(88 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'
- o GLOBAL® APG+ Shoulder System (K052472),
- o DELTA XTEND™ Reverse Shoulder System (K120174, K062250, K183077)
- o GLOBAL® STEPTECH® APG Shoulder System (K092122).
• DJO's
- o Reverse® Shoulder Prosthesis (K051075, K111629, K092873).
- o Turon® Shoulder System (K080402)
- o AltiVate™ Anatomic Shoulder System (K162024)
- · Integra's
o Titan™ Total Shoulder System (K100448, K112438, K142413, K152047)
· Stryker's
- o ReUnion RSA Reverse Shoulder System (K183039)
- o Reunion TSA Total Shoulder Arthroplasty System (K183039).
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 graft-space between implant and bone, based on the pre-operative planning of the surgeon. The graft serves as a visual reference for the surgeon in the OR.
The Materialise Shoulder Guide and Models must only be used within the intended use of the compatible components.
The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in a quantitative research sense. The document is a 510(k) premarket notification summary from the FDA, focusing on demonstrating substantial equivalence to a predicate device rather than presenting formal study results against predefined acceptance metrics.
However, based on the information provided, we can infer some "acceptance criteria" through the lens of substantial equivalence and list reported device performance related to this equivalence.
Here's an attempt to extract and frame the information according to your request, acknowledging the limitations of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria are not stated, we will infer them based on the substantial equivalence argument made by the manufacturer. The reported performance is based on the claim of similarity to the predicate device and the results of verification and validation activities mentioned.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (Based on Manufacturer's Claims) |
|---|---|
| Hardware Performance: | |
| Biocompatibility requirements met. | Previous testing for biocompatibility is applicable and demonstrates substantial equivalence. |
| Cleaning and debris requirements met. | Previous testing for cleaning and debris is applicable and demonstrates substantial equivalence. |
| Dimensional stability maintained. | Previous testing for dimensional stability is applicable and demonstrates substantial equivalence. |
| Packaging integrity maintained. | Previous testing for packaging is applicable and demonstrates substantial equivalence. |
| Accuracy and performance adequate for intended use (transferring pin positioning for glenoid components). | Testing verified that the accuracy and performance of the system is adequate to perform as intended. Stability of device placement and functional elements are the same as the predicate and previously cleared devices. Previously performed simulated surgeries with rapid prototyped bone models and cadaver testing on cleared devices (K153602, K131559) are considered applicable. |
| Software Performance (SurgiCase Shoulder Planner): | |
| Functionality (planning, visualization, editing, report generation) as intended. | The planning functionality, visualization options, and planning features are exactly the same as for the glenoid planning of the predicate device. The subject device has the same codebase and uses the same methods for design, verification, and validation as the predicate device. Software verification and validation were performed against defined requirements and user needs, following FDA guidance. The technological differences (humeral planning, range of motion, defect quantification, bone removal) have been demonstrated not to affect safety or effectiveness or raise new issues. |
| No new issues of safety or effectiveness compared to predicate. | The non-clinical performance testing indicates that the subject device is as safe, as effective, and performs as well as the predicate device. The technological differences in software have been demonstrated not to affect safety or effectiveness or raise new issues of safety or effectiveness compared to the predicate device. |
| Compliance with regulations and quality systems. | The Materialise Shoulder System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (13485) requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "previous simulated surgeries using rapid prototyped bone models and previous cadaver testing on previously cleared devices K153602 and K131559" which are considered applicable to the current device. However, no specific sample sizes (number of bone models or cadavers) for these tests are provided in this summary.
The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated. It can be inferred that these were laboratory-based tests conducted typically by the manufacturer or a third-party testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the context of the simulated surgeries or cadaver testing. The software validation involved "validation against user needs," implying input from intended users (surgeons), but the details are absent.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for evaluating the performance of the device in the context of the "simulated surgeries" or "cadaver testing."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The submission focuses on substantial equivalence based on technological similarity and prior testing, not on human reader performance improvement with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The software component, "SurgiCase Shoulder Planner," is a planning tool that assists a surgeon. It "allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data." This implies a continuous "human-in-the-loop" interaction for final plan approval. While software verification and validation were performed, the reported performance is within the context of assisting a surgeon, not as a standalone diagnostic or treatment decision-making algorithm. Therefore, a purely standalone (algorithm only without human-in-the-loop performance) study is not explicitly described or claimed. The software verification and validation would involve assessing the algorithm's output accuracy against its intended function (e.g., measurements, reconstructions), but this is not directly presented as "standalone performance" in the clinical decision-making sense.
7. The Type of Ground Truth Used
For the hardware (guidance system), the ground truth for "accuracy and performance" would likely be established through:
- Measurement against physical standards: For dimensional accuracy.
- Intraoperative positioning verification: During simulated surgeries or cadaver tests, assessing how well the guide facilitates the intended pin placement relative to anatomical landmarks. This would be a technical ground truth based on the precision of the physical guides.
For the software (SurgiCase Shoulder Planner), the ground truth for "validation against user needs" would likely involve:
- Expert Consensus/Clinical Expertise: Surgeons reviewing the generated plans, measurements, and reconstructions against their professional judgment and potentially 3D models or other imaging data to deem them clinically acceptable and accurate. This would involve expert consensus on the correctness of the planning outputs.
8. The Sample Size for the Training Set
The document describes premarket notification for a medical device cleared via substantial equivalence, not an AI/ML algorithm that undergoes explicit "training." While the software component has a "code base," it is described as using "exactly the same methods for design and verification and validation as the predicate device" rather than being a deep learning model trained on a dataset. Therefore, the concept of a "training set" in the context of machine learning does not apply as described in this document.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" for a machine learning model is not applicable here, the question of how its ground truth was established is not relevant to this document. The software's "ground truth" (i.e., correctness of its functions and outputs) is established through traditional software verification and validation against defined requirements and user needs, as mentioned in point 7.
§ 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.”