(28 days)
Hardware: The Materialise Shoulder Guide and Models are 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 Shoulder Guide and Models are single use only. The Materialise Shoulder Guide and Models can be used in conjunction with the following total and reverse shoulder implants systems and their respective compatible components: Depuy Synthes', DJO's, Smith+Nephew's, Lima's, Stryker's.
Software: SurgiCase Shoulder Planner is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder orthopedic surgery. The software is used to assist in the positioning of shoulder components. SurgiCase Shoulder 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 Shoulder Guide and Models.
Materialise Shoulder System™ is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific glenoid guide and models to transfer the glenoid plan to surgery. The device is a system composed of the following: a software component, branded as SurgiCase Shoulder Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient. Materialise Shoulder Guide and Models, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific glenoid guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the glenoid plan to surgery. The Materialise Shoulder Guide is designed and manufactured to fit the anatomy of a specific patient. A bone model of the scapula is delivered with the Materialise Shoulder Guide. A graft model can be delivered with the Materialise Shoulder Guide. The graft model visualizes the graftspace between implant and bone, based on the pre-operative planning of the surgeon. The graft model serves as a visual reference for the surgeon in the OR.
The provided text is a 510(k) summary for the Materialise Shoulder System™, which includes the Materialise Shoulder Guide and Models (hardware) and the SurgiCase Shoulder Planner (software). This submission is for an extension of compatibility with additional Lima's Implant components, not a new device requiring a full de novo performance study. Therefore, the information regarding acceptance criteria and performance studies is limited and focuses on showing equivalence to the predicate device.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the performance data in a qualitative manner, emphasizing equivalence to the predicate and existing testing. It does not provide a quantitative table of specific acceptance criteria (e.g., in terms of accuracy metrics, sensitivity, specificity) and corresponding performance outcomes for the newly added functionalities. Instead, it relies on the established performance of the predicate and the assertion that the changes do not affect safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software Functionality (Planning, Visualization, Features) | "The planning functionality, visualization options and planning features are the same for the glenoid planning of the subject device as for the predicate device." |
| Software Technology (Codebase, V&V Methods) | "The subject device has the same code base as the predicate device and uses the same methods for design and verification and validation as the predicate device." |
| Safety and Effectiveness of Software Changes | "The subject software technology differences have been demonstrated that they do not affect the safety or effectiveness, or that they do not raise any new issues regarding to the safety and effectiveness compared to the predicate device." |
| Hardware Intended Use, Design, Functionality, Operating Principles, Materials, Performance | "The subject hardware device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics compared with the predicate device." |
| Hardware Accuracy and Performance (General) | "Testing verified that the accuracy and performance of the system is adequate to perform as intended." (Applicable to previous versions, carried over) |
| Biocompatibility, Sterility, Cleaning, Debris, Dimensional Stability, Packaging | "Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device." |
2. Sample size used for the test set and the data provenance:
- Software Validation: The document states that "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" However, it does not specify the sample size used for the test set (number of cases/patients) or the data provenance (e.g., country of origin, retrospective/prospective). The validation is described as "verification against defined requirements, and validation against user needs," but no details on the specific data used for this validation are provided in this summary.
- Hardware Testing: For hardware, it mentions "simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559." Again, sample sizes (e.g., number of models or cadavers) are not provided. The data provenance is implied to be from previous testing of predicate/cleared devices, but no specific details are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given that the submission focuses on substantial equivalence for an expanded compatibility, explicit ground truth establishment by experts for specific new performance metrics is not detailed. The "approved glenoid pre-surgical plan" by a "qualified surgeon" for generating guides suggests expert involvement in the planning process, but not in a formal ground truth assessment for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. As no formal multi-reader ground truth establishment is described for a test set, an adjudication method would not be applicable in the context of the information given.
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:
- No MRMC comparative effectiveness study is mentioned. The device is a surgical planning tool and patient-specific instrumentation, not an AI diagnostic aid for human readers in the traditional sense. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's stated purpose and is not included in the submission summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The software component, SurgiCase Shoulder Planner, is described as assisting in the positioning of shoulder components and allowing the surgeon to "visualize, measure, reconstruct, annotate and edit pre-surgical plan data." The output is a "pre-surgical plan data file." This indicates a human-in-the-loop process where the surgeon interacts with and approves the plan.
- While software verification and validation were performed, the summary does not explicitly describe a "standalone" performance study of the algorithm only in isolation from human interaction for clinical decision-making. Its function is to facilitate human planning, not replace it.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the software, the ground truth for validation is implied to be against "defined requirements" and "user needs," which likely translates to the accuracy of planned measurements or component placements compared to a reference standard (e.g., expert-defined ideal parameters, possibly based on anatomical landmarks from CT images). However, the specific type of ground truth (e.g., expert consensus on optimal placement on a gold standard model) is not explicitly stated as pathology or outcomes data.
- For the hardware, "simulated surgeries using rapid prototyped bone models and previous cadaver testing" would involve assessing the accuracy of guide placement and the resulting pin positioning relative to the pre-surgical plan. The "ground truth" here would thus be defined by the pre-surgical plan itself and the anatomical accuracy of the physical model/cadaver.
8. The sample size for the training set:
- The document is a 510(k) summary for a substantial equivalence claim, primarily for extending compatibility. It describes software "design and verification and validation," implying a traditional software development lifecycle. It does not mention a training set in the context of machine learning or AI models, as this is not presented as an AI-driven device with a learning component.
9. How the ground truth for the training set was established:
- As no training set for a machine learning model is mentioned, 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.”