(27 days)
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
- significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- united humeral head fractures of long duration: .
- . irreducible 3- and 4-part proximal humeral fractures:
- avascular necrosis of the humeral head. .
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid components are intended for cemented fixation only; the humeral stem mav be implanted by press-fit or cement fixation.
The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads, and a glenoid component. The humeral stems are manufactured from Cobalt Chrome (CoCr) and have fins to provide rotational stability. The fins have suture holes for the attachment of soft tissue and bone in the case of proximal humeral fracture. A collar is present to resist stem subsidence. The stems have a male Morse-type taper to interface with the modular humeral heads.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a female Morsetype taper to interface with the humeral stems.
The glenoid components are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implants are available in a multi-pegged and keeled design and are intended for cemented fixation only.
The provided document focuses on a 510(k) premarket notification for a modification to the Shoulder Innovations Total Shoulder System. It describes the device, its intended use, and the proposed modification (geometry of the articular surface of the glenoid component). The document explicitly states: "No clinical testing was performed." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.
Instead, the document refers to non-clinical performance testing to demonstrate equivalence to predicate devices, specifically for glenoid loosening, and an engineering study for minimum poly thickness and range of motion.
Here's the breakdown of what can be extracted based on the provided text, and where information is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or reported performance metrics for the non-clinical tests mentioned. It only states that "Performance testing was performed to evaluate glenoid loosening" and "An engineering study was performed to evaluate the minimum poly thickness and range of motion," and that these demonstrated substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "performance testing" and an "engineering study" but does not give sample sizes for these non-clinical tests.
- Data Provenance: Not applicable, as no clinical data or human-derived data is mentioned. The studies are described as "engineering studies" and "performance testing," typically implying laboratory or bench testing.
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)
Not applicable, as no clinical data or ground truth established by human experts is mentioned. The testing was non-clinical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical data or human expert adjudication is mentioned.
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 study was done. The device described is a physical orthopedic implant, not an AI or imaging device with human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical ground truth was established. The "ground truth" for the non-clinical tests would be the physical properties and performance measured in a laboratory setting against established engineering standards or benchmarks for glenoid loosening, poly thickness, and range of motion.
8. The sample size for the training set
Not applicable. No training set is mentioned as no AI/machine learning component is described.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 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.”