(64 days)
The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.
The Stryker Spine LITe® Decompression System - Light Cable is a single use, sterile and disposable component. The Stryker Spine LITe® Decompression System - Light Cable consists of fiber optic cables contained within silicone tubing which can be connected to a light generator on one end and the tube of the Stryker Spine LITe® Decompression System on the other end.
This 510(k) summary is for the Stryker Spine LITe® Decompression System - Light Cable, which is a fiber optic light cable intended to provide surgical site illumination. The document focuses on establishing substantial equivalence to predicate devices and does not describe a study involving performance metrics for AI or machine learning algorithms. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable.
Here's an analysis based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain specific acceptance criteria and detailed performance metrics in the way one would expect for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "performance" described is in comparison to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics: | The LITe® Decompression System - Light Cable shares the same technological characteristics as the predicate devices: similar design, technical requirements. |
| Intended Use: | The LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use. This matches the function implied by similar predicate devices (NuVasive MaXcess Light Guide, Zimmer MIS Light). |
| Material & Safety (Implicit in Substantial Equivalence): | The device is a "single use, sterile and disposable component." Safety and biocompatibility are implicitly addressed through comparison to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable. The device is a physical medical device (fiber optic light cable), not an AI/ML algorithm that processes data. Therefore, there is no "test set" of data in the context of AI/ML evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable, as there is no "ground truth" establishment in the context of an AI/ML test set. The evaluation is focused on the device's physical design, materials, and intended function compared to existing legally marketed devices.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "adjudication method" for a test set as would be used for AI/ML performance evaluation. The substantial equivalence determination is made by the FDA based on the provided comparisons to predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers' improvement with AI vs without AI assistance
This information is not applicable. The device is a surgical light cable, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
This information is not applicable. The device is a physical light cable, not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable. As stated, there is no "ground truth" in the context of AI/ML evaluation for this device. The evaluation relies on comparing the device's technical specifications and intended use against predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.
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510K Summary
Stryker Spine - LITc® Dccompression System - Light Cable Traditional 510(k) Premarket Notification
11222 037
2010 10 10 0 2 2 0 3 7
5 10 (k) Simmaryof Safety and Effectiveness
Stryker Spine - Life® Decompression System - Light Cable
NOV 1 2012
.
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 |
|---|---|
| Contact Person | Ms. Tina MornakRegulatory Affairs AssociatePhone: 201-760-8193Fax: 201-962-4193Email: tina.mornak@stryker.com |
| Date Prepared | October 25, 2012 |
| Trade Name | Stryker Spine - LITe® Decompression System - Light Cable |
| Proposed Class | Class II |
| Classification Nameand Number | Light, Surgical, Fiber optic21 CFR 878.4580 |
| Common Name | Surgical lamp |
| Product Code | FST |
| Predicate Devices | NuVasive MaXcess Light Guide: K042034Zimmer MIS Light: K080367 |
| Device Description | The Stryker Spine LITe® Decompression System - Light Cable is asingle use, sterile and disposable component. The Stryker Spine LITe®Decompression System - Light Cable consists of fiber optic cablescontained within silicone tubing which can be connected to a lightgenerator on one end and the tube of the Stryker Spine LITe®Decompression System on the other end. |
| Intended Use | The Stryker Spine LITe® Decompression System - Light Cable isintended to provide surgical site illumination from a high intensitylight source when Stryker decompression tubes are in use. |
| Summary of theTechnologicalCharacteristics | The LITe® Decompression System - Light Cable shares the sametechnological characteristics as the predicate devices. Thesecharacteristics include similar design, technical requirements, |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle, which is a common symbol of the United States.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV
1 2012
Stryker Spine % Ms. Tina Mornak Regulatory Affairs Associate 2 Pearl Court Allendale, New Jersey 07401
Re: K122637
Trade/Device Name: Stryker LITe ® Decompression System-Light Cable Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: August 23, 2012 Received: August 29, 2012
Dear Ms. Mornak:
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
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Page 2 - Ms. Tina Mornak
forth in the quality systems (OS) 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S 2012.11.05 10:44:24 -05'00'
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Stryker Spine - LITe® Decompression System - Light Cable Traditional 510(k) Premarket Notification Confidential
Indications for Use
510(k) Number (if known): K_12243)
Device Name: Stryker LITe® Decompression System - Light Cable
Indications for Use:
The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.
Nilre Osle for nxm
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
AND/OR
510(k) Number K122637
Prescription Use _ X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
§ 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.