(140 days)
The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly 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, using near-infrared imaging.
The da Vinci SP Firefly Imaging System is a fully-integrated, adjunct imaging system for the da Vinci SP Surgical System. The da Vinci SP Firefly Imaging System consists of enhanced existing components of the da Vinci SP Surgical System: the endoscope controller, the endoscope, and supporting software functions. The endoscope controller provides a light source, either visible light or a near-infrared (NIR) excitation laser. The endoscope transmits visible light from the endoscope controller to illuminate the surgical site. The near-infrared light is used to fluoresce an intravenously-injected imaging agent, indocyanine green (ICG), which is imaged by the endoscope and displayed at the Surgeon Console.
The provided text contains insufficient information regarding the specific acceptance criteria and the detailed study that proves the device meets those criteria. The document states that the da Vinci SP Firefly Imaging System underwent various tests:
- Bench tests: To verify requirements and risk mitigations, focusing on endoscope design verification, illumination reliability testing, and human factors evaluation.
- Clinical validation testing: Using an animal model (porcine) to evaluate its safety and effectiveness for use in surgery.
However, the specific "acceptance criteria" (e.g., performance metrics, thresholds) and the "reported device performance" against these criteria are not explicitly listed in a table format, nor are details provided for most of the requested points.
Here's a breakdown of what can be inferred or what is explicitly missing:
Missing Information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set (e.g., number of cases, number of images).
- Data provenance for the test set (e.g., country of origin of the data, retrospective or prospective).
- Number of experts used to establish ground truth for the test set.
- Qualifications of those experts.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Effect size if an MRMC study was done.
- Whether a standalone (algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (beyond "animal model" for clinical validation).
- Sample size for the training set.
- How the ground truth for the training set was established.
Information provided (or can be reasonably inferred):
| Information Point | Details from the Text |
|---|---|
| 1. Table of Acceptance Criteria & Reported Device Performance | Acceptance Criteria: Not explicitly stated with specific metrics or thresholds. The text generally mentions "verify requirements and risk mitigations" and "evaluate its safety and effectiveness for use in surgery." |
Reported Device Performance: Not explicitly stated with specific results. The conclusion is that "no issues of safety or effectiveness" were found, and the device is "substantially equivalent to its predicate device." |
| 2. Sample size and Data Provenance (Test Set) | Sample Size: Not specified (e.g., number of animals, number of procedures).
Data Provenance: Animal model (porcine). The study was "clinical validation testing using an animal model," implying prospective data collection within that model. |
| 3. Number of experts & Qualifications (Ground Truth for Test Set) | Not specified. As it's an animal model validation, experts would likely be veterinary surgeons or researchers, but no details are provided. |
| 4. Adjudication method (Test Set) | Not specified. |
| 5. MRMC Comparative Effectiveness Study & Effect Size | Not mentioned. The studies described are focused on device function, safety, and effectiveness in an animal model, not on human reader performance with or without AI assistance. |
| 6. Standalone (Algorithm only) Performance | The device is an "imaging system" that "enables surgeons to perform minimally invasive surgery" and provides "visual assessment." This implies a human-in-the-loop system where the imaging assists the surgeon. There is no mention of an AI algorithm making independent diagnoses or assessments without human interpretation. Therefore, a standalone (algorithm only) performance study in the context of diagnostic AI is unlikely relevant or described here. |
| 7. Type of Ground Truth Used | For the "clinical validation testing," the ground truth was based on observations and assessments within an "animal model (porcine)" to evaluate "safety and effectiveness for use in surgery." This would typically involve direct observation, potentially pathology (if tissues were excised), and functional assessment during the surgical procedures in the animal model. For the bench tests, the ground truth would be based on engineering specifications and design verification. |
| 8. Sample Size for Training Set | Not applicable or not specified. The document describes verification and validation of an imaging system, not a machine learning model that would require a separate training set. The "supporting software functions" mentioned are likely embedded system software rather than adaptable AI requiring a large training dataset as understood in many AI/ML contexts. |
| 9. How Ground Truth for Training Set Established | Not applicable or not specified, for the same reasons as above. |
In summary, the provided text confirms that verification and validation were performed through bench testing and clinical validation in a porcine model, concluding that the device is safe, effective, and substantially equivalent to its predicate. However, it does not offer the granular detail requested concerning specific acceptance criteria, comprehensive performance metrics, expert involvement, or the methodology typically associated with validating an AI/ML algorithm. This is largely because the device in question is an imaging system, not an AI diagnostic/assistive algorithm in the typical sense that would necessitate such detailed ground truth and training/test set breakdowns.
§ 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.