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510(k) Data Aggregation
(207 days)
QUEST MEDICAL IMAGING
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.
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(315 days)
QUEST MEDICAL IMAGING
The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.
The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).
This 510(k) premarket notification for the Artemis Light Engine primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to voluntary standards, rather than extensive clinical performance studies with specific statistical acceptance criteria for a diagnostic algorithm.
Therefore, many of the requested categories regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies validating diagnostic AI, are not explicitly provided or are not applicable in the context of this submission. The device is an LED light source, not a diagnostic algorithm.
Here's a breakdown of the information available and what is not applicable based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is an LED light source and not a diagnostic AI, the acceptance criteria are not in terms of diagnostic metrics like sensitivity, specificity, or AUC, but rather functional performance.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from "Performance Testing") |
|---|---|
| Light output intensity control and linearity | "The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time." |
| Functionality as intended (safety & effectiveness) | "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." |
| Software functionality | "Software verification testing was successfully performed and completed." |
| Electromagnetic Compatibility (EMC) | Compliance with "IEC 60601-1-2 Edition 3: 2007-03 Medical Electrical Equipment Part1-2: General Requirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility - Requirements And Tests." |
| Risk Management | Compliance with "ISO 14971 Second edition 2007-03-01, Medical Devices - Application of Risk Management to Medical Devices." |
The "study that proves the device meets the acceptance criteria" is referred to as "Performance Testing", specifically "Bench Testing protocol attached." While the summary mentions this, the details of the protocol are not provided in the excerpt.
2. Sample size used for the test set and the data provenance
Not Applicable. As a medical device (LED light source), the testing mentioned refers to bench testing of the device's physical and software performance, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. Ground truth, in the context of diagnostic algorithms, involves expert labeling of patient data. This is an LED light source, so such a "test set" and "ground truth" are not relevant. The testing would have involved engineering and quality control personnel validating the device's technical specifications.
4. Adjudication method for the test set
Not Applicable. There is no "test set" of patient data requiring adjudication in this submission.
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
Not Applicable. The Artemis Light Engine is an LED light source for illuminating surgical sites, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with or without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. The Artemis Light Engine is a hardware device (LED light source with software control), not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. For a light source, "ground truth" would be related to objective physical measurements of light output, color temperature, intensity, control accuracy, and adherence to safety standards, verified through calibrated instruments and engineering specifications. It's not clinical "ground truth" as understood for diagnostic systems.
8. The sample size for the training set
Not Applicable. The device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not Applicable. No training set exists for this device.
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