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The Shoulder Innovations Total Shoulder System with Humeral Stemless is intended for use as an orthopedic implant for total shoulder arthroplasty to treat severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The Shoulder Innovations Total Shoulder System components are intended for single use only.

The Humeral Stemless components are indicated for press-fit, un-cemented use. The glenoid component is intended for cemented fixation only.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless, as the humeral head acts as the collar, and manufactured from Titanium Alloy (Ti-GAL-4V) conforming to ASTM F136 with fins to provide rotational stability and are coated with a rough, porous coating. The stems have a female 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 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) with a pegged design intended for cemented fixation.

This submission adds Humeral Stemless Implants to the Shoulder Innovations Total Shoulder System. The Humeral Stemless Implants are similar to the previously cleared humeral short stems (K173824), except that the Humeral Stemless Implants do not include the stem. The Humeral Stemless Implants have fins to provide rotational stability and a female Morse-type taper to interface with modular humeral heads, identical to the humeral short stems (K173824). The Humeral Stemless Implants are manufactured from Titanium Alloy (Ti-6Al-4V) conforming to ASTM F136 with a proximal porous coating of commercially pure titanium according to ASTM F67.

The Humeral Stemless Implants are for press-fit, uncemented use. All Humeral Stemless Implants are compatible with the previously cleared Total Shoulder System humeral heads (K173824) and previously cleared Total Shoulder System glenoid components (K111596 and K192365).

The provided text is a 510(k) premarket notification for a medical device (Shoulder Innovations Total Shoulder System with Humeral Stemless). It outlines the device description, indications for use, and a summary of non-clinical testing and substantial equivalence to predicate and reference devices.

Crucially, it clearly states that "Clinical testing was not necessary to demonstrate substantial equivalence" for this device. This implies that the device's acceptance was based on non-clinical testing and a comparison to already cleared devices, rather than a clinical study evaluating its performance against specific clinical acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as the document explicitly states no clinical study was performed for this specific submission to demonstrate substantial equivalence.

The provided text does not contain the information requested regarding acceptance criteria related to a clinical study proving device performance. There is no information about:

1. A table of acceptance criteria and reported device performance: No clinical performance metrics or predefined acceptance thresholds are mentioned.
2. Sample size used for the test set and data provenance: No clinical test set.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical ground truth was established from expert readings.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study was conducted.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: No clinical ground truth was used.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The document focuses on non-clinical testing (lever out, pull out, torque out, and fatigue testing) to demonstrate substantial equivalence based on mechanical properties and design similarity to predicate devices, rather than clinical efficacy or diagnostic performance.

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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.

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