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FLUOBEAM LX and FLUOBEAM LM are intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries.

The FLUOBEAM LX and FLUOBEAM LM can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue.

Use of the FLUOBEAM LX and FLUOBEAM LM devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

Upon interstitial administration and use of ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

FLUOBEAM LX and FLUOBEAM LM are imaging systems intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures.

Class 1 infrared laser light is used to excite the fluorescent tissues of parathyroid glands or the ICG or the pafolacianine and illuminate the regions of a patient's body to be observed. A camera inside the optical head captures the fluorescent image that is used to visualize the parathyroid glands or assess the blood vessels and related tissue perfusion. FLUOBEAM LX and FLUOBEAM LM consist of the following components: a hardware part with a camera unit (optical head) linked by a specific cable to a control box and a software part with FLUOSOFT LX or FLUOSOFT LM imaging software. The optical head contains a video camera and light sources (laser and LEDs) and is used by hand. The control box receives the video signal of the fluorescent image from the optical head, it digitizes it and sends it to a computer that outputs it on a display screen and/or records it. Adjustments of the fluorescent image are possible either by the optical head or via the FLUOSOFT LX imaging software and the FLUOSOFT LM imaging software on the computer.

The subject devices FLUOBEAM LX and FLUOBEAM LM have therefore exactly the same principle of operation of the predicate device. Only aesthetic aspects are different between FLUOBEAM LX and FLUOBEAM LM.

This Traditional 510(k) premarket notification of the FLUOBEAM LX and FLUOBEAM LM is to expand the indication for use statement to include the usage in the lymphatic system with the use of an ICG consistent with its approved label.

This Traditional 510(k) premarket notification of the FLUOBEAM LX and FLUOBEAM LM is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine, for use with infrared imaging.

The provided FDA 510(k) clearance letter and summary for the FLUOBEAM LX and LM Imaging Systems describe the device and its intended use, as well as the types of studies conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain a specific table of acceptance criteria nor detailed results of a study designed to explicitly "prove the device meets the acceptance criteria" in terms of clinical performance metrics. Instead, the focus is on demonstrating comparable performance to the predicate and reference devices through bench testing and, by extension, substantial equivalence for the expanded indications.

Based on the information provided, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly provide a table of acceptance criteria with corresponding reported device performance values in the style typically found in a clinical study report with quantitative metrics like sensitivity, specificity, accuracy, or a specific statistical threshold for performance.

Instead, the document states:

• "The results of these performance evaluations demonstrated that the FLUOBEAM LX and FLUOBEAM LM met the acceptance criteria defined in the product specification, functioned as intended, and performed comparably to the predicate device."
• "The FLUOBEAM LX and FLUOBEAM LM was able to visualize similar concentration samples of ICG compared to the reference device, both by analysis of the image contrast (SNR) and by observation of the images."
• "The FLUOBEAM LX and FLUOBEAM LM was able to visualize lower concentration samples of pafolacianine compared to the reference device, both by analysis of the image contrast (SNR) and by observation of the images."

This indicates that the "acceptance criteria" were qualitative (e.g., "capable of imaging ICG at different concentrations") and comparative (performing "similarly" or "better" than a reference device in terms of visualization capabilities and image contrast/SNR).

Without explicit quantitative acceptance criteria in the document, a direct table cannot be constructed. The reported performance is primarily descriptive and comparative to other devices.

2. Sample Size for the Test Set and Data Provenance

The document describes bench testing for the performance evaluation.

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." The testing involved "different concentrations" of ICG and pafolacianine in in vitro settings. This implies multiple samples at varying concentrations were used for the bench tests.
• Data Provenance: In vitro bench testing. No mention of human or animal data for the performance evaluation described. Therefore, there is no country of origin or retrospective/prospective designation relevant to clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For the bench testing described, the "ground truth" would be the known concentrations of ICG and pafolacianine and the objective measurement of image contrast (SNR). This type of ground truth does not typically involve human expert interpretation in the same way clinical imaging studies do.

Therefore, no experts were used to establish ground truth in the context of the in vitro performance tests.

4. Adjudication Method for the Test Set

Given that the performance data presented is from in vitro bench testing involving objective measurements of image contrast (SNR) and visual observation of images by the testers/engineers, an adjudication method for a test set (e.g., 2+1, 3+1 by clinical experts) is not applicable or mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided document. The performance evaluation focuses on the standalone device's capability and its comparison to predicate/reference devices through bench testing, not on human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The performance evaluation described is implicitly a standalone (algorithm only) assessment. The bench tests evaluated the system's ability to image ICG and pafolacianine at different concentrations and analyze image contrast (SNR) without human interpretation as part of the core performance metric. While "observation of the images" by humans is mentioned, the primary performance measure (SNR) and the ability to visualize specific concentrations are inherent properties of the imaging system itself.

7. Type of Ground Truth Used

For the performance evaluation described:

• Type of Ground Truth: The ground truth used was known concentrations of ICG and pafolacianine for the in vitro imaging tests. The assessment involved comparing the device's ability to visualize these known concentrations and analyzing the Signal-to-Noise Ratio (SNR).

8. Sample Size for the Training Set

The document describes the FLUOBEAM LX and LM as imaging systems, which typically do not involve machine learning algorithms that require a "training set" in the traditional sense. The software updates mentioned likely relate to operational software, not an AI model trained on data.

Therefore, a "training set" is not applicable or mentioned in the context of this device and its clearance.

9. How the Ground Truth for the Training Set Was Established

As noted above, a "training set" in the context of machine learning is not applicable for this device as described.

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FLUOBEAM® LX and FLUOBEAM® LX Red are intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the FLUOBEAM® LX and FLUOBEAM® LX Red are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries.

The FLUOBEAM® LX and FLUOBEAM® LX Red can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue.

Use of the FLUOBEAM® LX and FLUOBEAM® LX Red devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

FLUOBEAM® LX and FLUOBEAM® LX Red are imaging systems intended to provide realtime near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The FLUOBEAM® LX and FLUOBEAM® LX Red are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries.

FLUOBEAM® LX and FLUOBEAM® LX Red can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue. Use of the FLUOBEAM® LX and FLUOBEAM® LX Red devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

FLUOBEAM® LX and FLUOBEAM® LX Red enable surgeons to observe fluorescent images of parathyroid glands, blood vessels and related tissue perfusion. Fluorescence can be observed as a result of natural fluorescence of parathyroid glands or as a result of a fluorescent product, indocyanine green (ICG), injected intravenously into patients before the surgery allowing the perfusion assessment.

Class 1 infrared laser light is used to excite the fluorescent tissues of parathyroid glands or the ICG and illuminate the regions of a patient's body to be observed. A camera inside the optical head captures the fluorescent image that is used to visualize the parathyroid glands or assess the blood vessels and related tissue perfusion. FLUOBEAM® LX and FLUOBEAM® LX Red consist of the following components: a hardware part with a camera unit (optical head) linked by a specific cable to a control box and a software part with FLUOSOFT™ LX or FLUOSOFT™ LX Red imaging software. The optical head contains a video camera and light sources (laser and LEDs) and is used by hand. The control box receives the video signal of the fluorescent image from the optical head, it digitizes it and sends it to a computer that outputs it on a display screen and/or records it. Adjustments of the fluorescent image are possible either by the optical head or via the FLUOSOFT™ LX imaging software and the FLUOSOFT™ LX Red imaging software on the computer.

This special 510(k) premarket notification is intended to re-frame the indications for use statement to be consistent with specific indications of legally marketed ICG products, eliminating the need for the co-packaging with ICG.

The provided document is a 510(k) Premarket Notification from the FDA, specifically concerning a "Special 510(k)" for the FLUOBEAM® LX and FLUOBEAM® LX Red Imaging Systems.

Crucially, this document states: "No performance data are needed to support the modified indications for use. As noted above, there are no technological changes associated with the proposed labeling changes. Additionally, no new surgical procedures or tissue types are being referenced in the modified indications for use."

This means the submission is not presenting new performance studies or data to demonstrate the device meets acceptance criteria. Instead, it's leveraging the substantial equivalence to previously cleared devices (K190891 and K230898) and a reference device (K223020) because the changes are limited to refining the "Indications for Use" statement to align with existing ICG product labeling, thereby eliminating the need for co-packaging with ICG.

Therefore, for the information requested in your prompt, based solely on the provided text, we cannot fill in most of the table or answer many of the questions as no new performance study data is presented.

Here's what can be extracted from the document:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not applicable, as no new performance study data is presented. The submission relies on substantial equivalence.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable, as no new performance study data is presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable, as no new performance study data is presented.

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. This device is an imaging system, not an AI/CADe/CADx device that assists human readers in interpretation or diagnosis. It aids in visualization during surgery. No MRMC study is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm-only device; it's an imaging system where a human observes the generated images.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not explicitly stated for new data, as none was required. For the original clearance of the predicate devices, ground truth would likely have involved direct visual confirmation during surgery, correlation with anatomical knowledge, and potentially histopathological confirmation where applicable (e.g., for parathyroid tissue). The document reiterates that the device "is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues," implying that standard clinical and pathological evaluations remain the definitive ground truth for such aspects.

8. The sample size for the training set:

• Not applicable, as no new performance study data for a machine learning model is presented.

9. How the ground truth for the training set was established:

• Not applicable, as no new performance study data for a machine learning model is presented.

In summary: This 510(k) submission primarily focuses on a labeling change for an existing device, asserting that no new performance data is needed because "there are no technological changes associated with the proposed labeling changes. Additionally, no new surgical procedures or tissue types are being referenced in the modified indications for use." Therefore, the detailed performance study information requested is not present in this specific FDA clearance document.

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FLUOBEAM® LX Red is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The FLUOBEAM® LX Red is indicated for use in capturing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.

The FLUOBEAM® LX Red can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue. Use of the FLUOBEAM® LX Red device is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

FLUOBEAM® LX Red is an imaging system intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The FLUOBEAM® LX Red is indicated for use in capturing and viewing fluorescent images for the visual assessment of blood flow in adults as an adjunctive method for the evaluation of tissue perfusion, perfused organs, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.

FLUOBEAM® LX Red can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the autofluorescence of this tissue. Use of the FLUOBEAM® LX Red device is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues.

FLUOBEAM® LX Red enables surgeons to observe fluorescent images of parathyroid glands, blood vessels and related tissue perfusion. Fluorescence can be observed thanks to natural fluorescence of parathyroid glands or thanks to a fluorescent product, indocyanine green (ICG), injected intravenously into patients before the surgery allowing the perfusion assessment.

Class 1 infrared laser light is used to excite the fluorescent tissues of parathyroid glands or the ICG and illuminate the regions of a patient's body to be observed. A camera inside the optical head captures the fluorescent image that is used to visualize the parathyroid glands or assess the blood vessels and related tissue perfusion. FLUOBEAM® LX Red consists of the following components: a hardware part with a camera unit (optical head) linked by a specific cable to a control box and a software part with FLUOSOFT™ LX Red imaging software. The optical head contains a video camera and light sources (laser and LEDs) and is used by hand. The control box receives the video signal of the fluorescent image from the optical head, it digitizes it and sends it to a computer that outputs it on a display screen and/or records it. Adjustments of the fluorescent image are possible either by the optical head or via the FLUOSOFT™ LX Red imaging software on the computer.

The modified device FLUOBEAM® LX Red has therefore exactly the same principle of operation of the predicate device. The modified device FLUOBEAM® LX Red is a device modification of the FLUOBEAM® LX device. Compared to the predicate device FLUOBEAM® LX, change of wavelength and detection range is being implemented for modified device FLUOBEAM® LX Red to improve performance in terms of sensitivity for the location of parathyroid glands due to the auto-fluorescence of this tissue while maintaining sensitivity to indocyanine green (ICG).

The FLUOBEAM® LX Red is an imaging system designed to provide real-time near-infrared (NIR) fluorescence imaging of tissue during surgical procedures. It is indicated for visual assessment of blood flow using indocyanine green (ICG) as an adjunctive method, and for assisting in the location of parathyroid glands due to their autofluorescence.

Here’s a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: 5 patients for the clinical tests on ICG fluorescence imaging.
• Data Provenance: Not explicitly stated, but given it's for a European company (FLUOPTICS SAS, France), the data is likely from a European country. The text does not specify if it was retrospective or prospective, but clinical tests are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The general indication statement mentions that the device is intended to "assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care," suggesting that expert assessment and histology are the ground truth, but doesn't specify the number or qualifications of experts involved in the study itself.

4. Adjudication method for the test set:

• This information is not provided in the document.

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, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance was not mentioned. This device is an imaging system, not an AI-driven algorithm with a human-in-the-loop component.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This device is an imaging system, not solely an algorithm. Its performance is intrinsically linked to the physical hardware (camera, light source) and software for image acquisition and display. Therefore, a "standalone algorithm only" performance study, as typically understood for AI, is not applicable in this context. The document describes bench tests for image quality and sensitivity, and clinical tests for its imaging capabilities.

7. The type of ground truth used:

• For ICG fluorescence imaging for blood flow assessment: The ground truth is implied by comparison to the predicate device in clinical settings, and by the "visual assessment of blood flow." Ultimately, the standard of care for confirming tissue perfusion and viability would involve clinical observation, surgical assessment, and potentially other diagnostic tools.
• For parathyroid gland location: The ground truth is implied to be "visually identified gland/tissues" by experienced visual assessment and "biopsy with conventional histopathological confirmation per standard of care."

8. The sample size for the training set:

• This information is not provided as the document does not mention any machine learning or AI models with distinct training sets. The device's performance is established through engineering design, bench testing, and limited clinical validation.

9. How the ground truth for the training set was established:

• This information is not applicable as the document does not mention a training set in the context of machine learning or AI.

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