(190 days)
No reference devices were used in this submission.
No
The summary describes software for pre-surgical planning and generating patient-specific instrumentation based on CT scans and surgeon input. It focuses on visualization, measurement, reconstruction, and design tools. There is no mention of AI or ML in the intended use, device description, or performance studies. The validation studies focus on geometric accuracy and plan translation, not on performance metrics typically associated with AI/ML algorithms (like sensitivity, specificity, AUC).
No.
The device is a surgical planning software and a 3D positioner, which are tools to assist surgeons in total shoulder arthroplasty procedures, but they do not directly treat or diagnose a disease or condition in a patient.
No
The documentation explicitly states, "SmartSPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes."
No
The device description explicitly states that the SmartSPACE Shoulder System consists of both the SmartSPACE Shoulder Planner software and a 3D positioner, which is a hardware component used intraoperatively.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- SmartSPACE Shoulder System's Intended Use: The SmartSPACE Shoulder System is intended to assist surgeons in the pre-surgical planning and intraoperative positioning of glenoid components during shoulder arthroplasty procedures. It uses patient-specific CT scans to create a surgical plan and a 3D positioner to guide K-wire placement.
- No Specimen Examination: The system does not involve the collection, preparation, or examination of any specimens taken from the human body. It works directly with imaging data (CT scans) and provides physical guidance during surgery.
- Explicitly Stated Non-Diagnostic Use: The "Intended Use / Indications for Use" section explicitly states that the software "should not be used for diagnostic purposes."
Therefore, the SmartSPACE Shoulder System falls under the category of surgical planning and guidance devices, not In Vitro Diagnostics.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KWS, MBF, QHE
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.
Mentions image processing
SmartSPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan (Computed Tomography) images
Anatomical Site
Shoulder, glenoid
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
surgeons, pre-surgical planner for shoulder orthopedic surgery
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: 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 position should be compliant.
Key results: The validation method for performance testing was the same as the predicate. The subject device had sufficient validation.
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.
No reference devices were used in this submission.
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
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)
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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.