MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating quides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.

For pedicle diameters equal or less than ø4mm. Medacta provides for the pilot hole preparation into the lateral mass without penetrating the pedicle.

The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patientspecific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.

Device Description

MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7.

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 Cervical Guide fitting the patient's vertebral anatomy.

The MySpine Cervical 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 text is a 510(k) summary for the MySpine Cervical Guides. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing an acceptance criteria study. Therefore, much of the requested information about device performance against acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not present in this document.

However, based on the Performance Data section, we can infer some information about validation and the type of studies conducted.

Here's a breakdown of the available and missing information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document states that "Design Validation workshops... were conducted... to validate the design and the overall functionality of the subject device as well as to evaluate their accuracy." It also mentions "MySpine Cervical stability assessment to evaluate the stability of the subject lateral mass guides." However, specific numerical acceptance criteria and the corresponding reported performance values from these validation activities are not detailed.

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

This information is not explicitly provided. The document states that "Two validation workshops, one for the unilateral and the other for the mass lateral guides, have been performed." It does not specify the number of cases or subjects included in these workshops, nor the country of origin or whether the data was retrospective or prospective.

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

This information is not explicitly provided. While "Design Validation workshops" imply expert involvement, the number of experts and their qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This type of study was not explicitly conducted or reported. The document focuses on design validation and stability assessment, not a comparative effectiveness study with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device described is a physical surgical guide generated by software (MySpine software platform). The validation activities mentioned ("Design Validation workshops" and "stability assessment") seem to relate to the physical guides and their interaction (functionality, accuracy, stability), rather than a standalone assessment of the software algorithm's performance independent of the physical guide or human surgeon. So, a standalone algorithm-only performance study in the typical sense of AI algorithms detecting pathologies is not applicable/not reported for this type of device. The accuracy evaluation would likely be for the guide's ability to direct screw placement as planned.

7. The Type of Ground Truth Used

The document mentions that the surgical planning software uses "radiological images of the patients' anatomical landmarks" to create a "3D model of the vertebrae." The guides are "patient-specific guides fabricated based on the surgical plan." The "accuracy" of the guides was evaluated. It is highly probable that the ground truth for evaluating the accuracy of the guides would involve comparing the intended screw placement (from the surgical plan) with the actual placement achieved using the guide, potentially through post-operative imaging or cadaveric studies. However, the exact type of ground truth (e.g., expert consensus on optimal placement, direct measurement from a phantom/cadaver after guide use, pathology) is not explicitly stated.

8. The Sample Size for the Training Set

The document describes the device as a "patient-specific device" generated from a patient's CT scans. It does not mention a "training set" in the context of machine learning or AI models learning from a dataset. The MySpine software platform "allows the surgeon to complete 3D pre-operative planning based on the patient's spinal CT scans." This implies a custom generation for each patient rather than a model trained on a large dataset. Therefore, the concept of a "training set" as typically understood for AI algorithms is not applicable here.

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

As the concept of a "training set" is not applicable, this information is not provided.

Summary of Available Information from the Document:

Acceptance Criteria & Performance: Not explicitly stated, but "design validation workshops" focused on "overall functionality" and "accuracy," and a "stability assessment" were performed.
Study Type: Non-clinical studies (design validation workshops, stability assessment). No clinical studies were conducted.
Sample Size (Test Set): Not specified beyond "Two validation workshops."
Data Provenance (Test Set): Not specified.
Experts for Ground Truth: Implied by "validation workshops," but number and qualifications not specified.
Adjudication Method: Not specified.
MRMC Study: Not conducted.
Standalone Performance: Not applicable/not reported in the AI sense; validation likely involved the physical guides' performance.
Type of Ground Truth: Not explicitly stated, but likely related to comparing planned vs. actual screw placement using the guides.
Training Set Size: Not applicable.
Training Set Ground Truth: Not applicable.

Summary

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December 7, 2023

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized design. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

Medacta International SA % Mr. Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 6386 Global Drive, Suite 101 Memphis. Tennessee 38141

Re: K231515

Trade/Device Name: MySpine Cervical Guides Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: QSD Dated: May 25, 2023 Received: November 27, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Colin
O'neill -S

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

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Indications for Use

Submission Number (if known)

K231515

Device Name

MySpine Cervical Guides

Indications for Use (Describe)

For pedicle diameters equal or less than ø4mm. Medacta provides for the pilot hole preparation into the lateral mass without penetrating the pedicle.

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 Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality, Regulatory, and Clinical Research, Medacta USA

Date Prepared: May 25, 2023

II. Device

Device Proprietary Name:	MySpine Cervical Guides
Common or Usual Name:	Posterior cervical screw placement guide
Classification Name:	Posterior Cervical Screw System
Primary Product Code:	QSD
Regulation Number:	21 CFR 888.3075
Device Classification:	II

III. Predicate Device

Substantial equivalence is claimed to the following primary predicate device:

FIREFLY Cervical Navigation Guide, K220132, Mighty Oak Medical Inc. A
Additionally, the following predicate devices are used within the submission:
MySpine Pedicle Screw Placement Guides Extension, K203673, Medacta International SA A
A MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments, K173472, Medacta Interational SA

IV. Device Description

Medacta International SA

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the template used to generate the corresponding MySpine Cervical Guide fitting the patient's vertebral anatomy.

The MySpine Cervical Guides as well as their bone models are single-use and they can be provided in sterile or non-sterile version.

V. Indications for Use

MySpine Cervical is intended to be used with any 510(k) cleared, legally marketed, posterior cervical screw system (for its cleared indications for use) and its respective compatible components for cervical posterior spinal fixation procedures intended for fusion. MySpine Cervical guides are patient specific devices intended to be used as anatomical perforating guides, specific to a single patient's anatomy, to assist intra-operatively in the positioning of screws during posterior cervical fixation surgery between the levels of C2 to C7. For pedicle diameters equal or less than ø4mm. Medacta provides the guides for the pilot hole preparation into the lateral mass without penetrating the pedicle.

The use of the guides involves a surgical planning software, with which the surgeon preoperatively plans the surgical placement of the implants based upon the radiological images of the patients' anatomical landmarks and the selected surgical equipment. These components include patient-specific guides fabricated based on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Cervical guides are intended for single use only.

VI. Comparison of Technological Characteristics

The subject MySpine Cervical Guides are substantially equivalent to the predicate device, FIREFLY Cervical Navigation Guide (K220132), with regards to the following characteristics:

Lateral mass guides' design; ●
Instruments compatibility; ●
Manufacturing process; ●
Material;
Biocompatibility;
Device usage; and
Packaging. ●

The subject MySpine Cervical Guides differ respect to the predicate, FIREFLY Cervical Navigation Guide (K220132), with regards to the following characteristics:

Body region; ●
Unilateral guides' design;
Spinous process contact; ●
Design workflow & related software;
Sterility; and
Shelf-life. ●

Discussion

The technological differences between the subject and primary predicate device do not raise new questions of safety and effectiveness since the main differences (i.e. spinous process contact, design workflow & related software, sterility and shelf-life) of the subject devices are shared with Medacta MySpine devices cleared within K203673 and K173472.

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K231515 - Page 3 of 3

Medacta International SA

Medacta International SA has not made any change to the manufacturing process, material, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices with respect to the predicate devices.

The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices respect to the predicate devices.

VII. Performance Data

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

Non-Clinical Studies

. Design Validation workshops to validate the design and the overall functionality of the subject device as well as to evaluate their accuracy. Two validation workshops, one for the unilateral and the other for the mass lateral guides, have been performed.
MySpine Cervical stability assessment to evaluate the stability of the subject lateral mass guides. ●
. Biocompatibility data, shelf-life and sterilization studies submitted in support of the predicate devices were leveraged.

Clinical Studies:

No clinical studies were conducted.

VIII. Conclusion

The information provided above supports that the subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.