(309 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;
- 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 component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
The Shoulder Innovations Humeral Short Stem consists of modular humeral stems and heads and articulates with the Shoulder Innovations glenoid component (K111596). The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.
The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.
This document describes the 510(k) premarket notification for the Humeral Short Stem System by Shoulder Innovations Inc. It is a submission for a shoulder prosthesis, not an AI/ML powered device, therefore, the requested information on acceptance criteria for an AI/ML powered device, specifically points related to AI/ML model performance, ground truth establishment, expert adjudication, and MRMC studies, is not applicable to this document.
However, I can provide information about the acceptance criteria and the study proving the device meets the acceptance criteria within the context of non-clinical testing for a medical device like this shoulder prosthesis, as described in the document.
Here's an analysis of the provided text, focusing on the available information regarding device testing and acceptance:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical performance testing. It doesn't present a table with specific acceptance criteria values and reported performance values for each criterion. Instead, it states that tests were performed "per ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses" and that "Fatigue testing was also performed on the humeral components."
The conclusion in the "Summary of Substantial Equivalence" states: "The results of non-clinical testing and comparative analysis demonstrate that the design, function, intended use, and indications for use of the Shoulder Innovations Humeral Short Stem System is substantially equivalent to the predicate device." This implies that the device met the acceptance criteria defined by the specified ASTM standard and fatigue testing, although the specific numerical results and thresholds are not disclosed in this summary document.
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes (number of devices or test articles) used for the ASTM F2009 or fatigue testing.
For data provenance, it's non-clinical (laboratory) testing of the physical device components, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is for a mechanical device; "ground truth" in the context of human interpretation or clinical outcomes is not relevant here. The ground truth for mechanical testing is established by the specified ASTM standard and general engineering principles for mechanical integrity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This refers to consensus among human readers for image interpretation or diagnosis, which is not relevant for mechanical testing.
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:
Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this mechanical device, the "ground truth" for performance is based on established engineering standards and specifications. The document mentions:
- ASTM F2009 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses: This standard defines how to conduct the test and likely sets performance benchmarks or provides a methodology for comparison.
- Fatigue testing: This evaluates the device's ability to withstand repeated stress cycles, with acceptance criteria typically based on material properties, design life, and industry standards for implant durability.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for a mechanical device.
Summary of Device Performance Study (Non-Clinical):
The document indicates that Shoulder Innovations Inc. performed non-clinical testing to demonstrate the substantial equivalence of their Humeral Short Stem System to a predicate device (Biomet Comprehensive® Primary Shoulder Stems, K060692).
Key Tests Conducted:
- Axial Disassembly Force of Taper Connections: Tested per ASTM F2009. This standard evaluates the strength of the connection between modular components, ensuring they do not inadvertently separate during use. The implicit "acceptance criteria" here would be meeting or exceeding the performance of the predicate device, or a specified minimum force, as per the standard's requirements for secure modular junctions.
- Fatigue Testing: Performed on the humeral components. This test assesses the device's durability under cyclic loading, simulating the stresses it would experience in the body over time. The "acceptance criteria" for fatigue testing would typically involve demonstrating that the device can withstand a specified number of cycles at a certain load without failure, often compared to the predicate device's known performance or established industry benchmarks for implant longevity.
The document states that "Clinical testing was not necessary to demonstrate substantial equivalence," relying entirely on the non-clinical tests and a detailed predicate device comparison (pages 4-5) across various features (distal stem diameters, lengths, geometry, collar, modular system, bone integration, neck angle, fixation, material, sterility for both stem and head components). This comparative analysis serves as a form of "proof" that the device meets implied acceptance criteria by being "substantially equivalent" to a legally marketed predicate device.
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”