(283 days)
The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The OLYMPIC NAVIGATED INSTRUMENTS are comprised of nonsterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System (v 2.1.0) and are manufactured from stainless steel, as specified in ASTM F899.
The provided document describes the OLYMPIC NAVIGATED INSTRUMENTS, which are intended to be used with the Medtronic StealthStation® System during spinal surgery for precise anatomical localization. The document includes a 510(k) summary, which often details non-clinical testing for substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" for the OLYMPIC NAVIGATED INSTRUMENTS in the traditional sense of performance metrics (e.g., accuracy thresholds, sensitivity, specificity). Instead, the substantial equivalence claim is based on the device's similarity to predicate devices and the results of non-clinical analyses.
The reported performance is described in terms of demonstrating equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional equivalence to predicate devices | Dimensional analysis compared to predicate showed equivalence. |
| Acceptable anatomical simulated use performance | Anatomical simulated use evaluation showed equivalence. |
| Acceptable navigation accuracy | Navigation accuracy evaluation showed equivalence. |
| Equivalence in intended use, design, materials, mechanical safety, and performances to predicate devices | The device is considered substantially equivalent to predicate devices in these aspects. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Anatomical simulated use and navigation accuracy" as non-clinical tests. However, it does not specify the sample size used for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) as these are non-clinical simulated tests rather than studies involving human data.
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)
This information is not provided in the document. Given that the described tests are "Anatomical simulated use and navigation accuracy," it's likely they involved engineering assessments rather than expert clinicians establishing ground truth on a test set of medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method. This is consistent with non-clinical, simulated tests that would typically involve objective measurements rather than subjective expert interpretations requiring adjudication.
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 MRMC comparative effectiveness study was done or mentioned. The device described is a set of navigated instruments for surgical assistance, not an AI-powered diagnostic or interpretive tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device (OLYMPIC NAVIGATED INSTRUMENTS) is explicitly designed for use with the Medtronic StealthStation® System and assists the surgeon. It is an instrument, not a standalone algorithm. Its performance is intrinsically linked to its use in conjunction with other systems and human operators. The "navigation accuracy" test could be considered a form of standalone performance evaluation for the instruments themselves in a simulated environment, but not in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Anatomical simulated use and navigation accuracy" tests, the ground truth would likely be based on physical measurements validated against established anatomical models or precise measurement systems in a controlled lab setting, rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical studies on diagnostic devices. The document does not explicitly state the methodology for establishing this ground truth.
8. The sample size for the training set
This information is not applicable/not provided. The OLYMPIC NAVIGATED INSTRUMENTS are physical instruments. They are not an AI/ML algorithm that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable, as the device is not an AI/ML algorithm requiring a training set.
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April 27, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size in blue.
Astura Medical Parker Kelch Quality Manager 3186 Lionshead Avenue Suite 100 Carlsbad, California 92010
Re: K172166
Trade/Device Name: OLYMPIC Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 29, 2018 Received: March 30, 2018
Dear Parker Kelch:
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 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.
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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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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Indications for Use
510(k) Number (if known) K172166
Device Name OLYMPIC NAVIGATED INSTRUMENTS
Indications for Use (Describe)
The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of 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: OLYMPIC NAVIGATED INSTRUMENTS
| Date Prepared | July 17, 2017 |
|---|---|
| Submitted By | Astura Medical3186 Lionshead Ave, Suite 100Carlsbad, Ca 92010Phone: 760-814-8047 |
| Contact | Parker Kelch3186 Lionshead Ave, Suite 100Carlsbad, Ca 92010Phone: 760-814-8047 x413Email: quality@asturamedical.com |
| Trade Name | Olympic navigated instruments |
| Common Name | Navigated instruments |
| Classification Name | Stereotaxic instrument |
| Class | Class II |
| Product Code | OLO |
| Cfr Section | 21 CFR Section 882.4560 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Medtronic Instruments (K143628, K143375, K140454) |
| Reference Device(s) | OLYMPIC Posterior Spinal Fixation System (Screws), K143446 |
| Device Description | The OLYMPIC NAVIGATED INSTRUMENTS are comprised of nonsterile,reusable instruments including taps and drivers that can be operatedmanually. These instruments are intended to be used with the MedtronicStealthStation® System (v 2.1.0) and are manufactured from stainlesssteel, as specified in ASTM F899. |
| Materials | Stainless Steel per ASTM F899 |
| Substantial EquivalenceClaimed to PredicateDevices | The OLYMPIC NAVIGATED INSTRUMENTS are substantially equivalent tothe predicate devices in terms of intended use, design, materials used,mechanical safety and performances. |
| Indications for Use | The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in thepreparation and placement of OLYMPIC PSFS screws during spinal surgeryto assist the surgeon in precisely locating anatomical structures in eitheropen or minimally invasive procedures. These instruments are designedfor use with the Medtronic StealthStation® System, which is indicated forany medical condition in which the use of stereotactic surgery may beappropriate, and where reference to a rigid anatomical structure, such asa skull, a long bone, or vertebra, can be identified relative to a CT or MRbased model, fluoroscopy images, or digitized landmarks of the anatomy. |
| NON-CLINICAL TESTSUMMARY | The following analyses were conducted:● Dimensional analysis compared to predicate● Anatomical simulated use and navigation accuracyThe results of these evaluations indicate that the OLYMPIC NAVIGATEDINSTRUMENTS are equivalent to the predicate devices. |
| CONCLUSIONS: NON-CLINICAL AND CLINICAL | Astura medical considers the OLYMPIC NAVIGATED INSTRUMENTS to beequivalent to the predicate devices listed above. This conclusion is basedupon the devices' similarities in principles of operation, technology,materials, and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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§ 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).