(134 days)
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
The provided text describes the Alphatec Navigation Instruments and its 510(k) submission for market clearance. While it outlines the device's intended use, comparison to a predicate device, and general performance data, it does not provide detailed acceptance criteria or a specific study proving the device meets those criteria with the level of detail requested in the prompt.
The document states that "Engineering analysis and performance data demonstrate that the subject Alphatec Spine Navigation Instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance." It mentions "Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment," but does not provide the quantitative results or specific criteria for acceptance.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the available information, with notations where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (as stated in the document) |
|---|---|
| Accuracy: (Specific quantifiable target e.g., < 1.0mm) | "1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment." (Specific accuracy results not provided) |
| Compatibility: Seamless integration with Medtronic StealthStation System and NavLock Tracker | "Interface compatibility and functionality of the subject device." AND "compatibility... of the subject Alphatec NAV Instruments are substantially equivalent to the predicate Medtronic navigation instruments when used with the StealthStation System and NavLock Tracker." (Specific compatibility metrics not provided) |
| Functionality: Instruments perform intended surgical tasks (e.g., screw preparation and placement) | "Functionality of the subject device." AND "function, and performance." (Specific functional outcomes not provided) |
| Performance: Overall clinical utility in targeted procedures | "Performance testing of the subject and predicate device in a simulated surgical navigation use environment." (Specific performance metrics not provided) |
| Substantial Equivalence: To predicate device (K140454, Medtronic Navigation, Inc., Navigated CD Horizon Solera Screwdrivers and Taps) in indications for use, intended use, design, technology, functionality, and performance. | "It was demonstrated that the subject Alphatec NAV Instrument technology is substantially equivalent to the predicate." "Based upon the information provided..., it has been demonstrated that the subject Alphatec Spine Navigation Instruments are substantially equivalent to legally marketed predicate devices..." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "1:1 accuracy and performance testing," but does not detail how many tests or cases were involved.
- Data Provenance: Not specified. It was conducted in a "simulated surgical navigation use environment," which suggests laboratory or in-vitro testing rather than human patient data. Whether this was done by Alphatec Spine Inc. (Carlsbad, CA, USA) or an external entity is not clear.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not specified. The document refers to "simulated surgical navigation use environment" and "engineering analysis," implying technical evaluation rather than expert clinical review of ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified. Given the nature of the described testing (engineering analysis, 1:1 accuracy), it's unlikely a clinical adjudication method was used.
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
- No. This study is for surgical navigation instruments, not an AI or imaging diagnostic device that would involve human "readers." The device assists surgeons in locating anatomical structures. The term "AI" is not mentioned in the document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not an algorithm-only device. It's a set of "reusable instruments" intended to be used with the Medtronic StealthStation System and operated by a surgeon ("assist the surgeon"). Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document implies that "ground truth" for accuracy and compatibility testing was based on engineering measurements and the known capabilities/specifications of the Medtronic StealthStation System in a simulated environment. It does not refer to clinical ground truth like pathology or patient outcomes.
8. The sample size for the training set
- Not applicable. This is a navigation instrument, not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Alphatec Spine, Incorporated Ms. Renée Murphy Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K153603
Trade/Device Name: Alphatec Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 15, 2015 Received: December 17, 2015
Dear Ms. Murphy:
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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153603
Device Name Alphatec Navigation Surgical Instruments
Indications for Use (Describe)
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. SUBMITTER
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Phone: (760) 431-9286 Fax: (760) 431-0289
Contact Person: Renée L. Murphy Date Prepared: March 24, 2016
II. DEVICE
Name of Device: Alphatec Spine Navigation Instruments Common or Usual Name: Stereotaxic instruments Classification Name: Stereotaxic instruments (21 CFR 882.4560) Regulatory Class: II Product Code: OLO
III. PREDICATE DEVICE
K140454, Medtronic Navigation, Inc., Navigated CD Horizon Solera Screwdrivers and Taps
IV. DEVICE DESCRIPTION
The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
The purpose of this Traditional 510(k) Premarket Notification is to clear for market Alphatec NAV Instruments which are additions to the Arsenal™ Spinal Fixation System (K133221, K143149, K152968) and the Illico MIS® Posterior Fixation System (K123623) for use with the Medronic StealthStation System.
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V. INDICATIONS FOR USE
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
TECHNOLOGICAL COMPARISON TO PREDICATES VI.
The technological design features of the subject Alphatec Spine Navigation Instruments were compared to the predicate in indications for use, intended use, design, technology, materials, function, and performance. It was demonstrated that the subject Alphatec NAV Instrument technology is substantially equivalent to the predicate.
VII. PERFORMANCE DATA
Engineering analysis and performance data demonstrate that the subject Alphatec Spine Navigation Instruments are substantially equivalent to the predicate in compatibility, accuracy, function, and performance. Engineering analysis includes dimensional measurements of both predicate and subject devices. Verification testing includes interface compatibility and functionality of the subject device. Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.
Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject Alphatec NAV Instruments are substantially equivalent to the predicate Medtronic navigation instruments when used with the StealthStation System and NavLock Tracker.
VIII. CONCLUSION
Based upon the information provided in this Traditional 510(k) submission, it has been demonstrated that the subject Alphatec Spine Navigation Instruments are substantially equivalent to legally marketed predicate devices in regards to indications for use, intended use, design, technology, functionality, and performance.
§ 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).