(90 days)
The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.
The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current. This permits its use for cardiac visualization procedures when used in conjuction with the proper instrumentation for entry into the cardiac system.
The endoscopic video camera systems include a camera controller and a small camera head which is connected by a camera cable to the controller. Endoscopic procedures are displayed with the objective lenses attached to the camera head and the video monitors connected to the camera controller.
The camera heads are CF Equipment (cardiac floating) according to UL2601-1 / IEC601-1.
This document is a 510(k) summary for the Richard Wolf Medical Instruments Corp. 1 CCD Endocam 5502 and 3 CCD Endocam 5507. It declares substantial equivalence and does not detail a study proving specific acceptance criteria in the manner you've requested for a medical device's performance metrics. Instead, it focuses on general safety and effectiveness through compliance with regulatory standards and comparison to predicate devices.
Therefore, many of the requested fields cannot be directly populated from the provided text. I will explain why each field cannot be filled if the information is missing.
Here's the breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with specified standards: IEC601-1, IEC601-1-2, IEC1-1-2, IEC1-2-18, UL2601-1 (5507: UL pending) | "Independent laboratories tested Endocam 5502 and 5507 according to specified standard IEC601-1, IEC601-1-2, IEC1-1-2, IEC1-2-18 and UL2601-1 (5507: UL pending)." |
| Conformity to Medical Device Directive 93/42/EEC | "Camera systems 5502 and 5507 conform to the relevant provisions of Medical Device Directive 93/42/EEC." |
| Camera head classified as Cardiac Floating (CF) equipment | "The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current." |
| Leakage current less than 10uA for cardiac visualization procedures | "The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current." |
| Designed and tested to guarantee safety and effectiveness when used according to instruction manual | "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific "test sets" for performance evaluation in the way requested for a clinical or AI-based device study. Instead, it refers to regulatory compliance testing performed by "Independent laboratories." Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document describes compliance testing against standards, not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. The document refers to engineering and safety standard compliance testing, not a clinical study with image interpretation requiring 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:
This information is not applicable and not provided. The device is an endoscopic video camera system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The device is hardware (camera system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's acceptance is based on adherence to specified international and national electrical and medical device safety standards (e.g., IEC601-1, UL2601-1) and the Medical Device Directive 93/42/EEC, rather than clinical outcomes or expert consensus on diagnostic performance.
8. The sample size for the training set:
This information is not applicable and not provided. The device is a physical camera system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As above, no training set for an algorithm is mentioned.
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.