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510(k) Data Aggregation
(60 days)
General-purpose solid-state bipolar generator used to supply High Frequency currents via electrosurgical handpieces for the function of cutting or coagulating soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
The proposed Polaris™ Bipolar Electrosurgical Generator System includes a Generator as the main console, a Footswitch, an Irrigation Module, and a Light Source Module. The Generator contains a single bipolar channel for delivery with an electrode applying the energy to the patient. The Irrigation Module connects to tubing that allows fluid to be delivered to the surgical site to allow for clearing of debris from the surgical field. The Light Source Module connects to an optical fiber that supplies illumination to the surgical site to assist with surgeon visualization. The Footswitch is used to control the delivery of RF energy to the patient with one switch for Coagulate and one for Cut power. The Generator includes 4 Module ports for controlling and powering the Modules each have built in cords to connect to these ports on the Generator. The Modules mount to the Generator using a locking rail system so that they will not accidentally come loose during use. The Irrigation Module includes an IV pole that attaches to the Generator to support a saline bag that supplies the irrigation fluid.
The provided document is a 510(k) summary for the Polaris Bipolar Electrosurgical Generator System. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed results of a clinical study for a new AI/ML-driven device. Therefore, much of the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size for training/test sets, expert adjudication, MRMC study, ground truth establishment) is not present in this document.
However, I can extract the relevant "acceptance criteria" and "study results" related to the functional performance of this electrosurgical generator, which are presented as non-clinical performance data comparing the new device to its predicate.
Here's the information that can be extracted and how it relates to your request, with a clear indication of what is not available in this document:
1. A table of acceptance criteria and the reported device performance
| Test/Characteristic | Acceptance Criteria (Polaris vs. Aura Predicate) | Reported Device Performance (Polaris) |
|---|---|---|
| Thermal Effects on Tissue (Coagulation) | Coagulation sites of both generators (Polaris & Aura) must be substantially equivalent when set to the same output settings. This includes physical measurement of the coagulation site and relative temperature increase. All physical measurements and temperature changes should fit within a ± 20% tolerance. | Both devices were successful in achieving a similar, desired coagulation effect on similar tissue. Both heated tissue at similar rates to a similar peak temperature. The Engineering Report concluded that the Polaris is substantially equivalent to the Aura when operated by the intended user. |
| Waveform Testing | Outputs must be well within a 20% output variation between like systems (Polaris vs. Aura). (This implicitly implies frequency and voltage RMS, though explicit numerical limits are not given beyond the 20% variation). | Values for frequency and voltage RMS were "slightly different." The report notes that capturing absolute values from a sine wave of an RF generator may produce a 10% variation depending on signal maintenance and cycle extrapolation, and the values captured were an average over a 3-second period. Despite slight differences, the outputs were "well within the 20% output variation between like systems." Kirwan Surgical Products LLC determined the output waveform of the Polaris is substantially equivalent to the Aura. |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Compliance with listed standards (e.g., IEC 60601-1-2, IEC 61000-4-3, CISPR 11, FCC CFR 47 Part 15, IEC 60601-1-6, IEC 60601-2-2, IEC 62471, AIM 7351731, FDA Guidance for EMI). | The system passed all listed tests (Electrostatic Discharge, Radiated Immunity, Electrical Fast Transient/Burst, Surge, Conducted Immunity, Power Frequency Magnetic Field, Voltage Dips & Interruptions, Radiated Emissions, Conducted Emissions, Harmonic & Flicker, Exposure to Radio Frequency Identification Readers, Immunity to Known Sources of EMI). The system complies with the associated standards. |
| Software Verification & Validation | Compliance with FDA Guidance for "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was considered a "major" level of concern, meaning a failure could directly result in serious injury or death. All activities outlined in the Kirwan Polaris Software Development Plan (100-00068-004). | Software verification testing was conducted and documentation provided as recommended by FDA guidance. All software verification & validation activities are outlined and presumably completed as per the development plan. The report implies successful V&V given the overall substantial equivalence determination. |
| Human Factors Testing | Enables all user profiles (Surgeons/PAs, Nurses/BETs) to safely, effectively, and efficiently operate the system. Identify and document abnormal uses, unknown use errors, and difficult tasks. Determine root causes for use errors and evaluate risk acceptability. No hazardous situations (Severity level 3 or higher) resulting from use error or abnormal use. | All 27 identified functions/tasks necessary for effective use were fulfilled by all users. Users who didn't score perfectly were due to misunderstanding of test instructions or other external circumstances, with no noted issues of user error during final testing. All users were able to perform the 19 critical tasks identified to safely operate the system. No recorded instances of Use Error or Abnormal Use that would result in a Hazardous Situation with a severity level of 3 (or worse) were found. Conclusion: users can operate safely, effectively, and without formal training. |
2. Sample sizes used for the test set and the data provenance
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Thermal Effects & Waveform Testing:
- Test Set Sample Size: "one Aura Bipolar Electrosurgical Generator and one Polaris Bipolar Electrosurgical Generator." For thermal effects, they used "the same bipolar forceps sample part on the same tissue samples."
- Data Provenance: The testing was performed comparatively between the new device and the predicate. The tissue samples are noted as "Bovine" (Liver, Kidney, Muscle Tissue). This is a retrospective comparison against a legally marketed predicate, using in-vitro or ex-vivo animal tissue samples in a lab setting. No information on country of origin of the data.
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Electrical Safety & EMC, Software V&V, Human Factors: These describe engineering tests or simulated user studies, not typically involving patient data. No specific "data provenance" in terms of patient population or geographic origin is applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not describe a study that uses "experts" to establish "ground truth" in the way one would for diagnostic AI. The "ground truth" in this context is the physical and electrical performance characteristics of the device, measured by engineering tests.
- Thermal Effects & Waveform Testing: The ground truth is established by direct physical and electrical measurements using test equipment and procedures. There's no mention of experts establishing a subjective ground truth.
- Human Factors Testing: This involved "user profiles" (Surgeons/PAs, Perioperative Nurses, Biomedical Equipment Technicians), who are indeed experts in their field, but they are the test subjects evaluating the device's usability, not establishing a diagnostic ground truth. No specific number of such users is given beyond "The first user profile [Surgeons & Surgical Physician Assistants], and the second [Perioperative Nurses and Biomedical Equipment Technicians]." It states "27 Tasks" and "19 Critical Tasks" were successfully performed. "The few Users who did not score perfect..." implies a number greater than a few but less than a large cohort.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this type of device and study. Adjudication methods like 2+1/3+1 are typically used for establishing ground truth in diagnostic imaging studies, where human expert interpretation might disagree. Here, the "truth" is based on objective, quantifiable engineering measurements or observation of user interaction.
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 not an AI-assisted diagnostic device, nor is it a study comparing human reader performance. It's an electrosurgical generator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-driven device. The "standalone" performance refers to the generator's electrical and thermal output, which was indeed tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As described in point 3:
- Thermal Effects and Waveform Testing: The ground truth is objective physical (e.g., coagulation site size, temperature) and electrical (e.g., frequency, voltage RMS) measurements, compared against a predicate device.
- Human Factors Testing: The ground truth is the observer's assessment of whether users successfully and safely completed predefined tasks, based on pre-established criteria for safe and effective operation.
8. The sample size for the training set
Not applicable. This device 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 above, this device does not utilize a training set as it's not an AI/ML product.
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(236 days)
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.
The proposed system, FloNavi Endoscopic Fluorescence Imaging System (FloNavi System) is comprised of an image processing unit, a camera head, and a light source (including a flexible light guide cable).
There are two models of the proposed system. The primary components of each model are provided in Table 1.
Model 1: Image Processing Unit: OPTO-CAM214K, Camera Head: OPTO-CHD214KE/OPTO-CHD214KH, Light Source: OPTO-LED214K
Model 2: Image Processing Unit: OPTO-CAM2100, Camera Head: OPTO-CHD2100, Light Source: OPTO-LED2100
FloNavi Endoscopic Fluorescence Imaging System is capable of providing real-time endoscopic visible and near-infrared fluorescence imaging.
During surgical procedures, FloNavi may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the light source and the resulting reflecting light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.
To provide NIR fluorescence imaging, FloNavi is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the light source, and the fluorescence response is then imaged with the camera, processed and displayed on a video monitor.
The proposed system is designed to be used with rigid endoscopes, monitors and other ancillary equipment.
The requested information about the acceptance criteria and study proving device performance is not available in the provided text. The document is an FDA 510(k) clearance letter and summary, which confirms substantial equivalence to a predicate device based on non-clinical testing, but does not detail acceptance criteria or specific performance study results of the type requested.
The document explicitly states:
"No clinical tests were performed." and "Performance testing was conducted on imaging performance and light source performance to support the marketing claims and to confirm that safety and effectiveness of the FloNavi Endoscopic Fluorescence Imaging System is at least equivalent to the predicate device."
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Effect size of human readers with vs. without AI assistance (as no clinical AI assistance study is mentioned).
- Standalone performance (algorithm only) was done. (While non-clinical performance was done, it's not described in terms of specific standalone algorithm performance, but rather overall system performance.)
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
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