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This Single-use Flexible Ureteroscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra. bladder, ureter and renal pelvis.

This Single-use Flexible Cystoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder and renal pelvis.

This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

The subject device, Urology Videoscope System is consisting of a Single-use Flexible Ureteroscope (SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-24-P SUV-2B-B SUB-2B-P SUV-2C-B SUV-2C-P) or Single-use Flexible Cystoscope (SUV-1D-B SUV-1D-P) and an Endoscopic Image Processor (HDVS-S100A, HDVS-S100D) including the foot switch. The subject device has been designed to be used for endoscopic diagnosis and therapies within the urinary system such as urethra, bladder, ureter and renal pelvis.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single use devices. They are intended to be used in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the urinary system such as urethra, bladder, ureter and renal pelvis. There are ten models of Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope, with four kinds of insertion portion widths (2.5mm, 2.7mm, 2.8mm and 5.4 mm), four working lengths (380mm, 550mm, 635mm and 680mm), two different treatment section (with or without suction section).

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are single-channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Flexible Ureteroscope and Single-use Flexible Cystoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

The provided text is an FDA 510(k) clearance letter and summary for a Urology Videoscope System. It details acceptance criteria based on non-clinical performance data and various tests. However, it does not include information about a study proving device meets acceptance criteria related to human reader performance with or without AI assistance, a multi-reader multi-case (MRMC) comparative effectiveness study, or any AI component for which such an evaluation would be relevant.

The document primarily focuses on bench testing and technical performance of the Ureteroscope, Cystoscope, and Image Processor, rather than the diagnostic interpretive performance of an AI algorithm.

Therefore, many of the requested points in the prompt (2-9) are not applicable or cannot be answered from the provided text, as they pertain to AI/machine learning model evaluation in a diagnostic context.

Here's the information that can be extracted or deduced from the text, with explanations for what cannot be answered:

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

The document lists various performance tests conducted to demonstrate compliance with standards, implying these are the acceptance criteria for the respective tests. However, it does not provide specific numerical acceptance thresholds or detailed "reported device performance" values for each criterion, only that "The test results demonstrated that the subject device complies with the standard requirements" or that testing was "conducted on the subject device" to "demonstrate the subject endoscope can function as intended."

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

This information is not provided in the document as the studies described are non-clinical, bench-top, and engineering performance tests, not studies on image datasets. The device is manufactured in China.

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

This information is not applicable/not provided. The ground truth for the non-clinical tests would be established by engineering specifications, physical measurements, and adherence to international standards, not by clinical experts reading images.

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

This information is not applicable/not provided. Adjudication methods are relevant for clinical image interpretation studies, not for the technical performance tests described.

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

There is no mention of an AI component or any MRMC study in this document. The device is an endoscope system for visualization and therapy, not an AI-assisted diagnostic tool. The document explicitly states: "The clinical data is not applicable."

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

There is no mention of an AI algorithm in this document, therefore no standalone algorithm performance study was indicated.

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

For the non-clinical tests described, the "ground truth" would be the engineering specifications, physical parameters, and established international standards (e.g., ISO, IEC) against which the device's performance is measured. It is not clinical ground truth.

8. The sample size for the training set

This information is not applicable/not provided, as there is no AI or machine learning model mentioned that would require a training set.

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

This information is not applicable/not provided, as there is no AI or machine learning model mentioned.

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The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.

The Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or within the field of view from the body cavity.

The Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

The subject device, Broncho Videoscope System, is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor or Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.

The Single-use Broncho Videoscope is a single use in conjunction with Full HD Visualization Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi and lungs. The Single-use Broncho Videoscope has six models, which are available in three kinds of outer diameter of insertion section (02.8mm and 05.6mm), one working length (600mm), two different material of the insertion (Nylon and PEEK) and two plug types (Square type and round type). The six models with round type have been cleared in K210739.

The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, they have and the difference is only on the image adjustment functions.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a Broncho Videoscope System, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document primarily focuses on regulatory aspects such as:

• Device Name and Classification: Broncho Videoscope System, classified as Class II, product code EOO.
• Intended Use/Indications for Use: For endoscopic diagnosis and therapies within the respiratory system (trachea, bronchi, lungs).
• Regulatory Compliance: Mentions various FDA regulations like annual registration, device listing, good manufacturing practice, labeling, and prohibitions against misbranding.
• Comparison to Predicate Device: States that the subject device has the same indications for use and technological characteristics as the predicate device.
• Biocompatibility Testing: Notes that biocompatibility tests (cytotoxicity, sensitization, irritation) were re-conducted on representative models per ISO 1099-1, and the results comply with the requirements. This is presented as non-clinical testing supporting substantial equivalence.

While biocompatibility testing is mentioned, it is part of the non-clinical tests that support substantial equivalence to a predicate device, rather than a detailed study proving the device meets specific (quantitative) performance acceptance criteria as would be typical for an AI/ML medical device.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any MRMC study details, as these are not present in the provided text.

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This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.

Full HD Endoscopic Image Processor is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging.

This product is composed of Full HD Endoscopic Image Processor host, foot switch, power cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional.

There are four models (HDVS-S200B, HDVS-S200B, HDVS-S200D) for Full HD Endoscopic Image Processor, and the difference between the four models is only the difference in structure configuration.

The provided text is a 510(k) Summary for a medical device (Full HD Endoscopic Image Processor). It details the device's characteristics, intended use, and substantial equivalence to a predicate device. However, it does not contain information about the acceptance criteria and the detailed study results that specifically prove the device meets these criteria in the way you've outlined for AI/human performance studies.

The document states:

• "The following performance data were provided in support of the suivalence determination. The test results demonstrated that the subject device complies with the standard requirements."
• "The nonclinical test were conducted to demonstrate that the subject is as safe and effective as the predicate."
• "The clinical data is not applicable."

This indicates that the submission relies on non-clinical performance testing (electrical safety, EMC, optical performance, service life, package validation) to demonstrate substantial equivalence, rather than clinical studies or studies involving human readers/AI assistance in the manner of a diagnostic AI device. The device is an image processor, not a diagnostic AI algorithm that interprets images.

Therefore, I cannot extract the information requested for acceptance criteria and study proving device meets acceptance criteria, as the document does not provide this type of data. The questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are typically relevant for diagnostic AI/CADe devices, which is not what this device appears to be based on the provided summary.

In summary, the provided text does not contain the information required to answer your prompt because the device (Full HD Endoscopic Image Processor) is not a diagnostic AI device that would undergo such types of performance evaluations.

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The Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.

The Single-use Extraction Baskets is a single-use, sterile, disposable device. It is intended for the endoscopic removal of stones and stone fragments in the biliary system. The device consists of basket, sheath, and handle components. The basket component is constructed of stainless steel/nitinol wires. And the basket is connected to the handle of the operating portion through the insertion portion. Activating the handle allows the basket to open or close. This device is not compatible with any mechanical lithotripter.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called "Single-use Extraction Baskets." This type of document is concerned with demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing. It is not a document that details the rigorous clinical validation of an AI-powered diagnostic device, which is what your request implies by asking about acceptance criteria, ground truth, training sets, and MRMC studies.

Therefore, most of the information you requested regarding acceptance criteria and a study proving device performance (especially for an AI device) cannot be found in this document because the device in question is a mechanical medical device (extraction baskets), not an AI diagnostic tool, and the review process outlined here focuses on substantial equivalence through non-clinical and mechanical performance testing.

However, I can extract information related to what was used to demonstrate the device's performance for this specific 510(k) submission:

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

The document does not provide a formal table of acceptance criteria with numerical performance metrics for an AI device. Instead, it lists the types of performance tests conducted and states that the "test results demonstrated that the subject device complies with the standard requirements." "Compliance with standard requirements" is the implicit acceptance criterion for these non-clinical tests.

• Dimensions Testing
• Tensile Pull Testing
• Simulated-Use Functionality & Durability Testing
• Stone Capture Testing
• Deflection Testing | Demonstrates basic performance and performs as intended. | Confirmed that the subject device performs as intended. |
  | Comparative Testing | Performance comparable to the predicate device (K203322). | Demonstrated that the subject is as safe and effective as the predicate. |

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

• Sample Size for Test Set: Not specified in terms of numbers of devices or specific test runs for each mechanical test. The document states "The following performance data were provided..." without quantifying the test samples.
• Data Provenance: Not explicitly stated, given that these are non-clinical bench tests rather than patient data. These tests would typically be performed in a lab setting by the manufacturer.

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 and not provided in this document. Since the device is a mechanical extraction basket, there is no "ground truth" in the diagnostic sense or expert interpretation required for these performance tests. The ground truth for mechanical performance is typically defined by engineering specifications and objective measurements.

4. Adjudication method for the test set

• This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for human expert review processes, typically in clinical studies or for establishing ground truth in diagnostic AI datasets. This document describes non-clinical engineering and performance tests.

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 specifically for evaluating the impact of AI on human reader performance, usually in image-based diagnostics. This document is for a mechanical medical device, not an AI diagnostic tool.
• The document explicitly states: "The clinical data is not applicable."

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

• No, this is not applicable. The device is a "Single-use Extraction Basket," a physical tool, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The type of ground truth used

• For mechanical performance tests: The "ground truth" is established by engineering specifications, physical measurements, and industry standards (e.g., ISO, ASTM). For example, "Dimensions Testing" would verify that the device's dimensions meet pre-defined specifications. "Stone Capture Testing" would evaluate the basket's ability to capture stones under simulated conditions, with the "truth" being whether it successfully performed the action based on defined criteria.
• Not applicable for clinical or diagnostic "ground truth" derived from expert consensus, pathology, or outcomes data, as this is not an AI diagnostic device.

8. The sample size for the training set

• Not applicable. This device is a mechanical one and does not involve AI or machine learning that requires a "training set."

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

• Not applicable. As a mechanical device, there is no AI training set.

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The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.

This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

The subject device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.

The provided text is a 510(k) Summary for a medical device called the "Broncho Videoscope System." It details the device's technical specifications and compares it to a predicate device to establish substantial equivalence. However, the document explicitly states that "No clinical study is included in this submission" (page 6, section 7).

This means there is no information available in this document regarding acceptance criteria, reported device performance against those criteria, or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided input.

However, I can extract information related to non-clinical testing and general device characteristics as described in the summary:

Section 1-7: No information available as no clinical study was conducted.

Section 8: Sample size for the training set - Not applicable, as no clinical study for AI model training is mentioned.

Section 9: How the ground truth for the training set was established - Not applicable, as no clinical study for AI model training is mentioned.

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The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

The subject device consists of an insufflator, a high pressure tube and a pneumoperitoneum tube. The insufflator is a microprocessor-controlled CO2 insufflator that consists of the following major components and features: housing, power supply, pressure reducers, venting system, fluid sensor, gas heater, various setting keys and display elements. The insufflator is not intended to enter the field and cannot be sterilized. The pneumoperitoneum tube shall be cleaned, disinfected, and sterilized prior to subsequent use.

The provided document is a 510(k) summary for an Insufflator (K222812), intended to facilitate the use of a laparoscope by distending the peritoneal cavity with gas. It primarily focuses on demonstrating substantial equivalence to a predicate device (K030837) and a reference device (K153513) through non-clinical performance testing.

Based on the provided information, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" for specific performance metrics in a pass/fail format alongside the device's reported performance. Instead, it lists the standards and the types of comparative non-clinical performance testing performed, implying that meeting these standards and showing comparable performance to the predicate device would be the acceptance criteria.

However, we can infer some criteria from the "General Comparison" table (Table 2) and the "Performance Specifications" in Table 3 (which is incomplete in the provided text).

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

The document mentions "non clinical tests were conducted" and "comparative performance testing was also conducted on the subject and predicate devices." However, it does not specify the sample sizes used for these tests. The tests are non-clinical, meaning they involve lab testing of the devices themselves, not patient data. Therefore, questions of country of origin of data or retrospective/prospective are not applicable for this non-clinical submission.

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

This information is not applicable as the studies are entirely non-clinical performance and safety tests of a medical device (insufflator). There is no "ground truth" to be established by clinical experts for a test set in the context of this 510(k) submission.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as above. Non-clinical engineering tests do not involve expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (insufflator) and relies on non-clinical performance and safety testing. There are no human readers or cases involved in the presented studies.

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

This question is not applicable in the traditional sense for this device. The device is hardware with embedded software, not an AI algorithm performing diagnostic or therapeutic functions needing standalone performance evaluation in the context of AI/ML. The software verification and validation were performed as an integral part of the device's functionality.

7. The Type of Ground Truth Used:

As the studies are non-clinical performance tests, the "ground truth" would be established by:

• Engineering specifications and standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, ASTM D4169, AAMI TIR 30, AAMI TIR 12, ISO 15883-2, ISO 17665-1, ISO 14971, and IEC 60601-2-18.
• Expected physical and functional performance: Measured parameters like flow rate, pressure accuracy, temperature, and warning thresholds are compared against design specifications and the performance of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an insufflator, not a machine learning or AI model that requires a training set of data. The software within the device is likely deterministic control software, subject to standard software verification and validation, 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 mentioned or implied for this device.

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The Scivita 4KINSIGHT ICG Imaging System consists of a 4KINSIGHT UHD Fluorescence Imaging System, a Near-Infrared LED Light Source, and a 4K UHD LAPAROSCOPE.

Upon intravenous administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when indicated, during intraoperative cholangiography.

The Scivita 4KINSIGHT ICG Imaging System is indicated for use to provide real time endoscopic visible and nearinfrared fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration of TRADENAME (ICG drug product), the Scivita 4KINSIGHT ICG Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The subject device, Scivita 4KINSIGHT ICG Imaging System is consisting of a 4KINSIGHT UHD Fluorescence Imaging System including a 4K Fluorescence Camera Control Unit and a 4K Fluorescence camera head, a Near-Infrared LED Light Source and a 4K UHD Laparoscope.

The subject device can be offered in multiple configuration based on different combination of component models and subcomponent models. Details refer to Table 1 System Configuration.

The component, 4KINSIGHT UHD Fluorescence Imaging System, is designed to be used with endoscopes, light source, monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation. It is comprised of a 4K Fluorescence Camera Control Unit (model: 4KIR321, 4KIR311) and a 4K Fluorescence camera head (model 4KIR320C). The only difference between 4KIR321 and 4KIR3114K is: two HDMI output signal of 4KIR321 both are 4096×2160p; two HDMI output signal of 4KIR311 are respectively 4096×2160p and 1920×1080p.

The component, 4K UHD Laparoscope, is a rigid endoscope intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities. The subject device is also indicated for visualization of transanal and transvaginal applications.

The 4K UHD Laparoscope has 18 models which are available in two insertion widths (5.5 mm and 10 mm), four working lengths (290mm, 424mm, 450mm) and three different directions of view (0 ; 30 ° 45 9. The 4K UHD Laparoscope is a reusable device that is cleaned and sterilized before first use and each use.

The provided text is a 510(k) Summary for the Scivita 4KINSIGHT ICG Imaging System. It outlines the device's characteristics, indications for use, and a comparison to a predicate device (PINPOINT Endoscopic Fluorescence Imaging System, K182606) to demonstrate substantial equivalence.

Here's an analysis to extract the requested information about acceptance criteria and the study proving the device meets them:

Crucial Finding: The document explicitly states: "No clinical study is included in this submission." This means that the device's performance was not proven through a clinical study with human data. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical (engineering and lab-based) tests.

Therefore, for many of the requested points, direct answers regarding clinical study acceptance criteria, ground truth from human experts, MRMC studies, etc., cannot be provided from this document.

Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, the "acceptance criteria" here refer to the performance characteristics compared against the predicate device to establish substantial equivalence based on non-clinical testing. The "reported device performance" refers to the results of these non-clinical tests.

Table of Acceptance Criteria and Reported Device Performance (based on comparison to predicate)

The document primarily compares various technical specifications of the subject device to the predicate device to argue substantial equivalence. The "acceptance criteria" are implicitly that the subject device's performance is either "Same" as the predicate, "Better" than the predicate, or that any "Different" aspect does not affect safety or effectiveness.

Study Information (Based on the document provided):

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

   • Sample Size: Not applicable. The document explicitly states: "No clinical study is included in this submission." The evaluation is based on non-clinical (laboratory/bench) testing and comparison to a predicate device's specifications.
   • Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by Scivita Medical Technology Co., Ltd. (China-based company).

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

   • Not applicable. As no clinical study was performed, no expert ground truth was established for a test set of clinical images. The "ground truth" for non-clinical performance (e.g., resolution measurements) would be established by standard engineering measurement techniques and equipment.

3. Adjudication Method for the Test Set:

   • Not applicable. No human-read clinical test set.

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

   • No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission."

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

   • Not applicable. This device is an imaging system (hardware and software for image acquisition and display), not an AI algorithm intended to perform standalone diagnostic tasks. Its performance is evaluated fundamentally on image quality metrics and compliance with standards.

6. The Type of Ground Truth Used:

   • For the non-clinical tests, the "ground truth" implicitly comes from established engineering standards and measurement methodologies for optical performance, electrical safety, EMC, etc. (e.g., light intensity measured by a photometer, resolution determined by test charts and lenses, etc.). This is not clinical ground truth (e.g., pathology, expert consensus).

7. The Sample Size for the Training Set:

   • Not applicable. This is not an AI/ML device that requires a training set in the typical sense. It's a medical imaging hardware system.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided 510(k) summary focuses entirely on demonstrating substantial equivalence through non-clinical testing and direct comparison of technical specifications to a predicate device. It explicitly states that no clinical study was conducted. Therefore, questions related to clinical performance, human readers, ground truth establishment for clinical data, and AI/ML specific criteria are not addressed by this document.

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The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.

This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor (HDVS-S100A and HDVS-S100D) to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and an Endoscopic Image Processor including the foot switch. The proposed device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi and lungs.

The Single-use Broncho Videoscope is a single use device. The Single-use Broncho Videoscope has six models which are available in three kinds of outer diameter of insertion (Φ2.8mm, Φ4.2mm and Φ5.6mm), one working length (600mm) and two different material of the insertion (Nylon and PEEK). The single-use Broncho Videoscope is a single-channel endoscope. Only one working channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Broncho Videoscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

Here's a breakdown of the requested information based on the provided text, outlining the acceptance criteria and study details for the Broncho Videoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are broad, based on compliance with various international standards and demonstrating equivalence to a predicate device. The performance is reported as meeting these standards and being comparable to or better than the predicate.

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

• Test Set Sample Size: Not explicitly stated as a number of devices or "cases" for human studies. The testing appears to be primarily bench/laboratory-based on the device components. For the use-life testing, "un-aged" and "aged" single-use bronchoscopes were compared, and "new" and "accelerated aged and running" image processors were compared, implying at least two samples for these comparisons.
• Data Provenance: The studies are non-clinical (bench performance, testing against standards). The country of origin for the data is not specified, but the applicant is "Scivita Medical Technology Co., Ltd." in "Suzhou, Jiangsu, China," suggesting the testing may have occurred there. The studies are prospective in nature, as they are conducted specifically to support this 510(k) submission.

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

Not applicable for this submission. The ground truth for the non-clinical tests is established by compliance with international standards and direct objective measurements, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical submission relying on objective measurements against predefined standards and comparative bench testing.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."

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

• Yes, a standalone performance assessment was conducted for the device itself. The entire non-clinical testing section (bench performance, biocompatibility, electrical safety, etc.) is a standalone assessment of the device's technical specifications and performance against established standards and a predicate device. This is primarily a hardware device with associated software, not an AI algorithm in the typical sense that would necessitate a "human-in-the-loop" study for algorithm performance.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests includes:

• International Standards: Compliance with various ISO, ASTM, and IEC standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 8600 for endoscope performance).
• Predicate Device Performance: Direct comparison of objective measurements (e.g., optical parameters, suction function) against a legally marketed predicate device (Vathin Video Bronchoscope System K191828).
• Objective Measurements: Laboratory measurements of device specifications (e.g., field of view, depth of field, dimensions, weight, power).

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning or AI algorithm in the common sense that would require a "training set" of data for learning purposes. The "software" mentioned is for device control and image processing, not for diagnostic AI interpretation.

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

Not applicable, as there is no "training set."

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The 4K UHD Laparoscope is intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.

The 4K UHD Laparoscope is a rigid endoscope, which consists of lighting system and optical imaging system. The 4K UHD Laparoscope has 12 models which are available in two insertion portion widths (5.5 mm and 10 mm), four working lengths (290mm, 300mm, 320mm) and three different directions of view (0°, 30°, 45°). The 12 models are all connected with adaptor 2 for different brand source light. The 4K UHD Laparoscope can be connected to Scivita 4K UHD Camera System, Scivita LED Light Source or Wolf light source and SONY Monitor. The 4K UHD Laparoscope is a reusable device that is cleaned and steam sterilized before first use and each subsequent use.

The provided text describes the acceptance criteria and the study that proves the device meets them, specifically for the "4K UHD Laparoscope" (K203255).

Here's a breakdown of the requested information:

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

The document doesn't explicitly present a table of acceptance criteria with reported device performance in the typical sense of numerical thresholds and corresponding results for each. Instead, it describes adherence to recognized standards and qualitative comparisons to a predicate device. The performance is implied by the successful completion of these tests and the determination of substantial equivalence.

However, based on the non-clinical tests mentioned, we can infer some performance aspects and how "acceptance" was framed:

The study described is a non-clinical test program designed to compare the proposed device's performance against recognized standards and a legally marketed predicate device ("ULTRA" Telescopes, K150633, from Olympus Winter & Ibe GmbH). The goal was to establish Substantial Equivalence (SE).

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

• Sample Size for Test Set: Not specified in the document. The non-clinical tests typically involve a sample of the manufactured device models.
• Data Provenance: The tests were conducted by Scivita Medical Technology Co., Ltd. (based in China, as per the sponsor identification) as part of their 510(k) submission. The data is prospective from these internal tests.

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

Not applicable. This device is a hardware laparoscope, and the performance assessment is based on physical and optical measurements against engineering standards and comparison with a predicate device, not on expert interpretation of output data like medical imaging analysis. Therefore, there's no "ground truth" derived from medical experts in the context of diagnostic performance.

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

Not applicable. Since the "test set" refers to physical and optical performance characteristics of the device itself (e.g., cytotoxicity, electrical safety, optical resolution, depth of field), expert adjudication methods typically used for interpreting diagnostic outputs (like imaging) are not relevant here. The evaluation involves compliance with established standards and direct measurement/comparison.

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 document pertains to the clearance of a 4K UHD Laparoscope, which is a physical endoscopic device, not an AI-powered diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not relevant and was not performed.

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

No. This device is a hardware laparoscope. There is no algorithm to be tested in a standalone fashion.

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

For the non-clinical tests:

• Biocompatibility: Ground truth is defined by the absence of toxicity, irritation, or sensitization as per the criteria outlined in ISO 10993 standards.
• Electrical Safety & Performance: Ground truth is compliance with the requirements of IEC 60601-2-18.
• Endoscope Standards: Ground truth is compliance with the requirements of ISO 8600-1 and ISO 8600-5.
• Image Quality Performance: Ground truth is established by quantitative measurements (e.g., depth of field, geometric distortion) and comparison to the predicate device's performance, ensuring similar or improved characteristics that meet clinical needs.
• Sterilization Efficacy: Ground truth is achieving a Sterility Assurance Level (SAL) of 10^-6.

The overall "ground truth" for the submission is the determination of Substantial Equivalence to the predicate device based on these engineering and performance standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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4K UHD Camera System is used to provide imaging of the operative area in endoscopic surgery.

4K Camera Control Unit
The 4K camera control unit has been designed to be used with endoscopes, 4K camera head, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K camera head is compatible with the 4K camera control unit only.

4K Camera Head
The 4K camera head has been designed to be used with endoscopes, 4K camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

The proposed system, 4K UHD Camera System, comprises the 4K camera head, objective lens and power cable and video cables. The proposed system is reusable device, and provided non-sterile. The proposed camera head and should be cleaned and disinfected after each use.

The video cables include an SDI video cable and an HDMI video cable. The 4K camera control unit has two models (ES-CS4K100 and ES-CS4K200) with the only difference on signal output terminals, the detail difference refers to Table 3 of this document; the 4K camera head only has one model (ES-CS4K100C). Therefore, the 4K UHD Camera System is available in two models in combination of the 4K camera control unit and 4K camera head.

The Scivita Medical Technology Co., Ltd. 4K UHD Camera System (K200216) is designed to provide imaging for endoscopic surgery. My analysis of the provided text did not reveal a detailed acceptance criteria table nor a specific study demonstrating the device's fulfillment of those criteria. Instead, the document focuses on non-clinical performance testing and substantial equivalence to a predicate device.

Here's an analysis of the available information regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "the subject device met all predefined acceptance criteria" for various performance tests, but it does not provide specific numerical acceptance criteria or the numerical results (i.e., the reported device performance) for these tests.

The document details the general specifications of the device, which can be seen as implicit performance benchmarks:

2. Sample Size for the Test Set and Data Provenance

The document does not mention a "test set" in the context of clinical images or patient data. The performance tests mentioned (Depth of Field, Resolution, etc.) appear to be non-clinical engineering/technical evaluations of the device hardware and software, likely using test targets and technical measurements rather than patient data. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a test set of medical data is not applicable based on the provided text.

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

Since the tests described are non-clinical technical performance tests, the concept of "ground truth" derived from expert review of medical images is not applicable here. The ground truth for these tests would be objective technical standards and measurements.

4. Adjudication Method for the Test Set

Not applicable, as the tests described are non-clinical technical performance tests, not studies involving human interpretation of medical images.

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

No MRMC study was performed or mentioned in this document. The submission focuses on demonstrating substantial equivalence through technical performance verification and comparison to a predicate device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device described is a 4K UHD Camera System, which is a hardware system for image acquisition, not an AI algorithm for image analysis. The "software" mentioned as a "Moderate level of concern (LoC)" refers to the device's operational software, not an AI for diagnostic interpretation.

7. Type of Ground Truth Used

For the non-clinical performance tests mentioned ("Depth of Field Test," "Resolution Test," etc.), the "ground truth" would be established by predefined engineering specifications, standardized test methods, and objective measurements. The document does not specify how these performance criteria were set or verified beyond stating that "the subject device met all predefined acceptance criteria."

8. Sample Size for the Training Set

Not applicable. The device is a camera system, not an AI model that requires a training set of data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as the device is a camera system, not an AI model.

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