(184 days)
No
The document describes software for pre-surgical planning and patient-specific instrumentation design based on CT scans, but it does not mention or imply the use of AI or ML for image analysis, planning, or guidance. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a pre-surgical planner, 3D positioner, and guidance system that assists surgeons in planning and executing shoulder arthroplasty procedures, but it does not directly treat a disease or condition itself.
No
The device description explicitly states: "Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes."
No
While the summary describes a software component ("Smart SPACE Shoulder Planner software"), it also explicitly mentions and includes hardware components as part of the overall "Smart SPACE Shoulder System," specifically a "patient-specific 3D positioner" and "single use instrumentation" in the "Smart SPACE Shoulder Cubit Guidance." The benchtop performance studies also involve cadaveric specimens and the "Guidance System," further indicating hardware involvement.
Based on the provided information, the Smart SPACE Shoulder System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is designed to "assist in the intraoperative positioning of shoulder components" and for "pre-surgical planning for shoulder orthopedic surgery." This is a surgical planning and guidance system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces its role in surgical planning and execution of shoulder arthroplasty.
- Input Data: While it uses CT scan images, these are used for anatomical visualization and planning, not for analyzing biological samples.
- Explicit Statement: The "Smart SPACE Shoulder Planner software" section explicitly states that it "should not be used for diagnostic purposes."
IVD devices are typically used to test blood, urine, tissue, or other bodily fluids or samples to detect diseases, conditions, or infections. The Smart SPACE Shoulder System's function is entirely focused on surgical planning and execution based on anatomical imaging.
N/A
Intended Use / Indications for Use
Smart SPACE Shoulder 3D Positioner
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.
Product codes (comma separated list FDA assigned to the subject device)
QHE, KWS, OLO, MBF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan (Computed Tomography)
Anatomical Site
Shoulder
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
Surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
Sterilization, shelf life, and shipping validations were performed according to ISO 11135:2014, ISO 10993-7:2008, and ISO 11137-1:2018.
Biocompatibility Testing
Biocompatibility testing per ISO 10993-1:2018 was conducted to ensure the biocompatibility of the materials used in the 3D Positioner/3D Mapper, instrument adaptors, and Cubit sensors.
Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety and Electromagnetic Compatibility testing was performed on the Cubit sensors of the subject device. Electrical safety of the Cubit sensor was tested to IEC 60601-1:2012, and electromagnetic compatibility of the Cubit Sensor was tested to IEC 60601-1-2:2014. Additional testing was conducted on the Lithium Power Cell per IEC 62133-2. Intentional Radiator testing was conducted per Title 47 of the CFR, Ch. 1 (03-01-2020 ed.). Ingress Testing was conducted per IEC 60529 Ed. 2.2(2013).
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted in accordance with the requirements of ANSI AAMI IEC 62304:2006/A1:2015. The following FDA guidance documents were also followed: General Principles of Software Validation, Off-The-Shelf Software Used in Medical Devices, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, Postmarket Management of Cybersecurity in Medical Devices, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Usability Testing
Usability was validated in accordance with IEC 62366-1:2015 and 60601-1-6:2013.
Mechanical and Acoustic Testing
Mechanical and Acoustic testing was not applicable for this submission because the device is intended to be used as a temporary guide during a surgical procedure without critical mechanical performance testing requirements.
Animal Study
Animal performance testing was not required to demonstrate the safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
Benchtop Performance
The Smart SPACE Shoulder System was validated through non-clinical studies performed on cadaveric specimens.
Post-operative implant placement was compared with the executed implant position captured by the Guidance System.
Testing has successfully demonstrated that the subject device performs as well as the predicate device with respect to version, inclination, and entry point.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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
1
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
2
Indications for Use
510(k) Number (if known) K202151
Device Name Smart SPACE Shoulder System
Indications for Use (Describe)
Smart SPACE Shoulder 3D Positioner
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.
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.
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4
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
SUBMITTER l.
TechMah Medical LLC 2099 Thunderhead Rd., Suite 302 Knoxville, TN 37922 Tel: +1.877.725.6920 ext. 104
| Primary Contact Person: | Mary Vater, 510(k) Consultant |
|---|---|
| Primary Contact Email: | mary@fdaecopy.com |
| Contact Person: | Mohamed R. Mahfouz, Ph.D. |
| Date Prepared: | July 31, 2020 |
DEVICE II.
| Name of Device: | Smart SPACE Shoulder System |
|---|---|
| Classification Name: | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, | |
| Uncemented | |
| Orthopedic Stereotaxic Instrument | |
| Regulation: | 21 CFR §888.3660, 21 CFR §888.3670, and 21 CFR §882.4560 |
| Regulatory Class: | Class II |
| Product Classification Code: | OHE, KWS, MBF, OLO |
PREDICATE and REFERENCE DEVICES III.
| Predicate Manufacturer: | TechMah Medical LLC |
|---|---|
| Predicate Trade Name: | SmartSPACE Shoulder System |
| Predicate 510(k): | K191247 |
| Predicate Product Code: | QHE, KWS, MBF |
| Reference Manufacturer: | Orthosoft Inc. (d/b/a Zimmer CAS) |
| Reference Trade Name: | iASSIST Knee System |
| Reference 510(k): | K192080 |
| Reference Product Code: | OLO |
DEVICE DESCRIPTION IV.
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
5
Lima Corporate shoulder replacement implants; Verification testing was conducted utilizing those systems.
V. INDICATIONS FOR USE
Smart SPACE Shoulder 3D Positioner
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 presurgical 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
- Indications for Use The predicate and subject device have equivalent indications for use both -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------are indicated for use in total anatomic or reverse shoulder arthroplasty for planning of the procedure
6
and to assist in the accurate placement of surgical implants.
- Materials The predicate and subject device have the same patient contacting material for the 3D | Positioner/3D Mapper, which is PA2200. The Cubit sensor enclosures and adaptors to surgical instruments are made of Lustran 348 ABS, and the sensor power button is made of VersaFlex OM 1040x. Biocompatibility safety testing has been conducted on all materials and they were found to be biocompatible.
- Design The predicate and subject device use the same software technology for surgical planning and final design of the 3D positioner/3D mapper. The subject device has the additional optional use of the Guidance system, which contains sensors (pods) to determine the correct positioning and alignment of the surgical instruments. This new design feature has been verified and validated and performs as well as the guide.
- -Energy Source - The predicate and subject devices' software runs on computers. The 3D Positioner/3D Mapper and adaptors themselves do not have an energy source, but the subject device Cubit sensors that connect to the adaptors have lithium batteries. The energy source to the subject device has been safety and performance tested.
- Other Design Features Both the predicate and the subject device have single use components. -The predicate device components are provided non-sterile, and the subject device has both sterile and non-sterile components.
- Performance Testing – The subject and predicate device were primarily validated using non-clinical studies performed on cadaveric specimens. The subject device also underwent other testing. including electronics testing and usability engineering validation. The primary validation methods are the same and demonstrate compliance with the same recognized standards, demonstrating equivalence.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE REFERENCE DEVICE
The following characteristics were compared between the subject device and the reference device:
- Indications for Use The subject device has indications for use that include both the planning software and the guidance system. The reference device has equivalent indications for assisting in the accurate placement of surgical implants as the subject device.
- Materials - The subject device uses PA2200 for the 3D Positioner/3D Mapper. The Cubit sensor enclosures and adaptors to surgical instruments are made of Lustran 348 ABS, and the reference device uses an unspecified plastic for its equivalent instrument guides. Biocompatibility safety testing has been conducted on all materials for both the subject device and the reference device and they were found to be biocompatible.
- -Design - The subject and reference device both use wireless pods containing orientation sensors to support proper instrument alignment and accurate implant placement.
- -Energy Source – The subject and reference device both have software that runs on tablets powered by lithium batteries, and the Cubit sensors of the subject device and the pods of the reference device run on lithium batteries.
- Other Design Features The subject and the reference device have single use components which are provided both sterile and non-sterile.
- Performance Testing The subject and reference device were primarily validated using non-clinical studies performed on cadaveric specimens, software verification and validation testing, electronics testing, and usability engineering. The primary validation methods are the same and demonstrate compliance with the same recognized standards, demonstrating substantial equivalence.
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VII. SAFETY AND PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
Sterilization, shelf life, and shipping validations were performed according to ISO 11135:2014, ISO 10993-7:2008, and ISO 11137-1:2018.
Biocompatibility Testing
Biocompatibility testing per ISO 10993-1:2018 was conducted to ensure the biocompatibility of the materials used in the 3D Positioner/3D Mapper, instrument adaptors, and Cubit sensors.
Electrical safety and electromagnetic compatibility (EMC)
Electrical Safety and Electromagnetic Compatibility testing was performed on the Cubit sensors of the subject device. Electrical safety of the Cubit sensor was tested to IEC 60601-1:2012, and electromagnetic compatibility of the Cubit Sensor was tested to IEC 60601-1-2:2014. Additional testing was conducted on the Lithium Power Cell per IEC 62133-2. Intentional Radiator testing was conducted per Title 47 of the CFR, Ch. 1 (03-01-2020 ed.). Ingress Testing was conducted per IEC 60529 Ed. 2.2(2013).
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted in accordance with the requirements of ANSI AAMI IEC 62304:2006/A1:2015. The following FDA guidance documents were also followed: General Principles of Software Validation, Off-The-Shelf Software Used in Medical Devices, Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software, Postmarket Management of Cybersecurity in Medical Devices, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Usability Testing
Usability was validated in accordance with IEC 62366-1:2015 and 60601-1-6:2013.
Mechanical and Acoustic Testing
Mechanical and Acoustic testing was not applicable for this submission because the device is intended to be used as a temporary guide during a surgical procedure without critical mechanical performance testing requirements.
Animal Study
Animal performance testing was not required to demonstrate the safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
Benchtop Performance
The Smart SPACE Shoulder System was validated through non-clinical studies performed on cadaveric specimens.
Post-operative implant placement was compared with the executed implant position captured by the Guidance System.
Testing has successfully demonstrated that the subject device performs as well as the predicate device with respect to version, inclination, and entry point.
8
VIII. CONCLUSIONS
The Smart SPACE Shoulder System (Subject Device System) described in this section has an equivalent intended use and the same fundamental scientific technology as the cleared predicate device, the Smart SPACE Shoulder System (K191247). The additional technological characteristic of the subject device is comparable to the reference device, the iASSIST Knee System (K192080).
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.