(117 days)
Fluobeam® LX is intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. The Fluobeam® LX 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.
The Fluobeam® LX 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 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 is an imaging system intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. This device 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 tissuetransfer circulation in tissue and free flaps used in plastic, micro- and reconstructive and organ transplant surgeries.
Fluobeam® LX 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 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 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 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 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 on the computer.
The subject device Fluobeam® LX has therefore exactly the same principle of operation of the predicate device. Fluobeam® LX is only a second generation than the predicate Fluobeam® device.
The provided text describes the Fluobeam LX device and its substantial equivalence to a predicate device, but it does not contain specific acceptance criteria or an explicit study proving performance against those criteria in the format requested.
Instead, it refers to:
- Bench testing to support a determination of substantial equivalence, covering homogeneity of excitation illumination, live image quality (spatial resolution and acquisition frame rate), and fluorescence sensitivity.
- Clinical data acquired by independent surgeons in Europe to confirm bench test results.
- Performance and safety testing according to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1).
The document states: "The results of these performance evaluations demonstrated that the Fluobeam® LX met the acceptance criteria defined in the product specification, functioned as intended, and performed comparably to the predicate device." However, the specific acceptance criteria and the detailed results of the studies are not provided in this document.
Therefore, I cannot populate the table or answer all of your questions directly from the provided text.
Here is what I can infer or state based on the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from testing categories) | Reported Device Performance (General Statement) |
|---|---|
| Homogeneity of excitation illumination | Met acceptance criteria, functioned as intended, and performed comparably to the predicate device. |
| Live image quality (spatial resolution) | Met acceptance criteria, functioned as intended, and performed comparably to the predicate device. |
| Live image quality (acquisition frame rate) | Met acceptance criteria, functioned as intended, and performed comparably to the predicate device. |
| Fluorescence sensitivity | Met acceptance criteria, functioned as intended, and performed comparably to the predicate device. |
| Electrical safety (IEC 60601-1) | Met acceptance criteria, functioned as intended, and performed comparably to the predicate device. |
| EMC (IEC 60601-1-2) | Met acceptance criteria, functioned as intended, and performed comparably to the predicate device. |
| Laser safety (IEC 60825-1) | Met acceptance criteria, functioned as intended, and performed comparably to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Clinical data was acquired by independent surgeons in Europe. It's not explicitly stated if it was retrospective or prospective, but the phrasing "acquired by independent surgeons" suggests a form of prospective or concurrent data collection during clinical use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: "Independent surgeons" were involved, but the specific number is not provided.
- Qualifications of experts: They are described as "independent surgeons." No further details on their specific qualifications or experience are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. The text only mentions that surgeons "accepted to share the images with Fluoptics to compare the two devices."
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 focusing on human reader improvement with AI assistance was not described. The device is for real-time fluorescence imaging and is stated to assist, not replace, experienced visual assessment. The comparison was primarily between the new device (Fluobeam LX) and its predicate device (Fluobeam 800 Clinic).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is an imaging system intended to "assist, not replace, experienced visual assessment." It creates images for human interpretation, so a standalone "algorithm only" performance study in the sense of an automated diagnostic AI would not be applicable or described in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the parathyroid gland location, the device is an "adjunctive method to assist in the location of parathyroid glands" and its use "is intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care." This implies that the standard of care, including histopathological confirmation (pathology), would serve as the ultimate ground truth for actual parathyroid tissue, but the device assists in locating visually identified glands.
8. The sample size for the training set
- Not specified. This document only mentions "clinical data were also acquired by independent surgeons" (implying a test or validation set) and does not refer to a separate training set for an AI/algorithm in the way modern machine learning devices often do. The Fluobeam LX is an imaging system, and its performance evaluation focused on its imaging capabilities and equivalence to a predicate device, rather than training a predictive model.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as a training set for an AI model is not described in this document.
§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.
(a)
Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when used as intended; and
(iii) A shelf life for any sterile components.