(238 days)
The SIOS product is intended to optimize procedures in the operating room by providing consistent preoperative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities.
The SIOS product is limited to use with the following products:
- (1) Wolf Endocam 3CCD Endocam 5507,
- (2) Wolf Light Source Auto-CP 5131,
- (3) Wolf Insufflator Laparo CO2 Pacu 2332, and
- (4) Maquet OR Table ALPHAMAQUET 1150.
The Siemens Integrated Operating System (SIOS) is a system capable of networking select medical and non-medical equipment in the operating room (OR) and allowing trained medical personnel direct control of the equipment using remote control (i.e. voice command, touch screen console). The device combines a number of individual functional units through a standard interface to a centralized computer control station.
The provided text is a 510(k) summary for the Siemens Integrated Operating System (SIOS), which is an older document (dated December 15, 1999, with a corrected letter on July 27, 2015). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with acceptance criteria as would be expected for a novel AI/ML-driven device today.
Therefore, the document does not contain the detailed information required to populate a table of acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment methods, or information about expert adjudication, MRMC studies, or standalone performance. The SIOS is described as a system for controlling existing medical and non-medical equipment in an operating room and networking capabilities, not a diagnostic or AI-driven interpretative device that would typically undergo such performance evaluations.
Here’s a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) for the SIOS. Its purpose is to control other devices and handle data.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any specific test set or data used for performance evaluation in the context of a clinical study or diagnostic accuracy assessment. The submission focuses on the functionality and safety of the control system itself.
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)
- Cannot be provided. Since no specific test set requiring expert ground truth is mentioned, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This information is not relevant or present in the document given the nature of the device and the 510(k) submission type.
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
- Cannot be provided. An MRMC study is not mentioned. The SIOS is an integrated operating system for control and data handling, not a device that assists human readers in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. The SIOS is a system for controlling other devices; it doesn't have an "algorithm-only" performance that would be evaluated in this context. Its function is to facilitate human operators' control of other equipment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth is established as the device is not making diagnostic or interpretative claims.
8. The sample size for the training set
- Cannot be provided. Training sets are typically associated with machine learning or AI models, which are not described for the SIOS in this document.
9. How the ground truth for the training set was established
- Cannot be provided. As no training set is mentioned, this is not applicable.
Summary from the provided document:
The Siemens Integrated Operating System (SIOS) is a control and networking system for operating rooms. The 510(k) submission (K994231) demonstrates its substantial equivalence to predicate devices (HERMES™ Operating Room Control Center and Accessories by Computer Motion, and EndoALPHA™ Integrated Endosurgery System by Olympus). The "study" referenced in this context is the general comparison to these predicate devices, focusing on the technological characteristics and intended use rather than
quantitative performance metrics of a diagnostic or AI algorithm. The core functionality and safety were deemed equivalent by the FDA based on the comparison of features and intended use.
§ 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.