(207 days)
The Artemis Handheld Imaging System is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries.
The system uses direct visualization for open procedures, or via a laparoscope for minimally invasive procedures.
The Artemis Handheld System is intended for intraoperative and minimal invasive visual assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue.
The Artemis System consists of a hand held camera, Artemis Fast Lens; ring light for open procedures, and a laparoscope for minimally invasive procedures, controller (lap top) and a light source or Light Engine. The Artemis Light Engine (K141164) is Class II device for illumination of surgical sites for diagnostic purposes. The light Engine has imaging capabilities for fluorescence as well. The laparoscope is an OEM item branded for Quest and cleared via 510(k) Number K945266.
The Artemis Handheld Imaging System is a fluorescent imaging system intended for the visual assessment of blood flow for tissue perfusion and related tissue-transfer circulation in tissue and free flaps during plastic, reconstructive, and organ transplant surgeries. It can be used for direct visualization in open procedures or via a laparoscope for minimally invasive procedures.
The device's performance was evaluated through a series of tests, including in vitro characterization, in vivo animal models, and clinical case series studies.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria with corresponding reported device performance values. Instead, it broadly states that "Performance Testing" was conducted to verify conformance to user/design requirements and that "Design Test and Verification demonstrates that the device functions as it is intended and its performance does not raise any issues of safety and effectiveness."
However, based on the description, the implicit acceptance criteria are related to the ability of the device to:
- Visually assess blood flow and tissue perfusion using fluorescence.
- Demonstrate concentration-dependent sensitivity of Indocyanine Green (ICG).
- Satisfactorily demonstrate perfusion in various tissues.
| Acceptance Criteria (Implicit from document) | Reported Device Performance |
|---|---|
| Conformance to original user/design requirements. | "The performance testing to verify conformance to the original user / design requirements for both the system overall and the software was successfully conducted." |
| Software verification. | "Software is verification testing was successfully performed." |
| Functionality and absence of safety/effectiveness issues. | "Design Test and Verification demonstrates that the device functions as it is intended and its performance does not raise any issues of safety and effectiveness." |
| In vitro characterization of ICG sensitivity. | "included in vitro characterization, determining concentration dependent sensitivity of ICG dissolved in human serum albumin." (Result implied as successful/demonstrated, as it contributed to the overall conclusion of substantial equivalence). |
| Performance in in vivo animal models (e.g., comparative imaging qualitative assessments). | "in vivo animal models using nude Balb/c mice, as well as comparative imaging qualitative assessments with other NIR imaging devices on various anatomical structures." (Result implied as successful/demonstrated, as it contributed to the overall conclusion of substantial equivalence). |
| Performance in human vital structure imaging. | "human vital structure imaging performed at a medical research facility in the Netherlands." (Result implied as successful/demonstrated, as it contributed to the overall conclusion of substantial equivalence). |
| Satisfactory demonstration of perfusion in clinical case series (e.g., colon, skin flap reconstruction). | "Further perfusion imaging was assessed in case series studies performed in Germany. satisfactorily demonstrating perfusion in the colon and in skin tissue after skin flap reconstruction." (Result explicitly stated as "satisfactorily demonstrating perfusion"). |
| Compliance with relevant voluntary standards (e.g., IEC 60601-1-2, ISO 14971). | "The manufacturer complies with the following voluntary standards: IEC 60601-1-2 Edition 3: 2007-03, ISO 14971 Second edition 2007-03-01." |
| Substantial equivalence to predicate devices (PDE System K110480 and Fluobeam 800 K132475) regarding intended use and technical features. | "The Artemis System has similar intended use and technical features as the predicate devices listed above. Therefore, the Artemis System is substantially equivalent to the predicate marketed devices referenced herein." and "The reference device does not raise any new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions different test sets:
- In vitro characterization: The sample size is not specified, but it involved "ICG dissolved in human serum albumin."
- In vivo animal models: The sample size is not specified, but it involved "nude Balb/c mice."
- Human vital structure imaging: The sample size is not specified.
- Provenance: Performed at a "medical research facility in the Netherlands." This implies prospective data collection, but it's not explicitly stated.
- Clinical case series studies: The sample size is not specified.
- Provenance: Performed "in Germany." These were "case series studies," implying prospective data collection in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts used or their specific qualifications for establishing ground truth for any of the test sets.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed or provide any effect size of how much human readers improve with AI vs. without AI assistance. The study focuses on the device's capability for imaging and perfusion assessment.
6. Standalone (Algorithm Only) Performance:
The device described is an "imaging system" used for visual assessment by surgeons. It is not an AI algorithm intended for standalone diagnostic performance without human input. Therefore, a standalone (algorithm-only) performance study, in the typical sense of AI, was not conducted or is not applicable in the context of this device. The performance relates to the hardware's ability to capture and display fluorescent images.
7. Type of Ground Truth Used:
The ground truth used appears to be a combination of:
- Known concentrations/properties: For the in vitro characterization of ICG sensitivity.
- Observations in animal models: For in vivo performance, likely assessed by researchers/veterinarians involved in the animal studies.
- Clinical assessment/surgical observations: For human vital structure imaging and clinical case series, where "satisfactorily demonstrating perfusion" would be based on the clinical judgment of the medical professionals involved. It likely relies on expert observation and clinical parameters rather than a single definitive ground truth like pathology for specific disease detection.
8. Sample Size for the Training Set:
The document does not mention a training set in the context of machine learning or AI algorithms. The performance testing described relates to the verification and validation of the imaging system's hardware and software functionality, not an AI model.
9. How the Ground Truth for the Training Set Was Established:
Since there is no mention of a training set for an AI algorithm, the establishment of ground truth for a training set is not applicable in this document.
§ 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.