(126 days)
The Image 1 S is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization, image recording and documentation during general endoscopic and microscopic procedures.
The Image 1 S 4U camera head is intended to the Image1 S Camera Control Unit (CCU) and compatible endoscope for visualization, image recording and documentation during general endoscopic and microscopic procedure.
The Image1 S camera control unit is a medical device which consists of the Image1 S Connect (TC200US), Image1 S Connect II (TC201US) modules and the link modules. The link modules are Image1 S H3-Link (TC300US), Image1 S X-Link (TC301US), Image1 S D3-Link (TC302US) and Image1 S 4U-Link (TC304US).
The Image1 S Connect (TC200US) and the Image1 S Connect II (TC201US) modules can be connected to a minimum of one and a maximum of three links modules. The modularity enables customers to customize their Image1 S system to their specific current and future video needs.
The Image1 S includes, but not limited to, the following features:
• Brightness control
• Enhancement Control
• Automatic Light Source Control
• Shutter Control
• Image/Video Capture
When the Image1 S Connect II module is used with the 4U-Link and the Image1 S 4U camera head, it can output a 4K image to the monitor and also offers 7 increments of zoom ranging from 1x to 2.5x.
The software version of the Image1 S camera control is upgraded to version 4.0. Software version 4.0 introduces the KS HIVE, an Ethernet based interface that allows for communication between the Image 1 S camera control unit and certain KARL STORZ devices.
This is a premarket notification (510(k)) for an endoscopic video imaging system, the Image1 S CCU and Image1 S 4U Camera Head. The primary purpose of this 510(k) is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device (Image1 S, K160044). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the testing and analysis performed to demonstrate this substantial equivalence, rather than a clinical outcome-based performance study typically associated with AI/ML devices.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for an imaging system rather than an AI/ML diagnostic or prognostic device, the "acceptance criteria" are related to safety, effectiveness, and technological characteristics compared to the predicate device. The "reported device performance" are the results of the non-clinical tests demonstrating these aspects.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance / Outcome |
|---|---|---|
| Optical Performance | Comparative testing of optical parameters (e.g., imager type, sensor resolution, zoom capabilities) | Both subject and predicate use CMOS for imager type. Sensor resolution increased from 1920x1080p (predicate) to 3840x2160p (subject). Zoom capabilities expanded from 1x, 1.2x, 1.5x, 1.75x, 2x (predicate) to include 2.25x, 2.5x, and "Adaptive Zoom" (subject). |
| Software Performance | Software verification and validation testing, including compliance with FDA Guidance for "Software Contained in Medical Device" | Software version upgraded from 2.4 (predicate) to 4.0 (subject), introducing KS HIVE (Ethernet-based interface). Testing demonstrated the software functions as intended and is safe. (Level of concern: Moderate) |
| Electrical Safety & EMC | Compliance with international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18 | Device complies with all listed electrical safety and electromagnetic compatibility standards. |
| Reprocessing (Cleaning & Sterilization) | Validation of cleaning and sterilization for the Image1 S 4U camera head against specified standards (e.g., ANSI/AAMI/ISO 14937, AAMI TIR 12, ANSI/AAMI ST81, ST79, ST58, ISO 14161). | Reprocessing data submitted is in compliance with all relevant standards. |
| Design Specifications | Bench testing to ensure the device meets all its design specifications | Bench testing performed verified and validated that the Image1 S has met all its design specifications. |
| Substantial Equivalence | Demonstrated through differences that do not raise new questions of safety and effectiveness, compared to the predicate device. | Conclusions from all technical and performance tests demonstrated the subject device is as safe and effective as the predicate, and differences do not raise new questions of safety and effectiveness. |
2. Sample sizes 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: The document does not specify a "test set" in the context of clinical images or patient data that would typically be used for AI/ML performance evaluation. The testing primarily involved non-clinical bench testing, software verification/validation, and compliance with standards. Therefore, the "sample size" would refer to the various components and systems tested, but no numerical count is provided for this.
- Data Provenance: Not applicable as no clinical patient data was used for performance evaluation in this 510(k). The testing is primarily engineering and regulatory compliance based.
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)
- Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of clinical annotations by experts for AI/ML performance, was not established as this is not an AI/ML diagnostic device with a clinical performance study. The "ground truth" here is compliance with engineering standards, design specifications, and the functionality of the device as tested by engineers and technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There was no clinical ground truth established requiring expert adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an endoscopic video imaging system, not an AI/ML diagnostic assistant, so such a study is not relevant to this submission. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an AI/ML algorithm. The "standalone performance" refers to the device's functional operation (imaging, brightness control, zoom, etc.) as detailed in the non-clinical performance data and bench testing, which was indeed performed without human-in-the-loop diagnostic interpretations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For this device, the "ground truth" used is primarily engineering specifications, compliance with recognized international standards (e.g., IEC 60601 series, ANSI/AAMI reprocessing standards), and the functional design requirements of the imaging system. It's not clinical ground truth like pathology or expert consensus on disease.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not involve an AI/ML algorithm that would require a "training set" of clinical data.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there is no AI/ML 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.