Smart SPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Smart SPACE Shoulder Cubit Guidance

Smart SPACE Shoulder Cubit Guidance consists of a patient-specific 3D mapper, single use instrumentation, and an intraoperative guidance software. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.

Smart SPACE Shoulder Planner software

Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.

Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.

The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.

Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.

It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan.

The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.

Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.

Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

Device Description

The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software which assists the user in planning reverse and anatomic total shoulder arthroplasty. In addition, a choice of intraoperative execution of the surgical plan using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance. The Smart SPACE Shoulder System (subject device) is compatible with Lima Corporate shoulder replacement implants; Verification testing was conducted utilizing those systems.

AI/ML Overview

The provided text describes the Smart SPACE Shoulder System, which includes software for pre-surgical planning and patient-specific instrumentation (3D positioner or Cubit Guidance) for intraoperative positioning of shoulder components. The device aims to assist in total anatomic or reverse shoulder arthroplasty procedures.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document does not explicitly state quantitative acceptance criteria for device performance. Instead, it states that "Testing has successfully demonstrated that the subject device performs as well as the predicate device with respect to version, inclination, and entry point." This implies that the acceptance criteria were met if the subject device's performance was comparable to the predicate device in these key metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Performance comparable to predicate device regarding version	Subject device performs as well as the predicate device regarding version.
Performance comparable to predicate device regarding inclination	Subject device performs as well as the predicate device regarding inclination.
Performance comparable to predicate device regarding entry point	Subject device performs as well as the predicate device regarding entry point.
Materials used are biocompatible	Biocompatibility testing per ISO 10993-1:2018 was conducted and materials were found to be biocompatible.
Electrical safety of Cubit sensor meets standards	Electrical safety tested to IEC 60601-1:2012.
Electromagnetic compatibility of Cubit sensor meets standards	Electromagnetic compatibility tested to IEC 60601-1-2:2014.
Lithium Power Cell meets standards	Additional testing conducted on the Lithium Power Cell per IEC 62133-2.
Intentional Radiator meets standards	Intentional Radiator testing conducted per Title 47 of the CFR, Ch. 1.
Ingress Testing meets standards	Ingress Testing conducted per IEC 60529 Ed. 2.2(2013).
Software Verification and Validation performed as per guidelines	Conducted in accordance with ANSI AAMI IEC 62304:2006/A1:2015 and FDA guidance documents.
Usability validated per standards	Validated in accordance with IEC 62366-1:2015 and 60601-1-6:2013.
Sterilization effective and shelf-life validated	Sterilization, shelf life, and shipping validations performed according to ISO 11135:2014, ISO 10993-7:2008, and ISO 11137-1:2018.

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

The document states, "The Smart SPACE Shoulder System was validated through non-clinical studies performed on cadaveric specimens." However, it does not specify the number of cadaveric specimens used as the test set.

Sample Size: Not specified.
Data Provenance: Non-clinical studies performed on cadaveric specimens. The country of origin is not mentioned, and due to the nature of cadaveric studies, it would be considered prospective data collection for the validation.

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

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing the ground truth for the cadaveric studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth in the cadaveric studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device focuses on a surgical planning software and patient-specific instrumentation, not on image interpretation by human "readers" in the traditional sense of an MRMC study for diagnostic imaging. While the software assists surgeons (human users), the document does not describe an MRMC comparative effectiveness study directly measuring the improvement of human surgical performance with AI assistance versus without AI assistance. It compares the device's output (implant placement accuracy) to a predicate device, but not human reader performance.

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

The planning software component itself is "algorithm only" in the sense that it processes CT images to generate a surgical plan and 3D files. The "3D positioner" and "Cubit Guidance" are physical instruments derived from these plans. The statement "Post-operative implant placement was compared with the executed implant position captured by the Guidance System" suggests that the accuracy of the guidance system itself (which is algorithm-driven in its generation and subsequent validation through its use) was assessed in placing the implants in the cadaveric study. This implies a standalone performance evaluation of the system's ability to achieve planned implant positioning.

So, yes, a form of standalone performance was assessed through the cadaveric studies, focusing on the accuracy of the system's output (planned vs. executed implant placement).

7. The Type of Ground Truth Used

The ground truth for the cadaveric studies was established by comparing "Post-operative implant placement... with the executed implant position captured by the Guidance System." This suggests that the "true" or desired implant position was defined by the executed plan generated by the Smart SPACE Shoulder Planner software and then assessed against the actual placement in the cadaver. It's a form of system-defined ground truth related to the accuracy of implementing the surgical plan. This is not pathology, outcomes data, or expert consensus on a diagnostic image.

8. The Sample Size for the Training Set

The document does not provide any information about the training set size for the software component of the Smart SPACE Shoulder System.

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

Since information regarding the training set is not provided, the method for establishing its ground truth is also not specified.

Summary

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February 3, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TechMah Medical LLC Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738

Re: K202151

Trade/Device Name: Smart SPACE Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE, KWS, OLO, MBF Dated: August 3, 2020 Received: August 3, 2020

Dear Mary Vater:

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 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

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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) 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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-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-devices/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 Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty 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) K202151

Device Name Smart SPACE Shoulder System

Indications for Use (Describe)