Olympus Resection Electrodes with HF cable that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting. The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft). The accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side. The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons. The electrodes have a shaft diameter of 24 Fr, range in length from 261.8-336.7mm, and range in tip angle from 12° - 30° tips. The design of the HF cable plugs fits Olympus electrosurgical generators with Universal Socket. All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator.

This document is a 510(k) Premarket Notification from the FDA regarding Olympus Winter & Ibe GmbH's Resection Electrodes with HF cable. It describes the device, its intended use, and its equivalence to a predicate device.

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

The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as this is a traditional medical device (electrodes) rather than a diagnostic device or AI algorithm with such measures. Instead, the acceptance criteria are based on demonstrating comparable safety and effectiveness to the predicate device through various non-clinical performance and safety tests, and compliance with relevant standards.

Here's a summary of the performed tests as evidence of meeting safety and effectiveness requirements:

The study concluded that "The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device."

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

The document describes non-clinical performance and safety testing. It does not refer to "test sets" in the context of patient data. The samples for testing would be units of the device itself (electrodes and cables). The specific number of devices tested for each non-clinical test (e.g., how many electrodes were subjected to lifetime connection/disconnection tests) is not explicitly stated in this summary.

The provenance of this data is from regulatory submissions to the FDA, originating from the manufacturer, Olympus Winter & Ibe GmbH, which is located in Hamburg, Germany. The tests are non-clinical (laboratory/bench tests), not clinical studies; therefore, terms like retrospective/prospective or country of origin of patient data are not applicable.

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 non-clinical testing for a traditional medical device (electrosurgical electrodes and cables), not a diagnostic device or AI algorithm requiring expert-established ground truth from patient data.

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

This is 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

This is not applicable for the reasons stated above. The device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.

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

This is not applicable for the reasons stated above. The device is a physical electrosurgical electrode and cable, not an algorithm.

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

For the non-clinical tests conducted, the "ground truth" or reference for evaluating performance is typically defined by:

• Engineering specifications and design requirements: For mechanical, electrical, and functional performance.
• Applicable national and international standards: For electrical safety (e.g., IEC 60601 series), sterilization (ISO 11135), packaging (ISO 11607-1, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and biocompatibility (ISO 10993 series).
• Comparison to the predicate device: The goal is to demonstrate that the subject device is substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device.

8. The sample size for the training set

This is not applicable. The device is a traditional medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.

The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

The subject device ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel features a touch screen GUI that displays current settings, connection status, and allows access to menus for editing settings, procedures, and preferences. Compatible accessories include previously cleared footswitches.

The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm. The POWERSEAL devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. The jaws are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism opens and closes the jaws. A second control initiates bipolar energy delivery for sealing. A separate control activates a blade for tissue division.

The provided text details the 510(k) submission for the Olympus Electrosurgical Generator ESG-400 and Accessories, and the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The study described focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving direct performance against them in a traditional sense. The performance data provided is primarily in the context of comparative testing to established predicate devices.

Here's an attempt to extract the information requested, with indications where the information is not explicitly available in the provided document:

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly state specific numerical acceptance criteria for performance metrics (e.g., burst pressure in mmHG, or a specific range for coagulation time). Instead, it states that the device "met all acceptance criteria" for biocompatibility and that "performance requirements defined in the User Requirements Specification and Design Specification were met for both subject devices, and that they exhibit comparable performance characteristics to the predicate device and reference devices."

The performance is described qualitatively as being "comparable" or having "equivalent technology and performance" to predicate/reference devices. For example, for vessel sealing, the key performance indicator mentioned is "vessel burst pressure testing."

Therefore, a table of acceptance criteria and reported numerical performance values cannot be fully constructed from the provided text in the typical quantitative manner.

Table 1: Acceptance Criteria and Reported Device Performance (as inferred and stated qualitatively)

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

• Test Set Sample Size: The document does not specify exact sample sizes for the "test set" in terms of number of cases or samples for the animal studies or bench testing (e.g., how many vessels were sealed for burst pressure testing). It only states that "ex-vivo Vessel Burst Pressure testing was conducted."
• Data Provenance (Country of Origin, Retrospective/Prospective): Not explicitly stated. The studies were likely conducted in a controlled lab or animal facility. The document refers to FDA guidance documents, which are for U.S. regulatory submissions, but doesn't specify where the actual testing took place. It also doesn't specify if the animal studies or bench tests were retrospective or prospective, though performance testing is generally prospective.

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

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is typically related to clinical studies involving human interpretation or pathology. The reported studies are primarily bench (ex-vivo) and animal studies. Therefore, this information is not applicable in the context of the provided document. The "ground truth" for these studies would be objective measurements (e.g., burst pressure from instrumentation) rather than expert consensus on clinical findings.

4. Adjudication method for the test set

This is also typically relevant for clinical studies with human interpretation. For bench and animal studies (e.g., measuring vessel burst pressure), the "adjudication" is typically through objective measurements and statistical analysis, not a consensus process among experts as described by methods like 2+1 or 3+1. Therefore, this information is not applicable in the context of the provided document.

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

• MRMC Study Done: No. This study is for an electrosurgical device, not an AI-assisted diagnostic tool involving human readers.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: Not applicable to this type of device. The device itself is an electrosurgical tool, not an algorithm, and it is used by a human surgeon.

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

For the performance testing, the ground truth was established through objective physical measurements in bench and animal studies:

• Biocompatibility: In vitro and in vivo (animal tissue/systems) tests following ISO 10993 standards.
• Electrical/Thermal Safety & EMC: Measurements against IEC standards.
• Vessel Sealing Performance: Chronic and acute animal studies demonstrating seal performance, and ex-vivo vessel burst pressure testing. The "ground truth" here would be the measured burst pressure values and observed tissue effects.

8. The sample size for the training set

The document describes an electrosurgical device, not a machine learning or AI algorithm in the context of diagnostic imaging. Therefore, the concept of a "training set" in this context is not applicable. The "training" for such a device involves engineering design, prototyping, and testing against specifications and regulatory standards.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm being developed.

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ESG-410:
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields:

• Open surgery
• Laparoscopic surgery
• Endoscopic surgery
  Only for use by a qualified physician in an adequate medical environment.

PK Cutting Forceps (CF-PK0533):
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures.

ESG-410 Generator:
The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) that displays the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the Menu in order to edit settings/ procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to assess user-defined settings and procedures.

PK Cutting Forceps:
The PK Cutting Forceps are a bipolar electrosurgical device that may be utilized in laparoscopic and open general surgery to grasp, coagulate, transect, dissect and retract tissue. The PK Cutting Forceps were cleared via K142759. They are currently intended to be used only with the existing ESG-400 generator per the Indications for Use statement. This submission will demonstrate compatibility with the new ESG-410 generator, and the Indications for Use statement will remove a specific generator model and the compatible generators will be reflected in the labeling. Minor modifications, which did not affect safety and effectiveness, were assessed via internal documentation since the original clearance and will be identified within the submission.

The provided text describes a 510(k) premarket notification for an electrosurgical generator (ESG-410) and accessories, including PK Cutting Forceps. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through large-scale clinical trials.

Therefore, the information you're asking for, particularly regarding acceptance criteria tied to device performance in terms of patient outcomes or diagnostic accuracy, and detailed MRMC studies with expert adjudication and effect sizes, is not typically found in a 510(k) submission for a device like an electrosurgical generator.

The "acceptance criteria" for this type of device are primarily related to meeting recognized electrical safety, electromagnetic compatibility (EMC), thermal safety, software validation, and functional performance standards. The "study that proves the device meets the acceptance criteria" refers to a series of bench and non-clinical/preclinical tests designed to show that the new device performs comparably to the predicate device and meets relevant performance standards.

Let's break down what is available in the document related to your questions, and where specific requested information is not applicable or provided.

Acceptance Criteria and Reported Device Performance

The core "acceptance criterion" for a 510(k) submission is substantial equivalence to a predicate device. This is demonstrated by showing similar technological characteristics, intended use, and comparable safety and effectiveness. "Performance" here largely refers to meeting technical specifications and demonstrating similar tissue effects to the predicate, not clinical outcomes in patients.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Detailed Responses to Specific Questions:

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

   • See table above. The "performance" for this type of device is predominantly technical and functional performance against standards and predicate devices, not clinical effectiveness in terms of patient outcomes.

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

   • Sample Size: The document does not specify "sample sizes" in the typical clinical study sense for test sets of patients or cases. Instead, it refers to "bench studies" and "preclinical (simulated use) evaluation and testing of tissue effects." For tissue effects, it mentions "three clinically relevant tissue types were evaluated in all applicable modes." This implies material samples or ex-vivo tissue, not a patient cohort.
   • Data Provenance: The tests are described as bench and preclinical (simulated use), conducted by the manufacturer (Olympus Winter & Ibe GmbH) and contract manufacturer (STEUTE TECHNOLOGIES GMBH & CO. KG), both located in Germany. There is no mention of country of origin of patient data as no clinical studies were deemed necessary. The studies were non-clinical/preclinical.

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

   • This question is not applicable to this submission. Ground truth, in the context of diagnostic AI or similar devices, is established by expert review (e.g., radiologists) for specific patient cases. This device is an electrosurgical generator. Its "ground truth" is its ability to adhere to technical specifications, produce specific electrical waveforms, and achieve desired tissue effects in a controlled, non-clinical environment, which is assessed through engineering and physical measurements. No human expert "ground truth" for a test set of medical images/cases is mentioned or relevant here.

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

   • Not applicable. Adjudication methods are used in clinical studies where multiple readers interpret cases and their consensus/disagreement needs to be resolved to establish ground truth or compare diagnostic performance. This is a technical performance and safety submission for an electrosurgical device, not a diagnostic one.

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 type of study is typically performed for AI-powered diagnostic devices to assess how AI assistance impacts human reader performance. The ESG-410 is an electrosurgical generator, a surgical tool, and does not involve human "readers" interpreting images with or without AI assistance. Clinical and animal studies were explicitly stated as "not necessary."

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

   • The ESG-410 contains "software," and "software validation activities were performed." This implies standalone testing of the software's functionality, but not in the context of an "algorithm only" performance for things like diagnostic accuracy (e.g., a standalone AI imaging algorithm). For this device, standalone performance refers to its ability to generate the correct electrical outputs and control the surgical modes as programmed. This was part of the "non-clinical (electrical, dimensional, functional, stability)" testing.

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

   • The "ground truth" for this device's performance is based on engineering specifications, physical measurements of electrical output waveforms, and qualitative/quantitative assessment of tissue effects in simulated environments (preclinical/bench testing). This is not a "ground truth" derived from human experts, pathology, or patient outcomes data, as no clinical studies were performed.

8. The sample size for the training set:

   • Not applicable/Not mentioned. This is not an AI/machine learning device that requires a training set of data for an algorithm to learn from in the typical sense (e.g., imaging data for a diagnostic algorithm). The software validation refers to standard software development life cycle processes, not machine learning model training.

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

   • Not applicable. As explained above, there's no "training set" in the context of machine learning for this device. Its software and functional parameters are designed and validated based on established engineering principles and performance standards for electrosurgical devices, rather than learned from a data set with pre-established ground truth labels.

In summary, the provided FDA 510(k) document details a substantial equivalence claim for an electrosurgical generator and its accessories. The "acceptance criteria" and "proof" provided are consistent with a regulatory pathway for electrical surgical devices, focusing on meeting established technical performance standards and demonstrating comparability to predicate devices through bench and preclinical testing, rather than extensive clinical studies or AI algorithm performance validation metrics typical for imaging diagnostics.

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The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder.

Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures:

• Transurethral inspection of the ureters and renal pelvis for diagnosis
• Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter
• Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters
• Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis.

The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.

The OES Elite Ureteroscopes are inserted directly through the natural orifice urethra and are used to visualize a wide range of therapeutic procedures or to support diagnosis. The OES Elite Ureteroscopes are reusable semi-rigid endoscopes, which consist of an image relay system inside the main body and an outer tube that guides an image fiber bundle to transmit the endoscopic image. For therapeutic procedures, the device is used in combination with surgical instruments which can be introduced through the instrument channels.

The OES Elite Ureteroscopes and accessories are delivered in non-sterile condition. They are reusable and fully reprocessable. Before first and each subsequent use the device must be inspected and reprocessed according to defined and validated reprocessing methods in the instructions for use.

The OES Elite Ureteroscopes are available in different working lengths, ocular directions, image sizes, directions of views and with one or two instrument channels.

This document is a 510(k) summary for the Olympus OES Elite Ureteroscopes and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or AI performance metrics.

Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for AI test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone AI performance, etc., cannot be directly extracted from the provided text. The document pertains to the device's physical and optical characteristics and reprocessing validation, not an AI component.

However, I can extract the acceptance criteria and performance data that are present in the document, which relate to the ureteroscope's physical and optical properties.

Here's the information that can be derived from the text, formatted as closely as possible to your request, but acknowledging the limitations for AI-specific data:

Acceptance Criteria and Device Performance for Olympus OES Elite Ureteroscopes and Accessories

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

The document presents a comparison of the subject device (OES Elite Ureteroscopes) to predicate devices, implying that the subject device's performance is acceptable if it is comparable to or better than the predicate, and does not raise new safety or effectiveness concerns. The "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices and the internal design specifications of the new device that were verified.

Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical performance and verification tests to ensure the subject devices function as intended and meet design specifications, as well as being substantially equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to "nonclinical testing," "design verification and validation testing," and "comparative testing" of the physical devices. Data provenance is implied to be from internal testing by the manufacturer (Olympus Winter & Ibe GmbH). The nature of these tests (e.g., mechanical, optical) means they are conducted in a laboratory setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for device performance (e.g., resolution, dimensions, flow rate) is established through standardized engineering and laboratory measurements, not through expert human interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set
Not applicable, as ground truth is based on direct measurement and engineering standards, not subjective expert assessment.

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 document is for a medical device (ureteroscope), not an AI-powered diagnostic or assistive tool. No human reader studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device.

7. The type of ground truth used
The ground truth for the device's physical and optical characteristics is based on engineering specifications, direct measurements, and adherence to established international and national standards (e.g., ISO 8600 series for endoscopes, IEC for electrical safety, ASTM for transport, ISO 10993 for biocompatibility, FDA guidance for reprocessing).

8. The sample size for the training set
Not applicable. There is no AI "training set" for this device.

9. How the ground truth for the training set was established
Not applicable. There is no AI "training set" for this device.

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This instrument has been designed to be used with a video system center, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

The ENDOEYE HD II - High Definition Digital Video Laparoscope is a rigid video telescope used for endoscopic diagnosis, treatment, video observation and surgery within the thoracic and abdominal cavities including female reproductive organs. For laparoscopic applications, the video telescope is inserted via a trocar into the patient. The ENDOEYE HD II is used with a video system center, light source and monitor to achieve its intended function. In addition, the ENDOEYE HD II can be inserted in compatible instrument trays for reprocessing. The ENDOEYE HD II can provide an image with either white light or narrow band imaging and WA50040A and WA50042A include a heater function at the distal tip to reduce fogging of the lens.

This document describes the premarket notification (510(k)) for the Olympus ENDOEYE HD II, a rigid video telescope used for endoscopic diagnosis, treatment, video observation, and surgery. This is primarily a regulatory submission for a medical device and not a study proving an AI/ML device meets acceptance criteria.

Therefore, many of the requested details, such as acceptance criteria for AI/ML performance metrics, sample sizes for AI/ML test/training sets, expert adjudication methods for AI/ML ground truth, and MRMC studies, are not applicable to this document. This document focuses on demonstrating substantial equivalence to a predicate device through engineering performance data rather than sophisticated clinical or AI/ML performance studies.

However, based on the provided text, I can infer and state the following regarding "acceptance criteria" and "study" in the context of this device:

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

The document doesn't provide a table of specific numerical acceptance criteria for each performance test, nor does it present detailed quantitative performance results in a table. Instead, it states that "All samples tested met their predefined acceptance criteria." The acceptance criteria would be linked to the standards mentioned for each test.

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

• Sample size: The document does not specify the exact sample sizes (number of units) used for each individual test. It generally refers to "All samples tested."
• Data provenance: Not explicitly stated regarding country of origin or specific patient data. The tests are lab-based design verification and validation tests rather than clinical data tests. It's a regulatory submission from a German manufacturer (Olympus Winter & Ibe GmbH) to the US FDA. The tests are "Performance Data" and are likely performed in a controlled, prospective manner as part of the design and manufacturing process.

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

• Not applicable. This device is a hardware endoscopic camera. The "ground truth" for its performance is established by meeting engineering specifications and recognized international standards (e.g., IEC, ISO, ASTM) through objective physical and software testing, not by expert human interpretation of medical images or conditions.

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

• Not applicable. As the "ground truth" is established by adherence to engineering standards and objective measurements, there is no need for expert adjudication of medical findings.

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

• No. This is not an AI-enabled device. Therefore, no MRMC study looking at human reader improvement with or without AI assistance was conducted or is relevant for this regulatory submission.

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

• Not applicable. This device is a camera system, not an algorithm that performs a standalone diagnostic or analytical function.

7. The type of ground truth used:

• The ground truth is based on engineering specifications, recognized international standards (e.g., IEC, ISO, ASTM), and internal company acceptance criteria for hardware and software performance. This includes electrical safety, EMC, thermal safety, mechanical performance, transport resistance, service life, illumination, and software functionality.

8. The sample size for the training set:

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

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

• Not applicable. See point 8.

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