(14 days)
The intended use of the Stryker Visum™ LED Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.
The Stryker Visum™ LED Surgical Lighting System is intended to illuminate the operative site during surgical procedures. Light functions can be controlled from within the sterile field, from a wall mounted control panel, or through the Stryker SIDNE™ device (K022393). The Stryker Visum™ LED Surgical Lighting System will be used in indications the same as other surgical lights currently offered for commercial distribution in the United States.
The Stryker Visum™ LED Surgical Lighting System is suitable for all major and minor surgical procedures throughout the hospital. The light moves via an easy to move pivoting suspension and has a completely sealed lighthead for safety and hygiene. Intensity is variable from 50,000 Lux to 160,000 Lux and each lighthead has redundant light sources that are not affected by individual source failure. The light quality is based upon a multiple reflector design combined with a heat removing conductive path to provide shadow free, cool light.
All systems are ceiling, wall, or mobile mounted lights and each provides sufficient illumination for all types of surgical procedures. The ceiling mounted lights are available in single, dual, and triple configurations and may also be combined with a separate arm to hold a viewing monitor.
The provided text, K060802, describes a 510(k) premarket notification for the Stryker Visum™ LED Surgical Lighting System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and detailed performance data. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this type of regulatory submission.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device "meets the requirements set forth in FDA Guidance for Surgical Lamps, as well as electrical safety standards IEC 60601-1 and IEC 60601-2-41." It also mentions meeting "the sterility requirements of AAMI ST37 to achieve a SAL of 10^-6." The primary performance claim is its ability to "illuminate the operative site during surgical procedures with high intensity light."
While specific, quantifiable acceptance criteria are not presented in a table form in this document, the following can be inferred:
| Acceptance Criterion (Inferred from regulatory and performance statements) | Reported Device Performance |
|---|---|
| Electrical Safety Standards: | Meets IEC 60601-1 |
| Meets IEC 60601-2-41 | |
| Sterility Requirements for Reusable Handles: | Meets AAMI ST37 |
| Achieves a SAL of 10^-6 | |
| Illumination Intensity (range): | Variable from 50,000 Lux to 160,000 Lux |
| Light Source Redundancy: | Each lighthead has redundant light sources |
| Light Quality (Shadow-free, cool): | Based upon a multiple reflector design combined with a heat removing conductive path to provide shadow free, cool light |
| Substantial Equivalence to Predicate Devices: | Substantially equivalent to K031068 (Stryker Visum™ Surgical Lighting System) and K042382 (Med-General Technologies LLC's Dual LED Lite Engine) |
| Conformity to FDA Guidance: | Meets requirements set forth in FDA Guidance for Surgical Lamps |
2. Sample Size Used for the Test Set and Data Provenance:
This document does not describe a clinical study with a "test set" in the context of an AI/algorithm-driven device. It's a 510(k) submission for a physical medical device (surgical lighting system). Therefore, information on sample size and data provenance for a test set is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable, as this is not a study requiring expert ground truth for an AI algorithm. The device's performance is likely evaluated against engineering specifications, standards, and comparative testing to predicate devices, rather than expert-established ground truth on a dataset.
4. Adjudication Method:
Not applicable for a 510(k) submission for a physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not mentioned or implied, as this is not an AI-assisted diagnostic or interpretive device.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone algorithm performance study was not done. This device is a physical surgical lighting system, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's acceptance would be based on:
- Engineering Specifications: Adherence to design criteria for light intensity, color temperature, heat dissipation, maneuverability, etc.
- Regulatory Standards: Compliance with IEC 60601-1, IEC 60601-2-41, and AAMI ST37.
- Comparative Performance Data: Showing equivalence in performance characteristics to the predicate devices (K031068 and K042382).
- Safety Testing: Verifying electrical safety, sterility, and other physical safety parameters.
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/machine learning device. The "training" for a physical device would involve design, prototyping, and iterative testing, not the use of a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in this context. The "ground truth" for the device's design and development comes from established engineering principles, international performance standards, and the performance characteristics of existing, legally marketed predicate devices.
§ 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.