(118 days)
The Visum Blade LED Surgical Light is intended to illuminate the operative site during surgical procedures with high intensity light.
The Visum Blade LED Surgical Light System is indicated to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms, and all other health care facilities where the need for additional illumination exists.
The Visum Blade LED Surgical Light System (Blade) is suitable for all major and minor surgical procedures in operating rooms and all other healthcare facilities where the need for illumination exists. The light intensity is variable up to 160,000 Lux. The light quality is based upon high quality LED's to provide cool light with reduced shadow resolution.
A system consists of 1 - 4 light heads supported by a pivoting suspension system that is attached to the heath care facility's super structure by a mounting plate. The system requires at least one of the following: a power supply box, ceiling cover, drop tube, central axis and spring arm. The system may include optional end effectors such as but not limited to monitor mounts. The mounting plates may be configured to accommodate a single or tandem mount suspension system.
Independent, control of each light's intensity is via the light handle. An optional electronic wall control panel may be installed in the operating room for control by non-sterile users. Blade allows for an in-light camera option that may be added to a light head. This option requires a wall control for camera operation.
Based on the provided text, the "Visum Blade LED Surgical Light System" is a medical device, and the document describes its 510(k) submission. This is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets clinical acceptance criteria with specific performance metrics like sensitivity or specificity.
Therefore, the requested information regarding acceptance criteria for device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types and training set details cannot be fully extracted as such studies are not typically part of a 510(k) summary for this type of device. The focus here is on demonstrating substantial equivalence to existing devices, primarily through technological comparison and bench testing that shows no new questions of safety or effectiveness.
Here's a breakdown of what can be inferred or directly stated from the provided text, in relation to your request, with the understanding that typical AI/ML-related performance metrics are not applicable here:
1. A table of acceptance criteria and the reported device performance
For a surgical light system, "performance" relates to its physical characteristics and operational safety, not diagnostic accuracy. The document states:
| Acceptance Criteria (Implied by equivalence to predicates) | Reported Device Performance (Stryker Visum Blade LED Surgical Light System) |
|---|---|
| Illumination for surgical procedures | Light intensity variable up to 160,000 Lux. |
| Reduced shadow resolution | Light quality based upon high quality LEDs to provide cool light with reduced shadow resolution. |
| Control of light intensity | Independent control of each light's intensity via the light handle. Optional electronic wall control panel. |
| Does not have spot size adjustment (mechanical focus mechanism), unlike predicates, but this difference does not impact safety or effectiveness. | |
| Safety and Effectiveness of a Class II surgical lamp | Device raises no new questions of safety and effectiveness; performance can be considered equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Not applicable (N/A): This is a hardware device (surgical light), not one that processes data or requires a test set in the traditional sense of AI/ML or diagnostic devices. Performance is assessed through engineering specifications, bench testing, and comparison to predicate devices, not through a "test set" of clinical cases or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable (N/A): See point 2. There is no "ground truth" in the diagnostic sense for a surgical light system. The device's functionality is verified against engineering standards and comparison to similar devices.
4. Adjudication method for the test set
- Not applicable (N/A): See point 2.
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
- Not applicable (N/A): This is not an AI-assisted diagnostic device. It's a surgical light system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A): This is a hardware device; there is no "algorithm only" performance.
7. The type of ground truth used
- Not applicable (N/A): For this type of device, "ground truth" would relate to validated engineering specifications, safety standards, and the performance characteristics of its predicate devices, rather than clinical outcomes or pathological findings.
8. The sample size for the training set
- Not applicable (N/A): This device does not use an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable (N/A): This device does not use an AI/ML model that requires a training set or associated ground truth.
Summary from the provided text for a 510(k) submission:
The "study" or assessment for the Visum Blade LED Surgical Light System is a substantial equivalence demonstration to predicate devices (Burton's AIM 200 OR Major Surgical Light and Stryker's Visum LED Surgical Light System).
- Methodology: The substantial equivalence was established through:
- Technological Comparison: Comparing intended use, design, energy used/delivered, materials, performance, safety, effectiveness, and labeling to the predicate devices.
- Bench Testing: As indicated by "Performance Testing: See Section 18, Performance, Bench." (though Section 18 details are not provided in this excerpt). This bench testing would verify the physical and electrical characteristics of the device against relevant engineering standards and performance claims (e.g., light intensity, color temperature, safety).
- Conclusion: "The submitted information in this premarket notification shows that Blade raises no new questions of safety and effectiveness and the performance can be considered equivalent to the predicate devices."
- Approval: The FDA granted the 510(k) clearance (K132747) based on this demonstration of substantial equivalence.
§ 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.