(184 days)
Smart SPACE Shoulder 3D Positioner
Smart SPACE Shoulder System instrumentation consists of a patient-specific 3D positioner. It has been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Smart SPACE Shoulder Cubit Guidance
Smart SPACE Shoulder Cubit Guidance consists of a patient-specific 3D mapper, single use instrumentation, and an intraoperative guidance software. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Smart SPACE Shoulder Planner software
Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.
Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.
It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan.
The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.
The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software which assists the user in planning reverse and anatomic total shoulder arthroplasty. In addition, a choice of intraoperative execution of the surgical plan using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance. The Smart SPACE Shoulder System (subject device) is compatible with Lima Corporate shoulder replacement implants; Verification testing was conducted utilizing those systems.
The provided text describes the Smart SPACE Shoulder System, which includes software for pre-surgical planning and patient-specific instrumentation (3D positioner or Cubit Guidance) for intraoperative positioning of shoulder components. The device aims to assist in total anatomic or reverse shoulder arthroplasty procedures.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA document does not explicitly state quantitative acceptance criteria for device performance. Instead, it states that "Testing has successfully demonstrated that the subject device performs as well as the predicate device with respect to version, inclination, and entry point." This implies that the acceptance criteria were met if the subject device's performance was comparable to the predicate device in these key metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to predicate device regarding version | Subject device performs as well as the predicate device regarding version. |
| Performance comparable to predicate device regarding inclination | Subject device performs as well as the predicate device regarding inclination. |
| Performance comparable to predicate device regarding entry point | Subject device performs as well as the predicate device regarding entry point. |
| Materials used are biocompatible | Biocompatibility testing per ISO 10993-1:2018 was conducted and materials were found to be biocompatible. |
| Electrical safety of Cubit sensor meets standards | Electrical safety tested to IEC 60601-1:2012. |
| Electromagnetic compatibility of Cubit sensor meets standards | Electromagnetic compatibility tested to IEC 60601-1-2:2014. |
| Lithium Power Cell meets standards | Additional testing conducted on the Lithium Power Cell per IEC 62133-2. |
| Intentional Radiator meets standards | Intentional Radiator testing conducted per Title 47 of the CFR, Ch. 1. |
| Ingress Testing meets standards | Ingress Testing conducted per IEC 60529 Ed. 2.2(2013). |
| Software Verification and Validation performed as per guidelines | Conducted in accordance with ANSI AAMI IEC 62304:2006/A1:2015 and FDA guidance documents. |
| Usability validated per standards | Validated in accordance with IEC 62366-1:2015 and 60601-1-6:2013. |
| Sterilization effective and shelf-life validated | Sterilization, shelf life, and shipping validations performed according to ISO 11135:2014, ISO 10993-7:2008, and ISO 11137-1:2018. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The Smart SPACE Shoulder System was validated through non-clinical studies performed on cadaveric specimens." However, it does not specify the number of cadaveric specimens used as the test set.
- Sample Size: Not specified.
- Data Provenance: Non-clinical studies performed on cadaveric specimens. The country of origin is not mentioned, and due to the nature of cadaveric studies, it would be considered prospective data collection for the validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing the ground truth for the cadaveric studies.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth in the cadaveric studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This device focuses on a surgical planning software and patient-specific instrumentation, not on image interpretation by human "readers" in the traditional sense of an MRMC study for diagnostic imaging. While the software assists surgeons (human users), the document does not describe an MRMC comparative effectiveness study directly measuring the improvement of human surgical performance with AI assistance versus without AI assistance. It compares the device's output (implant placement accuracy) to a predicate device, but not human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The planning software component itself is "algorithm only" in the sense that it processes CT images to generate a surgical plan and 3D files. The "3D positioner" and "Cubit Guidance" are physical instruments derived from these plans. The statement "Post-operative implant placement was compared with the executed implant position captured by the Guidance System" suggests that the accuracy of the guidance system itself (which is algorithm-driven in its generation and subsequent validation through its use) was assessed in placing the implants in the cadaveric study. This implies a standalone performance evaluation of the system's ability to achieve planned implant positioning.
So, yes, a form of standalone performance was assessed through the cadaveric studies, focusing on the accuracy of the system's output (planned vs. executed implant placement).
7. The Type of Ground Truth Used
The ground truth for the cadaveric studies was established by comparing "Post-operative implant placement... with the executed implant position captured by the Guidance System." This suggests that the "true" or desired implant position was defined by the executed plan generated by the Smart SPACE Shoulder Planner software and then assessed against the actual placement in the cadaver. It's a form of system-defined ground truth related to the accuracy of implementing the surgical plan. This is not pathology, outcomes data, or expert consensus on a diagnostic image.
8. The Sample Size for the Training Set
The document does not provide any information about the training set size for the software component of the Smart SPACE Shoulder System.
9. How the Ground Truth for the Training Set Was Established
Since information regarding the training set is not provided, the method for establishing its ground truth is also not specified.
§ 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.”