(96 days)
iFuse-Navigation instruments are intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or 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. iFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
The iFuse-Navigation instrument set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.
The provided text describes a 510(k) premarket notification for the iFuse Implant System - iFuse Navigation. Let's extract the requested information regarding acceptance criteria and the study proving the device meets them.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a dedicated table format with reported device performance values. It describes the types of tests performed and implies that the device passed these tests to achieve substantial equivalence.
Based on the "Performance Data" section (Page 4), the following can be inferred:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Registration | Instruments can be registered to the StealthStation.® (Implies successful registration) |
| Accuracy | Performed for comparison to reference instruments. (Implies satisfactory accuracy compared to reference) |
| Rigidity | Connection between the TeraTracker and the instruments was evaluated. (Implies sufficient rigidity) |
| Compatibility with iFuse Implant System | Evaluated to ensure compatibility. (Implies successful compatibility) |
Note: The document only states that testing was "completed to ensure the functionality and compatibility" and that "verification and validation results support substantial equivalence." No specific numerical thresholds or measured performance values are provided.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size (e.g., number of tests, number of devices tested, number of simulated procedures) used for any of the performance tests.
It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not refer to the use of experts to establish ground truth for the performance tests. The tests described (Registration, Accuracy, Rigidity, Compatibility) appear to be engineering verification and validation tests rather than clinical studies requiring expert interpretation of results against a medical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is mentioned, as the tests do not appear to involve human interpretation necessitating such a method.
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. This device is a surgical navigation instrument, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an instrument used with a navigation system and by a surgeon, not a standalone algorithm. The performance tests appear to be evaluations of the instrument's interaction with the navigation system and its physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically understood in medical device validation (e.g., against pathology for a diagnostic device) does not seem applicable here in the traditional sense. The "ground truth" for the performance tests would be the established engineering specifications, system requirements, and the expected functional behavior of the instruments in conjunction with the StealthStation® system and iFuse Implant System. The tests aim to verify that the device meets these pre-defined specifications.
8. The sample size for the training set
The document does not mention a training set. This is consistent with the nature of the device as a physical surgical instrument and not an AI/machine learning system that requires a training phase.
9. How the ground truth for the training set was established
Not applicable, as no training set is discussed or implied.
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October 31, 2017
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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SI-BONE, Inc. Roxanne Dubois VP, Regulatory and Quality Assurance 3055 Olin Avenue, Suite 2200 San Jose, California 95128
Re: K172268
Trade/Device Name: iFuse Implant System- iFuse Navigation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 26, 2017 Received: July 27, 2017
Dear Roxanne Dubois:
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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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Katherine D. Kavlock -S
for 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) K172268
Device Name
iFuse Implant System - iFuse-Navigation
Indications for Use (Describe)
iFuse-Navigation instruments are intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or 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. iFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
| 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 - iFuse Implant System®
I. SUBMITTER
| SI-BONE, Inc. | |
|---|---|
| Address: | 3055 Olin Avenue, Suite 2200, San Jose, CA 95128 |
| Phone: | 408-207-0700; Fax: 408-557-8312 |
| Mobile: | 408-828-5019; Office: 408-207-0700 x2236 |
| Contact Person: | Roxanne Dubois, VP, Regulatory and Quality, SI-BONE, Inc. |
| Email: | rdubois@si-bone.com |
| Date Prepared: | July 26, 2017 |
II. DEVICE
| Name of Device: | iFuse Implant System - iFuse-Navigation |
|---|---|
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Regulation Numbers: | 21 CFR 882.4560- Stereotaxic instrument |
Product Codes: OLO; Stereotaxic Instrument
PREDICATE DEVICES III.
| Primary Predicate: | iFuse Implant System by SI-BONE: K131405, K162733 |
|---|---|
| Reference Predicates: | -K161210, Medtronic Reusable Instruments Compatible |
| with the STEALTHSTATION® System, | |
| -K150216, Medtronic Navigated StealthStation System | |
| with Synergy Cranial Software | |
| - K162921, Orthofix Navigated Instrument System |
IV. DEVICE DESCRIPTION
The iFuse-Navigation instrument set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System. 8 These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.
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V. INDICATIONS FOR USE
iFuse-Navigation instruments are intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or 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. iFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE VI.
The iFuse Navigation instruments are intended to be used with the iFuse Implant System® (implants and instruments). The iFuse-Navigation instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. These instruments have similar designs as the predicate instruments and incorporate the additional design features based on the reference devices to enable navigation and use with the StealthStation TeraTrackers. Like the predicate devices, the subject iFuse-Navigation instruments are made of stainless steel, PEEK and titanium alloy.
The iFuse-Navigation set is intended to be used with the Medtronic StealthStation using an O-arm imaging system instead of a C-arm imaging system. Based on that, the subject device includes a mounting bracket to enable the connection of a TeraTracker™.
The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing iFuse Implant System implants, instruments, or the StealthStation®.
VII. PERFORMANCE DATA
Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:
| Test | Description |
|---|---|
| Registration | Registration testing was performed to ensure that the instruments can be registered to the StealthStation.® |
| Accuracy | Accuracy testing was completed for comparison to the reference instruments. |
| Rigidity | Rigidity testing evaluated the connection between the TeraTracker and the instruments. |
| Compatibilitywith the iFuseImplant System | Compatibility with the iFuse Implant System has been evaluated to ensure that the iFuse-Navigation instruments are compatible with the iFuse Implant System. |
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VIII. CONCLUSIONS
The intended use of the subject iFuse-Navigation instruments, as part of the iFuse Implant System, is substantially equivalent to the intended use of the predicate instruments. The verification and validation results support substantial equivalence of the iFuse- Navigation instruments compared to the predicate and reference devices.
§ 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).