(120 days)
Hardware
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 following total and reverse shoulder implant systems and their respective compatible components: the Reverse® Shoulder Prosthesis (K051075, K111629, K092873, K112069), the Turon® Shoulder System (K080402, K123982), and the AltiVate™ Anatomic Shoulder System (K162024), 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 and Depuy Synthes' GLOBAL® APG+ Shoulder System (K052472), the DELTA XTEND™ Reverse Shoulder System (K120174, K062250) and the GLOBAL® STEPTECH® APG Shoulder System (K092122) and their respective components. The Materialise Glenoid Positioning System guide is single use only.
Software
Surgicase Planner is intended to be used as a pre-surgical planner for surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of glenoid components. SurgiCase Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Materialise Glenoid Positioning Guide.
Materialise Glenoid Positioning Guides are patient-specific medical devices that are designed to assist the surgeon in the placement of glenoid components.
This can be done by generating a pre-surgical plan or by generating a pre-surgical plan and manufacturing patientspecific guides to transfer the plan to surgery. The device is a system composed of the following:
- . a software component, branded as SurgiCase Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient.
- a hardware component, branded as the Materialise Glenoid Positioning System™ guide, which is a patient specific guide that is based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guides will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery. The guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Glenoid Positioning System guide. A graft model can be delivered with the Materialise Glenoid Positioning System guide.
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 clearance by the FDA (K172054). However, it does not explicitly detail a separate study proving the device meets specific acceptance criteria with reported device performance metrics in a tabular format. Instead, it refers to previous testing and substantial equivalence to predicate devices.
Based on the information provided, here's a breakdown of what can be extracted and what is not explicitly stated:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a table format with specific performance metrics. It generally mentions that "Testing verified that the accuracy and performance of the system is adequate to perform as intended." without providing quantitative values for accuracy or other performance measures.
Study Details
The document refers to prior testing, but not a specific new study with detailed methodology and results for the K172054 submission. Instead, it leverages the substantial equivalence to predicate devices and previously conducted cadaver testing.
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated with quantitative values in this document. The general criteria seem to be that "accuracy and performance of the system is adequate to perform as intended" and that it is "as safe, as effective, and performs as well as the predicates."
- Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) are reported for this specific submission (K172054). The document relies on previous testing for predicate devices.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for a new test set. The document refers to "previous cadaver testing on previously cleared devices K153602 and K131559." The sample size for these previous cadaver tests is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The previous testing mentioned was "cadaver testing."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned.
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Adjudication method for the test set:
- Not mentioned.
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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:
- No MRMC comparative effectiveness study is mentioned. This device is a surgical instrument and planning software, not an AI-assisted diagnostic tool for human readers in the typical sense.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is partially addressed. The "Performance Data" section states, "Testing verified that the accuracy and performance of the system is adequate to perform as intended." This implies some level of standalone technical verification. However, no specific details on how this "accuracy and performance" was measured for the algorithm alone are provided, nor are any quantitative results. The software's function is to generate a pre-surgical plan, which is then inspected, fine-tuned, and approved by a qualified surgeon, indicating a human-in-the-loop process for clinical use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that "previous cadaver testing" was used, which would typically involve physical measurements on cadaveric specimens, possibly treated as the ground truth for validating instrument placement accuracy. More specific details are not provided.
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The sample size for the training set:
- Not mentioned. The document primarily focuses on the device cleared under K172054 and its substantial equivalence, not on the training of its underlying algorithms (if applicable, beyond general software development).
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How the ground truth for the training set was established:
- Not mentioned.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than detailing a new, comprehensive study with specific acceptance criteria and detailed performance results for the K172054 submission itself. It leverages prior testing and clearances.
§ 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.”