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The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging Processor is a reusable monitor.

The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output of the Electronic Endoscope Imaging Processor via the encoding circuit. The Electronic Endoscope Imaging Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Electronic Endoscope Imaging Processor also controls the brightness of the LEDs on the endoscope.

The optical components and their arrangement at the distal tip for all models of the Single-use Bronchoscope are identical.

The Single-use Bronchoscope is single-use medical devices that are sterilized with ethylene oxide and intended for use in adults. This product is accompanied by an electronic endoscopic image processor, which supports the use of medical monitors. The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor.

This FDA 510(k) summary describes the Bronchoscope System (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1). The submission indicates that no clinical studies were performed to demonstrate substantial equivalence. Instead, a series of non-clinical (bench) tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate devices (K231107 and K191828).

Therefore, I will provide the acceptance criteria and performance as reported for the non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission relies on non-clinical testing for substantial equivalence, the "acceptance criteria" are typically compliance with recognized standards or meeting specific performance benchmarks defined in the device's design specifications. The "reported device performance" refers to the results of these tests confirming that the device meets those standards/specifications.

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test performed. However, these tests are typically performed on a statistically representative number of manufactured units according to the applicable standard requirements (e.g., a certain number of devices for electrical safety, biocompatibility batches, etc.).
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human subjects. The manufacturer is Shenzhen Sanping Image Technology Co., Ltd. located in Shenzhen, Guangdong, China. The data would therefore originate from testing facilities associated with the manufacturer or their designated testing laboratories. The data is prospective in the sense that it was generated specifically to support this 510(k) submission.

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

Not applicable. Since no clinical studies were performed, there was no test set requiring expert ground truth establishment for diagnostic or clinical performance. The non-clinical tests relied on validated reference methods and calibrated equipment to assess various physical and performance characteristics against established international standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no reported effect size regarding human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI/algorithm-only device. It is a Bronchoscope System, which functions as a direct visualization tool for medical professionals. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" implicitly refers to the specifications defined by the international consensus standards (e.g., IEC, ISO) and the device's own design specifications. The tests verify that the device's physical, electrical, mechanical, and imaging properties meet these predefined engineering and safety benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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