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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is capitalized. There is a registered trademark symbol to the upper right of the word. The word is likely a company logo or brand name.

DEC 3 0 2013

1410 Lakeside Parkway, #100 Flower Mound, TX 75028 t: 972 410 7100 f: 972 410 7001 www.stryker.com

Communications

Section 5 - 510(k) Summary for the Visum Blade LED Surgical Light System

PER 21 CFR 807.92

Date:	December 26, 2013
510(k) Owner/Sponsor:	Stryker Communications
Address:	1410 Lakeside Parkway, #100
	Flower Mound, Texas 75028
Establishment Number:	2031963
Telephone Number:	(972) 410-7181
Fax Number:	(972) 410-7201
Contact Person:	Trey Thorsen; Senior Regulatory Compliance Analyst
Email Address:	trey.thorsen@stryker.com
Proposed Device:	Visum Blade LED Surgical Light System (Blade)
Device Common Name:	Surgical Light, Surgical Lamp
Product Code:	FSY
FDA Regulation Number:	21 CFR 878.4580
Device Classification:	Class II
Predicate Devices:	Burton's AIM 200 OR Major Surgical Light (K101537). Stryker's Visum LED Surgical Light System (K060802)
Device Common Name:	Surgical Light, Surgical Lamp
Product Code:	FSY
FDA Regulation Number:	21 CFR 878.4580
Device Classification:	Class II

Device Description

{1}------------------------------------------------

Intended Use

The Visum Blade LED Surgical Light is intended to illuminate the operative site during surgical procedures with high intensity light.

Indications for Use

Technological Comparison

Like its predicates, Blade is a ceiling mounted surgical light that is available in single or tandem light head configurations. Both of the predicates and Blade provide illumination with reduced shadow resolution. All three devices have a removable, sterilizable light handle.

Blade uses an LED light source with Fresnel lenses to direct the light. Predicate devices use LED or halogen light sources with reflectors to direct the light.

Blade has two options for control of light intensity. Control is on the light head that allows the surgeon to control the light intensity from the sterile field. This is different than the predicates. Blade also allows light intensity to be controlled through a wall control, which is an optional feature.

The predicates have spot size adjustment (mechanical focus mechanism). Blade does not have this feature. The absence of this feature reduces cost, size, and complexity of the luminaire allowing Blade be marketable to a broader range of healthcare facilities.

The differences in the technological characteristics do not impact safety or effectiveness. For a complete comparison refer to Section 13 Substantial Equivalence of this premarket notification.

Performance Testing

See Section 18, Performance, Bench.

{2}------------------------------------------------

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. This conclusion is based on the comparison of Blade to indications/intended use, design, energy used/delivered, materials, performance, safety, effectiveness, and labeling of the predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure embracing or protecting another figure, representing the department's mission of protecting the health of all Americans and providing essential human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 30, 2013

Stryker Communications Mr. Trev Thorsen Senior Regulatory Compliance Analyst 1410 Lakeside Parkway, Suite 100 Flower Mound, Texas 75028

Re: K132747

Trade/Device Name: Visum Blade LED Surgical Light System Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: November 8, 2013 Received: November 12, 2013

Dear Mr. Thorsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - Mr. Trey Thorsen

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -- S 2013.12.30 75:56:53 -05'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

1410 Lakeside Parkway, #100 Flower Mound, TX 75028 t: 972 410 7100 f: 972 410 7001 www.stryker.com

Communications

Indications for Use

510(k) Number (if known): __K132747

Device Name: Visum Blade LED Surgical Light System

Indications for Use:

The Visum Blade LED Surgical Light System (Blade) 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A 요 11월 11일 : 1월 11일 : 1월 11일 : 1월 11일 : 1월 11일 : 1월 11일 : 1월 11일 : 1월 11일 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월 : 1월

for BSA

(Division Sign-off) Division of Surgical Devices 510(k) Number: K132747

Regulation Number and Section

§ 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.