(27 days)
The ConMed True HD 3MOS Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.
The ConMed True HD 3MOS Camera System consists of a camera control unit (CCU) and a camera head that is used in conjunction with endoscopes, light source, light guide cables, monitors and other ancillary equipment to allow for high definition visualization during minimally invasive surgical procedures.
The provided text is a 510(k) summary for the ConMed True HD 3MOS Camera System. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or the study design with the granularity requested. Medical device 510(k) submissions typically summarize the testing performed, but do not often provide the full study details, especially for performance characteristics that are not directly tied to a clinical outcome or a specific diagnostic accuracy metric.
However, based on the limited information available in the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document broadly states: "The tests results demonstrated the safety and effectiveness of the devices in accordance with design specifications and applicable standards." and "Performance testing were conducted to demonstrate that the True HD 3MOS Camera System performs according to specifications and functions as intended."
However, specific quantitative acceptance criteria (e.g., minimum resolution, signal-to-noise ratio, color accuracy range) and their corresponding measured performance results are NOT provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Performance testing" and "System Testing" (Verification and Validation including Functional testing, Video Image, Software). It also lists various standards evaluations (Electromagnetic compatibility, Electrical Safety, Reprocessing, Risk analysis, Software validation).
However, specific sample sizes for these tests (e.g., number of camera units tested, number of video sequences analyzed) are NOT provided. Details regarding data provenance (e.g., country of origin, retrospective or prospective nature of data collection) are also NOT provided. These are typically engineering performance tests, not clinical studies.
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)
This product is an endoscopic camera system for visualization during surgery. The primary performance characteristic is image quality for surgical viewing. The document does not mention any use of experts to establish 'ground truth' for image quality or clinical outcomes in the context of a diagnostic or comparative study with human readers. The assessment of image quality in such devices is typically done objectively against technical specifications and subjectively by engineers or clinical specialists without a formal 'ground truth' establishment process as seen in diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no experts were mentioned for establishing ground truth or evaluating diagnostic performance, there is no adjudication method described or applicable.
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 MRMC comparative effectiveness study was done or mentioned. This device is a camera system, not an AI software intended to assist human readers in interpretation. The goal is to provide high-definition visuals to the surgeon.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm only" performance. The ConMed True HD 3MOS Camera System is a hardware device (camera system) used for visualization. While it has software components, its primary function is not an "algorithm only" diagnostic performance that would typically be evaluated in this manner. The performance testing focuses on the camera's ability to produce images according to specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a camera system, "ground truth" would typically relate to objective image quality metrics (resolution, color accuracy, brightness, latency) compared against engineering specifications, or the ability to correctly visualize anatomical structures. The document states "The tests results demonstrated the safety and effectiveness of the devices in accordance with design specifications and applicable standards." This implies the "ground truth" for the device's performance is adherence to established technical specifications and standards (e.g., video resolution of 1920 x 1080 pixels). It does not mention ground truth based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This device does not appear to involve machine learning in a way that requires a 'training set' for a diagnostic algorithm. The software leveraged "key components from a camera base component procured from Panasonic (SOUP)." This implies it's an off-the-shelf software component, not a custom-trained AI model requiring a specific training dataset as understood in AI/ML performance evaluation. Therefore, there is no mention of a training set sample size.
9. How the ground truth for the training set was established
As there is no training set for a machine learning model, there is no ground truth establishment method described for a training set. The "ground truth" for this camera system would be based on its compliance with engineering and safety standards, as well as its ability to capture and display high-definition video during surgical procedures.
In summary: The provided 510(k) summary is for a hardware medical device (camera system) and focuses on demonstrating substantial equivalence through technical performance verification and validation, adherence to standards, and risk analysis. It does not contain the detailed information typically found in submissions for AI/ML-based diagnostic devices, which would involve concepts like training/test sets, ground truth establishment by experts, and comparative effectiveness studies with human readers.
§ 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.