Search Results

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

1. significant disability in degenerative, rheumatic disease of the glenohumeral joint;
2. 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 Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. 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.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a multi-pegged design intended for cemented fixation only.

The provided text describes a 510(k) premarket notification for a medical device, the Shoulder Innovations Total Shoulder System, and specifically a line extension to add "Augmented Glenoids." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document relies on non-clinical testing and comparison to predicate devices to demonstrate substantial equivalence, not a clinical study with detailed performance metrics against predefined acceptance criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of a typical acceptance criteria table with performance results. The document explains that non-clinical testing was performed according to ASTM F2028-17 and cadaver testing, and these tests "demonstrated that the Augmented Glenoids are adequate for their intended use." However, specific numerical acceptance criteria and performance values are not reported.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for the non-clinical tests. For cadaver testing, a sample size is typically provided, but it's absent here.
• Data Provenance: The cadaver testing is generally considered prospective in its data collection for the specific purpose of the study. The location of testing or origin of cadavers is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the document describes non-clinical and cadaveric testing, not a study evaluating human interpretation or diagnosis where expert ground truth would be established.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3.

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

This is not applicable. The device is an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests (ASTM F2028-17 and cadaver testing), the "ground truth" would be the physical measurements and observations from the tests themselves, demonstrating mechanical properties or performance under simulated conditions. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a clinical study.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as #8.

Ask a specific question about this device

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
2. 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.

Ask a specific question about this device