Smart SPACE Shoulder 3D Positioners and Anatomical Models
The Smart SPACE Shoulder 3D Positioners and Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to to transfer a pre-operative plan into surgery, designed on the basis of patient-specific pre-operative CT scans.
The Smart SPACE Shoulder 3D Positioners are intended, by quiding the surgical instruments in some steps of the orthopedic surgical procedure, to prepare the bone to host the implantable components.
The Smart SPACE Shoulder Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the surgeon. The model is intended to be used to check that the 3D Positioner(s) is properly placed on the anatomical compartment.
These devices must be exclusively utilized by an orthopedic surgeon who has a good knowledge of the specific operative technique.
Smart SPACE Shoulder 3D Positioners and Anatomical Models are indicated for use on adult patients that are candidates for primary elective reverse and anatomic total shoulder arthroplasty.

Smart SPACE Shoulder Planner
Smart SPACE Shoulder Planner is a medical device for surgeons component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
Smart SPACE Shoulder Planner does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner is intended to be used by an orthopedic surgeon, with clinical experience in shoulder replacement surgery to make decisions regarding implant position, orientation and sizing.
Smart SPACE Shoulder Planner is intended to be used for adult patients planning only. The Smart SPACE Shoulder Planner is intended for use with patients that are candidates for primary reverse and anatomic total shoulder arthroplasty.
The specific functionalities of the Smart SPACE Shoulder Planner version are described in the User Manual and Quick Start Guide provided by LimaCorporate.

Device Description

The Smart SPACE Shoulder Planner consists of a software which assists the user in planning anatomic total or reverse shoulder arthroplasty. It provides the user to select surgical execution using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance.
The Smart SPACE Shoulder system was cleared by TechMah Medical via K202151, K202454. K191247, and it includes the Smart SPACE Shoulder Planner, the Cubit Guidance system, the 3D Humeral and Glenoid Positioners and the Anatomical models. TechMah Medical became part of Limacorporate S.p.A in 2021.
With this registration, LimaCorporate aims to:

introduce an upgrade of the Smart SPACE Shoulder Planner; -
introduce the Smart SPACE Shoulder 3D Positioners and Anatomical Models manufactured by LimaCorporate, that are provided non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the Smart SPACE Shoulder Planner and 3D Positioners. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study.

Specifically, the document states: "Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices." This indicates that a study demonstrating the device meets acceptance criteria was not performed as part of this 510(k) submission. The FDA clearance is based on the device being substantially equivalent to a previously cleared device (K202151), not on a new clinical study.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

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

Cannot be provided: The document does not define specific acceptance criteria for performance, nor does it report performance metrics from a study designed to meet such criteria. It states that "the Smart SPACE Shoulder Planner and 3D Positioners manufactured by LimaCorporate S.p.A. and the Smart SPACE Shoulder System (K202151) manufactured by TechMah Medical LLC have substantially equivalent principles of operation and performance characteristics, with the exception of minor differences that aims to improve the software speed and memory usage, improve the user experience and solve bugs." This is a general statement of equivalence, not a report of measured performance against specific criteria.

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

Cannot be provided: No clinical or performance testing on a test set is described.

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)

Cannot be provided: No test set or ground truth establishment is described.

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

Cannot be provided: No test set or adjudication is described.

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

Cannot be provided: No MRMC study was done.

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

Cannot be provided: No standalone performance study is described. The device is a "pre-surgical planner" and "surgical instruments" intended for use by an orthopedic surgeon.

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

Cannot be provided: No ground truth is described because no new clinical performance study was conducted.

8. The sample size for the training set

Cannot be provided: The document does not mention the training of the AI or software, and therefore no training set size is provided. The device is an "upgrade" of an existing system, implying prior development, but details are not given here.

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

Cannot be provided: As no training set is described, neither is its ground truth establishment.

Based on the provided text, the key information regarding testing is:

Non-clinical testing: "The Software Testing has been performed on Smart SPACE Shoulder Planner according to the requirements of ANSI AAMI IEC 62304:2006/A1:2015." This refers to software lifecycle processes and safety, not clinical performance.
Clinical testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices."

Therefore, the document does not contain the information required to populate the fields related to specific acceptance criteria and a study proving those criteria were met, as no such study was performed or deemed necessary for this 510(k) clearance due to the substantial equivalence pathway.

Summary

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December 20, 2022

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 & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

LimaCorporate S.p.A % Kenneth Newman Regulatory Affairs Associate Lima USA Inc. 2001 NE Green Oaks Blvd. Ste 100 Arlington, Texas 76006

Re: K222405

Trade/Device Name: Smart SPACE Shoulder Planner and 3D Positioners Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE, KWS, MBF Dated: November 18, 2022 Received: November 21, 2022

Dear Kenneth Newman:

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

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801); medical device 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-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,

Image /page/1/Figure/5 description: The image shows a digital signature. The signature is by Farzana Sharmin -S. The date of the signature is 2022.12.20. The time of the signature is 13:50:10-05'00'.

For Victoria Lilling, M.D. 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)

· K222405

Device Name

Smart SPACE Shoulder Planner and 3D Positioners

Indications for Use (Describe)

Smart SPACE Shoulder 3D Positioners and Anatomical Models

The Smart SPACE Shoulder 3D Positioners and Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to to transfer a pre-operative plan into surgery, designed on the basis of patient-specific pre-operative CT scans.

The Smart SPACE Shoulder 3D Positioners are intended, by quiding the surgical instruments in some steps of the orthopedic surgical procedure, to prepare the bone to host the implantable components.

The Smart SPACE Shoulder Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the surgeon. The model is intended to be used to check that the 3D Positioner(s) is properly placed on the anatomical compartment.

These devices must be exclusively utilized by an orthopedic surgeon who has a good knowledge of the specific operative technique.

Smart SPACE Shoulder 3D Positioners and Anatomical Models are indicated for use on adult patients that are candidates for primary elective reverse and anatomic total shoulder arthroplasty.

Smart SPACE Shoulder Planner

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

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

Smart SPACE Shoulder Planner is intended to be used by an orthopedic surgeon, with clinical experience in shoulder replacement surgery to make decisions regarding implant position, orientation and sizing.

Smart SPACE Shoulder Planner is intended to be used for adult patients planning only. The Smart SPACE Shoulder Planner is intended for use with patients that are candidates for primary reverse and anatomic total shoulder arthroplasty.

The specific functionalities of the Smart SPACE Shoulder Planner version are described in the User Manual and Quick Start Guide provided by LimaCorporate.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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510(k) Summary

Date: December 20th, 2022

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy

U.S. Contact Person: Dr. Kenneth Newman Kenneth.Newman@limacorporate.com Lima USA Inc. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006, USA www.limacorporate.com Cell Phone: 682-597-3381

Trade name: Smart SPACE Shoulder Planner and 3D Positioners. Common Name: Shoulder Arthroplasty Implantation System

Classification Name

Product Code	Regulation and Classification Name
QHE	Shoulder Arthroplasty Implantation System per 21 CFR 888.3660
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented per21 CFR 888.3660
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncementedper 21 CFR 888.3670

Description:

The Smart SPACE Shoulder system was cleared by TechMah Medical via K202151, K202454. K191247, and it includes the Smart SPACE Shoulder Planner, the Cubit Guidance system, the 3D Humeral and Glenoid Positioners and the Anatomical models. TechMah Medical became part of Limacorporate S.p.A in 2021.

With this registration, LimaCorporate aims to:

introduce an upgrade of the Smart SPACE Shoulder Planner; -
introduce the Smart SPACE Shoulder 3D Positioners and Anatomical Models manufactured by LimaCorporate, that are provided non-sterile.

Indications for Use:

Smart SPACE Shoulder 3D Positioners and Anatomical Models

The Smart SPACE Shoulder 3D Positioners and Smart SPACE Shoulder Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to be a surgical tool to transfer a pre-operative plan into surgery, designed on the basis of

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patient-specific pre-operative CT scans.

The Smart SPACE Shoulder 3D Positioners are intended, by guiding the surgical instruments in some steps of the orthopedic surgical procedure, to prepare the bone to host the implantable components.

The Smart SPACE Shoulder Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the surgeon. The model is intended to be used to check that the 3D Positioners is properly placed on the anatomical compartment.

These devices must be exclusively utilized by an orthopaedic surgeon who has a good knowledge of the specific operative technique.

Smart SPACE Shoulder 3D Positioners and Anatomical Models are indicated for use on adult patients that are candidates for primary elective reverse and anatomic total shoulder arthroplasty.

Smart SPACE Shoulder Planner

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

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

The specific functionalities of the Smart SPACE Shoulder Planner version are described in the User Manual and Quick Start Guide provided by LimaCorporate.

Predicate Devices:

No.	Company	Device name	Cleared via
1	TECHMAHMEDICAL LLC	Smart SPACE Shoulder System	K202151, K202454,K191247,

Summary of technology comparison:

Traditional 510(k) - Smart SPACE Shoulder Planner and 3D Positioners December 20th, 2022

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The Smart SPACE Shoulder Planner and 3D Positioners manufactured by LimaCorporate S.p.A. and the Smart SPACE Shoulder System (K202151) manufactured by TechMah Medical LLC have substantially equivalent principles of operation and performance characteristics, with the exception of minor differences that aims to improve the software speed and memory usage, improve the user experience and solve bugs.

The Smart SPACE Shoulder 3D Positioners manufactured by LimaCorporate S.p.A. and the Smart SPACE 3D Positioners (K202151) manufactured by TechMah Medical LLC have substantially equivalent principles of operation, materials and performance characteristics.

The Smart SPACE Shoulder Glenoid 3D Positioners of the subject device are characterized by three similar designs that differ in minor design characteristics and are equivalent to the predicate device K202151. The Smart SPACE Shoulder Humerus 3D Positioner is provided with the same design of the device K202151.

Non-clinical testing

The Software Testing has been performed on Smart SPACE Shoulder Planner according to the requirements of ANSI AAMI IEC 62304:2006/A1:2015.

Clinical testing

Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices.

Conclusion

Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the Smart SPACE Shoulder Planner and 3D Positioners manufactured by LimaCorporate S.p.A are substantially equivalent to the predicate device identified in this premarket notification.

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.”