(322 days)
HJY VisualNext™ Endoscopic Vision System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.
The HJY VisualNext™ Endoscopic Vision System is a system used for viewing internal surgical sites during surgical procedures. The system consists of the following components:
- . Endoscope Control Unit (ECU) (Model number: HDSES01)
- . Endoscope (Model number: HDSE201)
The endoscope is physically connected via a 5m BNC cable to the Endoscope Control Unit (ECU). The Endoscope consists of 2 LED lamps and a CMOS camera, embedded in the proximal end of a rigid metal arthroscope, which captures the image and transmits to and is processed by the Endoscope Control Unit (ECU), subsequently output to and presented on an external monitor. Images are recordable and markable for further analysis. The Endoscope Control Unit (ECU) is not connectable to intranet or Internet.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the HJY VisualNext Endoscopic Vision System, a neurological endoscope.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various non-clinical tests performed, each with a "Purpose" (which implicitly contains the acceptance criteria) and "Results" (reported device performance). Since the original document doesn't provide a consolidated table of acceptance criteria with numerical targets before the results, the "Purpose" section of each test effectively serves as the acceptance criteria statement. For clarity, I will present the key performance parameters.
| Test Parameter | Acceptance Criteria (from "Purpose" / implies meeting pre-defined criteria) | Reported Device Performance ("Results") |
|---|---|---|
| Field of View (FOV) | To verify the characteristic of field of view of the subject device and compare to that of predicate device. (Passed pre-defined acceptance criteria) | Non-Aged: 120.15 ± 0.2 degrees; Aged: 120.41 ± 0.2 degrees. Both passed pre-defined acceptance criteria. Subject device FOV is larger than predicate. |
| Direction of View | To verify the characteristic of direction of view of the subject device and compare to that of predicate device. (Met requirements by ISO 8600-1; passed pre-defined acceptance criteria) | Non-Aged: 4.02 ± 0.2 degrees; Aged: 2.10 ± 0.2 degrees. Both passed pre-defined acceptance criteria and met ISO 8600-1 requirements. |
| Optical Magnification | To verify the characteristic of optical Magnification... and determine if both non-aged and aged test results will pass the pre-defined performance criteria. | Non-Aged: 0.014 @ 38 mm object distance; Aged: 0.013 @ 38 mm object distance. Both passed pre-defined acceptance criteria. |
| Distortion | To verify the characteristic of distortion... and determine if both non-aged and aged test results will pass the pre-defined performance criteria. | Non-Aged: Maximal distortion 22.7%; Aged: Maximal distortion 22.7%. Both passed pre-defined acceptance criteria. |
| **Image Intensity | ||
| Uniformity** | To verify the characteristic of the subjected device on image intensity uniformity and determine if both non-aged and aged test results will pass the pre-defined performance criteria. | Non-Aged: R:0.52, G:0.60, B:0.60; Aged: R:0.60, G:0.61, B:0.65. Both passed pre-defined acceptance criteria. |
| Signal-to-Noise Ratio | To verify the characteristic of signal-to-noise ratio of images... and determine if both non-aged and aged test results will pass the pre-defined performance criteria. | Non-Aged: R:20.47, G:40.90, B:22.24; Aged: R:20.24, G:35.18, B:21.47. Both passed pre-defined acceptance criteria. |
| Sensitivity | To verify the characteristic of sensitivity... and determine if both non-aged and aged test results will pass the pre-defined performance criteria. | Non-Aged: SNR@0.9 cd/m²: R:10.9058, G:9.99283, B:13.0905; Aged: SNR@0.81 cd/m²: R:13.14, G:8.88, B:14.85. Both passed pre-defined acceptance criteria. |
| Depth of Field | To verify the characteristic of depth of field of the subject device and compare to that of predicate device. (Passed pre-defined acceptance criteria) | Non-Aged: 5-100 mm; Aged: 5-100 mm. Both passed pre-defined acceptance criteria. Subject device DOF is wider than predicate. |
| Image Resolution | To verify the characteristic of spatial frequency response of the subject device and compare to that of predicate device. (Passed pre-defined acceptance criteria) | Non-Aged: 52.6% on axis, 37.1% @ 0.6 FOV (TV lines: 730); Aged: 54.1% on axis, 44.8% @ 0.6 FOV (TV lines: 670). Both passed pre-defined acceptance criteria. Similar to predicate (642 TV lines @ 15% MTF). |
| Working Length | To verify the working length of the endoscope and compare to that of predicate device. (Passed pre-defined acceptance criteria) | Working length: 180.76 mm. Passed pre-defined acceptance criteria. Longer than predicate. |
| Outer Diameter | To verify the outer diameter of the endoscope and compare to that of predicate device. (Passed pre-defined acceptance criteria) | Outer diameter: 5.28 - 5.32 mm. Passed pre-defined acceptance criteria. Wider than predicate. |
| **Image Quality Test | ||
| (Biological Tissue Model)** | To verify subject device performance in terms of image quality under different light levels and working distances in a clinically relevant biological tissue model to support the device intended use and substantial equivalence to the predicate. (Passed pre-defined acceptance criteria) | Image quality of non-aged and aged subject device passed criteria for brain and spine surgery. No significant difference (P=0.569) between non-aged and aged devices. Image quality comparable to FDA-cleared comparators for brain and spine endoscopy. |
2. Sample size used for the test set and data provenance:
- Sample Size for Physical/Optical Tests: For most physical and optical performance tests (FOV, Direction of View, Optical Magnification, Distortion, Image Intensity Uniformity, Signal-to-Noise Ratio, Sensitivity, Depth of Field, Image Resolution), the tests were conducted using a "Disposable endoscope and Endoscope Control Unit (ECU) in both non-aged and aged conditions." The specific number of individual units tested for each parameter is not explicitly stated beyond "disposable endoscope."
- Sample Size for Image Quality Test (Biological Tissue Model):
- ECU: Non-aged and aged ECU units were used. (Quantity not specified, but implied as at least one of each).
- Endoscopes: "Six pieces of endoscopes each from non-aged and aged conditions were used for brain and spinal surgery, respectively." This means 6 non-aged endoscopes for brain surgery, 6 non-aged for spinal surgery, 6 aged for brain surgery, and 6 aged for spinal surgery.
- Comparators: "Two cleared devices each for spine and brain were applied for comparing with non-aged and aged subject devices."
- Data Provenance: The tests were non-clinical laboratory studies. The "Image Quality Test utilizing a clinically relevant biological tissue model" was performed using a "live pig model" in "an animal operating room of a facility accredited under AAALACi standards," following "GLP standard." The country of origin for the data is not specified directly, but the company is based in Taiwan. The document states "No clinical test data was used to support the decision of substantial equivalence," indicating these were not human subject trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For the physical/optical tests, the "ground truth" is established by the measurement apparatus and methods themselves. For the Image Quality Test on a biological tissue model, the results state "The image quality of the non-aged and aged subject device passed the pre-defined acceptance criteria," and was "comparable to that of the FDA-cleared comparator devices." It's highly probable that expert assessment was involved in determining "image quality" or "comparability," but the number and qualifications of these experts are not explicitly mentioned in the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document. For most non-clinical performance tests, adjudication (as in clinical image review) is not typically applicable. For the image quality assessment in the biological tissue model, while agreement was tested, details of an adjudication method among multiple evaluators (if any) are not specified.
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:
This information is not applicable/not provided. The device is an endoscopic vision system, not an AI-assisted diagnostic tool for image interpretation by human readers. The studies described are non-clinical performance evaluations of the device's optical and imaging capabilities, and comparison of its image quality to a predicate device. No MRMC study regarding human reader performance with or without AI assistance was conducted or is relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided as the device is not an AI algorithm. It is an endoscopic vision system that provides direct visual output for human use. The performance tests are of the hardware's image capture and display capabilities in a standalone manner (i.e., the system itself creating the image).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the various physical and optical parameters, the "ground truth" is based on instrumented measurements against defined engineering specifications and comparison to the predicate device's characteristics. For the "Image Quality Test utilizing a clinically relevant biological tissue model," the ground truth for acceptability was based on pre-defined acceptance criteria and comparability to FDA-cleared comparator devices. While expert evaluation likely played a role in assessing "image quality" and "comparability," the final "ground truth" for the test was determined by whether these qualitative and quantitative assessments met the pre-defined criteria. The results state: "The image quality... passed the pre-defined acceptance criteria" and was "comparable to that of the FDA-cleared comparator devices." There is no mention of pathology or outcomes data being used as ground truth.
8. The sample size for the training set:
This information is not applicable/not provided. The HJY VisualNext Endoscopic Vision System is a hardware device (endoscope and control unit) that captures and displays images; it is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable/not provided as there is no training set for this type of device.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).