(48 days)
The SPY scope intra-operative imaging system (SPY scope) is intended to provide realtime endoscopic visible and near infrared fluorescence imaging. SPY scope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery.
The SPY® scope provides real-time high definition (HD) endoscopic video images of visible (VIS) and near infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive surgery. During such a procedure, the SPY scope functions like all conventional VIS light imaging systems used in surgical endoscopy. Visible light from the SPY scope light source illuminates the area of interest through the endoscope and the resulting reflected light is imaged by the SPY scope color HD camera and displayed on an HD video monitor.
The SPY scope device is comprised of the following components:
- Endoscopes for VIS and NIR illumination and imaging.
- A 3 CCD (charge coupled device) color video camera head with video coupler and accompanying sterile drape,
- Light source & video processor unit, and
- ICG imaging agent.
The provided text describes a 510(k) summary for the NOVADAQ SPY® scope Intra-operative Imaging System. It focuses on demonstrating substantial equivalence to predicate devices and detailing in vitro and in vivo testing for safety and effectiveness. However, it does not include acceptance criteria for device performance in terms of specific metrics (like sensitivity, specificity, accuracy) or a study explicitly designed to prove these criteria are met. The "testing" section is about validating the functionality and safety of the device, rather than a performance study against predefined metrics for clinical accuracy or efficacy.
Therefore, many of the requested items cannot be definitively answered from the provided text.
Here is a summary of what can be extracted and an indication of what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Metric) | Acceptance Threshold | Reported Device Performance | Comments |
|---|---|---|---|
| Clinical Performance (e.g., Sensitivity, Specificity, Accuracy for assessing vessels, blood flow, tissue perfusion) | Not specified | Not explicitly reported in terms of specific clinical metrics. | The text describes "successful imaging" of various anatomical features but does not provide quantitative diagnostic performance metrics against a defined ground truth for clinical accuracy. |
| Image Quality (VIS and NIR) | "at least equivalent to previously cleared endoscopes" | Achieved through "In Vitro Testing" with comparisons to cleared endoscopes. | This is a qualitative comparison rather than a quantitative performance metric. |
| Functionality (real-time VIS and NIR imaging capabilities) | Device functions as intended | "The above testing demonstrates that the SPY scope device is substantially equivalent in function... In addition, the data presented herein demonstrates that SPY scope device performs as intended." | Functionality was validated through animal studies. |
| Safety & Compliance (Electrical, EMC, Laser, Endoscopic equipment standards) | Conformance to various IEC and CFR standards | Achieved conformance to IEC 60601-1, -1-2, -1-4, -2-18; IEC 60825-1; 21 CFR 1040.10, 1040.11. | This relates to device safety and regulatory compliance, not clinical performance. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- In Vivo Testing: 6 dogs and 10 pigs.
- Data Provenance: Prospective animal studies conducted at:
- National Research Council of Canada, Winnipeg
- University of Rochester, New York
- Intuitive Surgical Inc. Sunnyvale, California
- St Joseph's Translational Research Institute, Atlanta, Georgia
- (Followed ethics approval by appropriate animal care committee).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The text mentions "The details of the imaging results varied depending upon the availability of complement and expertise," but it does not quantify the number or qualifications of experts involved in establishing ground truth for the animal studies.
4. Adjudication method for the test set
- Not specified. There is no mention of an adjudication method used for assessing the imaging results in the animal studies.
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
- No, an MRMC comparative effectiveness study was not done. The device predates the common use of AI in medical imaging devices and the study described focuses on technical functionality and safety, not on human reader performance with or without AI assistance. The device is the imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not explicitly described as a standalone algorithm performance study. The SPY scope itself is an imaging system used by surgeons. The animal studies aimed to validate the system's ability to visualize different anatomical features using ICG fluorescence in real-time, which implies "human-in-the-loop" application (the surgeon/researcher interpreting the imaging output). There isn't a separate "algorithm-only" performance evaluation independent of human observation.
7. The type of ground truth used
- Direct observation / Known physiological characteristics: For the animal studies, the "ground truth" for blood flow, perfusion, and lymphatic drainage was based on the known physiological properties of ICG (rapid binding to plasma proteins, liver uptake, lymphatic uptake) and direct visualization of these processes through the SPY scope system as ICG circulated. The "successful imaging" of features like flow through arteries/veins, organ perfusion, biliary anatomy, and lymphatics serves as the validation, implying that the observed fluorescence corresponded to these known anatomical and physiological events. There's no mention of a separate gold standard like pathology or external outcomes data being used to validate the accuracy of the device's interpretation of those physiological events.
8. The sample size for the training set
- Not applicable. This device is an imaging system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "testing" sections describe validation of the device's optical and functional capabilities.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for an AI/ML algorithm.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.