Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The Erisma®-LP Navigated Instruments are manual, non-sterile, reusable surgical instruments for use with the Medtronic StealthStation™ Navigation System to assist the surgeon in locating anatomical structures in either open, minimally invasive or percutaneous procedures for preparation and placement of the Clariance Erisma®-LP, Erisma®- MIS pedicle screw implants. The Erisma®-LP Navigated Instruments include the following instruments: Drivers, Tap, Bone Awl, Probes. The instrumentation is designed for use with the Medtronic StealthStation™ Navigation System hardware and software. These instruments are made of medical quality stainless steel according to the ASTM F899 and titanium alloy according to the ASTM F136.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Erisma®-LP Navigated Instruments. This document outlines the manufacturer's claim of "substantial equivalence" of their device to a legally marketed predicate device.

It's crucial to understand that a 510(k) submission primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive de novo clinical trials.

Unfortunately, the provided text does not contain the level of detail typically found in a clinical study report for AI-powered or diagnostic devices regarding acceptance criteria and performance data. The "Performance Data – Non-Clinical" section explicitly states that mechanical tests were performed, not a clinical study involving human patients or complex AI algorithms.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI or diagnostic performance (e.g., sensitivity, specificity, human reader improvement with AI) cannot be extracted from this document.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance

Not applicable in the context of this 510(k) submission.
The document describes non-clinical performance data for mechanical and compatibility aspects of a surgical navigation instrument, not a diagnostic or AI-driven performance study with acceptance criteria like accuracy, sensitivity, or specificity. The "Performance Data – Non-Clinical" section mentions:

Compatibility between Erisma®-LP Navigated Instruments and Medtronic Naclock Tracker.
Ability of Erisma®-LP Navigated Instruments to be registered by Medtronic StealthStation™ System.
Simulation of pedicle insertion.

The reported performance is that these tests "demonstrated the substantial equivalence of the system to legally marketed devices." No specific numerical "acceptance criteria" or "reported device performance" metrics (e.g., within X mm accuracy) are provided, as this is a general statement of equivalency for mechanical function.

2. Sample size used for the test set and the data provenance

Not applicable for a clinical test set.
The testing described is non-clinical/mechanical. There is no mention of a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable.
There was no clinical test set requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.
There was no clinical test set 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.
This device is a navigated surgical instrument, not an AI-powered diagnostic or interpretive device for human readers. Therefore, an MRMC study and AI assistance improvement are irrelevant to its nature.

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

No.
This is a physical surgical instrument system used in conjunction with "human-in-the-loop" (a surgeon) and the Medtronic StealthStation™ Navigation System. It is not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in a clinical sense.
For the mechanical tests, the "ground truth" would be engineering specifications and the performance of the predicate device.

8. The sample size for the training set

Not applicable.
This device likely does not use machine learning in a way that requires a "training set" of data in the common sense of AI/ML software. Its functionality relies on physical design and interface with the navigation system.

9. How the ground truth for the training set was established

Not applicable.
As above, no training set data.

In summary: The provided document is a 510(k) for a navigated surgical instrument (Erisma®-LP Navigated Instruments) intended to assist surgeons in spine surgery by precisely locating anatomical structures when used with the Medtronic StealthStation® System. The regulatory pathway is based on substantial equivalence to an existing predicate device (Medtronic Navigated CD Horizon Solera Screwdriver/Taps).

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical tests and compatibility assessments rather than clinical performance trials or AI/diagnostic performance studies. The document states these non-clinical tests "demonstrated the substantial equivalence of the system to legally marketed devices," which is the fundamental "acceptance criterion" for a 510(k) submission. No detailed quantitative acceptance criteria or clinical performance metrics (like accuracy, sensitivity, or human reader performance) are provided, nor would they typically be for this type of device and regulatory submission.

Summary

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February 26, 2021

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.

Clariance, SAS % Jennifer Daudelin Senior Project Manager M Squared Associates, INC 127 West 30th Street. Floor 9 New York, New York 10001

Re: K202956

Trade/Device Name: Erisma LP Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2021 Received: January 25, 2021

Dear Jennifer Daudelin:

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

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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 (OS) 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, MPH 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) K202956

Device Name

Erisma®-LP Navigated Instruments

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Class

NKB

510(k) Summary

Clariance SAS

The following information is provided as required by 21 CFR § 807.87 for the Clariance SAS 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Clariance SAS is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).

Sponsor:	CLARIANCE, SAS18 rue RobespierreF-62217 Beaurains, France
Contact:	Jennifer A. Daudelin, M.S.J.M Squared Associates, Inc.127 West 30th Street, Floor 9Ph: 347-954-0395Fax: 703-562-9797Email: jdaudelin@msquaredassociates.com
Date Prepared:	September 25, 2020
Proposed Class:	II
Proprietary Name:	ERISMA® LP_NAVIGATED INSTRUMENTS
Common Name:	Stereotaxic Instrument
Classification Name:	Stereotaxic Instrument
Regulation Number:	21 CFR 882.4560
Product Codes:	OLO
Predicate Device(s):
	Device Name	510(k) Number	Procode
Primary Predicate:
Medtronic SofamorDanek USA	Navigated CD HorizonSolera Screwdriver/Taps	K140454	OLO,HBE
Reference Devices:
Clariance SAS	Erisma-Lp SpinalFixation System	K153326	NKB

K162367

Erisma®-Lp Mis

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Indications for Use

Erisma®-LP Navigated Instruments are intended to be used in the preparation and placement of Erisma® LP 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

Performance Data – Non-Clinical

A series of mechanical tests have been performed to support the substantial equivalence of the Erisma®-LP Navigated Instruments with the Medtronic Navigated Instruments cleared in 510(k), K140454. CLARIANCE performed tests to demonstrate the compatibility between Erisma®-LP Navigated Instruments and Medtronic Naclock Tracker, the ability of Erisma®-LP Navigated Instruments to be registered by Medtronic StealthStation™ System, and a simulation of pedicle insertion, all of which demonstrated the substantial equivalence of the system to legally marketed devices.

There have been no changes to the manufacturing methods or patient contacting materials from the predicate Erisma® instruments cleared in 510(k)s K153326 and K162367; therefore, no new testing was required to demonstrate biocompatibility of the Erisma®-LP Navigated Instruments.

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Substantial Equivalence

The Erisma®-LP Navigated Instruments has the same indications for use and similar design features as compared with the predicate systems. The bench testing demonstrates that the performance characteristics of the Erisma®-LP Navigated Instruments are equivalent to those of the other legally marketed stereotaxic instrument devices, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate devices would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.

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).