The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System.

The Signature™ ONE Guides and bone models are intended for single use only.

Device Description

The Signature™ ONE System is developed to assist in preoperative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™M ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.

The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

Modifications have been made to Planning application to include Alliance™ Glenoid implant system as a Pure Planning option (i.e. no Guides and Bone Models). In addition, modifications have been made to the user interface of the overall planning application. The planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.

AI/ML Overview

This FDA 510(k) premarket notification for the Signature™ ONE System does not contain the specific acceptance criteria, detailed study results, and statistical information typically required to fully answer your request regarding device performance and its proof. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study proving the device meets predefined clinical acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) or corresponding reported device performance metrics in a table format for clinical efficacy. The "Device Performance Testing" section mentions "Engineering Analysis" to "ensure the performance of the implemented features and verify related design inputs" but does not provide details on what these performance metrics were or their targets.

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

The document does not specify any sample size for a test set for clinical performance evaluation. It mentions "patient-specific radiological images" are used for planning, but no details about a dedicated test set of patients or images for validation are provided. Therefore, data provenance (country of origin, retrospective/prospective) is also not available here.

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)

This information is not provided. The application is for a planning and guiding system, where the ground truth regarding surgical accuracy would typically be established by comparing the planned outcome to the actual intraoperative or post-operative outcome, often involving expert surgeons. However, no such study details are present.

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

This information is not provided as there is no described test set of clinical images or cases requiring ground truth 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a planning and guiding system, not an AI diagnostic tool where human reader performance would typically be enhanced.

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

The document describes the Signature™ ONE System as assisting in "pre-operative planning and/or intra-operative guiding of surgical instruments." This inherently implies a human-in-the-loop system (the surgeon). The "planning application" is a software component, but its performance is not described in a standalone, algorithm-only context of clinical efficacy in this document. The "Software Verification and Validation Testing" addresses the software's compliance with regulations like IEC 62304 and its concern level ("moderate"), implying testing of its functionality and reliability, but not its clinical performance as a standalone entity in terms of accuracy against ground truth.

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

This information is not provided. For a surgical planning and guidance system, ground truth would ideally come from direct measurements of surgical accuracy and alignment post-procedure, or potentially surrogate measures confirmed by expert assessment.

8. The sample size for the training set

This information is not provided. While the system uses "patient-specific radiological images" for planning, the document does not discuss a "training set" in the context of an AI/ML model where a large dataset is used to train an algorithm. The system appears to be based on computational algorithms for planning rather than a deep learning model trained on a vast image dataset.

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

This information is not provided as there is no discussed training set.

Summary of what is present:

Software Verification and Validation Testing: This was conducted to satisfy FDA guidance and IEC 62304 for medical device software. The software is classified as "moderate" level of concern.
Engineering Analysis: Performed to ensure performance of implemented features and verify design inputs.
Usability Engineering: Addressed user interactions.

In conclusion, this 510(k) notification focuses on the substantial equivalence of the Signature™ ONE System to previously cleared predicate devices, asserting that its modifications (like adding Alliance™ Glenoid system compatibility) do not raise new questions of safety and effectiveness. It provides a general overview of verification and validation activities (software, engineering, usability) but lacks the detailed performance study results and specific acceptance criteria that you requested for a comprehensive understanding of the device's proven clinical effectiveness.

Summary

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June 5, 2020

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION".

Orthosoft Inc. (d/b/a Zimmer CAS) Sankalp Dere Regulatory Affairs Specialist 75 Queen Street Suite 3300 Montreal, QC H3C 2N6 Canada

Re: K200615

Trade/Device Name: Signature™ ONE System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE, KWT, KWS, PHX, MBF Dated: March 6, 2020 Received: March 9, 2020

Dear Sankalp Dere:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

For: Michael Owens. MS Acting 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) K200615

Device Name

Signature™ ONE System

Indications for Use (Describe)

The Signature™ ONE Guides and bone models 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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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Signature™ ONE System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

Sponsor:	Orthosoft, Inc (d/b/a. Zimmer CAS)75 Queen St., Suite 3300Montreal, QC, CANADA H3C 2N6Establishment Registration Number: 9617840
Contact Person:	Sankalp DereRegulatory Affairs SpecialistTelephone: (514-861-4074 Ext 312)
Date:	March 6, 2020
Subject Device:	Trade Name: Signature™ ONE SystemCommon Name: Shoulder Arthroplasty implantationsystem
	Classification Name:• QHE- Shoulder Arthroplasty implantation system (21CFR 888.3660)
	Additional Product Codes:• KWT- Shoulder joint metal/polymer non-constrainedcemented prosthesis (21 CFR 888.3650)• KWS- Shoulder joint metal/polymer semi-constrainedcemented prosthesis (21 CFR 888.3660)• PHX- Shoulder joint metal/polymer semi-constrainedcemented prosthesis (21 CFR 888.3660)• MBF- Shoulder joint metal/polymer/metalnonconstrained or semi-constrained porous-coateduncemented prosthesis (21 CFR 888.3670)

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Predicate Device(s):

K190595(Primary)	Signature™System	ONE	Zimmer CAS
K192074(Secondary)	Signature™System	ONE	Zimmer CAS

Purpose and Device Description:

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Indications for Use:	The Signature™ ONE System is indicated, based onpatient-specific radiological images with identifiableplacement anatomical landmarks, to assist in pre-operativeplanning and/or intra-operative guiding of surgicalinstruments for shoulder replacement surgical procedureson patients not precluded from being radiologicallyscanned.
	The Signature™ ONE System is to be used with the glenoidcomponents of the following shoulder implant systems inaccordance with their indications and contraindications:Zimmer® Trabecular Metal™ Reverse Plus Shoulder,Comprehensive® Total Shoulder System,Comprehensive® Reverse Shoulder System,Comprehensive® Reverse Augmented Baseplates andAlliance™ Glenoid System.
	The Signature™ ONE Guides and bone models areintended for single use only.
Differences in Indications for Use:	The proposed device offers options specific to thecompatible implant components that are not present in thepredicate devices.
Summary of TechnologicalCharacteristics:	The rationale for substantial equivalence is based onconsideration of the following characteristics:Intended Use: Same as predicate devices Indications for Use: Same as predicate device withaddition of Alliance™ Glenoid system Materials: Same as predicate device Sterilization: Same as predicate device Design Features: Modifications have been made to theplanning application, but the patient specific guides andbone models remain unchanged.

Summary of Performance Data (Nonclinical and/or Clinical)

The following performance data was provided in support of the substantial equivalence determination:

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Device Performance Testing:

Verification and Validation Testing for Signature™ ONE System was conducted with the following aspects:

Engineering Analysis- Tests were documented through O Engineering Rationales to ensure the performance of the implemented features and verify related design inputs
Usability Engineering- addressed user interactions with the о Signature™ ONE System

Software Verification and Validation Testing

Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software is considered a "moderate" level of concern, a malfunction in the device could lead to a minor injury. The testing demonstrates that the Signature™ ONE System does not raise any new issues of safety and effectiveness as compared to the predicate devices.

Substantial Equivalence Conclusion

The proposed and predicate devices have the same intended use and similar technological characteristics and the same principles of The proposed device offers options specific to the operation. compatible implant components that are not present in the predicate devices. In sum, any differences between the devices does not raise new questions of safety and effectiveness and the proposed device is at least as safe and effective as the legally marketed predicate devices.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”