(112 days)
The 4K UHD Laparoscope is intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.
The 4K UHD Laparoscope is a rigid endoscope, which consists of lighting system and optical imaging system. The 4K UHD Laparoscope has 12 models which are available in two insertion portion widths (5.5 mm and 10 mm), four working lengths (290mm, 300mm, 320mm) and three different directions of view (0°, 30°, 45°). The 12 models are all connected with adaptor 2 for different brand source light. The 4K UHD Laparoscope can be connected to Scivita 4K UHD Camera System, Scivita LED Light Source or Wolf light source and SONY Monitor. The 4K UHD Laparoscope is a reusable device that is cleaned and steam sterilized before first use and each subsequent use.
The provided text describes the acceptance criteria and the study that proves the device meets them, specifically for the "4K UHD Laparoscope" (K203255).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of acceptance criteria with reported device performance in the typical sense of numerical thresholds and corresponding results for each. Instead, it describes adherence to recognized standards and qualitative comparisons to a predicate device. The performance is implied by the successful completion of these tests and the determination of substantial equivalence.
However, based on the non-clinical tests mentioned, we can infer some performance aspects and how "acceptance" was framed:
| Acceptance Criteria (Inferred from standards and comparisons) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Complies with ISO 10993-5 |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complies with ISO 10993-10 for Sensitization |
| ISO 10993-10:2010 (Tests for intracutaneous reactivity) | Complies with ISO 10993-10 for Intracutaneous Reactivity |
| Electrical Safety & Essential Performance | |
| IEC 60601-2-18:2009 (Basic safety and essential performance of endoscopic equipment) | Complies with IEC 60601-2-18 |
| Endoscope Standards | |
| ISO 8600-1:2015 (General requirements for medical endoscopes) | Complies with ISO 8600-1; Field of view meets requirements within 15% deviation. |
| ISO 8600-5:2005 (Determination of optical resolution) | Complies with ISO 8600-5 |
| Image Quality Performance | |
| Depth of Field | Range of 3-200 mm (Proposed device has a wider range than predicate device (6-200 mm), which "gives physicians more options." This is presented as an advantage meeting clinical needs.) |
| Geometric Distortion | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| Color Reproduction | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| SNR (Signal-to-Noise Ratio) | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| Intensity Uniformity | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| Image Frame Frequency | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| System Delay | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| Sterilization Efficacy | |
| Steam sterilization / Low-temperature plasma sterilization | Sterility Assurance Level (SAL) reached 10^-6 after steam sterilization and low-temperature plasma sterilization. |
| Labeling | |
| 21 CFR Part 801 | Complied with 21 CFR Part 801 |
The study described is a non-clinical test program designed to compare the proposed device's performance against recognized standards and a legally marketed predicate device ("ULTRA" Telescopes, K150633, from Olympus Winter & Ibe GmbH). The goal was to establish Substantial Equivalence (SE).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The non-clinical tests typically involve a sample of the manufactured device models.
- Data Provenance: The tests were conducted by Scivita Medical Technology Co., Ltd. (based in China, as per the sponsor identification) as part of their 510(k) submission. The data is prospective from these internal tests.
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)
Not applicable. This device is a hardware laparoscope, and the performance assessment is based on physical and optical measurements against engineering standards and comparison with a predicate device, not on expert interpretation of output data like medical imaging analysis. Therefore, there's no "ground truth" derived from medical experts in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Since the "test set" refers to physical and optical performance characteristics of the device itself (e.g., cytotoxicity, electrical safety, optical resolution, depth of field), expert adjudication methods typically used for interpreting diagnostic outputs (like imaging) are not relevant here. The evaluation involves compliance with established standards and direct measurement/comparison.
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
No. This document pertains to the clearance of a 4K UHD Laparoscope, which is a physical endoscopic device, not an AI-powered diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a hardware laparoscope. There is no algorithm to be tested in a standalone fashion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Biocompatibility: Ground truth is defined by the absence of toxicity, irritation, or sensitization as per the criteria outlined in ISO 10993 standards.
- Electrical Safety & Performance: Ground truth is compliance with the requirements of IEC 60601-2-18.
- Endoscope Standards: Ground truth is compliance with the requirements of ISO 8600-1 and ISO 8600-5.
- Image Quality Performance: Ground truth is established by quantitative measurements (e.g., depth of field, geometric distortion) and comparison to the predicate device's performance, ensuring similar or improved characteristics that meet clinical needs.
- Sterilization Efficacy: Ground truth is achieving a Sterility Assurance Level (SAL) of 10^-6.
The overall "ground truth" for the submission is the determination of Substantial Equivalence to the predicate device based on these engineering and performance standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.