(134 days)
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.
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.
The provided text describes BLUEPRINT™ Patient Specific Instrumentation, which consists of Aequalis Glenoid Guides (hardware) and BLUEPRINT 3D planning software. The hardware comprises patient-specific drill guides, and the software is a pre-surgical planner for shoulder orthopedic surgery.
The validation of this device was performed through non-clinical studies using cadaveric specimens or patient data. The summary outlines several validation tests and lists their acceptance criteria as "compliant" or "acceptable," but does not provide specific numerical thresholds for these criteria.
Here's the information requested based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Validation and/or Verification Method | Acceptance Criteria Description | Reported Device Performance |
|---|---|---|
| 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 |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "non-clinical studies performed on cadaveric specimen or performed by using patients' data" for validation. However, it does not specify the sample size for the cadaveric specimens or the patient data, nor does it explicitly state the country of origin or whether the patient data was retrospective or prospective. The "Clinical Case Series" also lacks specific sample size details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It refers to "reference method" and "reference reconstruction" for ground truth but doesn't detail how these were established by experts.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with AI vs. without AI assistance. The testing described is primarily focused on the software's accuracy against a "reference method."
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study of the algorithm's performance appears to have been done. The "Validation and/or Verification Method" in the table explicitly refers to comparing "software calculation" or "3D reconstruction" to a "reference method/reconstruction," indicating that the algorithm's output was directly assessed without human intervention in the loop for those specific tests. The "Clinical Case Series" test involved comparing a "Pre-operative Plan" (generated by the software) to the "post-operative implant position," which also implies an assessment of the software's planning accuracy.
7. The Type of Ground Truth Used:
The ground truth used appears to be a "reference method" or "reference reconstruction" for the various validation tests. For the clinical case series, the ground truth was the "post-operative implant position." While the document implies these are established standards or measurements, it does not explicitly state whether this was expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
The document does not specify the sample size for the training set used for the BLUEPRINT 3D planning software. It only mentions that the studies used "cadaveric specimen or performed by using patients' data."
9. How the Ground Truth for the Training Set was Established:
The document does not provide information on how the ground truth for the training set was established. It describes validation testing but not the process of training the algorithm.
§ 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.”