(65 days)
The Storz Communication Bus/STERIS OR-Light Interface device is an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System. This interface box allows SCB computer to control/monitor the STERIS Harmony LA Surgical Lighting System, a room camera and various ambient light settings. It contains software to display the STERIS Harmony LA OR-Lighting System's control parameter on a SCB computer screen. The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls.
The Karl Storz SCB/STERIS OR-Light Interface Box connects the Storz Communication Bus computer to the STERIS Harmony OR-Light Control System. It enables the SCB computer to display and control the Harmony's functions.
This document describes a 510(k) summary for the KARL STORZ Endoscopy - America, Inc. SCB/STERIS OR-Light Interface Box.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain any specific acceptance criteria or performance metrics for the device itself. Instead, it focuses on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions, where the main "acceptance criterion" is that the new device is as safe and effective as a legally marketed predicate device.
The "reported device performance" is implicitly that it functions as intended by allowing the SCB computer to "control/monitor" the STERIS Harmony LA Surgical Lighting System, a room camera, and various ambient light settings. The key assertion is: "The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe any specific test set, sample size, or data provenance related to performance testing of the device. This is because the device's function is an interface for control, and its safety and effectiveness are established through substantial equivalence to a predicate device with similar functionalities, rather than through
a clinical or performance study with a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth was established through expert consensus for this device notification as no specific performance study beyond substantial equivalence was provided.
4. Adjudication Method for the Test Set:
Not applicable. No adjudication method is mentioned as there was no test set or study described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. No MRMC study was conducted or described. This type of study is more relevant for diagnostic or image-interpretation devices, not for an interface box that relays controls.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The device is a hardware interface with software that relays controls; it is always "human-in-the-loop" as it is controlled by a surgeon via a monitor. The concept of "standalone algorithm performance" doesn't apply here.
7. Type of Ground Truth Used:
Not applicable. As no performance study requiring ground truth was described, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. The "truth" for this submission is the established safety and effectiveness of the predicate device and the claim that the new device operates similarly and introduces no new safety or effectiveness concerns.
8. Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of the Document's Approach to Acceptance:
The submission relies entirely on Substantial Equivalence to establish the device's "acceptance."
- Predicate Device: SCB/ValleyLabs Force FX Interface Box (K041912)
- Argument for Equivalence: "The Karl Storz SCB/STERIS OR-Light Interface Box is substantially equivalent to the predicate device SCB/ValleyLabs Force FX Interface Box (K041912) since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB/STERIS OR-Light Interface Unit and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."
In essence, the "study" proving the device meets "acceptance criteria" is the comparison to the predicate device, demonstrating that the new device performs similarly for its intended use, without introducing new risks. This is a regulatory pathway, not a performance study in the traditional sense of medical device evaluation for diagnostic or therapeutic efficacy.
§ 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.