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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.

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The Imalux OCT (Optical Coherence Tomography) Probe Sheath is a sterile, single-use, protective sheath that is used as an accessory with the Imalux OCT Imaging System. The Imalux OCT Probe Sheath is intended to serve as a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the probe.

The Imalux OCT (Optical Coherence Tomography) Probe Sheaths (Probe Sheaths) are sterile, single-use, protective sheaths for use with the Imalux OCT Imaging System. The sheaths are provided to fit the Imalux OCT Imaging System probe geometry and to help to prevent the transfer of microorganisms, body fluids, and material to the patient and healthcare worker during reuse of the Probe. The Probe Sheath does not impair the imaging performance of the Imalux OCT Imaging System. Adequate coupling between the Probe Sheath and the probe's distal end can be achieved without the use of an additional medium, such as gel, due to the pliability of the membrane window material. The Probe Sheath is constructed of rigid tubing with a flexible end cap membrane window at one end and with a plastic handle at the other end. The probe is inserted into the tubing at the handle and fed through the tubing until the probe's distal tip is flush with the Probe Sheath's membrane window. The handle includes a lock nut to secure the probe in place. The Probe Sheath is provided in various dimensional configurations necessary to accommodate the probe as well as to assist the user in probe positioning. Probe Sheaths are provided as sterile, single-use sheaths, individually packaged in Tyvek/Mylar pouches.

The medical device is the Imalux OCT Probe Sheath. The information provided describes the device, its intended use, and the testing conducted to demonstrate its safety and performance for 510(k) clearance.

Here's a breakdown of the requested 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

The document does not specify the exact sample sizes used for each test (biocompatibility, imaging, mechanical, microbial barrier, sterilization, packaging). It states "The Probe Sheath was verified for imaging, mechanical, and packaging performance" and "Microbial barrier testing demonstrated..." without providing specific numbers of units tested.

The data provenance is not explicitly stated in terms of country of origin, nor is it categorized as retrospective or prospective. These were laboratory and performance tests, not clinical studies involving patient data.

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

This information is not applicable to the type of testing described. The tests are laboratory-based performance and safety evaluations (e.g., sterilization validation, material strength, microbial barrier efficacy, biocompatibility). There is no "ground truth" established by human experts in the context of interpreting results, as would be the case for an AI diagnostic device.

4. Adjudication method for the test set

Not applicable. The tests are objective, laboratory-based physical, chemical, and biological evaluations, not requiring human adjudication of subjective interpretations.

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 a probe sheath, an accessory to an imaging system, not an AI diagnostic algorithm. Therefore, an MRMC study comparing human reader performance with and 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. This device is a probe sheath and does not involve an algorithm.

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

The "ground truth" for the tests performed is based on established scientific standards and methods, such as:

• Biocompatibility: Standards like AAMI/ANSI/ISO 10993 and FDA Blue Book Memorandum #G95-1, with results determined through laboratory assays for cytotoxicity, toxicity, reactivity, and sensitization.
• Mechanical & Imaging Performance: Engineering specifications and objective measurements (e.g., tensile strength testing, optical clarity measurements).
• Microbial Barrier: Laboratory challenge tests using a known virus size and concentration and measuring transmission.
• Sterilization: Validation per established sterilization standards to achieve a specific Sterility Assurance Level (SAL).

8. The sample size for the training set

Not applicable. This device is a physical accessory, not an AI model requiring a training set.

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

Not applicable. This device is a physical accessory and does not involve a training set or AI model.

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