(61 days)
IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.
IDSS SLC is an additional function of the IDSS, which is an integrated operating room system that controls video displays, observation cameras, audio video equipment, teleconferencing and the routing of videos and images from multiple sources to multiple destination via touch screen interface.
This document, a 510(k) Summary for the IDSS SLC device, does not contain a study proving the device meets acceptance criteria as typically understood for AI/ML medical devices.
The IDSS SLC is described as an additional function of an integrated operating room system that controls surgical lighting, video displays, observation cameras, audio/video equipment, and teleconferencing. Its primary function is to allow control of surgical lighting during a procedure from a centralized interface.
Instead of a typical performance study with acceptance criteria for an AI/ML diagnostic or prognostic device, this document describes a summary of nonclinical testing focused on the device's functional integrity, safety, and equivalence to predicate devices.
Here's a breakdown of the information that can be extracted, and what is not applicable (N/A) given the nature of this device and document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (implicit from nonclinical testing) | Reported Device Performance |
|---|---|
| Functional Requirements (Interfaces, Features) | Validation testing performed on interfaces and feature functional requirements. (Indicates conformance to specified functions) |
| Non-functional Reliability | Validation testing performed on non-functional reliability. (Indicates stable and consistent operation) |
| Electrical Safety (Patient/User Protection) | Conforms to EN 60601-1, EN 60601-1-2:2007, and CAN/CSA-C22.2 NO. 601.1. (Passed electrical safety standards) |
| Electromagnetic Compatibility (EMC) | Conforms to EN 60601-1-2:2007. (Passed EMC standards to prevent interference) |
| User Needs (Overall System) | Testing and evaluation indicate that the system meets the needs of the users. |
| No New Safety/Efficacy Issues vs. Predicate | Testing and evaluation indicate that the system does not raise any new safety and efficacy issues compared to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document describes nonclinical engineering and safety testing of a control system, not a study involving patient data or a test set in the traditional sense for AI/ML performance evaluation. The "test set" would be the device itself and its components undergoing various engineering validation tests.
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)
- N/A. Ground truth for clinical interpretation or diagnostic accuracy is not relevant here. The "ground truth" for this device's performance would be whether it accurately implements its programmed controls, adheres to safety standards, and functions reliably. This would be established by qualified engineers and testers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting clinical data. This is not relevant for the type of testing 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
- N/A. The IDSS SLC is a control system for surgical lights and other OR equipment. It is not an AI-assisted diagnostic or interpretative device that would be subject to an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not an AI algorithm in the context of clinical interpretation. The "standalone" performance would refer to the IDSS SLC system's ability to operate its functions as designed, which is covered by the validation testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is its conformance to engineering specifications, functional requirements, and established safety standards (e.g., EN 60601-1). This ground truth is based on predefined technical standards and the expected behavior of a physical control system.
8. The sample size for the training set
- N/A. This device does not use a training set for machine learning. The "training" for such a system would involve software development, component testing, and integration testing, which are distinct from AI model training.
9. How the ground truth for the training set was established
- N/A. As there is no training set mentioned in the context of AI/ML, this question is not applicable.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.