(140 days)
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: 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 BLUEPRINT™ 3D Planning Software. BLUEPRINT™ 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. BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide. BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).
Hardware: The BLUEPRINT™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses. The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated by the BLUEPRINTTM 3D Planning Software. All BLUEPRINT™ Glenoid Guides are patient-specific, single use and delivered non-sterile.
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 (anatomic and reversed). It is intended to help plan an operation by allowing surgeons to: Position and select glenoid implant, Position and select humeral implant, Display bone density and reaming surface, Simulate the prosthetic range of motion, Design a patient specific guide for the glenoid component.
The provided document is a 510(k) summary for the BLUEPRINT™ Patient Specific Instrumentation (K162800). It describes a medical device system composed of software (BLUEPRINT™ 3D Planning Software) and hardware (BLUEPRINT™ Glenoid Guides) used for pre-surgical planning and intraoperative guidance in shoulder arthroplasty procedures.
However, this document does not contain the specific details required to fully address all points in your request. It refers to previous 510(k) clearances (K143374 and K160555) for validation of the device, but it does not reproduce the detailed acceptance criteria and study results within this summary.
Based on the information available in this document, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This document does not explicitly state specific acceptance criteria (e.g., accuracy thresholds for guide placement) or detailed performance results in a table format. It broadly states that "The validation of BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was already proven via BLUEPRINT™ Patient Specific Instrumentation (K143374) and BLUEPRINT™ Patient Specific Instrumentation (K160555), including polyamide and titanium materials... The performed testing for validation of the design, manufacturing, biocompatibility, sterility, dimensions and the accuracy of the guide are applicable to the subject device."
To obtain this information, one would need to access the full 510(k) submissions for K143374 and K160555.
2. Sample size used for the test set and the data provenance:
This document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to previous validations but does not provide details about those studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with/without AI assistance. The software is described as a pre-surgical planner to assist surgeons, implying it's a tool, but not explicitly tested in an MRMC setting for diagnostic performance comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the software as a "pre-surgical planner" and the guides as assisting in "intraoperative positioning." This implies a human-in-the-loop scenario where the software aids the surgeon. It does not describe a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This document does not specify the type of ground truth used for validation. It refers to "accuracy of the guide" being validated, which suggests comparison to a known standard, but the nature of that standard (e.g., CMM measurements, post-operative CT) is not detailed.
8. The sample size for the training set:
This document does not mention any training set size as it concerns the validation of an already proven system. If the AI component (the 3D Planning Software) involved machine learning, this information would typically be in its original clearance or a more detailed technical document.
9. How the ground truth for the training set was established:
As no training set is mentioned in this document, this information is not available.
In summary:
This 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed technical report of a new primary clinical validation study with all the requested specifics. To get the requested information, one would need to consult the original 510(k) submissions for K143374 and K160555, as these are the documents indicated as containing the previous validation data.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
TORNIER SAS Aymen Azaiez Regulatory Affairs Specialist 161 rue Lavoisier 38330 Montbonnot Saint Martin France
Re: K162800
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: September 30, 2016 Received: October 5, 2016
Dear Aymen 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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/ResourcesforYou/Industry/default.htm. 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
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
BLUEPRINT Patient Specific Instrumentation
Indications for Use (Describe)
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
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 BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 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.
BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, blue font. Below that, the words "Implants Chirurgicaux" are in a smaller, bold, blue font.
510k Summary
Traditional 510(k) Premarket – BLUEPRINT™ Patient Specific Instrumentation
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1) Device name
| Trade name: | BLUEPRINT™ Patient Specific Instrumentation |
|---|---|
| Common name: | Patient Specific Instrumentation + 3D Planning Software |
| Classification name: | Prosthesis, Shoulder, Semi-constrained, Metal/Polymer Cemented($888.3660) |
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 Email: aymen.azaiez(@wright.com
4) Classification
Device class: Class II Classification panel: Orthopedic Product code: KWS
5) Primary Predicate Device and Reference devices
| Trade name | 510(k) Number | Decision date | Applicant |
|---|---|---|---|
| BLUEPRINT™ Patient SpecificInstrumentation(PRIMARY) | K160555 | 10th June 2016 | TORNIER SAS |
| Materialise Glenoid Positioning System(Reference) | K153602 | 26th April 2016 | MATERIALISE NV |
| TraumaCad Mobile Release 2.0 (Reference) | K160001 | 12th February 2016 | VOYANT HEALTH LTD |
| DYONICS PLAN HIP IMPINGEMENTPLANNING SYSTEM (Reference) | K132636 | 17th October 2016 | SMITH & NEPHEW, INC |
| OSIRIX MD (Reference) | K101342 | 20th August 2010 | PIXMEO SARL |
Image /page/4/Picture/14 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 provides a border around the 'T', further defining the logo's shape and structure. The overall design is simple, clean, and easily recognizable.
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
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6) Device description
BLUEPRINT™ Patient Specific Instrumentation is composed of two components: BLUEPRINT™ Glenoid Guides (hardware) and BLUEPRINT™ 3D Planning Software (software).
Hardware
The BLUEPRINT™ Glenoid Guides are patient-specially designed to facilitate the implantation of WRIGHT-TORNIER glenoid prostheses.
The BLUEPRINT™ Glenoid Guides are designed and manufactured based on a pre-operative plan generated by the BLUEPRINTTM 3D Planning Software. All BLUEPRINT™ Glenoid Guides are patient-specific, single use and delivered non-sterile.
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 (anatomic and reversed).
It is intended to help plan an operation by allowing surgeons to:
- Position and select glenoid implant,
- Position and select humeral implant,
- Display bone density and reaming surface, ●
- Simulate the prosthetic range of motion, 0
- Design a patient specific guide for the glenoid component. o
7) Materials
The commercially available BLUEPRINT™ Glenoid Guides are manufactured from medical grade polyamide (PA 2200) or titanium (Ti6Al4V).
8) Intended Use
Hardware
The BLUEPRINT™ Glenoid Guides are intended to be used as surgical instruments 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
The BLUEPRINT 3D Planning Software is intended to be used as a medical software to assist in pre-operative surgical planning for shoulder surgery.
Image /page/5/Picture/21 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 purple or blue. The logo appears to be 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
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Image /page/6/Picture/0 description: The image shows the logo for Tornier Implants Chirurgicaux. The word "TORNIER" is in large, bold, dark blue font. Below that, the words "Implants Chirurgicaux" are in a smaller, dark blue font.
9) Indications
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
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 BLUEPRINT™ 3D Planning Software.
BLUEPRINT™ 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.
BLUEPRINT™ 3D Planning Software does not include any system to manufacture the glenoid patient-specific guide.
BLUEPRINT™ 3D Planning Software is to be used for adult patients only and should not be used for diagnostic purpose.
10) Summary of technological characteristics
BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) has an equivalent intended use and the same fundamental scientific technology as the primary predicate and reference devices. The subject device is intended for total shoulder arthroplasty, (same as the predicate device) and for reverse shoulder arthroplasty (same as the reference device Materialise Glenoid Positioning System (K153602)). The subject device is equivalent to the predicate device for the main technological characteristics. Additionally, the subject device is equivalent to reference devices:
- Voyant Health, Ltd. TRAUMACAD VERSION 2.0 (K160001) for the humeral planning functionality -
- The Smith & Nephew DYONICS PLAN Hip Impingement Planning System (K132636) for the range of motion functionality
- -PIXMEO SARL OsiriX MD (K101342) for the bone density functionality
The design differences have been demonstrated to not affectiveness or raise new issues of safety or effectiveness.
Image /page/6/Picture/18 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is composed of two overlapping shapes, creating a layered effect. The color of the logo is a light shade of purple or blue. The overall design is 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
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Implants Chirurgicau
11) Performance data
BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was validated through nonclinical testing for the BLUEPRINT 3D Planning Software.
The validation of BLUEPRINT™ Patient Specific Instrumentation (Subject Device System) was already proven via BLUEPRINT™ Patient Specific Instrumentation (K143374) and BLUEPRINT™ Patient Specific Instrumentation (K160555), including polyamide and titanium materials, when used for helping the positioning of the Aequalis PerFORM (K111902) implant. The performed testing for validation of the design, manufacturing, biocompatibility, sterility, dimensions and the accuracy of the guide are applicable to the subject device. Technical, clinical and biological equivalences have been demonstrated in order to use BLUEPRINT™ Glenoid Guides with additional WRIGHT-TORNIER implants such as Aequalis PerFORM+ (K160975) and Aequalis Reversed II (K151293).
All BLUEPRINT™ Glenoid Guides aim to drill a K-wire guiding the main reaming, regardless of the implant planned. All BLUEPRINT™ Glenoid Guides have exactly the same design, except BLUEPRINT™ Glenoid Guides in titanium dedicated to be used with Aequalis PerFORM (K111902) and Aequalis PerFORM+ (K160975) implants which include an orientation hole for controlling rotation of the implant (cleared via BLUEPRINTTM Patient Specific Instrumentation (K160555)).
12) Conclusion
BLUEPRINT™ Patient Specific Instrumentation (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 (K160555) and the reference devices.
Based on the performance data presented for the design differences between the subject and predicate device, Tornier concludes that subject device is substantially equivalent to the predicate device.
Image /page/7/Picture/8 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is rendered in a light purple or blue color and appears to be constructed from geometric shapes, giving it a modern and somewhat abstract look. The hexagon provides a clear border around the 'T', making it stand out against the 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
§ 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.”