Search Results

The LuminScan(TM) Imaging System is is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two dimensional, cross sectional, real-time depth visualization.

LuminScan™ Imaging System is a general imaging system comprised of LuminScan™ Imaging System Console and LuminScan™ Disposable Imaging Kit.

The provided document is a 510(k) Summary for the LuminScan™ Imaging System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing comprehensive clinical study data for new claims.

Based on the provided text, the following information can be extracted regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "all the tests were found to be within their test acceptance criteria (passing test result)" for the Disposable Imaging Kit testing, System Performance Testing, and Reliability Testing. However, specific numerical acceptance criteria (e.g., minimum values, ranges, tolerances) are not detailed in the provided text. The tables only list the tests performed and a general "passing test result."

2. Sample Size Used for the Test Set and Data Provenance:

• Disposable Imaging Kit Testing: The specific sample sizes for each individual test (e.g., balloon burst, tensile strength) are not provided.
• Reliability Testing: The specific sample sizes for environmental and vibration testing are not provided.
• System Performance Testing: The specific sample size is not provided.
• Animal Testing: The sample size was 2 Bama miniature pigs (one male, one female). The provenance is implied to be internal testing by Micro-Tech (Nanjing) Co., Ltd., which is located in Nanjing, China. This was a prospective animal study as part of the device evaluation.
• No clinical performance data (human studies) was included in this 510(k) submission. Therefore, there is no human test set or data provenance mentioned for clinical performance.

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

• No human "test set" in the context of clinical images with expert-established ground truths is mentioned. The submission explicitly states: "This section is not applicable because there is not including any clinical performance data with this 510(k) Submission."
• For the animal testing, the "ground truth" was the in vivo imaging procedure itself and the assessment of image quality against design requirements. The document does not specify the number or qualifications of experts who evaluated the animal images.

4. Adjudication Method for the Test Set:

• Not applicable as no clinical performance data with human test sets and expert adjudication is presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. The submission states "there is not including any clinical performance data with this 510(k) Submission." Thus, no comparison of human readers with or without AI assistance was performed or reported here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• The LuminScan™ Imaging System is described as an "imaging tool" to provide 2D, cross-sectional, real-time depth visualization. It is an Optical Coherence Tomography (OCT) device, which generates images for human interpretation, not an AI algorithm that provides automated diagnoses or standalone performance metrics. Therefore, a standalone algorithm-only performance study as typically understood for AI/ML devices is not applicable here. The "System Performance Testing" and "Animal Testing" were likely evaluations of the device's ability to produce clear images suitable for human interpretation and meet its specified imaging capabilities.

7. The Type of Ground Truth Used:

• For the technical performance tests (Disposable Imaging Kit, Reliability, System Performance): The ground truth was based on engineering specifications, recognized standards (e.g., ISO, IEC), and design requirements.
• For animal testing: The "ground truth" was the visual assessment of the captured two-dimensional and cross-sectional OCT images of the animal esophagus, ensuring they met the device's design requirements for imaging procedure and image quality. This is an observational, expert-evaluated ground truth against technical specifications.

8. The Sample Size for the Training Set:

• The LuminScan™ Imaging System is an OCT imaging device, not explicitly an AI/ML-driven diagnostic algorithm that typically relies on large training datasets for image interpretation. While it contains software, the 510(k) summary classifies it as having a "Minor" level of concern for software failures, implying its primary function is image acquisition and display rather than complex automated analysis requiring extensive image training sets. Therefore, a "training set" in the context of machine learning is not discussed or specified in this document.

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

• Not applicable, as no training set for a machine learning algorithm is mentioned or implied by the device's description in this submission.

Ask a specific question about this device