MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.

The device is provided with two options:

Drill based
K-wire based

MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.

Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine MC and Drill Pilot guides are intended for single use only.

Device Description

The MySpine Pedicle Screw Placement Guides – MC (Midline Cortical) and Drill Pilot Instruments are a line extension to Medacta's MySpine Pedicle Screw Placement Guides. The MySpine Pedicle Screw Placement Guides – MC and S1 Guide Instruments are for use in spinal levels L5 to S1. The MySpine Pedicle Screw Placement Guides - Drill Pilot Guide Instruments are for use in spinal levels T1 to S1.

The MySpine product line is a patient matched, pedicle targeted, technology involving the production of patient specific guides for placement of the M.U.S.T. Pedicle Screw System based on the patient's anatomy. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are intended to be used with Medacta's M.U.S.T. Pedicle Screw System (K121115, K132878, K141988, K153664, K162061, and K171170) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudo-arthrosis, and failed previous fusion.

The MySpine platform allows the surgeon to complete pre-operative planning in 3D, based on the patient's spinal CT scans. Medacta International SA uses these images in combination with SW Mimics® (Materialize®) and W Solidworks® (Dassault Systèmes®) to import DICOM images from a patient's CT scans and then process the scans into accurate 3D models. CT imaging is used to create a 3D model of the vertebrae according to the patient's anatomy. The subsequent vertebral model represents the template used to generate the corresponding MySpine Screw Placement Guides to fit the patient's vertebral anatomy.

AI/ML Overview

The provided document is a 510(k) premarket notification for the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.

However, the document does not contain specific acceptance criteria or performance data for an AI-powered device. The MySpine system described is a patient-matched surgical guide system that uses pre-operative CT scans to create 3D models and fabricate patient-specific guides. It utilizes software for planning, but it is not an AI/ML-driven device as understood in the context of diagnostic or prognostic AI.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance for an AI/ML device from this document. The document primarily focuses on the physical design, manufacturing process, materials, and intended use of the surgical guides, along with non-clinical performance tests relevant to mechanical and design validation, and a statement that no clinical studies were conducted for this particular submission.

To answer your request, if this were an AI or ML-enabled device, the information would typically include:

A table of acceptance criteria and the reported device performance: This would detail metrics like sensitivity, specificity, accuracy, precision, recall, F1-score, AUC, etc., along with the target thresholds (acceptance criteria) and the actual performance achieved.
Sample size used for the test set and the data provenance: Number of cases/patients in the test set, and details like country of origin, whether it was retrospective or prospective data, etc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For example, 3 radiologists with 5+ years of experience each.
Adjudication method for the test set: How disagreements among experts establishing ground truth were resolved (e.g., 2+1 means 2 experts agree, if not, a 3rd expert adjudicates; 3+1 means 3 experts agree, if not, a 4th adjudicates).
If a multi reader multi case (MRMC) comparative effectiveness study was done: Details on the study design and the effect size (e.g., human readers improved AUC by X with AI assistance).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The results of the algorithm's performance without human intervention.
The type of ground truth used: For instance, expert consensus, pathology reports, clinical outcomes data, follow-up imaging, etc.
The sample size for the training set: Number of cases/patients used to train the AI model.
How the ground truth for the training set was established: Similar to the test set, but often less stringent or by different methods depending on the training methodology.

Since the provided document does not pertain to an AI/ML device, I am unable to provide the specific details requested. The "Performance Data" section (page 7) lists only non-clinical studies related to design validation, stability, post-operative evaluation (accuracy of the physical guide), and wear tests for the physical instruments. It explicitly states "no clinical studies were conducted."

Summary

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April 19, 2018

Medacta International SA % Elizabeth Rose, MST, RAC Manager, Regulatory Affairs - Medical Devices Mapi USA, Inc 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

Re: K173472

Trade/Device Name: MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PQC Dated: March 19, 2018 Received: March 19, 2018

Dear Ms. Rose:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173472

Device Name

MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments

Indications for Use (Describe)

MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. MySpine Drill Pilot is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.

The device is provided with two options:

Drill based
· K-wire based

MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.

MySpine MC and Drill Pilot guides are intended for single use only.

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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3.0 510(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 Affairs Manager, Medacta International SA Consultant: Elizabeth Rose, Regulatory Affairs Manager, Medical Devices, Mapi USA, Inc. Date Prepared: November 8, 2017 Date Revised: April 19, 2018

II. Device

Device Proprietary Name:	MySpine Pedicle Screw Placement Guides – MC and DrillPilot Instruments
Common or Usual Name:	Pedicle Screw Placement Guide
Classification Name:	Thoracolumbosacral Pedicle Screw System
Primary Product Code:	PQC
Regulation Number:	21 CFR 888.3070
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices: Primary Predicate

MySpine Pedicle Screw Placement Guides LP, K153273, Medacta International SA ●
Additional Predicate:
MySpine Pedicle Screw Placement Guides, K132788, Medacta International SA ●

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IV. Device Description

V. Indications for Use

MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use.

MySpine Drill Pilot is intended as a thoracic and lumbar posterior pedicle targeting guide for patients requiring spinal fusion between the levels of T1 to L5. The device is intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body. MySpine MC is intended as a lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1.

The device is provided with two options:

· Drill based
· K-wire based

MySpine MC drill based are intended for perforating a guiding hole to assist in the positioning of pedicle screws in the vertebral body.

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MySpine MC k-wire based are intended for the placement of K-wires to assist in the positioning of pedicle screws in the vertebral body.

Use of the guides involves a surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surgical equipments. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine MC and Drill Pilot guides are intended for single use only.

VI. Comparison of Technological Characteristics

The MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments and the predicate devices share the following characteristics:

. design;
software;
material of construction;
biocompatibility;
manufacturing process; ●
device usage;
. sterility:
shelf life; and
packaging.

The MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments have a different physical profile from the predicate devices.

The MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments are manufactured from medical grade nylon (Polyamide PA12) which is identical to predicate devices, Medacta's MySpine Pedicle Screw Placement Guides (K132788) and MySpine Pedicle Screw Placement Guides - LP (K153273).

Due to the extensive history of use in currently marketed medical devices, as well as similarities in the manufacturing processes between the subject and reference devices, additional biocompatibility testing was deemed unnecessary for the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments.

A comparison of the subject and predicate devices is provided in the table below.

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Technological comparison

Parameters	MySpine Pedicle ScrewPlacement Guides - MCand Drill Pilot Instruments	MySpine Pedicle ScrewPlacement Guides – LP(K153273)	MySpine Pedicle ScrewPlacement Guides(K132788)
Design	Patient specific surgicalinstruments generated frompatient's CT scan	Identical	Identical
Software	SW Mimics® (Materialize®)and W Solidworks® (DassaultSystèmes®)	Identical	Identical
Physical Profile	Drill Pilot Guides: guide drillto prepare hole forpositioning of the pediclescrewsMC and S1 Guides:drill based - guide drill to prepare hole for positioning of the pedicle screwsK-wire based - low profile guides	Low Profile	Standard Size
ManufacturingProcess	Additive manufacturing usinga sintering process of medicalgrade nylon on a lasersintering system.	Identical	Identical
Material	Medical Grade Nylon forsintering (PA12 MedicalGrade)	Identical	Identical
Biocompatibility	External communicatingdevices with limited (<24hours) contact duration	Identical	Identical
Device Usage	Single Use	Identical	Identical
Sterility	Gamma Radiation and Non-Sterile	Identical	Identical
Shelf Life	6 months after CT scan	Identical	Identical
Packaging	Individual packaging	Identical	Identical

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Discussion

There are differences between the subject and predicate devices with respect to the indications for use statement. The subject devices indications for use are being expanded to include lumbar and sacral posterior pedicle targeting guide for patients requiring spinal fusion between the levels of L1 to S1 with option of drill based or K-wire based positioning.

The differences in the indications for use and physical profile 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 intended use, materials of construction, design, manufacturing process, software, device usage, or of the subject devices. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments to the identified predicate devices.

VII. Performance Data

Risks were identified based on the proposed design and testing was conducted to mitigate those risks. Based on the risk analysis, testing was conducted according to written protocols with acceptance criteria. The following performance data was provided in support of the substantial equivalence determination:

Non-Clinical Studies

. Performance Tests
- O design validation: validated the design, intended use and procedure;
- stability assessment: verified the stability of contact points related to the degrees O of freedom;
- post-operative evaluation: validated the guide accuracy; and o
- wear test: quantified the debris generated by an instrument during pedicle O preparation and screws insertion, because of moving parts wear.

Clinical Studies

no clinical studies were conducted. .

VIII. Conclusion

Based on the above information, the MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments can be considered substantially equivalent to the identified predicate devices.

Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The MySpine Pedicle Screw Placement Guides - MC and Drill Pilot Instruments are as safe and effective as the

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predicate devices, Medacta's MySpine Pedicle Screw Placement Guides (K132788) and MySpine Pedicle Screw Placement Guides – LP (K153273).

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.