MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use. The MySpine S2-Alar/Alac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the selected surgical equipment. The MySpine guides are intended for single use only.

Device Description

The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. Identically to the other Medacta MySpine products, the MySpine S2-S1 Pedicle and Sacro-Iliac Screw Placement Guides are a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of pedicle and sacro-iliac screws based on patient's anatomy. Specifically, the subject MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used as anatomical perforating guides to assist intra-operatively in the preparation of the screw trajectory in S1, S2 and in the Ilium.

The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will represent the template used to generate the corresponding MySpine Screw Placement Guides fitting the patient's vertebral anatomy.

The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.

AI/ML Overview

The provided 510(k) summary does not contain specific acceptance criteria or details of a study proving the device meets said criteria as would typically be presented for an AI/ML powered device. This document describes a traditional medical device (surgical guides) and thus the standard clinical study information requested for AI/ML devices is not applicable.

However, based on the non-clinical studies mentioned, we can infer some performance aspects:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA summary does not explicitly state acceptance criteria or performance metrics in a quantitative table for this device. The listed non-clinical studies are:

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred from Study Type)
Software functions correctly and produces accurate models/guides based on CT scans.	Passed software validation.
Surgical guides provide accurate trajectory for screw placement in S1, S2, and Ilium.	Acceptable guide accuracy demonstrated through cadaver testing.
Guides are fit for purpose in a simulated surgical environment.	Acceptable performance in cadaver testing.

2. Sample Size for the Test Set and Data Provenance

Cadaver Testing: The document mentions "Cadaver testing" but does not specify the number of cadavers or the origin of the cadavers (e.g., country).
Software Validation: The document mentions "Software validation" which would typically involve a test set of radiological images (CT scans). The sample size for this test set and its provenance are not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. For cadaver testing, ground truth would likely be established through post-procedure imaging (e.g., CT scans) to verify screw placement accuracy, potentially assessed by surgeons or radiologists. For software validation, ground truth for image-based measurements would be established by experts.

4. Adjudication Method

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or is mentioned, as this is a surgical guide and not an AI-assisted diagnostic device. The device assists surgeons directly in placement, rather than providing an interpretation for a human reader.

6. Standalone Performance

The concept of "standalone performance" (algorithm only performance without human-in-the-loop) is not directly applicable in the same way it would be for an AI diagnostic device. The MySpine guides are a physical device derived from a surgical planning software, intended for human use during surgery. The device itself (the guide) has no "standalone" diagnostic or interpretive function. The software validation would speak to the accuracy of the software's output in creating the guides, but this is always in the context of human surgical use.

7. Type of Ground Truth Used

For Cadaver Testing: Likely involved a combination of direct observation during simulated surgery and post-procedure imaging (e.g., CT scans) to verify the accuracy of screw trajectory relative to the planned trajectory. This would be a form of expert assessment based on anatomical and imaging verification.
For Software Validation: Ground truth for image segmentation and measurement accuracy would be established by expert annotation or reference measurements on CT scans.

8. Sample Size for the Training Set

The document mentions "surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks." This implies that the software was trained, but the sample size of the training set (number of patients/CT scans) is not specified.

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

The document states the guides are "created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the selected surgical equipment." This suggests that the software's training likely involved manual identification of anatomical landmarks and desired screw trajectories by clinical experts (e.g., surgeons) on a collection of patient CT images. However, the specific methodology for establishing ground truth for training is not detailed.

Summary

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May 24, 2022

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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medacta International SA % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K220888

Trade/Device Name: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: QSR, PQC Dated: March 25, 2022 Received: March 28, 2022

Dear Mr. Lussier:

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,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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)

K220888

Device Name

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

Indications for Use (Describe)

Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.

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

I. Submitter

Medacta International SA

c/o Chris Lussier, Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118 (312) 244-0232

Additional Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Date Prepared: March 25, 2022 Date Revised: May 19, 2022

II. Device

Device Proprietary Name:	MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
Common or Usual Name:	Screw Placement Guide
Product Code, Name, Regulation	1) QSR, Sacroiliac Screw Placement Guide, 21 CFR 888.30402) PQC, Pedicle Screw Placement Guide, 21 CFR 888.3070
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following primary predicate device:

MySpine Pedicle Screw Placement Guides Extension, K203673, Medacta International SA
In addition the following predicate device is referenced within the submission :
MySpine S2-Alar/Alac Pedicle Screw Placement Guides, K200792, Medacta International SA

IV. Device Description

The MySpine software platform allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans. CT images are used to create a 3D model of the vertebrae that will

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represent the template used to generate the corresponding MySpine Screw Placement Guides fitting the patient's vertebral anatomy.

The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.

Indications for Use V.

MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are intended to be used with any 510(k) cleared, legally marketed, pedicle screw system (for its approved indications for use) and its respective components for non-cervical open, posterior spinal fixation procedures intended for fusion. The SI trajectory of the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guide is only intended to be used with M.U.S.T. SI Headless Screw System and its cleared indications for use. The MySpine S2-Alar/Alar-Iliac and MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides (hereinafter referred to as "MySpine guides") are intended to be used as anatomical perforating guides, specific to a patient's anatomy, to assist intraoperatively in the preparation of the screw trajectory in S1, S2 and in the Ilium. The guides are created using a surgical planning software which pre-operatively plans the positions of the components based upon radiological images of the patients' anatomical landmarks and the selected surgical equipment. The MySpine guides are intended for single use only.

Please see MySpine guides labelling for compatibility requirements between the MySpine guides and the 510(k) cleared pedicle screw system intended to be used.

VI. Comparison of Technological Characteristics

The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides and the predicate MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides share the following characteristics:

body region of use; ●
manufacturing process; ●
material; ●
biocompatibility; ●
device usage;
sterility;
shelf life; and ●
packaging. ●

The MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides differs from the predicate device, MySpine S2-Alar/Alac Pedicle Screw Placement Guides, with regards to the following characteristics:

design; and
instruments compatibility. ●

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Discussion

The differences between the subject and predicate devices do not raise new questions of safety and effectiveness. Medacta International SA has not made any changes to the manufacturing process, material, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.

The comparison of technological characteristics and performance data provided within this submission. shows that there are no new risks associated with the subject devices design, and supports the substantial equivalence of the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides to the identified predicate devices.

VII. Performance Data

Based on the risk analysis, testing activities were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:

Non-Clinical Studies

· Software validation
· Cadaver testing;
· Guide accuracy.

Biocompatibility data and sterilization studies submitted in support of the predicate devices were leveraged.

Clinical Studies:

No clinical studies were conducted. ●

Conclusion VIII.

The information provided above supports that the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides are substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.