(30 days)
The Imalux Niris Imaging System is intended to be used as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.
The Imalux Niris Imaging System utilizes near infrared (NIR) light to create high spatial resolution, real-time images of human tissue microstructure. The Niris Imaging System consists of an Imaging Console and a detachable, flexible fiberoptic Probe. The Imaging Console consists of internal optical and electrical components and a user interface system. The Niris Imaging Console contains optical and electrical components, including a super luminescent diode (SLD) light source. The NIR light is directed from the Console through the Probe's optical fiber to the patient's tissue. The optical light is backscattered from the patient's tissue, collected by the Probe's fiber, and, combined with a reference, to produce a high spatial resolution image of the tissue microstructure. By using a small lateral scanning mechanism contained within the Probe, the optical beam scans laterally across the tissue surface while simultaneously acquiring an in-depth profile at each lateral position. By combining in-depth and lateral scanning, the Niris Imaging System produces a two-dimensional, cross-sectional image of the tissue microstructure. The Imaging Console has a user interface for acquiring, displaying, and reporting images. Image data is stored onto the system and can be exported via Ethernet or USB data ports on the console.
The provided text describes the Imalux Niris™ Imaging System and its clearance as substantially equivalent to a predicate device, the Imalux OCT Imaging System (K033783). However, the document does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, beyond general statements about verification and validation.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
- Information not available in the provided text. The document states that "Image performance specifications have remained unchanged" from the predicate device and that "These design modifications have been verified and validated to fulfill the performance requirements of the device." However, no specific performance metrics or acceptance criteria are listed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not available in the provided text. There is no mention of a test set, sample size, or data provenance for any performance study.
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)
- Information not available in the provided text. Since no test set or ground truth establishment is described, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not available in the provided text. No adjudication method 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
- Information not available in the provided text. This document describes an imaging system, but it does not mention any AI component, let alone an MRMC study comparing human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information not available in the provided text. The device is an "imaging tool" intended for human evaluation of tissue microstructure. There is no mention of standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not available in the provided text. No ground truth is described.
8. The sample size for the training set
- Information not available in the provided text. No training set is mentioned as this device is not described as having a machine learning component.
9. How the ground truth for the training set was established
- Information not available in the provided text. No training set or associated ground truth establishment is mentioned.
Summary of what is available:
The provided document is a 510(k) summary for the Imalux Niris™ Imaging System. It focuses on demonstrating substantial equivalence to an existing predicate device (Imalux OCT Imaging System, K033783) rather than detailing specific performance studies with acceptance criteria.
Key points mentioned regarding performance validation are:
- The system uses near infrared (NIR) light to create high spatial resolution, real-time images of human tissue microstructure.
- "Image performance specifications have remained unchanged" from the predicate device.
- "These design modifications have been verified and validated to fulfill the performance requirements of the device."
- "the device has been tested for compliance to applicable safety testing standards."
However, the specific details of these verifications and validations, including methods, acceptance criteria, sample sizes, or ground truth establishment, are not included in this summary. Such details would typically be found in more extensive technical documentation submitted to the FDA, but not necessarily in the publicly available 510(k) summary.
§ 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.