(13 days)
The Carl Zeiss Surgical INFRARED 800 with the FLOW 800 option is a surgical microscope accessory used in viewing and visual assessment of intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with the FLOW 800 option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastic and reconstructive procedures and coronary artery bypass graft surgery.
INFRARED 800 with the FLOW 800 option is an accessory to the OPMI Pentero surgical microscope for visualizing blood flow intraoperatively. INFRARED 800 allows the surgical microscope to produce light to illuminate the fluorescence properties of the Indocyanine Green (ICG) dye and to detect the emitted fluorescent signal to examine the human vascular system during surgery. FLOW 800 provides the surgeon with a processing mode that allows convenient handling and visualization of the INFRARED 800 video data.
The provided 510(k) summary for the INFRARED 800 with FLOW 800 option does not contain explicit acceptance criteria or a dedicated study section detailing the device's performance against such criteria.
Instead, it relies on a "Substantial Equivalence" claim based on comparison to predicate devices and a review of existing clinical literature. This type of submission generally does not include a specific "acceptance criteria" table or a detailed "device performance" study as you might find for novel devices or those with specific quantitative performance claims.
However, I can extract information related to the device's clinical evaluation and training data based on the provided text.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, the document does not present a table of explicit acceptance criteria or a dedicated study with quantified device performance metrics against those criteria. The submission is a substantial equivalence claim, meaning the device is considered safe and effective because it is similar to already legally marketed devices.
The "performance" is implicitly demonstrated through:
- Technological Comparison: The device utilizes similar technology (surgical microscope, ICG dye, CCD cameras, real-time visualization of images) to the predicate devices (Leica FL800, Novadaq SPY Intra Operative Imaging System).
- Clinical Literature Review: The submission points to peer-reviewed medical literature demonstrating the use and effectiveness of the INFRARED 800 accessory with Indocyanine Green (ICG) angiography in hundreds of patients for various surgeries.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that the INFRARED 800 accessory with ICG angiography "has been used in hundreds of patients." This suggests the "test set" for the clinical literature review encompasses a large, but unspecified, number of patients.
- Data Provenance: The data comes from "clinical literature that discusses the relevant studies," which are described as "peer-reviewed medical literature." This indicates the data is retrospective, collected from previously published studies. The countries of origin are not specified, but peer-reviewed medical literature generally implies multinational sources.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify a number of experts or their qualifications for establishing ground truth within the context of a dedicated "test set" for this submission. The "ground truth" implicitly comes from the diagnostic and surgical outcomes reported in the peer-reviewed clinical literature that informed the substantial equivalence claim. These outcomes would have been determined by the operating surgeons and medical professionals involved in those published studies (e.g., neurosurgeons, plastic surgeons, cardiac surgeons).
4. Adjudication Method for the Test Set
No explicit adjudication method is described, as there wasn't a specific, controlled "test set" created for this 510(k) submission. The clinical evidence is derived from existing published studies, where the outcomes and diagnoses within those studies would have been adjudicated according to the standard practices of the respective clinical research teams.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on the device's equivalence to existing technology and its utility as demonstrated in clinical literature, not on assessing the improvement of human readers with AI assistance (which is not relevant for this type of imaging device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is not an algorithm, but rather a surgical microscope accessory that aids in viewing and visual assessment by a human surgeon. Therefore, a "standalone algorithm-only" performance study is not applicable and was not conducted. The "performance" is inherently human-in-the-loop.
7. The Type of Ground Truth Used
The ground truth is based on expert clinical observation and surgical outcomes reported in peer-reviewed medical literature. This includes:
- Assessment of closure/remnants of cerebral aneurysms
- Patency of vessels (including small perforating vessels)
- Real-time visualization of blood flow and vessel types in AVMs
- Assessment of patency in anastomosed vessels during bypass or free flap surgery
This is essentially "outcomes data" and "expert clinical consensus/observation" derived from actual surgical procedures.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of device development or algorithm training. Since this is a hardware accessory for visualization, and not an AI/ML algorithm that requires training, the concept of a "training set" as typically understood in AI is not applicable. The device's design and functionality would be based on general engineering principles and medical knowledge related to fluorescence imaging.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a "training set" in the context of algorithm development, there is no description of how ground truth for such a set was established.
In summary: The 510(k) submission for the INFRARED 800 with FLOW 800 option relies on a substantial equivalence pathway. It demonstrates this by comparing its technological features to legally marketed predicate devices and by referencing a body of existing clinical literature that documents the use and effectiveness of the INFRARED 800 accessory in "hundreds of patients." It does not present novel performance data against specific acceptance criteria, nor does it involve AI algorithms with distinct training and test sets in the modern sense.
§ 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.