(57 days)
EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface.
The EasySuite™ Surgical Light Control (ESLC) is an optional function in the EasySuite™, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room for management of audio systems, and for control of devices such as room lights. The ESLC function allows control of surgical lights from the EasySuite™ touch panel user interface.
This document describes the EasySuite™ Surgical Light Control (ESLC), a software application that allows control of surgical lights from the EasySuite™ touch panel user interface.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit quantitative acceptance criteria or detailed performance metrics. The device is a "Surgical Light Accessory" and its function is to control surgical lights. The primary claim for performance is its substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets specified requirements for controlling surgical lights. | Verification and validation testing confirmed that the ESLC application meets specified requirements. |
| Functions as intended: allows control of surgical lighting from the EasySuite™ touch panel user interface. | ESLC allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface. |
| Substantial equivalence to the predicate device (MainStream™ OR Surgical Light Control (MSLC)). | The ESLC is substantially equivalent to the MainStreamTM OR Surgical Light Control (MSLC), which was cleared to market in 510(k) # K081698. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Verification and validation testing was performed by Image Stream personnel." However, it does not specify the sample size used for the test set (e.g., number of test cases, scenarios, or a defined testing protocol with associated metrics).
The data provenance is internal to the manufacturer ("Image Stream personnel"). No information is given regarding the country of origin of the data, and it implies a prospective validation/verification process rather than retrospective data analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As this is a control system for surgical lights, ground truth might relate to correct operation or functionality rather than diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the device (a control system), a formal adjudication method (like 2+1 or 3+1 for diagnostic tasks) is unlikely to be directly applicable. Testing would likely involve functional checks against specified requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a surgical light control system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a software application designed to control hardware (surgical lights) via a human-machine interface (touch panel). Therefore, the concept of "standalone algorithm performance without human-in-the-loop" as typically understood in AI/diagnostic contexts does not directly apply. The "algorithm" (software) is inherently designed to be interacted with by a human operator to control a physical device. The verification and validation testing would have focused on the software's ability to execute commands and control the lights as intended.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the "type of ground truth." For a device like this, ground truth would likely be established empirically through:
- Functional Verification: Confirming that the system correctly sends commands to the surgical lights and that the lights respond as expected (e.g., turn on/off, adjust intensity).
- Requirements Traceability: Ensuring that all specified functional and performance requirements are met by the implemented software.
- Predicate Device Comparison: Demonstrating that the new device functions similarly to the cleared predicate device in its control capabilities.
8. The Sample Size for the Training Set
This information is not provided and is largely not applicable in the context of this device. The ESLC is described as a software application, not a machine learning or AI algorithm that would typically require a "training set" of data to learn from. Its functionality is deterministically programmed based on specified requirements.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no indication that this device uses a training set or machine learning model in the conventional sense.
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Attachment 3
510 (k) Summary
| Date prepared | September 22, 2010 |
|---|---|
| 510(k) Owner | Image Stream Medical, Inc.One Monarch DriveLittleton, MA01460 |
| NOV 2 3 2010 | |
| Phone: (978) 486-8494Fax: (978) 428-2694 | |
| Contact | Beth Cyr, Director of Quality Assurance |
| Trade name | EasySuite™ Surgical Light Control |
| Common name | Surgical Light Accessory |
| Classification name | Classification Name: Light, Surgical, AccessoriesClassification Panel: General & Plastic SurgeryCFR Section: 21 CFR 878.4580Class: 2Product Code: FTA |
| Predicate device | MainStream™ OR Surgical Light Control (MSLC), which was cleared tomarket in 510(k) # K081698. |
| Device description | The EasySuite™ Surgical Light Control (ESLC) is an optional function in theEasySuite™, which is an integrated operating room system for configurablecommunication of images from sources to displays within the operating roomfor management of audio systems, and for control of devices such as roomlights. |
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The ESLC function allows control of surgical lights from the EasySuite™ touch panel user interface.
EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user Intended use interface.
ESLC is an optional function in the EasySuite™ integrated operating room ESLC system. (The EasySuite™ system includes a touch panel user interface for Description quick routing of surgical images to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights. EasySuite™ also includes an audio management system
and a single point of entry for querying surgical charts and image archives.)
| Comparison tothe predicatedevice | Control Platform | |
|---|---|---|
| Function | ||
| Primary control of surgical |
| MSLC | ESLC | ||
|---|---|---|---|
| Control Platform | Crestron | Microsoft WindowsStandard Embedded | |
| Function | Control of surgical lights from a convenientintegrated operating room system. Control isdefined by setting the light intensity or the lights onor off. | ||
| Primary control of surgicallights | The surgical light controls from the surgical lightsystem manufacturer take precedence over theintegrated system. | ||
| Calculations performed | None | ||
| Primary purpose of integratedoperating room system. | The system is primarily medical video imagerouting and communication system, which alsocontrols functions such as ambient lighting. | ||
| Sterile field | No components are used in the sterile field. |
Image Stream Medical EasySuite Special 510k
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The EasySuite™ Surgical Light Control (ESLC) is a software application. Verification Non-Clinical and validation testing was performed by Image Stream personnel. The verification and Tests validation confirmed that the ESLC application meets specified requirements.
The ESLC is substantially equivalent to the MainStreamTM OR Surgical Light Conclusion Control (MSLC), which was cleared to market in 510(k) # K081698.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three vertical lines that form the staff and the snakes are represented by curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Image Stream Medical, Inc. % Ms. Beth Cyr Director of Quality Assurance One Monarch Drive Littleton, Massachusetts 01460
NOV 2 3 2010
Re: K102791
Trade/Device Name: EasySuite™ Surgical Light Control Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTA Dated: November 09, 2010 Received: November 10, 2010
Dear Ms. Cyr:
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. Ilsting 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
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Page 2 - Ms. Beth Cyr
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours. Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachments
| Attachment 1 | |
|---|---|
NOV 2 3 2010
Indications for Use Statement
10 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
| 510(k) Number (if known) | # K102791 |
|---|---|
| Device Name | EasySuite™ Surgical Light Control |
| Indications for Use | EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801. 109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| Neil R. Ogden for mxm (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices | |||
| 510(k) Number | K102791 |
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§ 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.