(88 days)
The Imalux OCT (Optical Coherence Tomography) Imaging System is intended to be used as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization.
The Imalux OCT (Optical Coherence Tomography) Imaging System utilizes near infrared (NIR) light to create high spatial resolution, real-time images near infrared (1127) be Imalux OCT Imaging System consists of an Imaging Console and a detachable, flexible fiberoptic Probe. The Imaging Console Console and a detailsptical and electrical components and a user interface system. The user interface system includes a keyboard, display, and standard Ethernet and USB ports for image data transfer.
As various tissue structural elements absorb, reflect, and scatter light As various NIR light that is backscattered from the tissue is collected and analyzed to present an image of the tissue microstructure. By analyzing andly200 to probesity as a function of tissue depth, over a lateral surface, a 2-dimensional image is constructed.
At any one lateral position, the in-depth OCT image is analogous to an At any one accrar presents backscattering intensity as a function of depth. By combining the in-depth scanning with lateral movement of the depth. Dy connemional image is created that is analogous to that of ultrasound B-scan, except that OCT uses light in lieu of sound waves. By using light instead of sound, the Imalux OCT Imaging System can achieve higher spatial resolution, but to a more shallow imaging depth, than ultrasound imaging since light is more readily attenuated in the tissue.
Here's a breakdown of the acceptance criteria and study information based on the provided text, while noting the limitations of the given document:
This 510(k) Summary does not contain a study specifically designed to demonstrate that the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested sections (like sample size of test set, expert qualifications, HRMC study, standalone performance) are not explicitly addressed in the document as they would be for a direct performance study.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical targets for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing the fundamental technology and intended use.
| Criteria/Characteristic | Imalux OCT Imaging System Performance | Predicate Device (Humphrey OCT Scanner) Performance | Comparison Outcome |
|---|---|---|---|
| Technology | Optical Coherence Tomography (OCT) | Optical Coherence Tomography (OCT) | Same |
| Light Source | Near Infrared (NIR) | NIR | Same |
| Imaging Mechanism | Real-time depth visualization, 2D cross-sectional images by analyzing backscattered light intensity as a function of depth and lateral movement. | Real-time depth visualization, 2D cross-sectional images using similar principles. | Same fundamental mechanism |
| Intended Use | Evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. | Evaluation of human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization. (Specifically ocular tissue for predicate) | Same general intended use, though specific target tissues differ. |
| Spatial Resolution | Achieves high spatial resolution. | Achieves high spatial resolution. | Comparable |
| Imaging Depth | Shallower imaging depth than ultrasound (due to light attenuation). | Shallower imaging depth than ultrasound. | Comparable |
| Probe/Imaging Head | Detachable, flexible fiberoptic Probe, facilitates imaging from different target tissues and reprocessing. | Fiberoptic imaging head, connected to console, requires patient positioning close to head (suitable for ocular use). | Design difference, but both transport NIR light and acquire images. Imalux design supports broader tissue types. |
| Safety Standards | Complies with EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60825-1, AAMI/ANSI/ISO 10993-1, AAMI/ANSI ST35. | (Not explicitly detailed for predicate in this summary, but assumed to meet standards for market clearance) | Imalux demonstrates compliance. |
The "study" or justification provided is the substantial equivalence argument presented in the 510(k) summary, which posits that because the Imalux device employs the same technology and has the same intended use as the legally marketed Humphrey OCT Scanner, it is "at least as safe and effective."
2. Sample size used for the test set and the data provenance
Not applicable/Not specified. The document does not describe a clinical performance study with a dedicated test set in the traditional sense (e.g., patient images interpreted by experts). The assessment is based on comparing technical characteristics and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. No such test set or expert ground truth establishment is described in this 510(k) summary.
4. Adjudication method for the test set
Not applicable/Not specified. No test set requiring adjudication is described.
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-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As an imaging system, its "performance" is in generating images. Its effectiveness is based on the quality of these images for human interpretation, not on an algorithm's standalone diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The submission does not describe a study involving ground truth for disease detection or diagnosis. The ground truth, in the context of device function, is implied to be the physical principles of OCT for accurate microstructure visualization.
8. The sample size for the training set
Not applicable. This device is an imaging system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of what the document does provide regarding "acceptance criteria" and "study":
The core of this 510(k) submission is the demonstration of substantial equivalence to a predicate device (Humphrey Optical Coherence Tomography (OCT) Scanner, K944523). The "acceptance criteria" are implicitly met by proving this substantial equivalence, meaning the new device is as safe and effective as the existing legally marketed device.
The "study" presented is not a traditional clinical trial with acceptance criteria for sensitivity/specificity, but rather an engineering and technological comparison to show equivalence. Key points of this comparison include:
- Same fundamental technology: Both utilize Optical Coherence Tomography (OCT) with Near Infrared (NIR) light.
- Same intended use: Both are for evaluating human tissue microstructure by providing 2D, cross-sectional, real-time depth visualization.
- Similar functional characteristics: Both achieve high spatial resolution and offer shallow imaging depth.
- Differences are not significant: The primary difference highlighted is the Imalux's detachable, flexible fiberoptic probe, which allows for imaging different tissue types (skin, mucosal membranes) and facilitates reprocessing, compared to the predicate's fixed imaging head designed for ocular tissue. This difference is presented as an enhancement that doesn't alter the fundamental safety or effectiveness for the stated intended use.
- Safety Standards Compliance: The device meets relevant electrical, laser, and biocompatibility standards.
The FDA's decision to clear the device (K033783) confirms their agreement that substantial equivalence was adequately demonstrated, thus implicitly accepting the device's safety and effectiveness compared to the predicate.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.