Search Results

Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.

Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley.

EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions.

The provided text is a 510(k) premarket notification for the EXPLORER AIR® II device. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K222240) rather than presenting a de novo clinical study with detailed acceptance criteria and performance data for a novel AI/software component.

Therefore, the information required to fully answer your request (acceptance criteria, study details like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided document.

The document states:

• "No clinical tests were conducted to support this submission."
• The primary argument for clearance is that the device is "substantially equivalent" to its predicate due to "minor differences for HW design 2.2 (due to manufacturability and EOL of certain components), Packaging 2.0 (same materials, improvements for repacking in case of service), and SW 2.2 (OTS updates, image visualization improvements, and removal of alignment step by the user prior to every procedure)."
• It mentions "Software verification and validation testing were updated and conducted" to meet FDA guidance, but it does not provide the specific acceptance criteria or the results of these tests in a detailed manner.

In summary, this document describes a submission based on substantial equivalence and non-clinical testing (software verification and validation), not a performance study of an AI algorithm with specific acceptance criteria and detailed clinical study results as you've requested.

Ask a specific question about this device

Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.

Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley.

EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760mm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

The provided text describes a 510(k) premarket notification for the EXPLORER AIR® II device. The submission is to expand the device's indications for use to include the infrared dye, pafolacianine. The document focuses on demonstrating substantial equivalence to predicate devices, particularly concerning the new imaging agent.

Here's an analysis of the acceptance criteria and the study proving the device meets them based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific pass/fail values. Instead, it describes performance verification related to its capability with the new imaging agent, pafolacianine, and comparison to predicate devices. The implicit acceptance criterion is that the device can effectively detect pafolacianine and perform comparably or better than existing cleared devices.

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

The document refers to "testing... in two devices" for pafolacianine detection. This suggests the sample size for the core performance test was limited to these two devices (likely two units of the EXPLORER AIR® II). The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified, but it implies a controlled laboratory setting. The comparison testing with the secondary predicate device also falls under this testing.

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

No information is provided regarding the use of experts to establish ground truth for the test set. The performance data presented seems to be based on objective measurements like image contrast (CNR) and visualization of known concentrations, rather than expert interpretation of a diagnostic task.

4. Adjudication method for the test set

No information on an adjudication method is provided. Given the nature of the tests (detection of known concentrations and image contrast analysis), an adjudication process by experts is not described or implied.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The performance data focuses on the device's technical capability to detect pafolacianine and a direct comparison of its imaging characteristics against a predicate device, not on human reader performance with or without AI assistance.

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

The performance tests described (pafolacianine detection at different concentrations, CNR analysis, visualization of samples) appear to be standalone assessments of the device's imaging capabilities without explicit human interpretation as part of the primary test endpoint. The software validation is also a standalone assessment of the algorithmic components.

7. The type of ground truth used

The ground truth for the pafolacianine testing appears to be based on:

• Known concentrations of pafolacianine.
• Objective measurements such as Contrast-to-Noise Ratio (CNR).
• Direct observation of the images to confirm visualization of lower concentration samples.

This indicates a quantitative and controlled experimental ground truth, rather than clinical outcomes or expert consensus on patient cases.

8. The sample size for the training set

The document does not mention a training set sample size or the use of machine learning models that would require one. The verification approach described is primarily focused on demonstrating the physical and software performance of the imaging system with the new dye, rather than the development of a predictive algorithm using a training set.

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

As no training set is mentioned for an algorithm, there is no information on how its ground truth was established.

Ask a specific question about this device

Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.

EXPLORER AIR® II is a fluorescence imaging system, which enables users to visually assess blood flow to evaluate tissue perfusion and tissue-transfer circulation. It can be used on any part of the body during plastic, reconstructive, gastrointestinal, and organ transplant surgeries. EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band centered around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

The provided text describes the regulatory clearance of the EXPLORER AIR® II device by the FDA. It outlines the device's intended use, technological characteristics, and comparisons to a predicate device (SPY Elite Intraoperative Perfusion Assessment System). However, it does not contain the detailed information required to describe specific acceptance criteria for AI/ML performance, nor a study design with a test set, ground truth experts, or MRMC study results.

The document discusses performance data related to:

• Electrical safety and electromagnetic compatibility (EMC)
• Photobiological safety
• Verification of optical, mechanical and functional requirements (including fluorescent performance, physical properties, environmental conditions, optical requirements, design/ergonomics, usage requirements, power supply, data export, mechanical restrictions)
• ICG (Indocyanine green) testing for detection capability and limit of detection
• Human factors validation
• Software verification and validation testing

While these are performance tests, they are focused on the hardware, general functionality, and safety of the imaging system itself, rather than an AI/ML algorithm's diagnostic or prognostic performance in assessing blood flow and tissue perfusion from the images. The device's function is described as "capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion," indicating that the visual assessment is primarily done by the human user. The software section mentions that a malfunction could lead to a delay in care if the physician were to rely on EXPLORER AIR® II instead of performing a visual assessment, implying the device is an assistive tool for visual assessment, not an automated diagnostic AI.

Therefore, I cannot extract the requested information about AI model acceptance criteria, test sets, expert ground truth, or MRMC studies from this document. The device described appears to be a medical imaging system that facilitates visual assessment by a human, not an AI/ML software as a medical device (SaMD) that performs automated analysis or provides diagnostic output based on AI.

To answer your request based on the provided text, I must state that the document does not contain the information about an AI/ML component's performance study as described in your prompt.

Ask a specific question about this device