(410 days)
The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.
The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134 and SC9144. These are the major components of the PINPOINT System.
During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.
To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.
When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.
The provided text includes a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which describes performance data. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
Here's what can be extracted and what information is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards.
- Reported Device Performance:
- Non-Clinical Performance:
- Conforms to IEC 60601-1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance).
- Conforms to IEC 60601-1-2:2007 (Electromagnetic compatibility).
- Conforms to IEC 60601-2-18:2009 (Particular requirements for the basic safety and essential performance of endoscopic equipment).
- Assessed as a Class 3R laser device with internal maximum Class 4 laser radiation according to IEC 60825:2007.
- Animal testing (porcine model) validated in vivo fluorescence imaging capability.
- Clinical Performance:
- Clinical evaluation based on literature search and post-market surveillance adverse event information found continued clinical safety and performance.
- Clinical study and case reports (Journal of Gastrointestinal Surgery, Surgical Innovation, Int! J Sur Case Reports) using the PINPOINT System support expanded Indications for Use.
- No new concerns related to safety and effectiveness were introduced.
- Non-Clinical Performance:
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified for clinical studies in this document. Animal testing used a "porcine model" (singular, but likely implying multiple animals or instances).
- Data Provenance:
- Non-Clinical: Novadaq Technologies Inc. and accredited third-party laboratories.
- Clinical: Clinical literature search, post-market surveillance (adverse event information), a clinical study, and case reports published in medical journals. The country of origin for the clinical data is not specified. It is likely retrospective for the literature review and post-market surveillance, and potentially prospective for the mentioned "clinical study," but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document refers to clinical studies and case reports, which would typically involve medical experts, but details about ground truth establishment and expert qualifications are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 MRMC study mentioned. This device appears to be an imaging system intended for direct visualization by surgeons, not an AI-assisted diagnostic tool for interpretation by readers. The document highlights its use "to provide real time endoscopic visible and near-infrared fluorescence imaging" and "enables surgeons to perform minimally invasive surgery" and "visual assessment."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an imaging system for direct surgeon use, not an algorithm. The "device is not intended for standalone use for biliary duct visualization" refers to its use in conjunction with white light and cholangiography, not to an algorithm's standalone performance.
7. The type of ground truth used
- Animal Testing: "In vivo fluorescence imaging capability" validated in a porcine model. This implies comparison against expected fluorescence patterns.
- Clinical Evaluation: Clinical literature and adverse event information. For the clinical study and case reports, the ground truth would typically be surgical outcomes, direct visualization during surgery, or other clinical assessments, but this is not explicitly detailed.
8. The sample size for the training set
- Not applicable as this is not an AI/machine learning device with a distinct training set. The device was "designed and developed."
9. How the ground truth for the training set was established
- Not applicable (see above).
Summary of Missing Information:
The provided text is a 510(k) summary demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards. It lacks the detailed specifications of acceptance criteria, specific clinical study designs (e.g., sample sizes, ground truth establishment methods, expert qualifications, adjudication, MRMC studies) that would be present for a novel AI/algorithm-based diagnostic device. The performance data presented focuses on regulatory compliance, technological characteristics, and general safety/performance based on existing literature and animal models, rather than detailed quantitative performance metrics from controlled clinical trials against specific acceptance criteria.
§ 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.