(76 days)
The HD-Camera HDC1000 is intended to be used during diagnostic and operative endoscopic procedures to provide illumination and visualization of body cavities, hollow organs and to allow for image recording and documentation. The HD-Camera HDC1000 is indicated for use with compatible rigid or flexible endoscopes and other video equipment and endoscopic accessories.
The HD-Camera HDC1000 is a video-management system that consists of a camera, an integrated light source and a capture module for storing and compressing video and still images. It is used in conjunction with an endoscope or microscope, a light cable and other endoscopic accessories to illuminate surgical sites and to view the surgical sites on video monitors during diagnostic and operative endoscopic procedures. The camera of the proposed device consists of a camera control unit (CCU), a coupler, and a camera head with an integral cable that connects to the camera control unit (CCU). The optical image is transferred from the surgical site to the camera head by compatible rigid and flexible endoscopes that are attached to the camera head using an optical coupler. The camera head including camera cable and the coupler are reusable devices and must be sterilized using the STERRAD ® advanced sterilization process or may be used with a sterile cover or sleeve. The camera control unit (CCU) is not intended to enter the sterile field, and cannot be sterilized.
This document describes the regulatory submission for the HD-Camera HDC1000, a medical device intended for diagnostic and operative endoscopic procedures to provide illumination, visualization, image recording, and documentation. The submission focuses on demonstrating substantial equivalence to a predicate device, the OVS1 Video System.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's technical specifications in a table format. Instead, it describes performance testing conducted to demonstrate conformance to standards and substantial equivalence to a predicate device. The performance data section refers to various standards that the device conforms to, which implicitly represent the acceptance criteria for those specific aspects.
Based on the information provided, here's a summary of the performance claims and an attempt to infer "acceptance criteria" from the comparative bench testing with the predicate device, where the implied criterion is comparability.
| Feature/Test | Acceptance Criteria (Implied / Conformance to Standards) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1:2005 | Test results demonstrate that the proposed device conforms toIEC 60601-1:2005. |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2007 | Test results demonstrate that the proposed device conforms to IEC 60601-1-2:2007. |
| Endoscopic Equipment Safety & Performance | Conformance to IEC 60601-2-18:2009 | Test results demonstrate that the proposed device conforms to IEC 60601-2-18:2009. |
| Software Development | Conformance to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304:2006 | Software was developed, tested, and verified in accordance with the FDA guidance document and IEC 62304:2006. |
| Cleaning Instructions Validation | Instructions validated for camera head and cable reprocessing. | Cleaning instructions provided in the labeling for the camera head and cable were validated. |
| Sterilization Validation | Conformance to AAMI/ANSI/ISO 14937:2009 and AAMI TIR12:2010. | Sterilization validation testing was performed in accordance with AAMI/ANSI/ISO 14937:2009 and AAMI TIR12:2010. |
| Overall Performance (Design Verification) | Device performs as intended, no new safety/effectiveness questions. | Design verification testing demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness. |
| Comparative Bench Testing | Performance substantially equivalent to the predicate device (OVS1 Video System) across key metrics. | Comparative bench testing was performed to demonstrate substantial equivalence, including "signal to noise ratio (SNR), resolution, latency, shading correction accuracy, white balance accuracy and maximum light source intensity." Specific numerical performance for these metrics is not provided in this excerpt. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "comparative bench testing was performed." However, it does not specify any sample size for this test set (e.g., number of devices tested, number of images/videos analyzed).
The data provenance is not explicitly mentioned but can be inferred as arising from bench testing conducted by independent laboratories. There is no indication of patient data or clinical studies; it is likely an engineering/technical evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The comparative bench testing described here appears to be a technical comparison against a predicate device and industry standards, rather than an evaluation requiring expert clinical interpretation to establish a ground truth.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the nature of the described testing (bench testing against technical standards and a predicate device). No human-based adjudication for ground truth is mentioned.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a camera system for endoscopic visualization, not an AI diagnostic tool. The document focuses on the camera's technical performance and equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done?
This question is not applicable as the device is an HD-Camera, a hardware system for image and video capture, not an algorithm or AI system for standalone performance evaluation.
7. The Type of Ground Truth Used
For the safety, EMC, software, cleaning, sterilization, and general design verification tests, the "ground truth" implicitly refers to the requirements specified in the respective international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, AAMI/ANSI/ISO 14937, AAMI TIR12) and conformity to FDA guidance documents.
For the comparative bench testing (SNR, resolution, latency, shading correction accuracy, white balance accuracy, maximum light source intensity), the "ground truth" is likely derived from measured technical specifications of both the proposed device and the predicate device, with the aim to demonstrate substantial equivalence. It refers to objective, measurable physical properties rather than subjective clinical diagnoses or pathology.
8. The Sample Size for the Training Set
This information is not applicable. The HD-Camera HDC1000 is a hardware device for image acquisition, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for this type of device.
§ 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.