(181 days)
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 and 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 which includes the Aequalis Glenoid Guides and BLUEPRINT 3D planning software is the responsibility of 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 the Aequalis PerFORM + shoulder prostheses. 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 -plan an operation by allowing surgeons to: - position and select the glenoid implant, - design a patient specific pin guide.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Validation &/or Verification Method | Acceptance Value /Criteria | Reported Device Performance |
|---|---|---|
| Verify that the patient-specific solution is compatible with the instrumentation of Aequalis Perform+ in terms of technical, biological and clinical equivalences | Proven technical, biological and clinical equivalences | Acceptable |
| Compare post-operative clinical data with pre-operative plans to verify the accuracy of the patient-specific solution in Aequalis Perform+ configuration | Correct positioning of the main pin | Acceptable |
| Perform tests of software features when the Aequalis Perform+ is selected | No dysfunction of the software features and the Aequalis Perform+ is correctly displayed | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the "Compare post-operative clinical data with pre-operative plans" study. It also does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies mentioned focus on the device's compatibility and accuracy rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes the "BLUEPRINT 3D planning software" as a "medical device for surgeon composed of one software component" intended to "assist in pre-operative surgical planning." This implies a human-in-the-loop scenario, where the software assists the surgeon. The study to "Perform tests of software features when the Aequalis PerFORM+ is selected" verifies the software's functionality and display, which seems to be a standalone test of the algorithm's output within the software environment. However, it's not a standalone performance study in the sense of the algorithm diagnosing or acting without human interpretation or intervention for clinical outcomes.
The "Compare post-operative clinical data with pre-operative plans" study indirectly assesses the software's effectiveness when used by surgeons, but it's still about the overall patient-specific solution, including the guide.
7. The Type of Ground Truth Used
For the study "Compare post-operative clinical data with pre-operative plans to verify the accuracy of the patient-specific solution in Aequalis PerFORM+ configuration", the ground truth is derived from post-operative clinical data, specifically assessing the "correct positioning of the main pin." This suggests an objective measurement from actual surgical outcomes.
For the other two validation methods, "technical, biological, and clinical equivalences" and "no dysfunction of the software features," the ground truth would be based on predefined technical specifications, biological assessments, and functional requirements of the software, as well as presumably expert review of the software's output.
8. The Sample Size for the Training Set
The document does not provide information on the sample size used for the training set for the BLUEPRINT 3D planning software.
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. Since it is pre-surgical planning software, it's possible that historical CT-scans and corresponding surgical outcomes or expert annotations were used, but this is not specified.
§ 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.”