(217 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Capability to detect pafolacianine at different concentrations and show consistent results. | The EXPLORER AIR® II was tested in two devices, showing consistent results and demonstrating detection of pafolacianine. A calculation of the lowest concentration at a specified contrast-to-noise ratio (CNR) was performed. |
| Comparative performance with secondary predicate device (K210265) regarding pafolacianine detection. | The EXPLORER AIR® II was able to visualize lower concentration samples of pafolacianine compared to the additional predicate device, both by analysis of the image contrast (CNR) and by observation of the images. |
| Software validation for the new indication. | Software verification and validation testing were updated and conducted, confirming the inclusion of the additional protocol for imaging pafolacianine. |
| Human factors assessment for the new indication. | An updated Human Factors Report concluded that user profiles, environment of use, training, user interactions, and procedure workflow remain the same, with identified risks, mitigations, and verification found acceptable. |
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.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.