(128 days)
The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Black Diamond Navigation Instruments are non-sterile, reusable instruments; including probes, bone taps, and inserters that are operated manually. These instruments are intended to be used within the context and limitations of the indications for use for Osseus Fusion System's FDA-cleared Black Diamond system and the Medtronic Synergy Experience StealthStation System S7 (v2.1.0). 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 Black Diamond Navigation Instruments are non-sterile, reusable instruments (probes, bone taps, and inserters) intended for use during the preparation and placement of Black Diamond pedicle screws in spinal surgery. The device aims to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures, specifically designed for use with the Medtronic Stealth Station System.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a table format. It mentions that "nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device" and lists the types of testing: Accuracy testing, Compatibility testing, and Performance testing. It concludes that "The results of these evaluations indicate that the Black Diamond Navigation Instruments are equivalent to predicate devices."
Without specific numerical thresholds or performance metrics for acceptance, a table cannot be fully constructed.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Nonclinical testing was performed to show that the subject Black Diamond Navigation Instruments are substantially equivalent to the predicate device." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The testing mentioned is non-clinical, suggesting that expert human assessment in a clinical context for ground truth may not have been the primary method.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document explicitly states: "No clinical studies were performed." Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a set of "Navigation Instruments" used with the Medtronic Stealth Station System. This implies it's a tool for surgeons, not a standalone AI algorithm. The document mentions "Accuracy testing" and "Performance testing" among the non-clinical tests. While these tests evaluate the device's inherent capabilities (e.g., how accurately it tracks, how it performs mechanically), they are likely evaluating the instrument's standalone performance within the context of the navigation system, rather than an AI algorithm's standalone performance. The text does not explicitly refer to an "algorithm only" standalone performance study.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the non-clinical testing. Given that the device is a navigation instrument for surgery, "Accuracy testing" would likely compare the instrument's reported position/orientation against a known, precise physical reference (e.g., measured by a coordinate measuring machine or similar highly accurate metrology equipment). Such a ground truth would be objective, physical measurements rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This further supports the interpretation that the device is a physical instrument rather than a machine learning algorithm that undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (as the device is not an AI algorithm requiring one in the traditional sense), this information is not applicable and not provided.
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January 17, 2020
Osseus Fusion Systems % J. D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401
Re: K192495
Trade/Device Name: Black Diamond Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 5, 2019 Received: September 11, 2019
Dear J. Webb:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192495
Device Name Black Diamond Navigation Instruments
Indications for Use (Describe)
The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments are specifically designed for use with the Medtronic Stealth Station 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 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: Black Diamond Navigation Instruments
| Date Prepared | January 9, 2020 |
|---|---|
| Submitted By | Osseus Fusion Systems, LLC2703 W. Mockingbird Ln., Ste. #102Dallas, TX 75204 |
| Primary Contact | J.D. Webb4313 W. 3800 SWest Haven, UT 84401512-590-5810 Telee-mail: jdwebb@orthomedix.net |
| Trade Name | Black Diamond Navigation Instruments |
| Common Name | Orthopedic Stereotaxic instrument |
| Classification Name | Stereotaxic Instrument |
| Class | ll |
| Product Code | OLO |
| CFR Section | 21 CFR section 882.4560 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | Navigated CD Horizon Solera Screwdrivers and Taps, Medtronic Sofamor Danek, USAInc. (K140454) |
| Secondary PredicateDevices | Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems,DePuy Spine, Inc (K140927)SeaSpine Navigation System, SeaSpine Orthopedics Corporation (K172517) |
| Reference PredicateDevices | Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810) |
| Device Description | Black Diamond Navigation Instruments are non-sterile, reusable instruments; includingprobes, bone taps, and inserters that are operated manually. These instruments areintended to be used within the context and limitations of the indications for use for OsseusFusion System's FDA-cleared Black Diamond system and the Medtronic SynergyExperience StealthStation System S7 (v2.1.0). Use of these navigation systems providesthe surgeon access to real-time, multi-plane 3D images (and 2D images) providingconfirmation of hardware placement. |
| Materials | Stainless steel per ASTM F899 |
| SubstantialEquivalence Claimedto Predicate Devices | The Black Diamond Navigation Instruments are substantially equivalent to thepredicate devices in terms of intended use, design, materials used, mechanical safety andperformances. |
| Indications for Use | The Black Diamond Navigation Instruments are intended to be used during the preparationand placement of Black Diamond pedicle screws during spinal surgery to aid the surgeonin precisely locating anatomical structures in either open or minimally invasive procedures.The Black Diamond Navigation Instruments are specifically designed for use with theMedtronic Stealth Station System, which is indicated for any medical condition in whichthe use of stereotactic surgery may be appropriate, and where reference to a rigidanatomical structure, such as a vertebra, can be identified relative to a CT or MR basedmodel, fluoroscopy images, or digitized landmarks for the anatomy. |
| Summary of thetechnologicalcharacteristicscompared topredicate | When compared to the predicate devices, Black Diamond Navigation Instruments havethe same intended use and similar technological characteristics, including:Design Materials of Construction Function/Performance Fundamental Scientific Technology Principle of Operation |
| Non-clinical TestSummary | Nonclinical testing was performed to show that the subject Black Diamond NavigationInstruments are substantially equivalent to the predicate device. The following testing wasperformed:Accuracy testing Compatibility testing Performance testing The results of these evaluations indicate that the Black Diamond Navigation Instrumentsare equivalent to predicate devices. |
| Clinical TestSummary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | Osseus Fusion Systems considers the Navigation Instruments to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples 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).