(87 days)
The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.
The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The device is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.
The provided text is for a K100884 510(k) submission for the Stryker Knifelight, which is a medical device (a lighted surgical knife), not an AI algorithm or a diagnostic tool that would typically involve acceptance criteria and a study to prove its performance in the way described in the prompt.
Therefore, much of the requested information (like performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets) is not applicable to this type of device and submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study for a new AI algorithm.
However, I can extract the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This submission is for a labeling change and a legal manufacturer location change for an existing device. The primary method of demonstrating safety and effectiveness for a 510(k) for such changes is substantial equivalence to a predicate device, not through specific performance metrics against pre-defined acceptance criteria in the way an AI algorithm would be evaluated.
Therefore, there are no specific numerical acceptance criteria or reported device performance metrics in the provided text. The "performance" is implicitly deemed equivalent to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (device is a surgical instrument, not an AI/diagnostic tool evaluated against specific performance metrics). The focus is on substantial equivalence to a predicate device for minor changes. | Not applicable (no new performance data is presented for this type of submission). The device is considered substantially equivalent to the predicate. |
Regarding the study that proves the device meets acceptance criteria:
Based on the provided text, there is no study in the sense of a clinical trial or performance evaluation with specific data points to prove the device meets acceptance criteria. The submission is a 510(k) premarket notification focused on substantial equivalence for a labeling change and legal manufacturer location change.
The entire submission implicitly "proves" that the device still meets regulatory requirements (which are the implicit "acceptance criteria" here) because:
- It is substantially equivalent to a legally marketed predicate device (Stryker Knifelight, K961122).
- The proposed modifications (manufacturer location, disposal info, warnings, contraindications) do not alter the fundamental safety or effectiveness of the device that was previously cleared.
Breakdown of other requested information:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a test set of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method for a test set is mentioned.
- 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. This is not an AI device, and no MRMC study is mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical instrument, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth established for a study.
- 8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
- 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.
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510(k) Summary of Safety and Effectiveness: Labeling Change Being Effected: Stryker Knifelight
| Proprietary Name: | Stryker Knifelight | JUN 2 5 20 |
|---|---|---|
| Common Name: | Lighted Knife | |
| Classification Name and Reference: | 21 CFR 878.4800Manual Surgical Instrument for General Use | |
| 21 CFR 878.4580Surgical Lamp | ||
| Proposed Regulatory Class: | Class I (Surgical Instrument) & Class II (SurgicalLamp) | |
| Product Codes: | 79 EMF (Surgical Instrument), 79 FSQ (SurgicalLamp) | |
| For Information contact: | Avital Merl-MarguliesRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365 Fax: (201) 831-3365 | |
| Date Prepared: | June 23, 2010 |
Description:
The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The device is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery.
The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.
Indications for Use:
The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.
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Proposed Modification:
The purpose of this premarket notification is to document the legal manufacturer location change and add disposal information, additional warnings & new contraindications to the package insert for the Stryker Knifelight device.
Predicate Device:
The subject Stryker Knifelight device is substantially equivalent to the predicate Stryker Knifelight device cleared under K961122.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation % Ms. Avital Merl-Margulies Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
JUN 2 5 2010
Re: K100884
Trade/Device Name: The Stryker Knifelight Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: March 24, 2010 Received: March 30, 2010
Dear Ms. Merl-Margulies:
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
. .
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Page 2 - Ms. Avital Merl-Margulies
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 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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.
Sincerely your
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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Stryker Knifelight
Change Being Effected 510(k)
. Indications for Use
510(k) Number (if known): _K/00 884
The Stryker Knifelight is a manual surgical instrument used for the release of the samal The Stryker Knitenght is a manual surgicul minute to illuminate the surgical site which
tunnel ligament. It features an integrated light source of surrounding tissue tunnel itgament. It reatures an integrated itgitt bears in the minimal disturbance of surrounding tissue.
Over-The-Counter Use X Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (Patt 21 CFR 801 Subpar 27)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Division of Surges and Restorative Devices
510(k) Number. K100884
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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.