Who is the manufacturer of SmartSPACE Shoulder System?

Techmah Medical, LLC filed the 510(k) submission for SmartSPACE Shoulder System (K191247).

What is the FDA product code for SmartSPACE Shoulder System?

KWS. It is classified under 21 CFR 888.3660 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for SmartSPACE Shoulder System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SmartSPACE Shoulder System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SmartSPACE Shoulder System

K191247 · Techmah Medical, LLC · KWS · Nov 15, 2019 · Orthopedic

Device Facts

Record ID	K191247
Device Name	SmartSPACE Shoulder System
Applicant	Techmah Medical, LLC
Product Code	KWS · Orthopedic
Decision Date	Nov 15, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3660
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

SmartSPACE Shoulder 3D Positioner SmartSPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. SmartSPACE Shoulder Planner software SmartSPACE 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. SmartSPACE 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 SmartSPACE Shoulder Planner software. SmartSPACE 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. SmartSPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation. SmartSPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.

Device Story

System comprises SmartSPACE Shoulder Planner software and patient-specific 3D positioner. Software imports patient CT scans (DICOM); allows surgeon to visualize, measure, reconstruct, annotate, and edit anatomic data; enables design of patient-specific instrumentation. Output includes surgical report and 3D file for guide fabrication. Surgeon uses 3D positioner intraoperatively to guide glenoid K-wire placement for anatomic or reverse shoulder arthroplasty. Used in clinical settings by surgeons. Benefits include improved accuracy of component positioning based on patient-specific anatomy.

Clinical Evidence

Bench testing only. Validation included cadaveric studies and patient data analysis. Metrics: Glenoid version/inclination angle accuracy, guiding wire placement error (version, inclination, entry point), and segmentation accuracy (mean distance error between 3D reconstruction and reference). Human factors validation performed.

Technological Characteristics

Materials: Medical grade polyamide (PA2200). Software: Runs on standard Windows PCs; supports DICOM CT imports. Non-sterile, single-use 3D positioners. No energy source in guides. Software performs 3D reconstruction, measurement, and surgical planning.

Indications for Use

Indicated for adult patients undergoing total anatomic or reverse shoulder arthroplasty. Used to assist in intraoperative positioning of glenoid components via patient-specific 3D positioners based on preoperative CT scans.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

BLUEPRINT Patient Specific Instrumentation (K162800)

Related Devices

K202454 — Smart SPACE Shoulder System · Techmah Medical, LLC · Dec 28, 2020
K241143 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · May 22, 2024
K202151 — Smart SPACE Shoulder System · Techmah Medical, LLC · Feb 3, 2021
K160555 — BLUEPRINT Patient Specific Instrumentation · Tornier S.A.S. · Jun 10, 2016
K242813 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner · Materialise NV · Oct 18, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. TechMah Medical LLC % Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. SHREWSBURY VT 05738 Re: K191247 Trade/Device Name: SmartSPACE Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, MBF, QHE Dated: October 21, 2019 Received: October 21, 2019 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 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 {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191247 Device Name SmartSPACE Shoulder System Indications for Use (Describe) SmartSPACE Shoulder 3D Positioner SmartSPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. SmartSPACE Shoulder Planner software SmartSPACE 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. SmartSPACE 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 SmartSPACE Shoulder Planner software. SmartSPACE 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. SmartSPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation. SmartSPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K191247 # 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: l. SUBMITTER TechMah Medical LLC 2099 Thunderhead Rd., Suite 302 Knoxville, TN 37922 Tel: +1.877.725.6920 ext. 104 Contact Person: Mohamed R. Mahfouz, Ph.D. Date Prepared: May 7, 2019 | II. DEVICE | | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name of Device: | SmartSPACE Shoulder System | | Classification Name: | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Uncemented | | Regulation: | 21 CFR §888.3660 and 21 CFR §888.3670 | | Regulatory Class: | Class II | | Product Classification Code: | QHE, KWS and MBF (The device is a planning system and surgical guides in product code QHE, intended to be used with devices in product codes KWS and MBF) | | III. PREDICATE DEVICE | | Predicate Manufacturer: Tornier SAS Predicate Trade Name: BLUEPRINT Patient Specific Instrumentation Predicate 510(k): K162800 No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION The SmartSPACE Shoulder System consists of the SmartSPACE Shoulder Planner software and a 3D positioner which assists the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using a 3D positioner for glenoid K-wire placement. #### V. INDICATIONS FOR USE SmartSPACE Shoulder 3D Positioner SmartSPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. ### SmartSPACE Shoulder Planner software SmartSPACE 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. Page 1 of 5. {4}------------------------------------------------ SmartSPACE 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 SmartSPACE Shoulder Planner software. SmartSPACE 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 presurgical plan. The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation. SmartSPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation. SmartSPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes. ### Compatible Implant Systems The following Lima implants are supported by the SmartSPACE Shoulder System: | Device | 510(k) | |----------------------------------------------|------------------| | SMR Reverse - Metal Black | K113254 | | SMR Reverse – TT Metal Back | K133349 | | SMR Anatomic - Metal Back | K113254 | | SMR Anatomic – TT Metal Back | K133349 | | SMR Anatomic - 3 Pegs Glenoid | K130642, K153722 | | SMR Anatomic - Cemented Glenoid (single peg) | K100858 | | Hybrid Anatomic | K163397 | | Hybrid Reverse | K163397 | #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence: | | SmartSPACE Shoulder System | BLUEPRINT Glenoid Guides and 3D Planning Software – K162800 | Comments on Substantial Equivalence | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | SmartSPACE Shoulder 3D Positioner SmartSPACE Shoulder System instrumentation consists of a patient- specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. | Hardware: The BLUEPRINT™ Glenoid Guides are patient-specific drill guides. They have been specially designed to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans. Software: | Essentially identical indications for use. Therefore, Substantially Equivalent. | | | SmartSPACE Shoulder Planner software | | | | | SmartSPACE 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. SmartSPACE 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 SmartSPACE Shoulder Planner software. SmartSPACE 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. SmartSPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation. SmartSPACE Shoulder Planner software is to be used for adult patients only and should not be used | BLUEPRINTTM 3D Planning Software is a medical device for surgeon composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery. BLUEPRINTTM 3D Planning Software runs on standard personal and business computers running Microsoft Windows or Mac OS operating systems. The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with BLUEPRINTTM 3D Planning Software. BLUEPRINTTM 3D Planning Software allows surgeon to visualize, measure, reconstruct, annotate and edit anatomic data. It allows surgeon to design glenoid patient-specific guides based on the pre-surgical plan. The software leads to the generation of a surgery report along with a 3D file of the glenoid patient-specific guide. BLUEPRINTTM 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide. BLUEPRINTTM 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose. | | | Materials | for diagnostic purposes. Medical grade polyamide | The commercially available | The main patient | | | PA2200 | BLUEPRINT Glenoid Guides are manufactured from medical grade polyamide (PA 2200) or titanium (Ti6Al4V). | contacting material of the guides is the same for the predicate and subject device. | | Design | The SmartSPACE Shoulder System consists of the following functional elements: • SmartSPACE Shoulder Planner software • SmartSPACE Shoulder 3D Positioner | Surgical Guides and Planning Software | Both subject and predicate devices have glenoid guides and presurgical planning software. Therefore, they are substantially equivalent. | | Energy Source | Guides (3D positioners) have no energy source. Software Only, used on user's computer. | Guides have no energy source. Software Only, used on user's computer. | Substantially Equivalent | | Other Features | Single-Use Non-Sterile | Single-Use Non-Sterile | Substantially Equivalent | | Performance Testing | The SmartSPACE Shoulder System was validated through non-clinical studies performed on cadaveric specimen or performed by using patients' data including: - Glenoid Version and Inclination Angle Validation Test - The version and inclination angle between reference method and the software calculation should be compliant. - Patient-Specific Guiding Wire Test - Version angle error, inclination angle error and entry point error should be compliant. - Segmentation Accuracy Test - Mean Distance Error in the surgical zone between 3D reconstruction and the reference reconstruction should be compliant. - Cadaver Validation Study - Pre-operative surgical plan compared to post-operative implant position should be compliant. | BLUPRINT Patient Specific Instrumentation was validated through non-clinical studies performed on cadaveric specimen or performed by using patients' data including: - Seating Validation Test - Reaming Validation Test - Orientation and Direction Angles Validation Test - Glenoid Version and Inclination Angle Validation Test - Humeral Head Subluxation and Direction Measure - Patient Specific Guiding Wire Test - Segmentation Accuracy Test - Clinical Case Studies | The primary validation method was the same. They both required use of the software to produce guides and then use of the guides on cadaveric specimens. For the subject device, the seating and reaming can be conducted using the coverage map within the software, so this feature was validated through software testing. The subject device does not require subluxation measurement. The subject device also underwent Human Factors Validation testing to ensure users were able to use the software and guides as intended with the available instructions for use and training videos | K191247, Page 2 of 5. {5}------------------------------------------------ K191247, Page 3 of 5. {6}------------------------------------------------ # VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. # Sterilization & Shelf-life Testing Testing was performed to validate the end-user sterilization protocol of the subject device. # Biocompatibility Testing Biocompatibility testing per ISO 10993-1 was conducted to ensure the biocompatibility of the materials used in the 3D positioners. # Software Verification and Validation Testing K191247, Page 4 of 5. {7}------------------------------------------------ Software Verification and Validation Testing was conducted in accordance with the requirements of IEC 62304. The subject device also underwent Human Factors Validation testing to ensure users were able to use the software and guide as intended with the available instructions for use and training videos. # Benchtop Performance The SmartSPACE Shoulder System was validated through non-clinical studies performed on cadaveric specimen or performed by using patients' data including: - । Glenoid Version and Inclination Angle Validation Test - The version and inclination angle between reference method and the software calculation should be compliant. - Patient-Specific Guiding Wire Test - Version angle error, inclination angle error and entry point error should be compliant. - | Segmentation Accuracy Test - Mean Distance Error in the surgical zone between 3D reconstruction and the reference reconstruction should be compliant. - Cadaver Validation Study Pre-operative surgical plan compared to post-operative implant l position should be compliant. # VIII. CONCLUSIONS The SmartSPACE Shoulder System (Subject Device System) described in this section has an equivalent intended use and the same fundamental scientific technology as the cleared BLUEPRINT Patient Specific Instrumentation (K162800). Based on the performance data presented for the design differences between the subject device and predicate device, TechMah Medical concludes that the subject device is substantially equivalent to the predicate device.

SmartSPACE Shoulder System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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SmartSPACE Shoulder System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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