(131 days)
The Materialise Glenoid Positioning System is intended to be used as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans.
The Materialise Glenoid Positioning System can be used in conjunction with Stryker's ReUnion RSA Reverse Shoulder System (K130895) and its respective components, with DJO's Encore Shoulder System (K051075), Turon™ to RSP Conversion Shell (K111629), Turon™ Shoulder System (K080402) and Reverse® Shoulder prosthesis (K092873) and their respective components, and Lima's SMR Shoulder System (K100858), SMR Reverse Shoulder System (K110598), SMR Modular Glenoid (K113254), SMR 3-Pegs Glenoid (K130642), SMR TT Metal Back Glenoid (K133349), SMR 40mm Glenosphere (K142139) and SMR Modular Glenoid (K143256) and their respective components.
The Materialise Glenoid Positioning System guide is single use only.
The Materialise Glenoid Positioning System™ consists of a software component, SurgiCase Planner and a hardware component, Materialise Glenoid Positioning System™ guide, and is designed to assist the surgeon in the placement of glenoid components.
Materialise Glenoid Positioning Guides are patient-specific medical devices that are designed to assist the surgeon in the placement of glenoid components.
The Materialise Glenoid Positioning Guides must only be used within the intended use of the compatible components.
The provided text describes the Materialise Glenoid Positioning System and its 510(k) submission for clearance. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly present a table of acceptance criteria with numerical targets. However, it implicitly states that the device was validated through non-clinical tests to ensure accuracy and performance, and demonstrate substantial equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy | Adequate for intended use | Verified to be adequate |
| Biocompatibility | Applicable to subject device | Reached through previous testing and found applicable |
| Cleaning | Applicable to subject device | Reached through previous testing and found applicable |
| Debris | Applicable to subject device | Reached through previous testing and found applicable |
| Dimensional Stability | Applicable to subject device | Reached through previous testing and found applicable |
| Packaging | Applicable to subject device | Reached through previous testing and found applicable |
| Overall Performance | As safe, effective, and performs as well as predicate device | Validated through non-clinical tests (rapid prototyped bone models) and cadaver testing; demonstrated equivalent product performance to predicate device (K131559). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." The text mentions "rapid prototyped bone models" and "cadaver testing." This suggests the test set consisted of physical models and cadavers rather than patient data.
- Data Provenance: Not specified regarding country of origin. The studies were non-clinical ("rapid prototyped bone models" and "cadaver testing"), implying they were experimental setups rather than retrospective or prospective patient data studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the text. The documentation focuses on engineering and performance testing rather than assessment by clinical experts for ground truth. The "pre-surgical plan" is "fine-tuned and approved" by a "qualified surgeon," but this is part of the device's operational workflow, not the establishment of ground truth for its performance validation studies.
4. Adjudication Method for the Test Set
This information is not provided in the text. Given the nature of the validation (physical models and cadavers), adjudication by multiple experts in the traditional sense is unlikely to have been the primary method for determining accuracy. Accuracy would likely have been measured against pre-defined engineering tolerances or direct physical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study described focuses on the device's accuracy and performance in a standalone context against a predicate, not on how it improves human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. The text states: "Materialise Glenoid Positioning System was validated through non-clinical tests using rapid prototyped bone models to verify the system is adequate to perform as intended." This refers to evaluating the system's ability to precisely guide positioning against a pre-planned target, which is an assessment of the algorithm/system's accuracy. Cadaver testing also validates the device's performance in a more realistic surgical environment.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests likely involved pre-defined anatomical landmarks and surgical plans (for the rapid prototyped bone models) and cadaveric anatomy matched against the pre-surgical plan. The measurement of accuracy would be against the intended positioning based on these pre-established targets. It's not expert consensus, pathology, or outcomes data in the traditional sense, but rather a direct measurement against a known "correct" position derived from the surgical planning.
8. The Sample Size for the Training Set
The text does not mention a "training set" or any information related to machine learning model training. The device is described as a software component (SurgiCase Planner) and a hardware component (patient-specific guides) that creates pre-surgical plans and assists in intraoperative positioning. This suggests a rule-based or engineering-based design, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), this information is not applicable/provided.
§ 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.”