MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. Use of the quides involves 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 surqiçal 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 Screw Placement Guides are intended for single use only.

Device Description

The MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided pedicle screw placement of the M.U.S.T pedicle screws (K121115). The M.U.S.T pedicle screws are guided through the patient's anatomically matched MySpine Pedicle Screw Placement Guides in order to provide optimal positioning according to the surgeon's preoperative planning. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans.

The components of the MySpine Pedicle Screw Placement Guides include a Drill Guide (Polyamide PA 2200), Sleeves for Awls, Probes and Screw Drivers (Polyamide PA 2200). Sleeves for taps and drills (Wrought stainless steel AISI 630. ASTM F 899), and Vertebral Bone Models (Polyamide PA 2200). The MySpine Pedicle Screw Placement Guides are single use, external communicating devices with limited (<24 hours) contact duration and are provided in sterile and non-sterile versions.

AI/ML Overview

The provided document describes the MySpine Pedicle Screw Placement Guides, a patient-specific surgical instrument. It details performance testing and establishes substantial equivalence to a predicate device, but it does not include a typical AI/ML medical device study with acceptance criteria, sample sizes, and expert validation for an algorithm's performance.

Instead, the performance testing focuses on traditional medical device validation, such as biocompatibility, dimensional accuracy, mechanical testing, and process reproducibility. The document mentions "software tools used to manufacture the MySpine Pedicle Screw Placement Guides were validated for their intended use," but this refers to the software used for design and fabrication, not an AI algorithm performing diagnostic or predictive tasks.

Therefore, the requested information elements related to AI/ML device studies cannot be extracted from this 510(k) summary.

However, I can extract information regarding the general performance testing and a design validation cadaver study.

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

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met ISO 10993 applicable to external communicating devices with limited (<=24 hrs) contact duration.
Dimensional Accuracy	Tested before and after sterilization, indicating acceptable performance. (Specific numerical criteria/results not provided).
Dimensional Precision	Tested before and after sterilization, indicating acceptable performance. (Specific numerical criteria/results not provided).
Mechanical Testing	Performed, indicating acceptable performance. (Specific parameters/results not provided).
Cleanliness	Assessed following factory cleaning, indicating acceptable performance. (Specific criteria/results not provided).
Shipping Test	Performed on the packaged device, indicating acceptable performance. (Specific criteria/results not provided).
Process Reproducibility	Assessed, indicating acceptable performance. (Specific criteria/results not provided).
Software Validation	Software tools used to manufacture the MySpine Pedicle Screw Placement Guides were validated for their intended use. (Specific criteria/results not provided).
Design Validation	Demonstrated through a cadaver laboratory, implying successful placement and/or proper function in a simulated surgical environment. (Specific criteria for success in the cadaver lab not provided, but the conclusion states all acceptance criteria for performance testing were met).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document mentions "worst case component size and option/design" were tested for non-clinical performance testing. For the design validation, it states "a cadaver laboratory" was used. The specific number of cadavers or components tested is not specified.
Data Provenance: Not specified for the non-clinical tests or the cadaver study. The cadaver study is prospective in the sense that the device was used in a controlled setting for validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not mention the use of experts to establish a "ground truth" for the performance or design validation in the sense of clinical decision-making or image interpretation. This refers to engineering and design validation tests on the physical device. The cadaver study would typically involve surgeons, but their number and specific qualifications are not stated.

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

Not applicable as the testing performed is for physical device performance and design validation, not for an algorithm's output requiring expert 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. An MRMC comparative effectiveness study was not conducted. This is not an AI/ML diagnostic or assistive device in the context typically studied by MRMC.

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

No. This is not an AI algorithm with standalone performance. The "software tools" mentioned are for manufacturing and surgical planning, where the human surgeon makes the final decisions and uses the physical guides.

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

For the non-clinical performance tests, the "ground truth" would be established by engineering specifications and measurements (e.g., dimensional accuracy within tolerances, material strength meeting standards).
For the cadaver laboratory design validation, the "ground truth" would be established by successful placement of pedicle screws as intended by the surgical plan using the guides, likely assessed by direct observation, imaging, or dissection. This is a form of simulated outcome verification.

8. The sample size for the training set

Not applicable. The device is a patient-specific surgical guide manufactured based on individual patient CT scans using pre-validated software. There is no "training set" for an AI algorithm in the context described.

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

Not applicable as there is no training set for an AI algorithm.

Summary

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MAY 2 3 2014 K132788 :: page 1 of 3

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510(k) Summary

Applicant/Sponsor: 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: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: (805) 910-6511 Fax: (805) 437-7553 Email: AGross@medacta.us.com

April 28, 2014 Date Prepared:

DEVICE INFORMATION

Trade/Proprietary Name: MySpine Pedicle Screw Placement Guides Common Name: Pedicle Screw Placement Guide Classification Name: orthosis, spinal pedicle fixation 21 CFR 888.3070 Class II Product Code: MNI

Predicate Device: K121115 M.U.S.T pedicle screw system, Medacta International

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Product Description

Indications for Use

MySpine is intended as a thoracic and lumbar posterior pedicle targeting quide for patients requiring spinal fusion between the levels of T1 to L5.

MySpine Screw Placement Guides are intended for single use only.

Comparison to Predicate Devices

The intended use of the MySpine Pedicle Screw Placement Guides is substantially equivalent to the M.U.S.T pedicle screw system (K12115). The technological characteristics of the MySpine Pedicle Screw Placement Guides do not raise new issues of safety and effectiveness compared to the primary predicate device (K12115). The technological characteristics including design, materials, contact duration, software, manufacturing process, device usage, sterility, packaging, labeling, and shelf-life of the MySpine Pedicle Screw Placement Guides are similar to those of the K093806 MvKnee Cutting Blocks reference device. The safety and effectiveness of the MySpine Pedicle

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Screw Placement Guides are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the MySpine Pedicle Screw Placement Guides was conducted in accordance with various international standards and FDA guidance documents.

Non-clinical testing included biocompatibility testing to ISO 10993 applicable to external communicating devices with limited (<=24 hrs) contact duration, dimensional accuracy and precision before and after sterilization, mechanical testing, cleanliness following factory cleaning, and a shipping test of the packaged device. Process reproducibility was assessed. The software tools used to manufacture the MySpine Pedicle Screw Placement Guides were validated for their intended use.

MySpine Pedicle Screw Placement Guides were tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing was conducted on the worst case component size and option/design. The testing met all acceptance criteria and verifies that the performances of the MySpine Pedicle Screw Placement Guides are substantially equivalent to the predicate devices. Design validation was accomplished with a cadaver laboratory.

Conclusion

Based on the above information, the MySpine Pedicle Screw Placement Guides can be considered as substantially equivalent to its predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002

May 23, 2014

Medacta International SA % Mr. Adam Gross Medacta USA 4725 Calle Quetzal, Unit B Camarillo, California 93012

Re: K132788

Trade/Device Name: MySpine Pedicle Screw Placement Guides Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI Dated: April 29, 2014 Received: April 30, 2014

Dear Mr. Gross:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Adam Gross

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) ド132788

Device Name

MySpine Pedicle Screw Placement Guides

Indications for Use (Describe)

MySpine is intended as a thoracic and lumbar posterior guide for patients requiring spinal fusion between the levels of TI to 1.5.

MySpine Screw Placement Guided to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T Pedicle Serew System and its cleared indications for use. Use of the guides involves 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 of the implant components intra-operatively per the surgical plan.

MySpine Screw Placement 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.