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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 Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures the following:

• · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• · Rheumatoid arthritis.
• · Revision where other devices or treatments have failed.
• · Correction of functional deformity.
• · Fracture of the humeral head
• · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.

The Ignite Anatomic Shoulder System is total shoulder arthroplasty system consisting of humeral heads (38 - 57mm diameters), offset taper adapters (multiple offsets), stems (66-82mm lengths), and glenoid components (multiple sizes).

The anatomic humeral consists of a wrought Cobalt-Chromium Humeral Head, a wrought Ti-6Al-4V Taper Adapter, and an additively manufactured Ti-6Al-4V Stem.

The All-Poly Anatomic Glenoid consists of Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.

The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.

The provided FDA 510(k) document is for the Ignite Anatomic Shoulder System, a medical device. This document describes the device itself and its equivalence to previously cleared devices. It does not contain information about an AI/ML powered device or a study involving acceptance criteria for such a device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Ignite Anatomic Shoulder System to the predicate devices." This indicates that the regulatory clearance was based on non-clinical testing and comparison to predicate devices, not on a clinical study evaluating its performance against specific acceptance criteria in patient populations.

The "Non-Clinical Testing" section lists various mechanical and material-related tests (e.g., Range of Motion, Biocompatibility, Wear Testing, Fatigue Testing) conducted to demonstrate the device's substantial equivalence to predicate devices, but these are for the physical implant itself, not an AI/ML component.

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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, 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.

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