(134 days)
Not Found
No
The summary describes software for pre-surgical planning and designing patient-specific guides based on CT scans and surgeon input. It does not mention any AI or ML algorithms for image processing, analysis, or decision support. The software facilitates visualization, measurement, and design based on anatomical landmarks, which is a standard function of medical imaging software, not necessarily indicative of AI/ML.
No.
The Aequalis Glenoid Guides and BLUEPRINT 3D planning software are intended to assist in intraoperative positioning and surgical planning for total anatomic shoulder arthroplasty, not for direct therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states: "BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose."
No
The device description explicitly states that the BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software). While the software is a component, the overall device includes hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Intended Use: The intended use of the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is to assist surgeons in the intraoperative positioning of glenoid components during shoulder arthroplasty procedures. This is a surgical planning and guidance tool, not a diagnostic test performed on a biological sample.
- Explicit Statement: The text explicitly states under the "Intended Use / Indications for Use" section: "BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose."
Therefore, the device's function and stated purpose clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
The BLUEPRINT 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.
BLUEPRINT 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 BLUEPRINT3D planning software.
BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan.
This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.
The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide.
BLUEPRINT 3D planning software does not include any system to manufacture the guide.
BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.
Product codes (comma separated list FDA assigned to the subject device)
KWS
Device Description
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software).
BLUEPRINT™ Patient Specific Instrumentation is the responsibility of Tornier including the Aequalis Glenoid Guides and BLUEPRINT 3D planning software. Tornier is the legal manufacturer for the hardware and the software.
The hardware
The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and are exclusively reserved for this use.
The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.
The software
BluePrint 3D Planning software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (= total anatomic shoulder replacement).
It is intended to help to plan an operation by allowing surgeons to:
- position and to select the glenoid implant, ●
- design a patient specific pin guide.
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 (orthopedic surgeons) in a clinical/surgical setting.
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)
Non-clinical studies were performed on cadaveric specimens or by using patients' data. These studies validated various aspects of the device, including:
- Seating validation Test: Acceptable
- Reaming validation Test: Acceptable
- Orientation and Direction angles Validation Test: Acceptable
- Glenoid Version and Inclination angle validation test: Acceptable
- Humeral Head subluxation and direction measure: Acceptable
- Patient Specific Guiding Wire test: Acceptable
- Segmentation Accuracy Test: Acceptable
- Clinical Case Series (Pre-operative Plan compared to post-operative implant position): Acceptable
The testing aimed to validate the procedure of generating a patient specific guide matching the patient anatomy according to software measures and preoperative planning (implant positioning). No safety or efficacy issues were raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Seating offset between reference method and the software calculation should be compliant
- Reaming offset between reference method and the software calculation should be compliant
- Orientation angle offset and the Humeral Head Subluxation direction offset between reference method and the software calculation should be compliant
- Version angle offset between reference method and the software calculation should be compliant
- A concordance correlation coefficient ρ between the reference method and the software calculation of the inclination should be compliant
- Humeral Head Subluxation offset and the Humeral Head Subluxation direction offset between reference method and the software calculation should be compliant
- Version angle error, inclination angle error and entry point error should be compliant
- Mean Distance Error in the surgical zone between 3D reconstruction and the reference reconstruction should be compliant
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.
CAS PSI Shoulder, Zimmer CAS (K131129), SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, Materialise N.V. (K112389), Signature Personalized Patient Care System - Glenoid Guide System, Biomet Manufacturing Corp (K130126), Match Point System, Match Point System Guide, SurgiCase Connect, Materialise N.V. (K131559), Aequalis PerFORM glenoid System, TORNIER SAS (K111902), OsiriX MD, Pixmeo, SARL (K101342)
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2015
TORNIER SAS Mr. Aymen Azaiez Regulatory Affairs Specialist 161 Rue Lavoisier 38330 Montbonnot Saint Martin France
Re: K143374
Trade/Device Name: BLUEPRINT Patient Specific Instrumentation Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: March 3, 2015 Received: March 9, 2015
Dear Mr. Azaiez:
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. 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
1
Page 2 - Mr. Aymen Azaiez
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143374
Device Name BLUEPRINT Patient Specific Instrumentation
Indications for Use (Describe)
The hardware
The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
The software
The BLUEPRINT 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.
BLUEPRINT 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 BLUEPRINT3D planning software.
BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan.
This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.
The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide.
BLUEPRINT 3D planning software does not include any system to manufacture the guide.
BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120
3
Image /page/3/Picture/0 description: The image shows the words "TORNIER Implants Chirurgicaux" in a dark blue font. The word "TORNIER" is in a larger font than the words "Implants Chirurgicaux". The words are stacked on top of each other, with "TORNIER" on top and "Implants Chirurgicaux" on the bottom.
Summary of Safety and Effectiveness information Traditional 510(k) Premarket – BLUEPRINT™ Patient Specific Instrumentation (K143374)
| 1) Device name | |
|---|---|
| Trade name: | BLUEPRINT™ Patient Specific Instrumentation |
| Common name: | Patient Specific Instrument |
| (§888.3660) | Classification name: Prosthesis, Shoulder, Semi-constrained, Metal/Polymer Cemented |
2) Submitter :
TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034
3) Company contact :
Tornier SAS Mr Aymen AZAIEZ Regulatory Affairs Specialist 161 rue Lavoisier 38334 Montbonnot Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail : aymen.azaiez@tornier.com
4) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | KWS, |
5) Equivalent / Predicate device :
CAS PSI Shoulder, Zimmer CAS (K131129) SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides, Materialise N.V. (K112389) Signature Personalized Patient Care System - Glenoid Guide System, Biomet Manufacturing Corp (K130126) Match Point System, Match Point System Guide, SurgiCase Connect, Materialise N.V. (K131559). Aequalis PerFORM glenoid System, TORNIER SAS (K111902) OsiriX MD, Pixmeo, SARL (K101342)
Image /page/3/Picture/11 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by two overlapping shapes, creating a three-dimensional effect. The color of the logo is a light shade of blue or lavender. The overall design is simple and modern, suggesting a tech-related or innovative company.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
4
Image /page/4/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, blue font on the top line. The words "Implants Chirurgicaux" are in a smaller, bold, blue font on the second line.
6) Device description :
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software (software).
BLUEPRINT™ Patient Specific Instrumentation is the responsibility of Tornier including the Aequalis Glenoid Guides and BLUEPRINT 3D planning software. Tornier is the legal manufacturer for the hardware and the software.
The hardware
The Aequalis Glenoid Guides are patient-specific instruments specially designed to facilitate the implantation of the Aequalis PerFORM shoulder prostheses and are exclusively reserved for this use.
The Aequalis Glenoid Guides are designed and manufactured based on a pre-operative plan generated only by the software BLUEPRINT™ 3D planning software.
The software
BluePrint 3D Planning software is composed of one software component connected to an Online Management System (OMS). The software installed on a computer is intended to be used by orthopedic surgeons, as a preoperative planning software for shoulder arthroplasty surgery (= total anatomic shoulder replacement).
It is intended to help to plan an operation by allowing surgeons to:
- position and to select the glenoid implant, ●
- design a patient specific pin guide.
Intended Use
The hardware
The Aequalis Glenoid Guides are intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic shoulder arthroplastv procedures using anatomic landmarks that are identifiable on patient-specific preoperative CTscans.
Image /page/4/Picture/15 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The logo is rendered in a light blue or lavender color, providing a soft and clean aesthetic. The hexagon shape provides a clear border for the logo.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
5
Image /page/5/Picture/0 description: The image displays the word "TORNIER" in large, bold, dark blue font. Below it, in a smaller, but still bold, dark blue font, are the words "Implants Chirugicaux". The text appears to be a logo or heading, possibly for a medical or surgical company.
The software
The BLUEPRINT 3D planning software is intended to be used as a medical software to assist in pre-operative surgical planning for shoulder surgery.
7) Materials :
The Aequalis Glenoid Guides are manufactured from polyamide 2200 medical grade.
8) Indications :
The hardware
The Aequalis 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 shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT-scans.
Aequalis PerFORM Anatomic Glenoid Guide is used by surgeons to facilitate the placement of the Aequalis PerFORM glenoids.
The software
The BLUEPRINT 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.
BLUEPRINT 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 BLUEPRINT3D planning software.
BLUEPRINT 3D planning software allows surgeon to visualize, measure, reconstruct, and annotate anatomic data. It allows surgeon to design patient specific guides based on the presurgical plan.
This device is intended for use provided anatomic reference points necessary for positioning of the guide are present on the CT scan.
The software leads to the generation of a surgery report along with a 3D file of the patient-specific guide.
BLUEPRINT 3D planning software does not include any system to manufacture the guide.
BLUEPRINT 3D planning software is to be used for adult patients only and should not be used for Diagnostic purpose.
Image /page/5/Picture/18 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light blue color and appears to be constructed from geometric shapes, giving it a modern and somewhat abstract look. The hexagon provides a clear border for the logo, making it stand out against a white background. The logo is simple, clean, and likely represents a company or organization whose name begins with the letter 'T'.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
6
9) Summary of technological characteristics
Table 1: Main features comparison
| Main features or
system
characteristics | BLUEPRINTTM
Patient Specific
Instrumentation | CAS PSI
Shoulder Guide
(K131129) | SurgiCase Guides
(K112389) | Signature Personalized
Patient Care System -
Glenoid Guide System
(K130126) | Match Point
System Guide
(K131559) | Aequalis
PerFORM
glenoid System
(K111902) | OsiriX
MD
(K101342) |
|-----------------------------------------------|----------------------------------------------------|----------------------------------------|-------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------------|---------------------------|
| Material | Polyamide 2200 | Polyamide | Polyamide 2200 | Plastic | Polyamide 2200 | UHMWPE +
CoCr | NA |
| Standard | USP Class VI
compatible | Unknown | USP Class VI
compatible | Unknown | USP Class VI
compatible | ISO 5834-2
ISO 5832-7 | NA |
| Product Code | KWS | KWS, PBF | PBF | KWS, KWT, PAO-, and
MBF | KWS | KWS | LLZ |
| Surgical
procedure | Total anatomic
shoulder
arthroplasty | Reversed shoulder
arthroplasty | Upper extremities | Total and reverse shoulder
arthroplasty | Total and reverse
shoulder
arthroplasty | Anatomic
shoulder
arthroplasty | Mammogr
aphy |
| Single-use | Yes | Yes | Yes | Yes | Yes | Yes | NA |
| Sterile | No | No | No | No | No | Yes | NA |
| Manufacturer | Tornier SAS | Zimmer | Materialise N.V. | Biomet | Materialise N.V | Tornier SAS | Pixmeo,
SARL |
Device comparison showed that the proposed device is substantially equivalent in intended use, materials to the predicate devices.
Image /page/6/Picture/5 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light blue color and appears to be constructed from geometric shapes, giving it a modern and abstract look. The hexagon surrounding the 'T' is outlined in the same light blue color, providing a border for the central design element. The logo is simple, clean, and likely represents a company or organization whose name begins with the letter 'T'.
TORNIER S.A.S. Tél. : 33 (0)4 76 61 35 00 161, rue Lavoisier Fax : 33 (0)4 76 61 35 33 38334 MONTBONNOT CEDEX FRANCE
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
SIEGE SOCIAL 161, rue Lavoisier - 38330 MONTBONNOT SAINT MARTIN - FRANCE
GFM-00000123 REV B - Tornier
Section 5 – Page 4 / Page 6
7
Implants Chirurgicaux
10) Non-clinical testing
BLUEPRINT™ Patient Specific Instrumentation was validated through non-clinical studies performed on cadaveric specimen or performed by using patients' data:
| Validation and / or
Verification Method | Acceptance Criteria description | Verification
and
Validation
Results |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Seating validation Test | The seating offset between reference method and the
software calculation should be compliant | Acceptable |
| Reaming validation Test | The Reaming offset between reference method and the
software calculation should be compliant | Acceptable |
| Orientation and Direction
angles Validation Test | The orientation angle offset and the Humeral Head
Subluxation direction offset between reference method and the
software calculation should be compliant | Acceptable |
| Glenoid Version and
Inclination angle validation
test | The version angle offset between reference method and the
software calculation should be compliant
A concordance correlation coefficient $ρ$ between the
reference method and the software calculation of the
inclination should be compliant | Acceptable |
| Humeral Head subluxation
and direction measure | The Humeral Head Subluxation offset and the Humeral Head
Subluxation direction offset between reference method and the
software calculation should be compliant | Acceptable |
| Patient Specific Guiding
Wire test | Version angle error, inclination angle error and entry point
error should be compliant | Acceptable |
| Segmentation Accuracy
Test | Mean Distance Error in the surgical zone between 3D
reconstruction and the reference reconstruction should be
compliant | Acceptable |
| Clinical Case Series | Pre-operative Plan compared to post-operative implant
position | Acceptable |
This testing aims to validate the procedure of generating a patient specific guide matching the patient anatomy according to software measures and preoperative planning (implant positioning).
Non clinical testing was performed on BLUEPRINT™ Patient Specific Instrumentation to assess the performance of the device and to demonstrate substantial equivalence to the predicate devices. No safety or efficacy issues were raised with this device based on the testing.
Image /page/7/Picture/6 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is formed by two overlapping shapes, creating a three-dimensional effect. The hexagon and the "T" are both light blue. The logo appears simple and modern.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A
8
Implants Chirurgicau
11) Substantial equivalence conclusion
Based upon this comparative study, substantial equivalence of BLUEPRINT™ Patient Specific Instrumentation to the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision making Process:
- BLUEPRINT™ Patient Specific Instrumentation is compared to the predicate devices. -
- -BLUEPRINT™ Patient Specific Instrumentation has the same intended use as predicate devices: CAS PSI Shoulder, SurgiCase Guides, Signature Personalized Patient Care System - Glenoid Guide System, Match Point System Guide.
- -BLUEPRINT 3D planning software comparison analysis showed that the proposed substantially equivalent to similar features of automatic segmentation to predicate device Osirix.
- -BLUEPRINT 3D planning software user manual is similar in indications precautions, warnings, and instructions as the predicate devices: CAS PSI Shoulder, SurgiCase Guides, Signature Personalized.
- -Major technological characteristics are equivalent between BLUEPRINT™ Patient Specific Instrumentation and the predicate devices:
- Equivalence of general features -
- Equivalent surgical procedures -
- -Equivalent materials
- Equivalent intended use, indications for use -
Therefore, in the light of the above information, the BLUEPRINT™ Patient Specific Instrumentation is found to be equivalent to the predicate devices.
Image /page/8/Picture/13 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is formed by two overlapping "T" shapes, creating a unique and modern design. The hexagon and the "T" are both colored in a light blue or lavender hue, providing a soft and clean aesthetic. The logo appears simple yet distinctive, suitable for a brand identity.
TORNIER S.A.S. 161, rue Lavoisier 38334 MONTBONNOT CEDEX FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 S.A.S. au capital de 35 043 008 € SIRET : 070 501 275 000 21 R.C.S. : 070 501 275 CODE APE : 3250 A