Search Results

Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging.

Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Not Found

This document is an FDA 510(k) clearance letter for the FloNavi Endoscopic Fluorescence Imaging System. It does not contain information about the acceptance criteria, device performance, study design, or validation results. Therefore, I cannot provide the requested information based on the provided text.

The letter primarily covers:

• The FDA's determination of substantial equivalence.
• Regulatory classifications and product codes.
• Applicable regulations for the device.
• Guidance on when a new 510(k) might be required for changes.
• General controls and other requirements such as the Quality System (QS) regulation and Unique Device Identification (UDI) Rule.
• Contact information for the FDA.
• Indications for Use for the device.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness, or the 510(k) submission itself, which would detail the performance testing and validation efforts.

Ask a specific question about this device

Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.

Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging and visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.

Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope, Exoscope and relevant accessories.

During surgical procedures, Stellar Imaging System is used to provide real-time visible and fluorescence imaging similar to that provided by conventional imaging system used in endoscopic surgery and innovative 3D visible and fluorescence imaging in endoscopic surgery. Besides, Stellar Imaging System is also used to provide real-time fluorescence confirmation in open field.

The Stellar Imaging System including the laparoscope and the exoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using a camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc.

The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

The provided text is a 510(k) Summary for the Stellar Imaging System. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety standards. It does not contain information about the acceptance criteria for a study, the results of such a study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The section titled "VII. Performance data" only lists the non-clinical tests conducted to verify compliance with various safety and performance standards. It states: "Performance comparison testing are also conducted on the subject device and predicate/reference device, demonstrate that the proposed system performs according to specifications and functions as intended." However, no specific details or results of this performance comparison testing are provided within this document.

Therefore, I cannot fulfill your request for the specific information you asked for, as it is not present in the provided text.

Ask a specific question about this device

The Insufflator (OPTO-IFL1000) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic laparoscopic procedures.

Insufflator (OPTO-IFL1000) is a CO2 insufflation device for creating and maintaining a pneumoperitoneum during laparoscopic examinations and operations. It is capable of establishing the surgical field of view and operating space. CO2 gas can be injected into abdominal cavity by the device, and the gas separates the abdominal wall from the internal organs of the abdominal cavity, forming a space for the operation and visual field. The device is to be used with the following insufflation tubes:

• 1. OPTO-T1000H (with heating function)
• 2. OPTO-T1000 (without heating function)

The provided document is a 510(k) summary for the Insufflator (OPTO-IFL1000) from Guangdong OptoMedic Technologies, Inc. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain the detailed information required to answer many of the specific questions about the device's acceptance criteria and the study proving it meets those criteria, particularly for an AI/ML-based medical device.

The document states: "Performance testing were also conducted and demonstrate that the proposed system performs according to specifications and functions as intended. And the test result shows that the preset acceptance criteria are met." It then lists several performance tests, but it does not specify what those "preset acceptance criteria" are numerically, nor does it provide the reported device performance values against these criteria. Furthermore, it does not describe a study involving "human readers" or "AI assistance," as this is an insufflator, not an imaging analysis AI.

Therefore, many of the questions cannot be answered from the provided text. I will answer what is available and indicate where information is missing.

Acceptance Criteria and Study for Insufflator (OPTO-IFL1000)

Based on the provided document, the device is an Insufflator (OPTO-IFL1000), which is a physical medical device designed to create and maintain pneumoperitoneum during laparoscopic procedures, not an AI/ML-based diagnostic or imaging device. Therefore, questions related to AI performance, human readers, ground truth establishment by experts, and training/test set sample sizes for AI models are not applicable to the information presented for this specific device.

The document discusses "Performance data" and lists various tests conducted to verify the device met all design specifications and is substantially equivalent to a predicate device. The "acceptance criteria" are generally implied to be satisfaction of these test specifications and compliance with relevant standards.

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

The document lists performance tests but does not provide a table with specific numerical acceptance criteria or the numerically reported device performance for these tests. It only states that "the preset acceptance criteria are met."

Below is a table of the performance tests mentioned, with the understanding that specific numerical criteria and results are not detailed in the provided text.

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

For a physical device like an insufflator, "test set" and "data provenance" (country of origin, retrospective/prospective) are typically not relevant in the same way they are for AI/ML models using patient data. The "test set" would refer to the specific Insufflator (OPTO-IFL1000) unit(s) used for the described performance and safety testing. The document does not specify the number of units tested. The provenance of the testing itself is implied to be conducted by the manufacturer, Guangdong OptoMedic Technologies, Inc., in China.

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

This question is applicable to AI/ML devices that interpret data (e.g., medical images) where expert consensus is used to establish ground truth. For a physical device like an insufflator, "ground truth" pertains to its functional performance characteristics, which are measured using validated test methods and equipment, not by human expert interpretation of device output in the same way. Therefore, this information is not applicable and not provided.

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

Not applicable for a physical device performance test.

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

Not applicable. This device is an insufflator, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is not an algorithm. Its performance is inherent to its physical and software functionality.

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

For this physical device, "ground truth" would be established by:

• Compliance with recognized standards: Such as ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, AAMI TIR 30, AAMI TIR 12.
• Engineering specifications and measurements: Direct measurement of pressure, flow, temperature, alarm triggers, etc., against predefined engineering tolerances and clinical requirements.
• Software verification and validation: Testing to ensure the software functions as intended to control the device and its safety features.

The document states that "The software verification and validation testing were conducted and the test results demonstrated the software function met the requirements. The software for this device was considered a 'Major' level of concern." This indicates that software functionality, which dictates much of the device's "ground truth" operation, was rigorously tested.

8. The sample size for the training set

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

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

Not applicable.

Ask a specific question about this device

Upon intravenous administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence angiography.

The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.

Upon interstitial administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The FloNavi Open Field Fluorescence Imaging System is an imaging system used in hospitals for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation for use in imaging during various surgical procedures.

The FloNavi Open Field Fluorescence Imaging System has two system models: HD system and 4K system. Each system consists of the following main components: Imaging Head, Image Processing Unit, power supply cord and video cables.

The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging. The cameras in the Imaging Head capture the fluorescent image under near infrared illumination or a color image under white light illumination. The Image Processing Unit receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the FloNavi Open Field Fluorescence Imaging System are possible through switches at either the Imaging Head or the Image Processing Unit.

The FloNavi Open Field Fluorescence Imaging System is a reusable device and provided nonsterile. Its components should be cleaned and low-level disinfected prior to the first use and after every subsequent use.

The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion and for visualization of the lymphatic system. It is a Class II device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device as being "Substantially Equivalent (SE) to the predicate device" (SPY Portable Handheld Imaging (SPY-PHI) System, K200737). The acceptance criteria are implicitly linked to the predicate device's performance and the subject device's ability to meet its own design specifications and relevant safety standards.

2. Sample Size and Data Provenance for Test Set

The document mentions "Performance testing and animal testing" were conducted.

• Sample Size:
  • Performance Testing: Not specified.
  • Animal Testing: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth - Test Set

Not applicable/Not specified. The document does not describe a clinical study involving human readers or expert-established ground truth for the "test set" in the context of diagnostic accuracy. The testing primarily focuses on the device's functional and safety performance, as well as animal studies.

4. Adjudication Method for Test Set

Not applicable/Not specified. No such adjudication method is mentioned as the studies described appear to be non-clinical performance and animal studies, not reader studies for diagnostic accuracy.

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

No. The document does not mention a MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device appears to be an imaging system, not an AI-powered diagnostic algorithm enhancing human reading.

6. Standalone (Algorithm Only) Performance Study

No. The document presents the FloNavi Open Field Fluorescence Imaging System as a standalone imaging device, not an AI algorithm. The performance testing and animal testing evaluate the device itself.

7. Type of Ground Truth Used

For the performance and animal testing mentioned, the "ground truth" would likely be based on:

• Engineering Specifications: For the technical performance aspects (e.g., image resolution, light output).
• Physiological Response: In animal testing, the "ground truth" for fluorescence imaging would be the actual blood flow, tissue perfusion, or lymphatic system visualization as observed and validated within the animal model, potentially through direct observation or comparison with established methods.

8. Sample Size for Training Set

Not applicable. This device is presented as an imaging system, not an AI/machine learning algorithm requiring a separate training set.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no mention of an AI/machine learning component requiring a training set.

Ask a specific question about this device

The OptoMedic Laparoscopes are intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The OptoMedic Laparoscopes are intended to be used by trained healthcare professional in diagnostic and therapeutic procedures.

The OptoMedic laparoscopes are rigid endoscopes that are used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source. The Laparoscope has 8 models which are available in two insertion widths (5.6 mm and 10.1mm), two working lengths (320mm and 310mm) and two different directions of view (0° and 30°).

This document is a 510(k) Premarket Notification for the OptoMedic Laparoscope, signifying its clearance by the FDA based on substantial equivalence to predicate devices. The information provided is primarily focused on the device's technical specifications and comparisons, rather than a clinical study demonstrating performance against specific acceptance criteria in the context of AI/ML.

Therefore, for the request regarding acceptance criteria and a study proving the device meets them, it's important to understand that this submission is for a medical device (a laparoscope), not an AI/ML diagnostic tool. As such, the typical metrics and study designs for AI/ML performance (like those related to sensitivity, specificity, reader studies, etc.) are not directly applicable or provided in this document.

However, I can extract the information related to the device's performance testing as described for regulatory clearance, which serves a similar purpose to demonstrating that the device meets its design specifications and is safe and effective for its intended use.

Here's a breakdown based on the provided document, addressing the closest analogues to your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are generally derived from recognized industry standards and regulatory requirements for safety, performance, and functionality. The "reported device performance" is the demonstration that the device complies with these standards.

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

The document does not detail specific "sample sizes" in the context of clinical or AI/ML test sets. The performance evaluation primarily involved non-clinical tests conducted to verify compliance with national and international standards. These tests typically involve physical and functional evaluations of the device itself rather than patient data.

• Sample Size: Not applicable in the context of AI/ML test sets. For device testing, it would involve a representative number of device units.
• Data Provenance: Not applicable in the context of clinical data. The testing involves the physical device and its components, complying with engineering and safety standards.

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

This information is not applicable to this type of device clearance. Ground truth, in the context of image analysis or diagnostic performance, is not established for a rigid laparoscope in this document. The "ground truth" for this device's performance is its adherence to the technical specifications defined by the relevant standards (e.g., whether its field of view is indeed 68°, its resolution meets the specified criteria, or its materials are biocompatible). These are verified through engineering and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of data (often medical images) to establish a consensus ground truth. This document describes non-clinical engineering and bench testing, not clinical data review.

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

No. This document does not mention any MRMC comparative effectiveness study. These studies are typically conducted for AI/ML diagnostic tools to evaluate how AI assistance impacts human reader performance. The OptoMedic Laparoscope is a physical medical instrument, not an AI system.

6. If a Standalone (Algorithm Only) Performance Study was Done

No. This is not an AI/ML algorithm. Therefore, a standalone algorithm performance study was not conducted or reported.

7. Type of Ground Truth Used

The "ground truth" used for this device's regulatory clearance is compliance with established engineering, safety, and performance standards (e.g., ISO, IEC, AAMI standards) as verified through non-clinical laboratory testing. This is distinct from clinical ground truth based on pathology, expert consensus, or outcomes data, which would be relevant for diagnostic devices or AI algorithms.

8. 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, as there is no AI/ML training set for this device.

Ask a specific question about this device