(90 days)
The 1 CCD ENDOCAM 5520 is designed for video endoscopy and video microscopy and can be used for diagnostic and therapeutic applications.
The 1-CCD Endocam 5520 device is a further development of previous 1-CCD Endocams with additional features. Various Camera Heads with and without integrated lenses and CCD endoscopes are available.
This document is a 510(k) premarket notification for a medical device, specifically an endoscopic video camera system. It is a submission to the FDA for market clearance and not a study reporting device performance against acceptance criteria in the way a clinical trial or performance study would. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not present in this type of regulatory document.
However, based on the provided text, I can extract and infer some information, particularly regarding the performance data and the demonstration of safety and effectiveness for regulatory purposes.
Here's an attempt to answer your request based only on the provided text and acknowledging its limitations:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (from the document) |
|---|---|---|
| Safety and Effectiveness | Device poses same type of questions about safety or effectiveness as predicate devices. New technological characteristics have not diminished safety or effectiveness. | "The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness." |
| Substantial Equivalence | Device is substantially equivalent to legally marketed predicate devices. | "The submitted devices are substantially equivalent to existing 510(k)-devices sold by Richard Wolf." |
| Standard Conformity | Device conforms to specified safety standards. | "The Endocam systems 5520 was tested for conformity with the specified standards UL2601-1, IEC601-2-18, CSA22.2No.601.1." |
| Intended Use | Device is designed for video endoscopy and video microscopy for diagnostic and therapeutic applications. | "The 1 CCD ENDOCAM 5520 is designed for video endoscopy and video microscopy and can be used for diagnostic and therapeutic applications." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No specific "test set" in terms of patient data or images is mentioned for evaluating a defined performance metric. The "testing" refers to compliance with electrical and safety standards.
- Data Provenance: Not applicable. This document does not describe a study involving patient data or images. The "testing" mentioned is for product safety and electrical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. This document describes a regulatory submission, not a study that requires establishing ground truth by medical experts for performance evaluation.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No "test set" and thus no adjudication method for medical evaluation were used or described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an endoscopic video camera system, not an AI-powered diagnostic tool.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone performance study as described (i.e., algorithm only) was not done. The device is a hardware endoscopy system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the traditional sense of medical performance evaluation. The "ground truth" for this submission revolves around conformity to electrical and safety standards (UL, IEC, CSA) and the functional performance of the hardware device, as opposed to diagnostic accuracy on medical cases.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. No "training set" in the context of machine learning or algorithm development is relevant to this device or document.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set.
Summary of Limitations:
It is crucial to understand that this document (a 510(k) premarket notification) is a regulatory filing for an endoscopic camera system, aiming to demonstrate its "substantial equivalence" to existing, legally marketed devices. It focuses on engineering standards, safety, and functional characteristics rather than the clinical performance evaluation of an AI-driven diagnostic device. Therefore, many of the questions asked, which are typical for AI/ML medical device performance studies, are not addressed or relevant in this context.
§ 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.