(84 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 AltiVate Anatomic Shoulder (K162024), 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 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.
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.
The Materialise Glenoid Positioning Guides must only be used within the intended use of the compatible components.
The provided text describes the 510(k) premarket notification for the Materialise Glenoid Positioning System. It claims substantial equivalence to a predicate device (K153602) and mentions performance data from previous testing. However, it does not contain the detailed acceptance criteria or the study that directly proves the device meets specific acceptance criteria in terms of quantitative performance metrics.
The text states: "Previous testing for biocompatibility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate squivalence with the predicate device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. The stability of the device placement, surgical technique, intended use and functional elements of the same as that of the predicate Materialise Glenoid Positioning System (K153602), and therefore previous cadaver testing on predicate device K153602 and previously cleared device K131559 (which is the predicate for K153602) is considered applicable to the subject device."
This indicates that some performance evaluation was done for the predicate devices, and that information is being leveraged for the current submission. However, the specific acceptance criteria (e.g., maximum allowable deviation, accuracy thresholds) and the results of a study against those criteria for the current device are not presented in this document.
Therefore, I cannot provide a complete answer to your request based solely on the provided text. I will, however, outline what information is available and explicitly state what is missing.
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The text states: "Testing verified that the accuracy and performance of the system is adequate to perform as intended." This is a qualitative statement, not a quantitative table of acceptance criteria and performance against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "previous cadaver testing on predicate device K153602 and previously cleared device K131559".
- Sample size: Not specified.
- Data provenance: Cadaver testing. Country of origin not specified.
- Retrospective/Prospective: Not specified, but cadaver testing is typically prospective for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
- MRMC study: Not mentioned. The device is a surgical instrument/guide, not typically an AI-driven image interpretation system that would involve "human readers" in the sense of diagnostic interpretation. It assists surgeons in positioning glenoid components based on preoperative planning.
- Effect size: Not applicable given the nature of the device and the lack of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a "patient specific guide that is based on a pre-surgical plan" and a "software component, branded as SurgiCase Planner. This software is a planning tool used to generate a pre-surgical plan for a specific patient." The "Materialise Glenoid Positioning System guides are patient specific templates which transfer the pre-operatively determined pin positioning to the patient intraoperatively, assisting the surgeon."
This indicates a human-in-the-loop process where a qualified surgeon inspects, fine-tunes, and approves the pre-surgical plan generated by the software. Therefore, a purely standalone algorithm-only performance as an output without human involvement is not the intended use model described. However, the accuracy of the output of the software (the surgical plan and subsequent guide design) would have been validated, which is essentially a standalone performance evaluation of the software component's mathematical and geometrical accuracy. The details of this validation are not in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the "cadaver testing" and the nature of the device (positioning guide), the ground truth for measuring accuracy would likely be physical measurements against an intended planned position or anatomical landmark, potentially established by expert surgeons or precise measurement tools. However, the specific method of establishing this ground truth is not detailed in the document.
8. The sample size for the training set
The document describes premarket notification for a medical device that includes "a software component" for planning and "a hardware component" (patient-specific guide). It mentions "previous cadaver testing" which sounds more like a validation/testing stage rather than training for a machine learning model. If the software component involves machine learning or AI, the training set details are not provided. The text focuses on the device being "substantially equivalent" to a predicate, implying that much of the foundational validation comes from the predicate's testing.
9. How the ground truth for the training set was established
As described in point 8, a "training set" in the context of machine learning is not explicitly mentioned, and thus how its ground truth was established is not provided. If the software uses algorithms that are not machine learning-based, then the concept of a training set as typically defined for AI may not apply. The emphasis is on the software generating a "pre-surgical plan" and its accuracy.
§ 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.”