(78 days)
The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.
The Schoelly FlexiScope 50MH / 50MHC system is comprised of a camera handpiece and a combination light source / video processor; the system is intended for use with currently marketed endoscopes. The light source utilizes visible light to provide illumination of the area under endoscopic examination. The compact camera system component attaches to the proximal eyepiece of the user-supplied flexible or rigid endoscope. Images are optically captured via the endoscope. The image is transferred to the camera's CCD (charge coupled device) sensor through the scope objective lens, where it is converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc.
The provided 510(k) summary for the Schoelly FlexiScope 50MH / 50MHC does not contain information related to acceptance criteria, device performance metrics, or a study proving the device meets specific performance criteria in the way a diagnostic AI device would.
This device is a light source and video camera system for endoscopy, not a diagnostic AI or image analysis tool. Its approval is based on establishing substantial equivalence to predicate devices through comparisons of labeling, physical, and performance design characteristics, and compliance with electrical safety and electromagnetic compatibility standards.
Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary. I will address the relevant points and indicate when information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). The "acceptance criteria" for this type of device are primarily related to safety, electrical performance, and functional equivalence to predicate devices. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Electrical Safety | Compliance with IEC 60601-1-1 |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-1; IEC 60601-1-2 |
| Functional Equivalence: | |
| Provides illumination | "light source utilizes visible light to provide illumination" |
| Provides video visualization of optical images | "Images are optically captured via the endoscope... converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc." |
| Compatibility with endoscopes | "intended for use with currently marketed endoscopes" |
| Predicate Device Comparison: | Substantial equivalence to AngioLaz Video Endoscopic System (K933868) and AMD Telemedicine AMD-300s Illumination & Imaging System (K940270) based on "labeling, physical and performance design characteristics." |
2. Sample size used for the test set and the data provenance
Not applicable. This device is not a diagnostic tool that relies on a "test set" of patient data for performance evaluation in the conventional sense of AI. Its "testing" involved electrical and electromagnetic compatibility standards and functional verification, not analysis of clinical images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on clinical findings, pathology results) is not relevant for the regulatory approval of an endoscopic light source and camera system.
4. Adjudication method for the test set
Not applicable for the same reasons as points 2 and 3.
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. This is a medical device for visualization, not an AI-powered diagnostic system. MRMC studies demonstrating human reader improvement with AI assistance are not relevant to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device itself is a "standalone" hardware component, in the sense that it functions to provide light and video. It does not employ an algorithm for independent diagnostic performance.
7. The type of ground truth used
For the safety and performance claims, the "ground truth" used would be the compliance with recognized electrical and electromagnetic standards (IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18) and the functional equivalence to its predicate devices. This is ascertained through engineering tests and direct comparison, not clinical pathology or outcomes data in the way an AI diagnostic would be evaluated.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.