(24 days)
The IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization. image recording and documentation during general endoscopic and microscopic procedures.
The modified Image1 SPIES (Storz Professional Image Enhancement System) camera control unit includes an additional camera head that can be connected to the X-link module and software updates for improvement of existing features and bug fixes. The SPIES Camera System is intended and designed for use during endoscopic and microscopic procedures.
The document provided is a 510(k) summary for the Karl Storz Endoscopy America, Inc. Image1 SPIES System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving a device meets
clinical acceptance criteria through a specific study in the way a novel AI algorithm might.
Based on the provided text, here's a breakdown of the acceptance criteria and the study that "proves" the device meets them, keeping in mind the context of a 510(k) for an endoscopic camera system:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific numerical acceptance criteria (e.g., minimum resolution in lp/mm, acceptable latency in ms) in a table format. Instead, it states that the device "met all its specifications." The performance validation involved a series of bench tests.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Resolution | Met specifications |
| Brightness | Met specifications |
| White Balance | Met specifications |
| Color Performance | Met specifications |
| Latency | Met specifications |
| Temporal Noise | Met specifications |
| Residual Spatial Noise | Met specifications |
| Step Response of Automated Exposure System | Met specifications |
| Software Verification Tests | Met specifications |
The "bench test data for the Image1 SPIES System demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications. The performance validation test report can be provided upon request."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "sample size" in terms of cases or patients for the bench tests. The testing performed was on the device itself and its components.
- Data Provenance: Not applicable in the context of clinical data. The tests were bench tests conducted on the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for bench tests is based on engineering specifications and direct physical measurements, not expert consensus on medical images.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Bench testing relies on objective measurements against predefined technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically done for diagnostic aids or AI algorithms that assist human readers in interpreting medical images, assessing the impact on diagnostic accuracy, sensitivity, or specificity. The Image1 SPIES System is a camera control unit for visualization, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Yes, in a sense, the bench testing performed is analogous to a standalone performance evaluation for the device's technical specifications. The performance of the camera control unit itself (resolution, brightness, etc.) was evaluated independently of human interpretation of clinical outcomes. However, this is not an "algorithm only" study as would be described for AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the bench tests was based on engineering specifications and objective physical measurements. For example, resolution would be measured against a standard test pattern, and latency would be measured with specialized equipment.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this 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.