The navigated instruments are specifically designed for use with the 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.

When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.

Device Description

The Spinous Process Clamps are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the StealthStation™ System and are intended to be reusable.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the StealthStation™ Spinous Process Clamps. This document outlines the device's characteristics, intended use, and a comparison to a predicate device, along with a summary of performance testing.

However, the document does not describe an AI/ML-driven device or a study involving "human readers" improving with "AI vs without AI assistance." It pertains to a physical stereotaxic instrument used in spinal surgery for rigid attachment to a patient's anatomy for navigation.

Therefore, many of the specifics requested in your prompt (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for AI, training set details) are not applicable to this type of medical device submission.

The document discusses performance testing relevant to a mechanical device, such as functional verification, useful life testing, navigation accuracy testing, and packaging verification, as well as biological endpoint testing. These tests are to ensure the device's safety and effectiveness as a physical surgical tool and reference system, not as an AI diagnostic or assistive tool.

To answer your prompt, I will extract the information that is present and explicitly state when information is not applicable given the nature of the device.

Acceptance Criteria and Device Performance for Medtronic StealthStation™ Spinous Process Clamps

The device in question, the StealthStation™ Spinous Process Clamps, is a physical stereotaxic instrument, not an AI/ML-driven device. Therefore, the "acceptance criteria" and "study" described in the provided text relate to the mechanical and biological performance of this instrument, not to the performance of an AI algorithm or its impact on human reader performance.

The "studies" are performance tests designed to demonstrate the device's substantial equivalence to a predicate device and its safety and effectiveness for its intended use as a surgical instrument.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics like those typically seen for AI/ML device validations (e.g., sensitivity, specificity, AUC thresholds). Instead, the performance testing described is qualitative or refers to compliance with established standards for mechanical and biological safety.

Category	Acceptance Criteria (Implied / Stated Objective)	Reported Device Performance (Summary)
Functional	Device satisfies functional requirements.	Functional Verification confirms the design satisfies functional requirements.
Useful Life	Device operates normally throughout its useful life.	Useful Life Testing confirms normal operation throughout its useful life.
Navigational Accuracy	Robustness and navigational accuracy are verified.	Navigation Accuracy Testing verifies robustness and navigational accuracy.
Packaging Integrity	Device can withstand ship testing per ASTM D4169 and ISTA 2A.	Packaging Verification confirms packaging withstands ship testing per ASTM D4169 and ISTA 2A.
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic; negligible risk of adverse biological effects to patients.	Biological endpoint testing (per ISO 10993-1:2018) indicates non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-pyrogenic.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patient data or algorithm testing. The performance testing likely involved a limited number of physical devices (e.g., clamps) for mechanical and biological evaluations. This is not a data-driven AI model.
Data Provenance: Not applicable. The "data" comes from physical testing of the device, not from patient medical records or imaging scans. The testing would have occurred in a laboratory or manufacturing environment.
Retrospective/Prospective: Not applicable. The testing is a controlled, experimental assessment of the device's physical properties and performance, not a study on historical or future patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This section is relevant for AI/ML applications where expert labeling is used to create ground truth for image classification, segmentation, etc. For a mechanical device, "ground truth" relates to engineering specifications, physical measurements, and compliance with industry standards, which are evaluated by engineers and technical specialists, not typically "experts" in the context of medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used in studies involving human interpretation of complex medical data, especially for establishing ground truth in AI model development. This device's testing involves objective engineering and biological assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is specific to evaluating the impact of an AI algorithm on human reader performance, usually in diagnostics. This device is a physical surgical instrument, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, not applicable. This concept pertains to the performance of an AI algorithm by itself. The StealthStation™ Spinous Process Clamps are physical devices that are used with a navigation system and by a human surgeon. Their performance is inherently related to their physical interaction and functionality for surgical navigation.

7. The Type of Ground Truth Used

Engineering Specifications and Standardized Test Methods: For functional verification, useful life, packaging, and navigational accuracy, the "ground truth" would be the pre-defined engineering specifications, design requirements, and objective measurements obtained using established test methodologies (e.g., ASTM, ISTA, internal quality standards).
ISO 10993-1:2018 Standards: For biocompatibility, the ground truth is established by the accepted biological safety endpoints and testing protocols outlined in the ISO 10993 series of standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

Summary

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July 8, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Medtronic Navigation Victoria Baldock Associate Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K211442

Trade/Device Name: StealthStation Spinous Process Clamps Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 7, 2021 Received: May 10, 2021

Dear Victoria Baldock:

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.

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

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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 mediation-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,

For: 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211442

Device Name StealthStation™ Spinous Process Clamps

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Ref 21 CFR 201 Subpart D)	X
Over-The-Counter Use (21 CFR 201 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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K211442

Page 1 of 4

510(k) Summary

May 07, 2021

l. Company: Medtronic Navigation 826 Coal Creek Circle Louisville, CO 80027 Telephone Number: (720) 890-3500

Contact: Victoria Baldock Associate Regulatory Affairs Specialist Telephone Number: (423) 863-5907 Email: tori.a.baldock@medtronic.com

Rishi Sinha (Alternate) Regulatory Affairs Director Telephone Number: (720) 890-2485 Email: rishi.k.sinha@medtronic.com

Proprietary Trade Name: StealthStation™ Spinous Process Clamps II.
lll. Common Name: Orthopedic Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
V. Classification: Class II
VI. Product Code: OLO (Stereotaxic Instrument)

VII. Predicate Devices:

The legally marketed predicate devices are identified below:

Predicate	510(k) Clearance
Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE® & CLYDESDALE® Inserter	K131425

VIII. Product Description:

IX. Indications for Use:

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X. Comparison of the Technological Characteristics:

The subject Spinous Process Clamps (Generation 4) utilize the same fundamental scientific technology and have the same mode of operation and functionality as the predicate Spinous Process Clamps (Generation 2) (K131425). The subject devices have equivalent materials and sterilization/reprocessing methods as the predicate (K131425). The changes in design features between the subject and the predate do not raise any new risks or any concerns about the safety and effectiveness. The subject devices also meet the established navigational accuracy requirements.

Feature	Subject DevicesStealthStation™ SpinousProcess Clamps	Predicate DevicesNavigated CAPSTONE®Trials, CLYDESDALE®Trials, and CAPSTONE®& CLYDESDALE®Inserter (K131425)
Intended Use	When used with aMedtronic StealthStation™Navigation System, theSpine Referencing fixationdevices are intended toprovide rigid attachmentbetween patient and patientreference frame for theduration of the surgery. Thedevices are intended to bereusable.	When used with aMedtronic StealthStation™Navigation System, theSpine Referencing fixationdevices are intended toprovide rigid attachmentbetween patient andpatient reference frame forthe duration of the surgery.The devices are intendedto be reusable.
Indications for Use	The navigated instrumentsare specifically designed foruse with theStealthStation™ System,which is indicated for anymedical condition in whichthe use of stereotacticsurgery may beappropriate, and wherereference to a rigidanatomical structure suchas a skull, a long bone, orvertebra can be identifiedrelative to a CT or MRbased model, fluoroscopyimages, or digitizedlandmarks of the anatomy.	The navigated instrumentsare specifically designedfor use with theStealthStation™ System,which is indicated for anymedical condition in whichthe use of stereotacticsurgery may beappropriate, and wherereference to a rigidanatomical structure suchas a skull, a long bone, orvertebra can be identifiedrelative to a CT or MRbased model, fluoroscopyimages, or digitizedlandmarks of the anatomy.

Table 1. Comparison of Technological Characteristics

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Sterilization Method	Non-sterile, Steam sterilization, Reusable	Non-sterile, Steam sterilization, Reusable
Material	Titanium, 17-4 Stainless Steel, 300 Series Stainless Steel	Titanium, 17-4 Stainless Steel, 300 Series Stainless Steel
Thread Relief	Screw engaged threads with clamping mechanism at all time, due to full threaded screw design. Removal of two washer components due to screw changes.	Unengaged screw when clamps are open, due to thread relief in screw design.
Jaw Shape	Single Clamps: Concave shape of jaws to align to the spinous process bulbous topDouble Clamps: Non-concave	Single Clamps: Non-concaveDouble Clamps: Non-concave
Teeth	Single Clamps: Small teeth on the upper (concave) part of jaws, same size teeth as predicate on lower part of jawsDouble Clamps: Teeth all same size	Single Clamps: Teeth all same sizeDouble Clamps: Teeth all same size
Distal End Shape	Single Clamps: Pointed jaw at distal endDouble Clamps: Blunt jaw at distal end	Single Clamps: Blunt jaw at distal endDouble Clamps: Blunt jaw at distal end
Clamping Range	Single Clamps: 11 mmDouble Clamps: 9 mm	Single Clamps: 9 mmDouble Clamps: 9 mm
Size Offerings	Short, Medium, and Tall	Short and Tall

XI. Discussion of the Performance Testing:

Testing conducted to demonstrate equivalency of the subject device to the predicate is summarized as follows:

Performance TestingActivity	Description
Functional Verification	Confirms that the Spinous Process Clamp designsatisfies functional requirements.
Useful Life Testing	Confirms that the Spinous Process Clamps canoperate normally throughout their useful life.

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Navigation Accuracy Testing	Verifies the robustness and navigational accuracy ofthe Spinous Process Clamps.
Packaging Verification	Confirms that the Spinous Process Clamps whenpackaged in their packaging can withstand shiptesting per ASTM D4169 and ISTA 2A.

Additionally, biological endpoint testing, conducted per recommendations from ISO 10993-1:2018, indicates that the subject devices are non-cytotoxic, non-sensitizing, nonirritating, non-toxic, and non-pyrogenic and pose a negligible risk of adverse biological effects to patients when used as intended.

XII. Conclusion:

The subject devices have shown through comparison to be substantially equivalent to the identified predicate.

Regulation Number and Section

§ 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).