(133 days)
Smart SPACE Shoulder 3D Positioners and Anatomical Models
The Smart SPACE Shoulder 3D Positioners and Anatomical Models are intended to be used as surgical instruments for adult patients that are candidates for primary elective shoulder replacement surgery and they are intended to to transfer a pre-operative plan into surgery, designed on the basis of patient-specific pre-operative CT scans.
The Smart SPACE Shoulder 3D Positioners are intended, by quiding the surgical instruments in some steps of the orthopedic surgical procedure, to prepare the bone to host the implantable components.
The Smart SPACE Shoulder Anatomical Models are a 3D representation of the patient anatomical condition, as previously evaluated by the surgeon. The model is intended to be used to check that the 3D Positioner(s) is properly placed on the anatomical compartment.
These devices must be exclusively utilized by an orthopedic surgeon who has a good knowledge of the specific operative technique.
Smart SPACE Shoulder 3D Positioners and Anatomical Models are indicated for use on adult patients that are candidates for primary elective reverse and anatomic total shoulder arthroplasty.
Smart SPACE Shoulder Planner
Smart SPACE Shoulder Planner is a medical device for surgeons component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
Smart SPACE Shoulder Planner does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner is intended to be used by an orthopedic surgeon, with clinical experience in shoulder replacement surgery to make decisions regarding implant position, orientation and sizing.
Smart SPACE Shoulder Planner is intended to be used for adult patients planning only. The Smart SPACE Shoulder Planner is intended for use with patients that are candidates for primary reverse and anatomic total shoulder arthroplasty.
The specific functionalities of the Smart SPACE Shoulder Planner version are described in the User Manual and Quick Start Guide provided by LimaCorporate.
The Smart SPACE Shoulder Planner consists of a software which assists the user in planning anatomic total or reverse shoulder arthroplasty. It provides the user to select surgical execution using either a glenoid 3D positioner or Smart SPACE Shoulder Cubit Guidance.
The Smart SPACE Shoulder system was cleared by TechMah Medical via K202151, K202454. K191247, and it includes the Smart SPACE Shoulder Planner, the Cubit Guidance system, the 3D Humeral and Glenoid Positioners and the Anatomical models. TechMah Medical became part of Limacorporate S.p.A in 2021.
With this registration, LimaCorporate aims to:
- introduce an upgrade of the Smart SPACE Shoulder Planner; -
- introduce the Smart SPACE Shoulder 3D Positioners and Anatomical Models manufactured by LimaCorporate, that are provided non-sterile.
The provided document is a 510(k) summary for the Smart SPACE Shoulder Planner and 3D Positioners. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, a study that proves the device meets those criteria, or the methodology of such a study.
Specifically, the document states: "Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices." This indicates that a study demonstrating the device meets acceptance criteria was not performed as part of this 510(k) submission. The FDA clearance is based on the device being substantially equivalent to a previously cleared device (K202151), not on a new clinical study.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document does not define specific acceptance criteria for performance, nor does it report performance metrics from a study designed to meet such criteria. It states that "the Smart SPACE Shoulder Planner and 3D Positioners manufactured by LimaCorporate S.p.A. and the Smart SPACE Shoulder System (K202151) manufactured by TechMah Medical LLC have substantially equivalent principles of operation and performance characteristics, with the exception of minor differences that aims to improve the software speed and memory usage, improve the user experience and solve bugs." This is a general statement of equivalence, not a report of measured performance against specific criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided: No clinical or performance testing on a test set is described.
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)
- Cannot be provided: No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided: No test set or adjudication is described.
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
- Cannot be provided: No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided: No standalone performance study is described. The device is a "pre-surgical planner" and "surgical instruments" intended for use by an orthopedic surgeon.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided: No ground truth is described because no new clinical performance study was conducted.
8. The sample size for the training set
- Cannot be provided: The document does not mention the training of the AI or software, and therefore no training set size is provided. The device is an "upgrade" of an existing system, implying prior development, but details are not given here.
9. How the ground truth for the training set was established
- Cannot be provided: As no training set is described, neither is its ground truth establishment.
Based on the provided text, the key information regarding testing is:
- Non-clinical testing: "The Software Testing has been performed on Smart SPACE Shoulder Planner according to the requirements of ANSI AAMI IEC 62304:2006/A1:2015." This refers to software lifecycle processes and safety, not clinical performance.
- Clinical testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the subject devices to the predicate devices."
Therefore, the document does not contain the information required to populate the fields related to specific acceptance criteria and a study proving those criteria were met, as no such study was performed or deemed necessary for this 510(k) clearance due to the substantial equivalence pathway.
§ 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.”