(145 days)
The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.
The Navigable Pedicle Preparation Instruments are manual surgical instruments which are designed to interface with already-cleared surgical navigation systems. Instruments in this system may be pre-calibrated to already-cleared surgical navigation systems, or may be manually calibrated to already-cleared surgical navigation systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general manual functions within the orthopaedic surgical environment.
This is a 510(k) summary for a set of surgical instruments, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.
The document describes the Synthes Navigable Pedicle Preparation Instruments, which are manual surgical instruments designed to interface with existing surgical navigation systems.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet performance requirements for intended use | "The Navigable Pedicle Preparation Instruments met the performance requirements, providing assurance of device performance for their intended use." |
| No safety or effectiveness issues | "No safety or effectiveness issues were raised by the performance testing." |
2. Sample size used for the test set and data provenance (Not applicable for AI/ML):
The document mentions "usability testing" as a validation activity in the "Performance Data" section. However, it does not specify sample sizes for test sets, data provenance (e.g., country of origin), or whether the data was retrospective or prospective, as these details are typically associated with clinical studies or AI/ML performance evaluations, not characterization of manual surgical instruments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (Not applicable for AI/ML):
This information is not provided because the validation involved usability testing of manual instruments, not the establishment of ground truth for an AI/ML algorithm.
4. Adjudication method (Not applicable for AI/ML):
This concept is not relevant to the validation described.
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 for AI/ML):
No MRMC study was conducted as this device is not an AI/ML system or a reading assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for AI/ML):
This is not applicable as the device is a set of manual surgical instruments.
7. The type of ground truth used (Not applicable for AI/ML):
Ground truth as it relates to AI/ML performance is not relevant here. The validation focused on the functional performance and usability of the physical instruments.
8. The sample size for the training set (Not applicable for AI/ML):
There is no "training set" in the context of manual surgical instrument validation, as this is a concept associated with AI/ML model development.
9. How the ground truth for the training set was established (Not applicable for AI/ML):
This is not applicable for the reasons stated above.
In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of manual surgical instruments through non-clinical performance testing (usability testing). It does not contain the detailed information related to AI/ML device validation, such as specific acceptance criteria for algorithm performance, sample sizes for test/training sets, expert involvement in ground truth establishment, or comparative effectiveness studies of AI assistance. The document explicitly states: "Clinical data was not needed for the Navigable Pedicle Preparation Instruments."
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122211
@ SYMTHES® Spine
DEC 1 7 2012
5 510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | DePuy Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Hemal MehtaRegulatory Affairs SpecialistTelephone: 610-719-5424Facsimile: 610-719-5102Email: mehta.hemal@synthes.com |
| Date Prepared: | December 14, 2012 |
| Trade Name: | Synthes Navigable Pedicle Preparation Instruments |
| Classification: | Sec. 882.4560Class IIOrthopaedicProduct Code: OLO, HAW |
| PredicateDevices: | K070106 BrainLab VectorVision Fluoro3D SystemK050438 Medtronic StealthStationK003111 Stryker SpineMap |
| DeviceDescription: | The Navigable Pedicle Preparation Instruments are manual surgicalinstruments which are designed to interface with already-cleared surgicalnavigation systems. Instruments in this system may be pre-calibrated toalready-cleared surgical navigation systems, or may be manuallycalibrated to already-cleared surgical navigation systems usingmanufacturers' instructions. These instruments are intended to be used inspine applications to perform general manual functions within theorthopaedic surgical environment. |
| Intended Use/Indications forUse: | The Synthes Navigable Pedicle Preparation Instruments are intended toassist the surgeon in precisely locating anatomical structures in eitheropen, minimally invasive, or percutaneous procedures. These areindicated for use in surgical spinal procedures, in which the use ofstereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as the pelvis or a vertebra can be identifiedrelative to the acquired image (CT, MR, 2D fluoroscopic image or 3Dfluoroscopic image reconstruction) and/or an image data based model ofthe anatomy. These procedures include but are not limited to spinalfusion. |
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| ® SYNTHES® | |
|---|---|
| Spine |
| 510(k) SummaryComparison ofthe device topredicatedevice(s): | The design features, materials, and indications for use of the subjectSynthes Navigable Pedicle Preparation Instruments are substantiallyequivalent to the predicate devices identified. |
|---|---|
| PerformanceData(Non-Clinicaland/or Clinical): | Synthes conducted validation activities including usability testing. TheNavigable Pedicle Preparation Instruments met the performancerequirements, providing assurance of device performance for theirintended use. No safety or effectiveness issues were raised by theperformance testing. Clinical data was not needed for the NavigablePedicle Preparation Instruments. |
Par(2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2012
Synthes Spine % Mr. Hemal Mehta Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K122211
Trade/Device Name: Synthes Navigable Pedicle Preparation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO, HAW Dated: October 23, 2012 Received: October 24, 2012
Dear Ms. Guerin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Heather Guerin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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@ SYNTHES® Spine
Indications for Use Statement 4
K122211 510(k) Number: (if known)
Synthes Navigable Pedicle Preparation Instruments Device Name:
Indications for Use:
The Synthes Navigable Pedicle Preparation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion.
X Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[2017-12-09] 14:23:06 -05'00'
(Division Sign-off) Division of Surgical Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________ K122211
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).